On October 5, Celltrion Healthcare Co. announced that it has signed a contract with Ventegra, a major U.S. Medical Benefits Manager (MBM) “who administers pharmacy benefits through its Pharmacy Services Administration (PSA) model that has been effectively displacing traditional PBM’s.” According to the press release, YUFLYMA (adalimumab-aaty) will be a…
FDA grants interchangeable designation to Pfizer’s adalimumab biosimilar – On October 5, 2023, Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has designated ABRILADA (adalimumab-afzb) as an interchangeable biosimilar to HUMIRA (adalimumab). ABRILADA was originally approved by the FDA in November 2019. The new interchangeable designation was…
On August 29, 2023, the PTAB issued final written decisions in IPR2022-00578 and IPR2022-00579, filed by Celltrion on two patents related to tocilizumab — U.S. Patent Nos. 8,580,264 and 10,874,677, owned by Chugai Seiyaku Kabushiki Kaisa, Genentech, Inc, and Hoffmann La Roche, Inc. The ’264 patent claims are directed to…
It has been reported that Celltrion has finalized a settlement with Johnson & Johnson (“J&J”) in the United States relating to CT-P43, Celltrion’s ustekinumab biosimilar to J&J’s STELARA®, which would permit Celltrion to launch the product in the U.S. market on March 7, 2025, if approved by FDA. This settlement…
On August 18, Samsung Bioepis Co., Ltd. (“Samsung Bioepis”), filed a petition for Inter Partes Review, IPR2023-01312, challenging the validity of claims 1-18 of U.S. Patent No. 10,464,992, assigned to Regeneron Pharmaceuticals, Inc. (“Regeneron”). According to the petition, the ’992 patent claims “encompass a formulation comprising the VEGF inhibitor protein,…
Last week, Regeneron filed a motion to terminate IPR2023-00620, an IPR filed by Celltrion on February 28, 2023, seeking cancellation of claims 1-4 of Regeneron’s U.S. Patent No. 10,406,226 which is generally directed to methods of manufacturing VEG-F antagonists, including aflibercept. Regeneron’s motion to terminate is based on Regeneron’s filing…
On July 19 and 20, 2023, the PTAB granted institution of IPR2023-00442, filed by Samsung Bioepis regarding Regeneron’s Patent No. 10,130,681 which is directed to treating angiogenic eye disorders with alibercept, and institution of IPR2023-00462, filed by Celltrion regarding Regeneron’s Patent No. 10,464,992 which is directed to formulations of VEGF…
In the last week, seven adalimumab biosimilars referencing HUMIRA entered the U.S. market: Boehringer Ingelheim’s CYLTEZO (adalimumab-adbm); Sandoz’s HYRIMOZ (adalimumab-adaz); Organon and Samsung Bioepis’s HADLIMA (adalimumab-bwwd); Coherus Biosciences’s YUSIMRY (adalimumab-aqvh); Celltrion’s YUFLYMA (adalimumab-aaty); Fresenius Kabi’s IDACIO (adalimumab-aacf); and Biocon’s HULIO (adalimumab-fkjb). With Amgen’s AMJEVITA (adalimumab-atto), launched in January 2023, there…
On June 29 and 30, 2023, respectively, Formycon AG (“Formycon”) and Celltrion Inc. (“Celltrion”) announced submission to the FDA of aBLAs for their aflibercept biosimilar candidates. Formycon and Celltrion are the second and third biosimilar developers to announce submissions of aflibercept aBLAs, following Viatris Inc.’s submission in October 2021. As…
Celltrion and US-based Rani Therapeutics (“Rani”) announced that they entered an agreement to develop RT-105, an orally administered adalimumab biosimilar made using the RANIPILL platform. The announcement explains that RANIPILL capsules are Rani’s payload agnostic oral delivery technology intended to replace subcutaneous or intravenous injection of biologics or drugs, and…