As we previously reported, on January 11, 2024, Regeneron Pharmaceuticals, Inc. (“Regeneron”) moved to establish a multi-district litigation (“MDL”) for its aflibercept BPCIA litigation, and to transfer its case against Amgen, Inc. (“Amgen”) to the Northern District of West Virginia under 28 U.S.C. § 1407. The litigation consists of six…
As we settle into 2024, we reflect on the significant legal developments of 2023 that hold potential impact on the biologics and biosimilars market. The following is a recap of some of the top five legal decisions and developments in the biosimilars and biologics space in 2023 that we covered…
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…
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…
Meitheal Pharmaceuticals, Inc. (“Meitheal”) has entered into an exclusive licensing deal with Tonghua Dongbao Pharmaceutical Co., Ltd. (“THDB”) to market three insulin biosimilars (insulin aspart, insulin lispro, and insulin glargine) in the United States. The agreement grants Meitheal and its parent company, Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (“NKF”), exclusive…
On September 6, 2023, the Association for Accessible Medicines (AAM) released its 2023 U.S. Generic & Biosimilar Medicines Savings Report highlighting the significant economic contributions of generic and biosimilar medicines. Notably, the U.S. healthcare system, including patients, employers and taxpayers, saved $408 billion in 2022 by using FDA-approved generic and…
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 May 26, 2023, the European Commission granted the marketing authorization to Samsung Bioepis for EPYSQLI, a biosimilar referencing SOLIRIS (eculizumab) developed by Alexion for the treatment of the paroxysmal nocturnal hemoglobinuria (PNH) that had global sales of approximately $5 trillion last year. As the first hematology biosimilar developed by…
Advanz Pharma (“Advanz”) and Alvotech announced that they entered an exclusive partnership agreement regarding supply and commercialization of five biosimilars in Europe, with Alvotech responsible for the development and commercial supply of the biosimilars, and Advanz responsible for registration and commercialization in Europe. Per the announcement, the agreement includes proposed…
On April 25, 2023, Bristol-Myers Squibb (“BMS”) filed a complaint in the District of Delaware against AstraZeneca related to AstraZeneca’s anti-PD-L1 antibody product, IMFINZI (durvalumab), alleging willful infringement of U.S. Patent No. 9,402,899 (“the ’899 patent”). BMS alleges that the ’899 patent covers “Nobel Prize winning methods of treating cancer”…