Biobetters: The Advantages and Challenges of Being BetterJune 2015
The Biologics Price Competition and Innovation Act of 2009 (BPCIA) was passed as part of health reform signed into law by President Barack Obama in March 2010. The BPCIA created an abbreviated pathway for Food and Drug Administration approval of biologic medicinal products that are ‘‘biosimilar’’ to an already FDA-approved product. Because biologic drugs, also referred to as biologics, are complex molecules made in living organisms rather than chemically synthesized, biosimilars are not copies of an approved biologic product. Instead, the BPCIA requires a biosimilar to be ‘‘highly similar’’ to the approved product without any clinically meaningful differences in terms of safety, purity and potency.
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