The Patient Protection and Affordable Care Act is most well-known for creating a mandate requiring individuals to have health insurance. However, another provision of the Act, the Biologics Price Competition and Innovation Act, created a new process for companies to introduce biosimilars, products that are highly similar to licensed drugs in terms of purity, safety, and potency, but have minor differences in the inactive ingredients. This provision seeks to alleviate strain on companies introducing biosimilars by creating an abbreviated pathway for their approval by the Food and Drug Administration, similar to an Abbreviated New Drug Application under the Hatch-Waxman Act. This article provides a comprehensive overview of the Biologics Price Competition and Innovation Act and contrasts it with the Hatch-Waxman Act and European Law on Biosimilars. Strategies for patent claiming and resolving patent disputes are then discussed.
Shawn P. Gorman, Adrian Pishko, John Iwanicki & Judith Stone-Hulslander, The Biosimilars Act: The United States’ Entry into Regulating Biosimilars and its Implications, 12 J. Marshall Rev. Intell. Prop. L. 322 (2013)