Supreme Court Interprets Provisions Of Biologics Price Competition And Innovation Act

Supreme Court Interprets Provisions Of Biologics Price Competition And Innovation Act


On June 12, 2017, in its final patent-related decision of the October 2016 term, the U.S. Supreme Court issued a unanimous decision interpreting two disputed provisions in the Biologics Price Competition and Innovation Act of 2009, 42 U.S.C. 262 . The BPICA governs U.S. Food and Drug Administration market approval of "biosimilars," or biologic products that are highly similar to a biologic product previously approved for commercial marketing.



from Biotech News