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.
The US Food and Drug Administration (USFDA) conducted the inspection from December 14 to December 22, 2023. The inspection closed with six observations, Zydus Lifesciences said in a regulatory filing.
Bengaluru: Biocon Sdn Bhd., a step-down subsidiary of Biocon Biologics Limited has received a communication from the U.S. Food and Drug Administration (FDA) pursuant to its July 2023 cGMP inspection.