Teva Pharmaceutical Industries and Samsung Bioepis have entered a license and commercialization agreement for OPUVIZ, an aflibercept biosimilar referencing Eylea, in Canada. The partnership aims to bring the biosimilar to the Canadian market, leveraging the strengths of both companies.

Under the agreement, Samsung Bioepis is responsible for the registration and manufacture of the products. Teva Canada, a subsidiary of Teva Pharmaceutical Industries, will oversee commercialization activities. This division of responsibilities aligns with each company's expertise.

OPUVIZ is a biosimilar referencing Eylea, a treatment for various retinal diseases. The agreement marks a significant step in expanding access to biosimilar treatments in Canada.

Key Responsibilities

The collaboration highlights the growing importance of biosimilars in the pharmaceutical market. Both companies are expected to leverage their capabilities to ensure a successful launch.

Teva Pharmaceutical Industries Ltd. plans to advance TEV-'408, an investigational anti-interleukin-15 monoclonal antibody, into a Phase 2b study for vitiligo in the fourth quarter of 2026. The decision follows encouraging results from an ongoing Phase 1b, open-label study in adults with active or stable non-segmental vitiligo (NSV), a chronic autoimmune disease causing loss of skin pigmentation. TEV-'408 is designed for convenient quarterly (Q12W) subcutaneous dosing and was well-tolerated with no safety signals observed to date.

Data from the Phase 1b study demonstrated improvements in skin pigmentation. At baseline, 66% of enrolled participants had vitiligo affecting more than 10% of body surface area. At week 24, in evaluable participants, nearly 75% reported improvement in facial vitiligo, with half reporting "much" or "very much" improved. Additionally, 42% achieved F-VASI50 and 21% achieved F-VASI75.

Key Phase 1b Efficacy Results at Week 24

Richard Francis, President and Chief Executive Officer of Teva, stated that TEV-'408 exemplifies the innovative programs the company is prioritizing to strengthen its immunology pipeline. He noted that the program reflects progress in the Pivot to Growth strategy and a commitment to differentiated innovation.

Eric Hughes, Executive Vice President, Global R&D and Chief Medical Officer at Teva, emphasized that the data strengthen confidence in the IL-15 pathway and highlight Teva's scientific expertise. TEV-'408 is also being evaluated for celiac disease in a Phase 2a study and was granted Fast Track designation by the U.S. FDA in May 2025. Teva’s agreement with Royalty Pharma provides up to $500 million of strategic R&D funding to accelerate the clinical research program of TEV-'408.