Biobetters: The Advantages and Challenges of Being Better

June 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.

To continue reading Irena Royzman and Andrew Cohen’s article from Bloomberg BNA’s Life Sciences Law & Industry Report, please click here.