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By Gina ShawThe FDA and the Department of Health and Human Services have issued new draft guidance that would remove the requirement for clinical “switching” studies to demonstrate that a biosimilar is interchangeable with its reference biologic.The proposal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