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Recent Biosimilar Approvals By the FDA

Big Molecule Watch

Approval of Accord’s Trastuzumab Biosimilar : On September 18, 2024, Accord announced that the Food and Drug Administration (FDA) approved a 420 mg dosage of HERCESSI (trastuzumab-strf), a biosimilar to Genentech’s HERCEPTIN (trastuzumab), to treat HER2-overexpressing breast and gastric or gastroesophageal junction adenocarcinoma.

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Aflibercept Biosimilar Updates in Europe

Big Molecule Watch

On September 19, 2024, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Sandoz’s aflibercept biosimilar AFQLIR. On September 20, 2024, Samsung and Biogen announced that the CHMP also adopted a positive opinion for their aflibercept biosimilar OPUVIZ.

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EU Committee Recommends Approval of 6 New Biosimilars in July 2024 Meeting

Big Molecule Watch

The Committee for Medicine Products for Human Use (“CHMP”) recommended 14 medicines for European Medicines Agency Approval (“EMA”) approval (“marketing authorization”), during its monthly meeting on July 22-25, 2024. The post EU Committee Recommends Approval of 6 New Biosimilars in July 2024 Meeting appeared first on Big Molecule Watch.

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Data Supports Approval of Biosimilar Aflibercept for Diabetic Macular Edema

Pharmacy Times

In May 2024, the first biosimilars for aflibercept were approved, which included aflibercept-jbvf (Yesafili; Biocon Biologics), known as MYL-1701P.

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Biocon Biologics Obtains U.S. FDA Approval for Biosimilar Aflibercept

Express Pharma

Food and Drug Administration (US FDA) has approved the company’s first-to-file application for Yesafili (aflibercept-jbvf), an interchangeable* biosimilar aflibercept. ” Matt Erick, Chief Commercial Officer of Advanced Markets, Biocon Biologics said, “Biosimilars are crucial for making healthcare more affordable and accessible.”

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Updates on Aflibercept Biosimilar Approvals and BPCIA Litigation

Big Molecule Watch

FDA approves first interchangeable biosimilars to EYLEA (aflibercept) to treat macular degeneration and other eye conditions Regeneron’s regulatory exclusivity for EYLEA expired on May 18, 2024. Two days later, on May 20, 2024, the FDA announced that it has approved Mylan Pharmaceuticals, Inc. and Biocon Biologics, Inc.’s

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Sandoz to Acquire CIMERLI from Coherus for $170 Million

Big Molecule Watch

On January 22, 2024, Sandoz announced its plans to acquire the U.S. biosimilar ranibizumab CIMERLI (ranibizumab-eqrn) from Coherus BioSciences, Inc. According to Sandoz, “closing is anticipated in 1H 2024, subject to standard conditions and approval.” Coherus”) for an upfront cash purchase payment of USD 170 million.