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…
On September 17, Express Scripts, Inc. (“Express Scripts”), one of the largest pharmacy benefit managers (PBMs) in the United States, brought suit against the Federal Trade Commission (“FTC”) over its July 2024 interim report on the PBM industry. Express Scripts claims that the FTC’s report, titled “Pharmacy Benefit Managers: The Powerful…
On July 9, 2024, the Federal Trade Commission (“FTC”) released an interim report describing their ongoing study of pharmacy benefit managers (“PBMs”) and their impact on access to and affordability of medicines. According to the FTC, “PBMs are at the center of the complex pharmaceutical distribution chain that delivers a wide…