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Biosimilar versions of Eylea® (aflibercept) and Xolair® (omalizumab) were listed on the Formulary as Limited Use Benefits with the August 2025 Formulary update and biosimilar version of Actemra® (tocilizumab) was listed as a Limited Use Benefit with the May 2025 Formulary update. In accordance with this New Start Rule, ODB program recipients who are treatment-naïve will only receive coverage for the biosimilar versions of these biologics, provided that they meet the applicable Limited Use criteria for the products. (ontario.ca, Updated November 21, 2025 ↗) ODB program recipients who are using Eylea®, Actemra®, or Xolair® during the transition period and require continued coverage of their product after the end of the transition period, must have their prescriber apply to the EAP for a medically necessary exemption. Requests for medically necessary exemptions are assessed on a case-by-case basis, and prescribers are encouraged to apply during the transition period to avoid an unintended gap in coverage. Requests for medically necessary exemptions must include documentation that the recipient has tried up to two biosimilar versions (where applicable) and experienced an adverse effect documented on the Health Canada side effect reporting form. A copy of each completed Health Canada reporting form must be included in the EAP request. Medically necessary exemptions will not be considered for ODB recipients subject to the New Start Rule. (ontario.ca, Updated November 21, 2025 ↗)

Reason for Use code 729 For the treatment of patients with neovascular (wet) age-related macular degeneration (AMD) in a treatment-naive eye. Initial diagnosis should be confirmed by an appropriate diagnostic procedure and administration should be done by a qualified ophthalmologist experienced in intravitreal injections. Patients receiving concurrent administration of other anti-VEGF intravitreal injections are not eligible for reimbursement. Treatment should be initiated with a monthly intravitreal injection for the first 3 consecutive doses, followed by one injection every 2 months. The interval between two doses should not be shorter than one month. Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy. Coverage will be provided for patients responding to therapy with another anti-VEGF agent who switch to this product. Coverage will NOT be provided for patients who have failed to respond to other anti-VEGF agents. Coverage limit: LU Authorization Period: 1 year Reason for Use code 730 For the treatment of patients with clinically significant macular edema secondary to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO). Patients receiving concurrent administration of other anti-VEGF intravitreal injections are not eligible for reimbursement. Treatment should be initiated with an intravitreal injection once every month. The interval between two doses should not be shorter than one month. The treatment interval may be extended up to 3 months based on visual and anatomic outcomes. Prescribers are advised to periodically assess the need for continued therapy. Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy. Coverage will be provided for patients responding to therapy with another anti-VEGF agent who switch to this product. Coverage will NOT be provided for patients who have failed to respond to other anti-VEGF agents. Coverage limit: LU Authorization Period: 1 year Reason for Use code 731 For the treatment of patients with clinically significant diabetic macular edema (DME) for whom laser photocoagulation is also indicated; and a hemoglobin A1c of less than 12 percent. Patients receiving concurrent administration of other anti-VEGF intravitreal injections are not eligible for reimbursement. Treatment should be initiated with a monthly intravitreal injection for the first 5 consecutive doses, followed by one injection every 2 months. The interval between two doses should not be shorter than one month. Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy. Coverage will be provided for patients responding to therapy with another anti-VEGF agent who switch to this product. Coverage will NOT be provided for patients who have failed to respond to other anti-VEGF agents. Coverage limit: LU Authorization Period: 1 year

Aflivu · DIN 02554178 Manufacturer: Apotex Inc.; listing date 2025-08-29 Health Canada: Marketed since 2025-07-02 · brand AFLIVU · ATC S01LA05 AFLIBERCEPT · form Solution · route Intravitreal · ingredients AFLIBERCEPT 2 MG/0.05ML · company Apotex inc · schedule Schedule d, Prescription

DIN 02554178: Aflivu Raw flags: sec12=Y, sec3=Y Item: 523600155; group id 609; item number 1570; lccId 00416; manufacturer id APX Source form: Inj Sol-0.05mL Pref Syr (Preservative-Free); strength: 2mg/0.05mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $850.8000; ministry $850.8000 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02554178 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=104305

Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02554178

Shortage record checked 2026-09-13T08:10:21.292534+00:00

Biosimilar versions of Eylea® (aflibercept) and Xolair® (omalizumab) were listed on the Formulary as Limited Use Benefits with the August 2025 Formulary update and biosimilar version of Actemra® (tocilizumab) was listed as a Limited Use Benefit with the May 2025 Formulary update. In accordance with this New Start Rule, ODB program recipients who are treatment-naïve will only receive coverage for the biosimilar versions of these biologics, provided that they meet the applicable Limited Use criteria for the products. (ontario.ca, Updated November 21, 2025 ↗) ODB program recipients who are using Eylea®, Actemra®, or Xolair® during the transition period and require continued coverage of their product after the end of the transition period, must have their prescriber apply to the EAP for a medically necessary exemption. Requests for medically necessary exemptions are assessed on a case-by-case basis, and prescribers are encouraged to apply during the transition period to avoid an unintended gap in coverage. Requests for medically necessary exemptions must include documentation that the recipient has tried up to two biosimilar versions (where applicable) and experienced an adverse effect documented on the Health Canada side effect reporting form. A copy of each completed Health Canada reporting form must be included in the EAP request. Medically necessary exemptions will not be considered for ODB recipients subject to the New Start Rule. (ontario.ca, Updated November 21, 2025 ↗)

Reason for Use code 729 For the treatment of patients with neovascular (wet) age-related macular degeneration (AMD) in a treatment-naive eye. Initial diagnosis should be confirmed by an appropriate diagnostic procedure and administration should be done by a qualified ophthalmologist experienced in intravitreal injections. Patients receiving concurrent administration of other anti-VEGF intravitreal injections are not eligible for reimbursement. Treatment should be initiated with a monthly intravitreal injection for the first 3 consecutive doses, followed by one injection every 2 months. The interval between two doses should not be shorter than one month. Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy. Coverage will be provided for patients responding to therapy with another anti-VEGF agent who switch to this product. Coverage will NOT be provided for patients who have failed to respond to other anti-VEGF agents. Coverage limit: LU Authorization Period: 1 year Reason for Use code 730 For the treatment of patients with clinically significant macular edema secondary to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO). Patients receiving concurrent administration of other anti-VEGF intravitreal injections are not eligible for reimbursement. Treatment should be initiated with an intravitreal injection once every month. The interval between two doses should not be shorter than one month. The treatment interval may be extended up to 3 months based on visual and anatomic outcomes. Prescribers are advised to periodically assess the need for continued therapy. Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy. Coverage will be provided for patients responding to therapy with another anti-VEGF agent who switch to this product. Coverage will NOT be provided for patients who have failed to respond to other anti-VEGF agents. Coverage limit: LU Authorization Period: 1 year Reason for Use code 731 For the treatment of patients with clinically significant diabetic macular edema (DME) for whom laser photocoagulation is also indicated; and a hemoglobin A1c of less than 12 percent. Patients receiving concurrent administration of other anti-VEGF intravitreal injections are not eligible for reimbursement. Treatment should be initiated with a monthly intravitreal injection for the first 5 consecutive doses, followed by one injection every 2 months. The interval between two doses should not be shorter than one month. Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy. Coverage will be provided for patients responding to therapy with another anti-VEGF agent who switch to this product. Coverage will NOT be provided for patients who have failed to respond to other anti-VEGF agents. Coverage limit: LU Authorization Period: 1 year

Enzeevu · DIN 02562510 Manufacturer: Sandoz Canada Inc.; listing date 2026-01-30 Health Canada: Marketed since 2026-02-09 · brand ENZEEVU · ATC S01LA05 AFLIBERCEPT · form Solution · route Intravitreal · ingredients AFLIBERCEPT 2 MG/0.05ML · company Sandoz canada incorporated · schedule Prescription, Schedule d

DIN 02562510: Enzeevu Raw flags: sec12=Y, sec3=Y Item: 520000044; group id 574; item number 1527; lccId 00416; manufacturer id SDZ Source form: Inj Sol-0.05mL Pref Syr (Preservative-Free); strength: 2mg/0.05mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $850.8000; ministry $850.8000 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02562510 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=106539

Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02562510

Shortage record checked 2026-09-13T08:10:21.292534+00:00

Biosimilar versions of Eylea® (aflibercept) and Xolair® (omalizumab) were listed on the Formulary as Limited Use Benefits with the August 2025 Formulary update and biosimilar version of Actemra® (tocilizumab) was listed as a Limited Use Benefit with the May 2025 Formulary update. In accordance with this New Start Rule, ODB program recipients who are treatment-naïve will only receive coverage for the biosimilar versions of these biologics, provided that they meet the applicable Limited Use criteria for the products. (ontario.ca, Updated November 21, 2025 ↗) ODB program recipients who are using Eylea®, Actemra®, or Xolair® during the transition period and require continued coverage of their product after the end of the transition period, must have their prescriber apply to the EAP for a medically necessary exemption. Requests for medically necessary exemptions are assessed on a case-by-case basis, and prescribers are encouraged to apply during the transition period to avoid an unintended gap in coverage. Requests for medically necessary exemptions must include documentation that the recipient has tried up to two biosimilar versions (where applicable) and experienced an adverse effect documented on the Health Canada side effect reporting form. A copy of each completed Health Canada reporting form must be included in the EAP request. Medically necessary exemptions will not be considered for ODB recipients subject to the New Start Rule. (ontario.ca, Updated November 21, 2025 ↗)

