(RTTNews) - Biogen Inc. (BIIB) announced Monday that the European Commission (EC) has granted approval for TOFIDENCETM, a biosimilar monoclonal antibody referencing ROACTEMRA. The intravenous ...

Cambridge, Mass., June 24, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced that the European Commission (EC) has granted approval for TOFIDENCETM, a biosimilar monoclonal antibody ...

This week, Biogen announced that the European Commission has approved TOFIDENCE, a tocilizumab biosimilar referencing Roche’s ROACTEMRA. TOFIDENCE was approved by the FDA in September 2023. TOFIDENCE ...

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Organon has acquired regulatory and commercial rights in the United States from Biogen for Tofidence, a biosimilar to Actemra for intravenous infusion. Tofidence, the first approved tocilizumab ...

With Tofidence (tocilizumab-bavi), a monoclonal antibody from Biogen Inc., the U.S. FDA has approved the first biosimilar to the Roche Group AG’s Actemra (tocilizumab), a blockbuster with declining ...

Earlier in June 2026, Organon reported that the FDA approved a supplemental Biologics License Application for TOFIDENCE, expanding this tocilizumab biosimilar’s US label to cover CAR T cell-induced ...

Organon & Co. OGN recently announced that the FDA has approved a supplemental Biologics License Application (sBLA) for TOFIDENCE (tocilizumab-bavi), expanding the drug’s indications to include severe ...

Organon Secures US Food and Drug Administration Approval Expanding Indications for TOFIDENCE® (tocilizumab-bavi) in Cytokine Release Syndrome (CRS) and Pediatric COVID-19 Organon (NYSE: OGN) today ...