Tagged as: Biosimilars News

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…

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Sandoz New Global "Act4Biosimilars" Initiative - Big Molecule Watch

On May 31, 2022, Sandoz announced the launch of a new global initiative called “Act4Biosimilars” to help address health inequity and inequality worldwide. Act4Biosimilars aims to increase patient access to advanced medicines by facilitating greater approvability, accessibility, acceptability and affordability (the 4 A’s) of biosimilars. The initiative is supported by…

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Teva Receives Approval for First Ophthalmology Biosimilar in Europe

Earlier this week, Teva Pharmaceutical Industries Ltd. (Teva) announced that the UK Medicines & Healthcare Regulatory Agency (MHRA) approved ONGAVIA, a ranibizumab biosimilar referencing Genentech’s LUCENTIS.  Ranibizumab inhibits vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina. The United Kingdom is…

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International Biosimilar Approval and Launch Updates

On March 30, 2022, Fresenius Kabi announced that the European Commission approved STIMUFEND, a pegfilgrastim biosimilar referencing NEULASTA, for patients with non-myeloid cancer who are receiving myelosuppressive chemotherapy.  STIMUFEND, to launch in a prefilled syringe, is Fresenius’s first approved molecule in its oncology biosimilar portfolio and second biosimilar approved in…

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Regeneron’s Disclaimer of Aflibercept Formulation Patent Causes PTAB Denial of Institution of Celltrion PGR

On March 15, 2022, the Patent Trial and Appeal Board (PTAB) denied institution of post-grant review (PGR) proceedings initiated by Celltrion Inc. concerning Regeneron Pharmaceutical’s U.S. Patent No. 10,857,231 (the ’231 Patent) after Regeneron disclaimed the patent.  The ’231 patent has claims directed to formulations of aflibercept, the active ingredient…

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