The Hatch-Waxman Act (Drug Price Competition and Patent Term Restoration Act), introduced in 1984, was a revolutionary piece of legislation that paved the way for the approval of small-molecule generic drugs offering patients safe, efficacious, and cost effective therapeutic options. Generic therapies continue to be an important treatment option, but as new, complex medications come to market, it's important that follow-on versions are properly evaluated to ensure patient safety.
Jill B. Conner, PhD
Last year, the Affordable Care Act enacted a pathway for biosimilar drugs to address the approval of these increasingly complex products. The FDA must now work to implement this new law and the framework for approval of products deemed "biosimilar" or "interchangeable." The new pathway, however, is mostly silent as to the treatment of non-biologic complex drugs (NBCDs), such as glatiramoids and liposomal drugs. For the next 10 years, any follow-on versions of biologic products and NBCDs will be approved under the Federal Food, Drug, and Cosmetic Act, if the innovative product was approved under that pathway. After 10 years, all biologics, follow-on and innovator, will be approved or deemed approved under the Public Health Service Act. A wide range of industry experts have provided recommendations to the FDA surrounding the approval pathway for these types of therapies; most recently, several global experts convened at a workshop in Leiden, Netherlands, to discuss the necessary requirements, with a specific focus on the importance of balancing the safety and immunogenicity concerns associated with certain complex drugs against an approach that encourages competition in the market.