DEAL WATCH: Recent Biosimilar Collaboration Announcements

In recent weeks, several drug makers announced collaborations for the development, manufacture, and/or commercialization of a variety of biosimilars or follow-on biologics.  Below are some highlights:

On September 3, 2019, Polpharma Biologics and Sandoz announced that they have entered into a global commercialization agreement in connection with Polpharma’s proposed biosimilar of Biogen’s TYSABRI (natalizumab), currently in Phase III clinical development for the treatment of relapsing-remitting multiple sclerosis. According to the companies’ press releases, Polpharma will be responsible for development, manufacturing, and supply, and Sandoz will commercialize and distribute the biosimilar product in all markets upon approval through an exclusive global license.

Also on September 3, Celltrion and Lonza announced that they have entered into a contract manufacturing agreement under which Lonza will produce drug substance for Celltrion’s REMSIMA, a biosimilar of REMICADE (infliximab) that is approved in Europe and the U.S. for a certain autoimmune diseases, including Crohn’s disease and rheumatoid arthritis.

On August 28, Alvotech and Prestige Biopharma announced that they have entered into “a new contract manufacturing partnership for one of Prestige Biopharma’s biosimilar candidates.” The press release does not identify the specific biosimilar candidate that the deal concerns, but notes that Prestige is developing HD201, a proposed biosimilar of HERCEPTIN (trastuzumab); HD204, a proposed biosimilar of AVASTIN (bevacizumab), and PBP1502, a proposed biosimilar of HUMIRA (adalimumab). Prestige’s website indicates that it is additionally developing biosimilars of PROLIA/XGEVA (denosumab), EYLEA (aflibercept), SOLIRIS (eculizumab), YERVOY (ipilimumab). Prestige also announced on August 28 that it has entered into a collaboration with Huons under which Huons has exclusive sales rights in South Korea for HD204 and PBP1502. Huons states that it now holds exclusive sales rights in South Korea to three Prestige biosimilars, having previously entered into an exclusive sales right agreement for HD201.

On August 26, iBio announced that it has expanded the scope of its business venture with CC-Pharming Ltd. by granting CC-Pharming (1) an exclusive, royalty-bearing commercial license to iBio’s plant-derived “bio-better rituximab (‘iBio Rituximab’) product candidates for the territory of China”; and (2) “a research license to iBio’s FastPharming System and know-how for the evaluation of multiple product opportunities.” The agreement reportedly “expands the scope of iBio and CC-Pharming’s July 2018 Master Joint Development Agreement, which provides for the co-development of products and manufacturing facilities, utilizing iBio’s technology, for the Chinese biopharmaceutical market.” According to the press release, the expanded deal “provides for CC-Pharming to be responsible for the development, launch and commercialization of iBio’s bio-better rituximab in China, including costs associated with the marketing and sales of the licensed product,” while “iBio retains all rights to commercialize iBio technology-based products in markets outside of China.” The press release further states that the two companies “are currently evaluating the business feasibility of developing additional biopharmaceutical products for oncology, metabolic disorders, and fibrotic disease.”