Summary
This memorandum provides background on the Food and Drug Administration’s (FDA’s) implementation of the Biologics Price Competition and Innovation Act’s (BPCIA) abbreviated licensure pathway for products that are biosimilar to – or interchangeable with – a licensed biologic reference product. After a lengthy wait for implementing guidance, key pieces of which remain pending, biosimilars implementation has begun to accelerate. The FDA and Centers for Medicare and Medicaid Services’ (CMS) policy on biosimilars naming, reimbursement and other areas will significantly affect both biosimilar and innovator therapies as it is codified. States also are wading into biosimilars policy with varying policy objectives, including easing biosimilar adoption or curtailing unwanted switching among therapies.