On May 13, 2025, Biogen Inc. and Biogen MA Inc. (“Biogen”) filed a Complaint for Declaratory Judgment and Permanent Injunctive Relief against Neurimmune Holding AG and Neurimmune SubOne AG (“Neurimmune”) in the U.S. District Court for the District of Massachusetts. Biogen alleges that Neurimmune wrongfully attempted to “lay claim to…
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 October 24, 2014, Amgen initiated the first litigation under the Biologics Price Competition and Innovation Act (“BPCIA”), asserting infringement of two patents. Over the last two calendar years, Amgen, Biogen, Genentech, and Regeneron have all filed BPCIA complaints (sometimes several) asserting 20 or more patents. Does this reflect a…
On November 18, 2024, Samsung Bioepis announced that the European Commission (EC) has approved its aflibercept biosimilar, OPUVIZ. Referencing Regeneron’s biosimilar product EYLEA, OPUVIZ is a 40 mg/mL solution for injection, approved for the treatment of neovascular age related macular degeneration, visual impairment due to macular oedema secondary to retinal…
On September 19, 2024, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Sandoz’s aflibercept biosimilar AFQLIR. On September 20, 2024, Samsung and Biogen announced that the CHMP also adopted a positive opinion for their aflibercept biosimilar OPUVIZ. AFQLIR and OPUVIZ…
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…
Genentech, Hoffmann-La Roche, and Biogen have settled their BPCIA litigation against Dr. Reddy’s Laboratories (“DRL”) and Fresenius Kabi. As we previously reported, Genentech, Hoffmann-La Roche, and Biogen filed a complaint in the U.S. District Court for the District of New Jersey in November 2023, alleging that DRL’s proposed rituximab biosimilar…
Genentech, Roche, and Biogen filed a Complaint on November 17 against Dr. Reddy’s Laboratories (“DRL”) and Fresenius in the U.S. District Court for the District of New Jersey, alleging infringement of 15 patents under the BPCIA based on DRL’s submission of an aBLA for DRL_RI, a proposed biosimilar of RITUXAN (rituximab)…
Recently, Biogen and Samsung Bioepis’s ranibizumab biosimilar (BYOOVIZ) was granted interchangeable status by the U.S. Food and Drug Administration. BYOOVIZ was deemed interchangeable to Genentech’s LUCENTIS for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, and myopic choroidal neovascularization. BYOOVIZ, the first FDA approved…