MedCity News August 31, 2023
Legislation introduced by Utah Senator Mike Lee would eliminate testing to show a biosimilar can be substituted for a reference biologic product. Lee contends the current testing requirement adds costs and delays market access for these lower-cost biological medicines.
Samsung Bioepis is one of several companies angling to market a follow-on version of the blockbuster immunology drug Humira, and the company recently reported preliminary data from a study showing its product could be substituted for the AbbVie medicine. Proposed federal legislation would eliminate this requirement, which bill sponsors characterize as unnecessary and expensive.
Sen. Mike Lee, a Utah Republican, initially introduced the bill last fall. The bill was recently reintroduced with a Democratic sponsor, Ben Ray Lujan from New Mexico....