On March 10, 2023, the PTAB denied institution of IPR2022-1524, filed by Apotex Inc. regarding Regeneron’s Patent No. 11,253,572. As we previously reported, Apotex filed an IPR petition against the ’572 patent in September 2022, challenging claims that generally relate to methods for treating angiogenic eye disorders with a claimed dosing regimen…
Celltrion and Samsung recently filed IPR petitions challenging claims of Regeneron patents directed to treating angiogenic eye disorders with aflibercept. Specifically, Celltrion and Samsung have each filed petitions challenging U.S. Patent No. 10,130,681: IPR2023-00442 (Samsung), IPR2023-00532 (Celltrion), and U.S. Patent No. 10,888,601: IPR2023-00566 (Samsung), IPR2023-00533 (Celltrion). As we previously reported, Mylan…
According to news reports, Celltrion recently launched VEGZELMA (bevacizumab) in Japan. In September 2022, the drug received sales approval from the Japanese Ministry of Health, Labor and Welfare for the treatment of metastatic colorectal cancer, non-small cell lung cancer, and more. Japan is home to the world’s second largest bevacizumab…
Last week, Celltrion filed an IPR petition, PTAB IPR2023-00462, seeking cancellation of claims 1-18 of U.S. Patent No. 10,464,992 (“the ’992 patent”), assigned to Regeneron Pharmaceuticals, Inc. According to the Petition, the challenged claims of the ’992 patent “encompass a formulation comprising the VEGF inhibitor protein, aflibercept, which Regeneron markets…
This week, Celltrion obtained full label approval from Health Canada to sell Vegzelma (CT-P16), a bevacizumab biosimilar indicated for the treatment of metastatic colorectal cancer, non-small cell lung cancer, epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and glioblastoma. Celltrion has secured sales licenses for Vegzelma in 35 countries,…
Yesterday, Celltrion and US-based Rani Therapeutics (“Rani”) announced that they will jointly develop an oral formulation of CT-P43, a biosimilar to Stelara® (ustekinumab), indicated for the treatment of psoriasis, Crohn’s disease, and ulcerative colitis. Celltrion’s CT-P43 biosimilar is currently only available in two injectable formulations – intravenous and subcutaneous. According…
On December 22, 2022, Celltrion USA announced that it submitted a Biologics License Application (BLA) for a subcutaneous formulation of infliximab, CT-P13, to the U.S. Food and Drug Administration (FDA). According to Celltrion, the BLA is based on phase III pivotal data that evaluated the efficacy and safety of CT-P13 as a…
Celltrion recently confirmed that it proved the effectiveness of its subcutaneous infliximab biosimilar, RemsimaSC (CT-P13 SC) in two global Phase III trials. The Phase III study was a 54-week study conducted on 438 patients of ulcerative colitis and 343 Crohn’s disease patients. According to Celltrion “[t]he results showed that RemsimaSC…
On October 12, 2022, Amgen released its 2022 Biosimilar Trends Report. Since we posted on Amgen’s report preview in July, the total number of biosimilars that have been approved in the United States has increased from 36 to 39 (with the approval of Coherus’s CIMERLI (ranibizumab-eqrn) in August and Fresenius…
Celltrion announced this week that the FDA has approved VEGZELMA (bevacizumab-adcd), a biosimilar to AVASTIN, for treatment of six types of cancer: metastatic colorectal cancer; recurrent or metastatic non-squamous non-small cell lung cancer (nsNSCLC); recurrent glioblastoma; metastatic renal cell carcinoma; persistent, recurrent, or metastatic cervical cancer; and epithelial ovarian, fallopian…