In a letter to the Senate Committee on Health, Education, Labor, and Pensions, members of the Alliance of Specialty Medicine expressed concerns regarding the Biosimilar Red Tape Elimination Act (S.1954). This legislation addresses the designation of interchangeable biosimilar products. The Alliance is concerned with the presumption that an approved biosimilar product may be deemed interchangeable with the reference biologic product without requiring additional switching studies by the biopharmaceutical manufacturer. Members are also concerned that health insurance plans and their pharmacy benefit managers (PBMs) may use this Act as a vehicle to exacerbate existing step therapy protocols. You can access the full letter by clicking on the link below.
