Inventions made in a particular country are generally first-filed in that country before entering the United States via a direct Paris Convention filing or, more commonly, a PCT national stage entry. Convenience, national pride, and foreign filing license laws encourage such home country first-filings. It is well known that the…
On February 23, 2025, Celltrion announced that the European Commission (“EC”) approved its tocilizumab biosimilar, AVTOZMA® (CT-P47), referencing Roche’s ROACTEMRA®. Tocilizumab is a monoclonal antibody that acts as an interleukin-6 (IL-6) inhibitor to reduce inflammation in the body. The EC approved AVTOZMA® for all indications of the reference product, including moderate…
On January 31, 2025, Celltrion announced that the FDA approved its tocilizumab biosimilar, AVTOZMA® (tocilizumab-anoh), referencing Genentech’s ACTEMRA®. Tocilizumab is a monoclonal antibody that can act as an interleukin-6 (IL-6) inhibitor to reduce inflammation in the body. The FDA approved AVTOZMA® for subcutaneous injection or intravenous infusion for treatment of…
The European Medicines Agency’s (EMA) Committee for Medicinal Use Products (CHMP) recently recommended approval of six new biosimilars. The CHMP recommended approval of four biosimilars developed by Celltrion: (1) AVTOZVMA (tocilizumab), for the treatment of rheumatoid arthritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, giant cell arteritis, CAR-T cell-induced…
On July 2, 2024, Fresenius Kabi (“Fresenius”) announced the immediate availability of TYENNE (tocilizumab-aazg), in a subcutaneous formulation, in the United States. TYENNE, a biosimilar to ACTEMRA (tocilizumab), was developed by Fresenius for use in the treatment of several autoimmune diseases, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic…
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 is an intravenous formulation of an interleukin-6 receptor antagonist, and is approved for the treatment of moderate to severe active rheumatoid arthritis, polyarticular…
On April 25, 2024, the Committee for Medicinal Products for Human Use (“CHMP”) adopted a positive opinion, recommending the granting of marketing authorization for Biogen Netherlands B.V.’s biosimilar TOFIDENCE (tocilizumab), for the treatment of rheumatoid arthritis (RA), systemic juvenile idiopathic arthritis (sJIA), polyarticular juvenile idiopathic arthritis (pJIA) and coronavirus disease…
On April 15, 2024, Fresenius Kabi announced the U.S. launch of its ACTEMRA biosimilar, TYENNE (tocilizumab-aazg) as an intravenous formulation. As we previously reported, Fresenius Kabi received FDA approval for both intravenous and subcutaneous formulations on March 5, 2024, making TYENNE the first tocilizumab biosimilar approved in both formulations. TYENNE is…
On March 7, Fresenius Kabi announced that the FDA has approved its tocilizumab biosimilar, TYENNE (tocilizumab-aazg) for inflammatory and immune diseases indications including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis. TYENNE is the second FDA approved biosimilar of ACTEMRA (following Biogen’s TOFIDENCE (tocilizumab-bavi)…
On February 12, 2024, Chugai, Genentech, and Hoffmann-La Roche filed a motion for voluntary dismissal of their appeals of the PTAB’s Final Written Decisions in IPR2022-00578 and IPR2022-00579. The appeals concerned IPRs filed by Celltrion where the PTAB found all challenged claims of U.S. Patent Nos. 8,580,264 and 10,874,677 were…