Biosimilars Development

In November 2010, the US Food and Drug Administration held a two-day public hearing to discuss regulatory pathways for the development of generic versions of biologics — also known as biosimilars, after 12 years of patent exclusivity. While the many factors impacting the approach to the regulatory pathway in the United States are still being assessed and evaluated, Europe and Asia have defined pathways in place.

Because of the nature of biologics, biosimilar development requires a specific skill set: immunochemistry expertise, clinical development expertise with biologics, pharmacovigilance, an understanding of existing generic drug development approaches, and regulatory expertise. You will find all of these at PharmaNet.

In addition to providing insight into global requirements, PharmaNet consulting professionals include former senior-level FDA officials at the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) who offer unique insight into the agency’s thinking on this important development.