The Biologics Price Competition and Innovation Act of 2009, enacted as part of the Affordable Care Act, established a uniform process for approval of “generic” versions of biopharmaceuticals previously approved by the U.S. Food and Drug Administration. The BPCIA also set forth conditions for regulatory exclusivity and a streamlined process for any patent litigation.
But the law was nearly useless for companies hoping to market these so-called biosimilars because there was no FDA guidance on how to qualify as a drug that pharmacists are permitted to substitute for the brand name product.
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