Reason for Use code 729 For the treatment of patients with neovascular (wet) age-related macular degeneration (AMD) in a treatment-naive eye. Initial diagnosis should be confirmed by an appropriate diagnostic procedure and administration should be done by a qualified ophthalmologist experienced in intravitreal injections. Patients receiving concurrent administration of other anti-VEGF intravitreal injections are not eligible for reimbursement. Treatment should be initiated with a monthly intravitreal injection for the first 3 consecutive doses, followed by one injection every 2 months. The interval between two doses should not be shorter than one month. Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy. Coverage will be provided for patients responding to therapy with another anti-VEGF agent who switch to this product. Coverage will NOT be provided for patients who have failed to respond to other anti-VEGF agents. Coverage limit: LU Authorization Period: 1 year Reason for Use code 730 For the treatment of patients with clinically significant macular edema secondary to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO). Patients receiving concurrent administration of other anti-VEGF intravitreal injections are not eligible for reimbursement. Treatment should be initiated with an intravitreal injection once every month. The interval between two doses should not be shorter than one month. The treatment interval may be extended up to 3 months based on visual and anatomic outcomes. Prescribers are advised to periodically assess the need for continued therapy. Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy. Coverage will be provided for patients responding to therapy with another anti-VEGF agent who switch to this product. Coverage will NOT be provided for patients who have failed to respond to other anti-VEGF agents. Coverage limit: LU Authorization Period: 1 year Reason for Use code 731 For the treatment of patients with clinically significant diabetic macular edema (DME) for whom laser photocoagulation is also indicated; and a hemoglobin A1c of less than 12 percent. Patients receiving concurrent administration of other anti-VEGF intravitreal injections are not eligible for reimbursement. Treatment should be initiated with a monthly intravitreal injection for the first 5 consecutive doses, followed by one injection every 2 months. The interval between two doses should not be shorter than one month. Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy. Coverage will be provided for patients responding to therapy with another anti-VEGF agent who switch to this product. Coverage will NOT be provided for patients who have failed to respond to other anti-VEGF agents. Coverage limit: LU Authorization Period: 1 year

Eydenzelt · DIN 02563045 Manufacturer: Celltrion Inc.; listing date 2026-01-30 Health Canada: Marketed since 2026-08-11 · brand EYDENZELT · ATC S01LA05 AFLIBERCEPT · form Solution · route Intravitreal · ingredients AFLIBERCEPT 2 MG/0.05ML · company Celltrion inc. · schedule Prescription, Schedule d

DIN 02563045: Eydenzelt Raw flags: sec12=Y, sec3=Y Item: 520000042; group id 574; item number 1526; lccId 00416; manufacturer id CEI Source form: Inj Sol-0.05mL Pref Syr (Preservative-Free); strength: 2mg/0.05mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $850.8000; ministry $850.8000 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02563045 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=106587

Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02563045

Shortage record checked 2026-09-13T08:10:21.292534+00:00

Biosimilar versions of Eylea® (aflibercept) and Xolair® (omalizumab) were listed on the Formulary as Limited Use Benefits with the August 2025 Formulary update and biosimilar version of Actemra® (tocilizumab) was listed as a Limited Use Benefit with the May 2025 Formulary update. In accordance with this New Start Rule, ODB program recipients who are treatment-naïve will only receive coverage for the biosimilar versions of these biologics, provided that they meet the applicable Limited Use criteria for the products. (ontario.ca, Updated November 21, 2025 ↗) ODB program recipients who are using Eylea®, Actemra®, or Xolair® during the transition period and require continued coverage of their product after the end of the transition period, must have their prescriber apply to the EAP for a medically necessary exemption. Requests for medically necessary exemptions are assessed on a case-by-case basis, and prescribers are encouraged to apply during the transition period to avoid an unintended gap in coverage. Requests for medically necessary exemptions must include documentation that the recipient has tried up to two biosimilar versions (where applicable) and experienced an adverse effect documented on the Health Canada side effect reporting form. A copy of each completed Health Canada reporting form must be included in the EAP request. Medically necessary exemptions will not be considered for ODB recipients subject to the New Start Rule. (ontario.ca, Updated November 21, 2025 ↗)

