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Fresenius Kabi Announces FDA Approval of Adalimumab Biosimilar

Earlier today, Fresenius Kabi announced that the U.S. Food and Drug Administration (FDA) approved IDACIO (adalimumab-aacf), a biosimilar referencing HUMIRA.  IDACIO is approved for use in the treatment of chronic autoimmune diseases for all eligible indications of the reference product and, according to Fresenius, is expected to launch in the…

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Biogen Announces EMA Acceptance of Tocilizumab Biosimilar Application

Biogen Inc. (“Biogen”) recently announced that the European Medicines Agency (EMA) has accepted the marketing authorization application for BIIB800 (BAT1806), a biosimilar candidate referencing Roche’s ACTEMRA (tocilizumab).  ACTEMRA, an anti-interleukin-6 receptor monoclonal antibody, is approved in Europe as an intravenous formulation for severe, active and progressive rheumatoid arthritis, juvenile idiopathic polyarthritis, active…

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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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Year in Review: Top-Five U.S. Biosimilar Market Developments of 2021

As we ring in the new year, we look back at the top U.S. biosimilar market developments of 2021. Here are our top five: 1. SEMGLEE Launches As First-Ever Interchangeable Biosimilar In July, the FDA approved Viatris Inc.’s (formerly Mylan Pharmaceuticals Inc.) SEMGLEE (insulin-glargine-yfgn), a biosimilar to LANTUS (insulin glargine)….

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