On 8 July 2026, Teva and Samsung Bioepis announced that they have entered an agreement for the commercialisation in Canada of Opuviz®/SB15 (aflibercept), biosimilar to Regeneron/Bayer’s Eylea®. Under the terms of the licence and commercialisation agreement, Samsung Bioepis is responsible for the manufacture and registration of Opuviz®, while Teva has the Canadian commercialisation rights.
Samsung Bioepis had previously partnered with Biogen in relation to Opuviz® in Canada (and certain other countries) under a November 2019 agreement. However, in October 2024, Biogen notified Samsung Bioepis of its decision to terminate that agreement for the US and Canada and the commercialisation rights reverted to Samsung Bioepis.
SB15 was approved in Canada in October 2025 but has not yet been launched on the Canadian market. Samsung Bioepis entered settlement agreements with Regeneron/Bayer in relation to SB15 for the US & Canada (announced February 2026) and for Europe and ROW (announced January 2026), which provided agreed launch dates for SB15 in the jurisdictions covered by the agreements. However, the agreed launch date for Canada has not been made public.
Other aflibercept biosimilars approved in Canada include Biocon’s Yesafili® (June 2025, launched July 2025 following a settlement with Regeneron/Bayer), Amgen’s Pavblu® (July 2025), Apotex’s Aflivu™ (July 2025), Sandoz’s Enzeevu® (October 2025, launched February 2026), Celltrion’s Eydenzelt® (November 2025), and Formycon/Klinge/Valorum Biologics’ Ahzantive™ (November 2025).
Opuviz® was the third aflibercept biosimilar to be approved in the EU in November 2024 and was launched in Europe through direct sales in May 2026. SB15 was approved in Korea (as Afilivu®) in February 2024 and in Australia (as Opuviz®) in September 2025. Opuviz® was approved in the US in May 2024 and is set for a US launch from January 2027 under Samsung Bioepis’ settlement agreement with Regeneron/Bayer.