As the Affordable Care Act approaches the 10-year anniversary of its being signed into law, one aspect of the ACA is poised to finally take effect this month. When the Biologics Price Competition and Innovation Act of 2009 (BPCIA) was enacted as part of the ACA, Congress left much of the details up to the FDA to determine. In addition to creating the 351(k) biosimilar approval pathway, Congress via the BPCIA intended to bring all biologics together under the same law, which it planned to do through the “deemed to be a license” provision.
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