Ha Kung Wong and Melissa Gibson at FITZPATRICK, CELLA, HARPER & SCINTO review the US FDA approval pathway for biosimilar applications.
On March 23, 2010, the Biologics Price Competition and Innovation Act (BPCIA) was signed into law in the US. The BPCIA amended Section 351 of the Public Health Service Act (PHSA, 42 U.S.C. § 262), which governs the Food and Drug Administration (FDA) approval process for biologic license applications (BLAs). Similar to the Hatch-Waxman Act, the BPCIA is 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.
What are biologics?
The BPCIA defines three categories of biologics:
• innovative biologics,
• biosimilars, and
A biologic is defined as “a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide), or analogous product, or arsphenamine or derivate of arsphenamine (or any trivalent organic arsenic compound) applicable to the prevention, treatment, or cure of a disease or conditions of human beings.”2 Examples of biologics include human growth hormone, erythropoietins, insulin and monoclonal antibodies. Request a free trial to read more.