Reason for Use code 729 For the treatment of patients with neovascular (wet) age-related macular degeneration (AMD) in a treatment-naive eye. Initial diagnosis should be confirmed by an appropriate diagnostic procedure and administration should be done by a qualified ophthalmologist experienced in intravitreal injections. Patients receiving concurrent administration of other anti-VEGF intravitreal injections are not eligible for reimbursement. Treatment should be initiated with a monthly intravitreal injection for the first 3 consecutive doses, followed by one injection every 2 months. The interval between two doses should not be shorter than one month. Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy. Coverage will be provided for patients responding to therapy with another anti-VEGF agent who switch to this product. Coverage will NOT be provided for patients who have failed to respond to other anti-VEGF agents. Coverage limit: LU Authorization Period: 1 year Reason for Use code 730 For the treatment of patients with clinically significant macular edema secondary to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO). Patients receiving concurrent administration of other anti-VEGF intravitreal injections are not eligible for reimbursement. Treatment should be initiated with an intravitreal injection once every month. The interval between two doses should not be shorter than one month. The treatment interval may be extended up to 3 months based on visual and anatomic outcomes. Prescribers are advised to periodically assess the need for continued therapy. Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy. Coverage will be provided for patients responding to therapy with another anti-VEGF agent who switch to this product. Coverage will NOT be provided for patients who have failed to respond to other anti-VEGF agents. Coverage limit: LU Authorization Period: 1 year Reason for Use code 731 For the treatment of patients with clinically significant diabetic macular edema (DME) for whom laser photocoagulation is also indicated; and a hemoglobin A1c of less than 12 percent. Patients receiving concurrent administration of other anti-VEGF intravitreal injections are not eligible for reimbursement. Treatment should be initiated with a monthly intravitreal injection for the first 5 consecutive doses, followed by one injection every 2 months. The interval between two doses should not be shorter than one month. Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy. Coverage will be provided for patients responding to therapy with another anti-VEGF agent who switch to this product. Coverage will NOT be provided for patients who have failed to respond to other anti-VEGF agents. Coverage limit: LU Authorization Period: 1 year

Yesafili · DIN 02558238 Manufacturer: Biosimilar Collaborations Ireland Limited; listing date 2025-08-29 Health Canada: Marketed since 2026-05-22 · brand YESAFILI · ATC S01LA05 AFLIBERCEPT · form Solution · route Intravitreal · ingredients AFLIBERCEPT 2 MG/0.05ML · company Biocon biologics canada inc · schedule Prescription, Schedule d

DIN 02558238: Yesafili Raw flags: sec12=Y, sec3=Y Item: 523600157; group id 609; item number 1571; lccId 00416; manufacturer id BCL Source form: Inj Sol-0.05mL Pref Syr (Preservative-Free); strength: 2mg/0.05mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $850.8000; ministry $850.8000 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02558238 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=106151

Shortage status: resolved shortage (ended 2026-03-16); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02558238

Shortage record checked 2026-09-13T08:10:21.292534+00:00

Biosimilar versions of Eylea® (aflibercept) and Xolair® (omalizumab) were listed on the Formulary as Limited Use Benefits with the August 2025 Formulary update and biosimilar version of Actemra® (tocilizumab) was listed as a Limited Use Benefit with the May 2025 Formulary update. In accordance with this New Start Rule, ODB program recipients who are treatment-naïve will only receive coverage for the biosimilar versions of these biologics, provided that they meet the applicable Limited Use criteria for the products. (ontario.ca, Updated November 21, 2025 ↗) ODB program recipients who are using Eylea®, Actemra®, or Xolair® during the transition period and require continued coverage of their product after the end of the transition period, must have their prescriber apply to the EAP for a medically necessary exemption. Requests for medically necessary exemptions are assessed on a case-by-case basis, and prescribers are encouraged to apply during the transition period to avoid an unintended gap in coverage. Requests for medically necessary exemptions must include documentation that the recipient has tried up to two biosimilar versions (where applicable) and experienced an adverse effect documented on the Health Canada side effect reporting form. A copy of each completed Health Canada reporting form must be included in the EAP request. Medically necessary exemptions will not be considered for ODB recipients subject to the New Start Rule. (ontario.ca, Updated November 21, 2025 ↗)

