Samsung Bioepis suspends development for its biosimilar referencing Eylea (aflibercept); the FDA updates its labeling recommendations for interchangeable biosimilars; Alvotech receives a Form 483 after the FDA reinspected its Iceland-based manufacturing facility.
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.
Alexion Pharmaceuticals, Inc. and Alexion Pharma International Operations Ltd. (collectively, "Alexion") filed a complaint on January 3, 2024, against Samsung Bioepis Co. Ltd.
On January 10, 2024, Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed a Complaint in the U.S. District Court for the Central District of California against Amgen Inc. (“Amgen”).