Biosimilars Law In Limbo

Law360, New York (January 25, 2012, 3:08 PM EST) -- On March 23, 2010, the Biologics Price Competition and Innovation Act was signed into law as part of the larger health care reform bill, the Patient Protection and Affordable Care Act of 2010. The BPCIA is designed to create an approval pathway for biological products that are demonstrated to be highly similar to U.S. Food and Drug Administration-approved biological products.

Although the biosimilars law was enacted, it is not a settled matter. The political debate between supporters and opponents is still ongoing regarding many aspects of...
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