Reason for Use code 729 For the treatment of patients with neovascular (wet) age-related macular degeneration (AMD) in a treatment-naive eye. Initial diagnosis should be confirmed by an appropriate diagnostic procedure and administration should be done by a qualified ophthalmologist experienced in intravitreal injections. Patients receiving concurrent administration of other anti-VEGF intravitreal injections are not eligible for reimbursement. Treatment should be initiated with a monthly intravitreal injection for the first 3 consecutive doses, followed by one injection every 2 months. The interval between two doses should not be shorter than one month. Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy. Coverage will be provided for patients responding to therapy with another anti-VEGF agent who switch to this product. Coverage will NOT be provided for patients who have failed to respond to other anti-VEGF agents. Coverage limit: LU Authorization Period: 1 year Reason for Use code 730 For the treatment of patients with clinically significant macular edema secondary to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO). Patients receiving concurrent administration of other anti-VEGF intravitreal injections are not eligible for reimbursement. Treatment should be initiated with an intravitreal injection once every month. The interval between two doses should not be shorter than one month. The treatment interval may be extended up to 3 months based on visual and anatomic outcomes. Prescribers are advised to periodically assess the need for continued therapy. Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy. Coverage will be provided for patients responding to therapy with another anti-VEGF agent who switch to this product. Coverage will NOT be provided for patients who have failed to respond to other anti-VEGF agents. Coverage limit: LU Authorization Period: 1 year Reason for Use code 731 For the treatment of patients with clinically significant diabetic macular edema (DME) for whom laser photocoagulation is also indicated; and a hemoglobin A1c of less than 12 percent. Patients receiving concurrent administration of other anti-VEGF intravitreal injections are not eligible for reimbursement. Treatment should be initiated with a monthly intravitreal injection for the first 5 consecutive doses, followed by one injection every 2 months. The interval between two doses should not be shorter than one month. Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy. Coverage will be provided for patients responding to therapy with another anti-VEGF agent who switch to this product. Coverage will NOT be provided for patients who have failed to respond to other anti-VEGF agents. Coverage limit: LU Authorization Period: 1 year

Eydenzelt · DIN 02563037 Manufacturer: Celltrion Inc.; listing date 2026-01-30 Health Canada: Marketed since 2026-03-02 · brand EYDENZELT · ATC S01LA05 AFLIBERCEPT · form Solution · route Intravitreal · ingredients AFLIBERCEPT 2 MG/0.05ML · company Celltrion inc. · schedule Schedule d, Prescription

DIN 02563037: Eydenzelt Raw flags: sec12=Y, sec3=Y Item: 520000043; group id 574; item number 1528; lccId 00416; manufacturer id CEI Source form: Inj Sol-0.05mL Vial Pk (Preservative-Free); strength: 2mg/0.05mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $850.8000; ministry $850.8000 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02563037 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=106586

Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02563037

Shortage record checked 2026-09-13T08:10:21.292534+00:00

Biosimilar versions of Eylea® (aflibercept) and Xolair® (omalizumab) were listed on the Formulary as Limited Use Benefits with the August 2025 Formulary update and biosimilar version of Actemra® (tocilizumab) was listed as a Limited Use Benefit with the May 2025 Formulary update. In accordance with this New Start Rule, ODB program recipients who are treatment-naïve will only receive coverage for the biosimilar versions of these biologics, provided that they meet the applicable Limited Use criteria for the products. (ontario.ca, Updated November 21, 2025 ↗) ODB program recipients who are using Eylea®, Actemra®, or Xolair® during the transition period and require continued coverage of their product after the end of the transition period, must have their prescriber apply to the EAP for a medically necessary exemption. Requests for medically necessary exemptions are assessed on a case-by-case basis, and prescribers are encouraged to apply during the transition period to avoid an unintended gap in coverage. Requests for medically necessary exemptions must include documentation that the recipient has tried up to two biosimilar versions (where applicable) and experienced an adverse effect documented on the Health Canada side effect reporting form. A copy of each completed Health Canada reporting form must be included in the EAP request. Medically necessary exemptions will not be considered for ODB recipients subject to the New Start Rule. (ontario.ca, Updated November 21, 2025 ↗)

