The Patent Lawyer
On March 23, 2010, the Biologics Price Competition and Innovation Act (BPCIA) was signed into law in the US. Similar to the Hatch-Waxman Act, the BPCIA was intended to create incentives for the manufacture of highly similar biological products (or biosimilars) by creating an abbreviated regulatory approval process and marketing exclusivities for the first interchangeable product. Although biological drug products (or biologics) represented five of the top 10 selling drugs in the United States in 2012, with combined sales over $18.6 billion,1 there has not been an application for a biosimilar in the three and a half years since the BPCIA has been enacted. This raises the question whether the incentives for filing an application for a biosimilar are outweighed by the uncertainties in the approval process. Ha Kung Wong and Melissa Gibson discuss how these uncertainties and the incentives provided for biosimilars might impact the development of biologics into the future.