Teva Canada and Samsung Bioepis have entered a licensing and commercialization agreement for OPUVIZ® (aflibercept), a biosimilar to EYLEA®, following Health Canada’s approval in October 2025. The partnership expands access to anti‑VEGF therapies for retinal diseases in Canada
Written By: Nalam Karthik, PharmD
Reviewed By: Pharmacally Editorial Team
Teva Pharmaceutical Industries and Samsung Bioepis have entered into a licensing and commercialization agreement for OPUVIZ® (aflibercept), a biosimilar referencing EYLEA® (aflibercept), in Canada. The agreement follows Health Canada’s approval of OPUVIZ in October 2025 and supports the companies’ efforts to expand access to biosimilar therapies for retinal diseases in the Canadian market.
Under the terms of the agreement, Samsung Bioepis will oversee regulatory registration and manufacturing of OPUVIZ, while Teva Canada, a subsidiary of Teva Pharmaceutical Industries Ltd., will lead commercialization activities. Financial terms of the partnership were not disclosed.
Expanding Access to an Ophthalmic Biosimilar
OPUVIZ is approved in Canada for multiple retinal conditions treated with anti-vascular endothelial growth factor (anti-VEGF) therapy. The biosimilar is indicated for neovascular (wet) age-related macular degeneration (AMD), visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO), diabetic macular edema (DME), and myopic choroidal neovascularization (mCNV).
Aflibercept is a recombinant fusion protein that binds vascular endothelial growth factor (VEGF), reducing abnormal blood vessel growth and vascular leakage in the retina. Anti-VEGF therapies have become the standard of care for several sight-threatening retinal diseases, although their high treatment costs have accelerated interest in biosimilars that can improve affordability and patient access.
Samsung Bioepis’ aflibercept biosimilar is already marketed in Europe and the Republic of Korea, providing the company with commercial experience before its Canadian launch.
Strategic Expansion of Biosimilars Portfolio
Fabien Paquette, General Manager of Teva Canada, said the agreement strengthens the company’s biosimilars portfolio while expanding its presence in ophthalmology. He noted that the collaboration reflects Teva Canada’s strategy of providing high-quality treatment options to patients and healthcare professionals through partnerships.
Kwang Ryu, Vice President and Team Leader of Business Development at Samsung Bioepis, said the agreement supports the company’s broader North American growth strategy and expands access to ophthalmic biologic medicines in Canada. He added that the collaboration with Teva is intended to improve patient access to high-quality treatment options while supporting sustainable healthcare delivery.
Commercial Launch Plans
The agreement builds on Samsung Bioepis’ growing global biosimilars portfolio and Teva’s strategy of expanding beyond traditional generic medicines into specialty products and biosimilars.
OPUVIZ also enters an increasingly competitive Canadian market for aflibercept biosimilars, as multiple manufacturers expand their ophthalmology portfolios following the loss of exclusivity for reference aflibercept products.
Although OPUVIZ has already received regulatory approval in Canada, Teva Canada has not announced a commercial launch date. The company said additional details regarding product availability and launch timing will be provided at a later stage.
The planned launch also aligns with broader efforts across Canadian provinces to expand biosimilar use through reimbursement policies intended to improve patient access and support the long-term sustainability of public healthcare spending.
The partnership adds another aflibercept biosimilar to the Canadian ophthalmology market, where biosimilars are expected to increase treatment access and potentially reduce healthcare costs for patients requiring long-term anti-VEGF therapy.
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About the Writer
Nalam Karthik (LinkedIn) is a healthcare writer and PharmD graduate with interests in pharmacovigilance, drug safety, clinical data analysis, and quality assurance. He is passionate about translating clinical and pharmaceutical knowledge into accessible healthcare content while staying engaged with advancements in drug development and patient safety initiatives.
