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International Biosimilar Market Updates

Stelis Biopharma Receives Positive Recommendation for FORSTEO Biosimilar in Europe On November 14, Stelis Biopharma Limited (Stelis), the biologics arm of Strides Pharma Science Limited, announced that its first biosimilar product KAULIV received a positive recommendation from European Medicines Agency (EMA) for granting market authorization.  KAULIV is a biosimilar referencing…

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Organon Launches HERCEPTIN and AVASTIN Biosimilars in Canada

Organon, a global woman’s health company, recently announced its launch of two biosimilar products in Canada. On November 7, Organon announced the launch and availability of AYBINTIO in Canada.  AYBINTIO is a biosimilar product referencing AVASTIN (bevacizumab) and is approved for adults with certain aggressive forms of cancers, including metastatic…

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Fresenius Kabi Announces FDA Approval of Pegfilgrastim Biosimilar

On September 6, Fresenius Kabi announced that the U.S. Food and Drug Administration (FDA) approved STIMUFEND (pegfilgrastim), a biosimilar referencing NEULASTA, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.  The company states that it expects to launch the product in…

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China NMPA Approves TYVYT (sintilimab) - Big Molecule Watch

On June 24, 2022, Innovent Biologics, Inc. and Eli Lilly and Company announced that the National Medical Products Administration (NMPA) of China approved the supplemental New Drug Application (sNDA) for TYVYT (sintilimab)—a monoclonal antibody that targets and binds to PD-1 molecules resulting in the death of cancer cells—in combination with…

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Viatris and Biocon Biologics Launch Bevacizumab Biosimilar ABEVMY in Canada

On May 19, 2022, Viatris Inc. and Biocon Biologics Ltd. announced that ABEVMY, a bevacizumab biosimilar, is now available in Canada.  According to the press release, Viatris and Biocon Biologics co-developed ABEVMY, which references Roche’s AVASTIN (bevacizumab), a recombinant humanized monoclonal antibody that selectively binds to human vascular endothelial growth…

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FDA Approves First Interchangeable Biosimilar Insulin Product (UPDATE - 11/23/2021)

July 28, 2021 – the U.S. Food and Drug Administration (FDA) approved Viatris Inc.’s (formerly Mylan Pharmaceuticals Inc.) SEMGLEE (insulin glargine-yfgn), a biosimilar to LANTUS (insulin glargine). According to the press release, SEMGLEE is indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and…

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