Is-Relief-in-Sight-for-Interchangeable-Biosimilars

By Gina ShawThe FDA and the Department of Health and Human Services have issued new draft guidance that would remove the requirement for clinical “switching” studies to demonstrate that a biosimilar is interchangeable with its reference biologic.The proposal is part of a broader federal effort to speed biosimilar development, increase competition, and lower drug costs, HHS announced in a joint press release.“This is a decisive action to spur competition and bring down the cost