Celltrion Submits Denosumab BLA to FDA: On November 30, 2023, it was reported that Celltrion had completed submission of its application to the FDA for CT-P41, its denosumab biosimilar of Amgen’s PROLIA and XGEVA. According to the report, once CT-P41 is approved in the U.S., “it is expected to secure…
Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed a Complaint on November 29, 2023, against Formycon AG (“Formycon”) in the U.S. District Court for the Northern District of West Virginia, alleging infringement of 39 patents under the BPCIA based on Formycon’s submission of an aBLA for FYB203, a proposed biosimilar of EYLEA (aflibercept). …
Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed a Complaint on November 22 against Samsung Bioepis Co., Ltd. (“Bioepis”) in the U.S. District Court for the Northern District of West Virginia, alleging infringement of 37 patents under the BPCIA based on Bioepis’s submission of an aBLA for SB15, a proposed biosimilar of EYLEA…
Acuitas Therapeutics Inc. (“Acuitas”) filed a complaint on November 13 against CureVac in the U.S. District Court for the Eastern District of Virginia, alleging incorrect inventorship of four U.S. Patents related to COVID-19 mRNA-LNP vaccines and assigned to CureVac, namely U.S. Patent Nos. 11,241,493, 11,471,525, 11,576,966, and 11,596,686, (collectively, the…
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)…
Bayer’s aflibercept 8 mg recommended for approval in Europe: On November 10, 2023, Bayer announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending aflibercept 8 mg for approval for extended treatment intervals in two major retinal…
Earlier today, UK’s Medicines and Healthcare products Regulatory Agency (MHRA) granted conditional marketing authorization to Vertex Pharmaceuticals and CRISPR Therapeutics for their CRISPR/Cas9 gene therapy, CASGEVY (exagamglogene autotemcel), marking the world’s first regulatory approval for a CRISPR-based gene-edited therapy. CASGEVY is the first medicine to be licensed that uses the…
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…
As previously reported, in February 2023, Formycon and Fresenius Kabi entered into a global license agreement to commercialize FYB202, a ustekinumab biosimilar of Janssen’s STELARA, in key global markets after successful regulatory approvals. The European Medicines Agency accepted Formycon’s Marketing Authorization Application for FYB202 on September 29, 2023. It was recently…
On November 1, 2023, Fresenius Kabi announced the launch of its tocilizumab biosimilar TYENNE referencing ROACTEMRA (tocilizumab) in the European Union. TYENNE is the first tocilizumab biosimilar available in Europe for the treatment of several inflammatory and immune diseases, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and…