Reason for Use code 729 For the treatment of patients with neovascular (wet) age-related macular degeneration (AMD) in a treatment-naive eye. Initial diagnosis should be confirmed by an appropriate diagnostic procedure and administration should be done by a qualified ophthalmologist experienced in intravitreal injections. Patients receiving concurrent administration of other anti-VEGF intravitreal injections are not eligible for reimbursement. Treatment should be initiated with a monthly intravitreal injection for the first 3 consecutive doses, followed by one injection every 2 months. The interval between two doses should not be shorter than one month. Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy. Coverage will be provided for patients responding to therapy with another anti-VEGF agent who switch to this product. Coverage will NOT be provided for patients who have failed to respond to other anti-VEGF agents. Coverage limit: LU Authorization Period: 1 year Reason for Use code 730 For the treatment of patients with clinically significant macular edema secondary to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO). Patients receiving concurrent administration of other anti-VEGF intravitreal injections are not eligible for reimbursement. Treatment should be initiated with an intravitreal injection once every month. The interval between two doses should not be shorter than one month. The treatment interval may be extended up to 3 months based on visual and anatomic outcomes. Prescribers are advised to periodically assess the need for continued therapy. Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy. Coverage will be provided for patients responding to therapy with another anti-VEGF agent who switch to this product. Coverage will NOT be provided for patients who have failed to respond to other anti-VEGF agents. Coverage limit: LU Authorization Period: 1 year Reason for Use code 731 For the treatment of patients with clinically significant diabetic macular edema (DME) for whom laser photocoagulation is also indicated; and a hemoglobin A1c of less than 12 percent. Patients receiving concurrent administration of other anti-VEGF intravitreal injections are not eligible for reimbursement. Treatment should be initiated with a monthly intravitreal injection for the first 5 consecutive doses, followed by one injection every 2 months. The interval between two doses should not be shorter than one month. Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy. Coverage will be provided for patients responding to therapy with another anti-VEGF agent who switch to this product. Coverage will NOT be provided for patients who have failed to respond to other anti-VEGF agents. Coverage limit: LU Authorization Period: 1 year

Aflivu · DIN 02554194 Manufacturer: Apotex Inc.; listing date 2025-08-29 Health Canada: Marketed since 2025-07-02 · brand AFLIVU · ATC S01LA05 AFLIBERCEPT · form Solution · route Intravitreal · ingredients AFLIBERCEPT 2 MG/0.05ML · company Apotex inc · schedule Schedule d, Prescription

DIN 02554194: Aflivu Raw flags: sec12=Y, sec3=Y Item: 523600156; group id 611; item number 1574; lccId 00416; manufacturer id APX Source form: Sol for Intravitreal Inj-0.05mL Vial Pk; strength: 2mg/0.05mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $850.8000; ministry $850.8000 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02554194 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=104306

Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02554194

Shortage record checked 2026-09-13T08:10:21.292534+00:00

Biosimilar versions of Eylea® (aflibercept) and Xolair® (omalizumab) were listed on the Formulary as Limited Use Benefits with the August 2025 Formulary update and biosimilar version of Actemra® (tocilizumab) was listed as a Limited Use Benefit with the May 2025 Formulary update. In accordance with this New Start Rule, ODB program recipients who are treatment-naïve will only receive coverage for the biosimilar versions of these biologics, provided that they meet the applicable Limited Use criteria for the products. (ontario.ca, Updated November 21, 2025 ↗) ODB program recipients who are using Eylea®, Actemra®, or Xolair® during the transition period and require continued coverage of their product after the end of the transition period, must have their prescriber apply to the EAP for a medically necessary exemption. Requests for medically necessary exemptions are assessed on a case-by-case basis, and prescribers are encouraged to apply during the transition period to avoid an unintended gap in coverage. Requests for medically necessary exemptions must include documentation that the recipient has tried up to two biosimilar versions (where applicable) and experienced an adverse effect documented on the Health Canada side effect reporting form. A copy of each completed Health Canada reporting form must be included in the EAP request. Medically necessary exemptions will not be considered for ODB recipients subject to the New Start Rule. (ontario.ca, Updated November 21, 2025 ↗)

