Blog Big Molecule Watch September 15, 2022

Genentech and Samsung Bioepis Settle Bevacizumab Biosimilar Patent Dispute

As we previously reported, on June 28, 2020, Genentech, Inc. (“Genentech”) filed a complaint against Samsung Bioepis Co., Ltd. (“Samsung”) in the District of Delaware, alleging infringement of fourteen patents under the BPCIA based on Samsung’s submission of an aBLA for SB8, a proposed biosimilar of AVASTIN (bevacizumab). On September 7, 2022, Genentech and Samsung filed a joint stipulation of dismissal of their BPCI patent litigation. According to the stipulation, the parties “have entered into a Bevacizumab Settlement Agreement, and mutually agree to voluntarily dismiss all claims and counterclaims asserted in the above-captioned consolidated case without prejudice.”

Samsung Bioepis announced in November 2019 that the FDA had accepted its application for its bevacizumab biosimilar, but the product has not been approved by the FDA.  In August 2020, the European Commission granted marketing authorization for the product, marketed as AYBINTIO (bevacizumab).

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