CHMP positive opinion is based on a robust analytical, non-clinical and clinical data package comparing TOFIDENCE„ to the reference product ROACTEMRA® CAMBRIDGE, Mass., April 25, 2024 (GLOBE...
Fresenius Accelerates Momentum in its (Bio)Pharma Business and Launches Tyenne®, its Third Approved Biosimilar in the U.S.
JERSEY CITY, N.J., Jan. 28, 2024 /PRNewswire/ -- Celltrion USA today announced the submission of Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for CT-P47, a biosimilar candidate of the reference product ACTEMRA® (tocilizumab)[1].
Roche settles US patent lawsuit against Biogen over blockbuster arthritis drug
GUANGZHOU, China, Oct. 8, 2023 /PRNewswire/ -- Bio-Thera Solutions, Ltd (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of biosimilars and innovative assets, announced that its partner Biogen recently received notification from the United States Food and Drug Administration (FDA) on the approval of TOFIDENCE (tocilizumab-bavi) intravenous formulation, a biosimilar monoclonal antibody referencing ACTEMRA. The TOFIDENCE intravenous formulation is approved for the treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis.
Fresenius Kabi`s Tyenne (tocilizumab) Receives Approval in Europe
CAMBRIDGE, Mass., Sept. 29, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced that the U.S. Food and Drug Administration (FDA) has approved TOFIDENCE (tocilizumab-bavi) intravenous formulation, a biosimilar monoclonal antibody referencing ACTEMRA. The TOFIDENCE intravenous formulation is approved for the treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis.
Fresenius Kabi, a global health care company that specializes in biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs for critical and chronic conditions, announced today that the European Commission (EC) granted marketing authorization for its tocilizumab biosimilar Tyenne®, referencing RoActemra®** (tocilizumab), valid for all member states of the European Union.
July 14 (Reuters) - Roche ROG.S and two of its subsidiaries sued biotech company Biogen BIIB.O in Massachusetts federal court on Thursday, accusing its proposed similar version of Roche's blockbuster rheumatoid arthritis drug Actemra of infringing several of their patents.
HYDERABAD, India--(BUSINESS WIRE)--Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; hereafter referred to as “Dr. Reddy’s”), a global pharmaceutical company, announced that its tocilizumab biosimilar candidate, DRL_TC, successfully met its primary and secondary endpoints in a Phase I study. This Phase I study used an intravenous (IV) formulation to evaluate the pharmacokinetic equivalence, safety and immunogenicity of Dr. Reddy’s tocilizumab biosimilar candidate in comparison to reference products.