Reason for Use code 729 For the treatment of patients with neovascular (wet) age-related macular degeneration (AMD) in a treatment-naive eye. Initial diagnosis should be confirmed by an appropriate diagnostic procedure and administration should be done by a qualified ophthalmologist experienced in intravitreal injections. Patients receiving concurrent administration of other anti-VEGF intravitreal injections are not eligible for reimbursement. Treatment should be initiated with a monthly intravitreal injection for the first 3 consecutive doses, followed by one injection every 2 months. The interval between two doses should not be shorter than one month. Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy. Coverage will be provided for patients responding to therapy with another anti-VEGF agent who switch to this product. Coverage will NOT be provided for patients who have failed to respond to other anti-VEGF agents. Coverage limit: LU Authorization Period: 1 year Reason for Use code 730 For the treatment of patients with clinically significant macular edema secondary to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO). Patients receiving concurrent administration of other anti-VEGF intravitreal injections are not eligible for reimbursement. Treatment should be initiated with an intravitreal injection once every month. The interval between two doses should not be shorter than one month. The treatment interval may be extended up to 3 months based on visual and anatomic outcomes. Prescribers are advised to periodically assess the need for continued therapy. Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy. Coverage will be provided for patients responding to therapy with another anti-VEGF agent who switch to this product. Coverage will NOT be provided for patients who have failed to respond to other anti-VEGF agents. Coverage limit: LU Authorization Period: 1 year Reason for Use code 731 For the treatment of patients with clinically significant diabetic macular edema (DME) for whom laser photocoagulation is also indicated; and a hemoglobin A1c of less than 12 percent. Patients receiving concurrent administration of other anti-VEGF intravitreal injections are not eligible for reimbursement. Treatment should be initiated with a monthly intravitreal injection for the first 5 consecutive doses, followed by one injection every 2 months. The interval between two doses should not be shorter than one month. Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy. Coverage will be provided for patients responding to therapy with another anti-VEGF agent who switch to this product. Coverage will NOT be provided for patients who have failed to respond to other anti-VEGF agents. Coverage limit: LU Authorization Period: 1 year

Yesafili · DIN 02535858 Manufacturer: Biosimilar Collaborations Ireland Limited; listing date 2025-08-29 Health Canada: Marketed since 2026-05-22 · brand YESAFILI · ATC S01LA05 AFLIBERCEPT · form Solution · route Intravitreal · ingredients AFLIBERCEPT 2 MG/0.05ML · company Biocon biologics canada inc · schedule Prescription, Schedule d

DIN 02535858: Yesafili Raw flags: sec12=Y, sec3=Y Item: 523600158; group id 611; item number 1575; lccId 00416; manufacturer id BCL Source form: Sol for Intravitreal Inj-0.05mL Vial Pk; strength: 2mg/0.05mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $850.8000; ministry $850.8000 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02535858 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=102467

Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02535858

Shortage record checked 2026-09-13T08:10:21.292534+00:00

Biosimilar versions of Eylea® (aflibercept) and Xolair® (omalizumab) were listed on the Formulary as Limited Use Benefits with the August 2025 Formulary update and biosimilar version of Actemra® (tocilizumab) was listed as a Limited Use Benefit with the May 2025 Formulary update. In accordance with this New Start Rule, ODB program recipients who are treatment-naïve will only receive coverage for the biosimilar versions of these biologics, provided that they meet the applicable Limited Use criteria for the products. (ontario.ca, Updated November 21, 2025 ↗) ODB program recipients who are using Eylea®, Actemra®, or Xolair® during the transition period and require continued coverage of their product after the end of the transition period, must have their prescriber apply to the EAP for a medically necessary exemption. Requests for medically necessary exemptions are assessed on a case-by-case basis, and prescribers are encouraged to apply during the transition period to avoid an unintended gap in coverage. Requests for medically necessary exemptions must include documentation that the recipient has tried up to two biosimilar versions (where applicable) and experienced an adverse effect documented on the Health Canada side effect reporting form. A copy of each completed Health Canada reporting form must be included in the EAP request. Medically necessary exemptions will not be considered for ODB recipients subject to the New Start Rule. (ontario.ca, Updated November 21, 2025 ↗)

Reason for Use code 694 For the treatment of patients with neovascular (wet) age-related macular degeneration (AMD) in a treatment-naive eye. Initial diagnosis should be confirmed by an appropriate diagnostic procedure and administration should be done by a qualified ophthalmologist experienced in intravitreal injections. Patients receiving concurrent administration of other anti-VEGF intravitreal injections are not eligible for reimbursement. Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy. Coverage will be provided for patients responding to therapy with another anti-VEGF agent who switch to Eylea HD. Coverage will not be provided for patients who have failed to respond to other anti-VEGF agents. Recommended Dose: Treatment should be initiated with a monthly intravitreal injection for the first 3 consecutive doses, followed by one injection every 8 to 16 weeks. Coverage limit: LU Authorization Period: 1 year Reason for Use code 695 For the treatment of patients with clinically significant diabetic macular edema (DME) for whom laser photocoagulation is also indicated; and a hemoglobin A1c of less than 12 percent. Patients receiving concurrent administration of other anti-VEGF intravitreal injections are not eligible for reimbursement. Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy. Coverage will be provided for patients responding to therapy with another anti-VEGF agent who switch to Eylea HD. Coverage will not be provided for patients who have failed to respond to other anti-VEGF agents. Recommended Dose: Treatment should be initiated with a monthly intravitreal injection for the first 3 consecutive doses, followed by one injection every 8 to 16 weeks. Coverage limit: LU Authorization Period: 1 year

