Global partnerships for biosimilar commercialization announced

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The biosimilar market is expanding rapidly, with key partnerships announced in mid-2025. Alvotech–Dr Reddy’s, Samsung Bioepis–NIPRO, and Formycon’s collaborations with Bio Usawa and Valorum Biologics aim to commercialize biosimilars for pembrolizumab, ustekinumab, ranibizumab, and aflibercept, targeting global markets ahead of patent expirations.

Harmonize V13F28

In June and July 2025, partnerships were announced between Alvotech and Dr Reddy’s Laboratories to produce and market a biosimilar candidate referencing Keytruda (pembrolizumab), as well as between Samsung Bioepis and NIPRO for multiple biosimilar candidates in Japan. Additionally, Formycon announced collaborations with African biotechnology company Bio Usawa Biotechnology and US-based Valorum Biologics to commercialize its ranibizumab and aflibercept biosimilars. 

Anticipating Merck’s Keytruda (pembrolizumab) losing market exclusivity in 2028, Alvotech and Dr Reddy’s have partnered to co-develop, manufacture, and commercialize a biosimilar candidate referencing theproduct. 

South Korea’s Samsung Bioepis and Japan’s NIPRO have entered into a license, development, and commercialization agreement for multiple biosimilar candidates, including Samsung Bioepis’ SB17 (an ustekinumab biosimilar candidate), in Japan. Samsung Bioepis will handle development, manufacturing, and supply, while NIPRO will oversee commercialization in Japan.

Bioeq, the exclusive global licensee of Formycon’s FYB201 (a ranibizumab biosimilar candidate), has partnered with Bio Usawa Biotechnology under an exclusive agreement. This grants Bio Usawa the rights to register and commercialize FYB201 under the brand name BioUcenta in Africa. 

Additionally, Klinge Biopharma–the exclusive global rights holder for Formycon’s FYB203/Ahzantive (anaflibercept biosimilar)–has entered into a license agreement with Valorum Biologics for commercialization in the US and Canada. 

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