By now it is well settled that we have entered the biosimilars era in the U.S. pharmaceutical industry timeline. The Supreme Court of the United States upheld the Patient Protection and Affordable Care Act of 2011 sealing the fate of its Title VI, the Biologics Price Competition and Innovation provision (BPCIA). The question is no longer whether, but when the first biosimilar product will reach the U.S. market.
The BPCIA provision amended the Public Health Service Act, creating the regulatory framework of an abbreviated process for biological products into the U.S. market. It further granted the Secretary of Health and Human Services the ability to set the pathway for approval of such products. Despite the issuance of the draft guidance by the Food and Drug Administration (FDA) setting forth a stepwise approach in demonstrating biosimilarity between a proposed biologic and a reference product, there remains much ambiguity for strategizing and obtaining biosimilar products into the American market.
This article highlights two considerations for companies interested in exploring the created path to biosimilar commercialization.
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The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
