Biosimilar Dealmaking Moves The Needle Forward

The establishment of a regulatory approval pathway in the US – via the enactment of the Biologics Price Competition and Innovation Act of 2009 as part of the Affordable Care Act – has given way to approval of the first US biosimilars, two of which have launched to date (Sandoz International GMBH's Zarxio (filgrastim-sndz) and Pfizer Inc.'s Inflectra (infliximab-dyyb). In the European Union, where there has been a regulatory pathway for considerably longer, 23 biosimilars are approved. The potential cost-savings from biosimilars provide incentives to companies to advance these therapeutics. And dealmaking has helped those efforts.