Eylea HD · DIN 02554798 Manufacturer: Bayer Inc., Health Care Division; listing date 2025-07-31 Health Canada: Marketed since 2025-04-07 · brand EYLEA HD · ATC S01LA05 AFLIBERCEPT · form Solution · route Intravitreal · ingredients AFLIBERCEPT 8 MG/0.07ML · company Bayer inc · schedule Schedule d, Prescription

DIN 02554798: Eylea HD Raw flags: sec12=Y, sec3=Y Item: 523600154; group id 610; item number 1572; lccId 00404; manufacturer id BAH Source form: Inj Sol-0.07mL Pref Syr; strength: 8mg/0.07mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $1250.0000; ministry $1250.0000 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02554798 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=104362

Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02554798

Shortage record checked 2026-09-13T08:10:21.292534+00:00

Biosimilar versions of Eylea® (aflibercept) and Xolair® (omalizumab) were listed on the Formulary as Limited Use Benefits with the August 2025 Formulary update and biosimilar version of Actemra® (tocilizumab) was listed as a Limited Use Benefit with the May 2025 Formulary update. In accordance with this New Start Rule, ODB program recipients who are treatment-naïve will only receive coverage for the biosimilar versions of these biologics, provided that they meet the applicable Limited Use criteria for the products. (ontario.ca, Updated November 21, 2025 ↗) ODB program recipients who are using Eylea®, Actemra®, or Xolair® during the transition period and require continued coverage of their product after the end of the transition period, must have their prescriber apply to the EAP for a medically necessary exemption. Requests for medically necessary exemptions are assessed on a case-by-case basis, and prescribers are encouraged to apply during the transition period to avoid an unintended gap in coverage. Requests for medically necessary exemptions must include documentation that the recipient has tried up to two biosimilar versions (where applicable) and experienced an adverse effect documented on the Health Canada side effect reporting form. A copy of each completed Health Canada reporting form must be included in the EAP request. Medically necessary exemptions will not be considered for ODB recipients subject to the New Start Rule. (ontario.ca, Updated November 21, 2025 ↗)

Reason for Use code 694 For the treatment of patients with neovascular (wet) age-related macular degeneration (AMD) in a treatment-naive eye. Initial diagnosis should be confirmed by an appropriate diagnostic procedure and administration should be done by a qualified ophthalmologist experienced in intravitreal injections. Patients receiving concurrent administration of other anti-VEGF intravitreal injections are not eligible for reimbursement. Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy. Coverage will be provided for patients responding to therapy with another anti-VEGF agent who switch to Eylea HD. Coverage will not be provided for patients who have failed to respond to other anti-VEGF agents. Recommended Dose: Treatment should be initiated with a monthly intravitreal injection for the first 3 consecutive doses, followed by one injection every 8 to 16 weeks. Coverage limit: LU Authorization Period: 1 year Reason for Use code 695 For the treatment of patients with clinically significant diabetic macular edema (DME) for whom laser photocoagulation is also indicated; and a hemoglobin A1c of less than 12 percent. Patients receiving concurrent administration of other anti-VEGF intravitreal injections are not eligible for reimbursement. Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy. Coverage will be provided for patients responding to therapy with another anti-VEGF agent who switch to Eylea HD. Coverage will not be provided for patients who have failed to respond to other anti-VEGF agents. Recommended Dose: Treatment should be initiated with a monthly intravitreal injection for the first 3 consecutive doses, followed by one injection every 8 to 16 weeks. Coverage limit: LU Authorization Period: 1 year

Eylea HD · DIN 02545004 Manufacturer: Bayer Inc., Health Care Division; listing date 2024-12-30 Health Canada: Marketed since 2024-09-03 · brand EYLEA HD · ATC S01LA05 AFLIBERCEPT · form Solution · route Intravitreal · ingredients AFLIBERCEPT 8 MG/0.07ML · company Bayer inc · schedule Schedule d, Prescription

DIN 02545004: Eylea HD Raw flags: sec12=Y, sec3=Y Item: 523600153; group id 610; item number 1573; lccId 00404; manufacturer id BAH Source form: Inj Sol-0.07mL Vial Pk; strength: 8mg/0.07mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $1250.0000; ministry $1250.0000 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02545004 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=103362

Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02545004

Shortage record checked 2026-09-13T08:10:21.292534+00:00