Samsung Bioepis, AffaMed Form Biosimilars Licensing Pact for China

Samsung Bioepis, a Incheon, Korea-based biosimilars company, has formed a licensing agreement for biosimilars in China with AffaMed Therapeutics, a newly formed biopharmaceutical company founded and funded by C-Bridge Capital, a private-equity firm headquartered in Singapore and New York. Samsung Bioepis is a biosimilars joint venture of Samsung BioLogics, an Incheon, South Korea-based contract biologics manufacturer, and Biogen.

Under the agreement, AffaMed Therapeutics, which is focused on identifying and licensing late-stage candidates for commercialization in emerging Asia Pacific markets, will collaborate with Samsung Bioepis across several areas, including clinical development, regulatory registration, and commercialization in China. Samsung Bioepis will receive an upfront payment as well as royalties on sales. Additional financial details were not disclosed.

The agreement covers multiple biosimilar candidates from Samsung Bioepis. These include SB11 and SB12, which respectively reference Roche’s Lucentis (ranibizumab), a drug to treat wet age-related macular degeneration, diabetic retinopathy and diabetic macular edema (2018 global sales of CHF 1.66 billion [$1.65 billion]), and Alexion Pharmaceuticals’ Soliris (eculizumab), an immunosuppressive drug for treating two rare blood disorders (paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome) (2018 global sales of $3.56 billion), as well as SB3, a biosimilar candidate referencing Roche’s Herceptin (trastuzumab), a breast-cancer drug (2018 global sales of CHF 6.98 billion ($6.94 billion).

Samsung Bioepis has four biosimilars approved and marketed across Europe, which reference blockbuster innovator drugs. These include: the ant-TNF trio for treating various inflammatory diseases of Benepali (etanercept), which references Amgen’s Enbrel (2018 global sales of $5.01 billion); Flixabi (infliximab), which references Johnson & Johnson’s Remicade (2018 global sales of $5.33 billion), and Imraldi (adalimumab), which references AbbVie’s Humira (2018 global sales of $19.94 billion), as well as an oncologic biosimilar, Ontruzant (trastuzumab), which references Roche’s Herceptin.

In the US, the company has one biosimilar on the market, Renflexis (infliximab-abda), a biosimilar to Johnson & Johnson’s Remicade. Another biosimilar, Ontruzant (trastuzumab-dttb), a biosimilar to Roche’s Herceptin, was approved by the US Food and Drug Administration (FDA) in January 2019. A third biosimilar candidate, SB5 (adalimumab), a biosimilar to AbbVie’s Humira is under review by the FDA.

Source: Samsung Bioepsis

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