On March 5, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed the District Court for the Northern District of West Virginia’s entry of a preliminary injunction preventing Celltrion, Inc. (“Celltrion”) from launching CT-P42, its aflibercept biosimilar of EYLEA®. As we have previously reported, the Federal Circuit recently…
On February 18, 2025, Alvotech and Teva Pharmaceuticals (“Teva”) announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT06, a proposed biosimilar to EYLEA® 2 milligram (mg). AVT06 is an aflibercept biosimilar candidate for the treatment of eye disorders such…
CHMP Adopts Positive Opinion for Aflibercept, Pegfilgrastim Biosimilars: On January 30, 2025, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions recommending the grant of marketing authorizations for three biosimilar products—Amgen’s PAVBLU and SKOJOY, and CuraTeQ Biologics’ DYRUPEG. Amgen’s PAVBLU and SKOJOY, both biosimilars referencing EYLEA…
On January 29, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed the District Court for the Northern District of West Virginia’s entries of preliminary injunction preventing Samsung Bioepis Co., Ltd. (“Samsung”) and Formycon AG (“Formycon”) from marketing their aflibercept biosimilars of EYLEA®. The district court granted preliminary injunctions…
On January 10, 2025, Teva Pharmaceutical Industries Ltd. and Samsung Bioepis Co., Ltd. announced that they entered into a licensing agreement to commercialize EPYSQLI® (eculizumab-aagh), Samsung’s biosimilar of Soliris®, in the United States. According to the agreement, Samsung Bioepis will handle the development, regulatory registration, manufacturing, and supply of the…
As 2024 has come and passed, we saw another year of significant developments in litigation involving biologics and biosimilars. The following is a recap of the top four legal developments that we covered on the Big Molecule Watch last year. The Aflibercept BPCIA Litigations Continue Into 2025 As was the…
As 2025 begins, we would like to reflect on last year’s regulatory developments in the biologics and biosimilars space. Here are some of the top regulatory developments from 2024. 1. FDA Approvals in 2024 There were 17 FDA approvals of Biologic License Applications (“BLAs”), including for Autolus Inc.’s AUCATZYL…
The European Medicines Agency’s (EMA) Committee for Medicinal Use Products (CHMP) recently recommended approval of six new biosimilars. The CHMP recommended approval of four biosimilars developed by Celltrion: (1) AVTOZVMA (tocilizumab), for the treatment of rheumatoid arthritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, giant cell arteritis, CAR-T cell-induced…
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…
After the Federal Circuit’s denial last month of Regeneron’s motion for an injunction pending appeal, seeking to prevent Amgen from launching its aflibercept biosimilar, Amgen announced on its Q3 earnings call last week that it has launched its aflibercept biosimilar, PAVBLU. On the call, Murdo Gordon, Amgen’s Executive Vice President of…