The public has wondered for some time why seemingly outrageous pricing for insulin and other critical medications has been tolerated. In a move that may bring some relief, the U.S. Food and Drug Administration (FDA) has amended its definition of a biologic product. While it may seem like a bureaucratic move with little relevancy, it is a needed transitional step resulting from the Biologics Price Competition and Innovation Act of 2009 (BPCIA).
Source: Regulatory Focus, February 20, 2020. Link. This transition will open new pathways for manufacturers to bring biosimilar and interchangeable versions of insulin and other transitioning products to market,” and that, when these products “are eventually approved, a variety of new treatment options will be available, which may make pricing more competitive,” said FDA Commission Stephen Hahn.