Annals of Unintended Consequences: How FDA regulations undermine the biosimilar marketplace and the BPCIA – The Cancer Letter

In March 2010, as part of Affordable Care Act, Congress passed a well-conceived and critical legislative bill, the Biologic Pricing and Competition Innovation Act of 2009 (BPCIA)i. Despite its intentions, BPCIA has been instituted so that it complicates prescribing while increasing health care costs and reducing competition, rather than resulting in the anticipated benefits.

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