Pfenex Statement On FDA Release Of Draft Interchangeability Guidance

We commend the FDA on the release of draft guidance for establishing interchangeability between a biosimilar and a reference product, an important step in creating a robust market for biosimilars in the United States and ensuring greater patient access to medicines. This recommendation, which directs a biosimilar developer to submit data from a switching study in order to demonstrate interchangeability, signals the FDA’s support for the safety and efficacy of a biosimilar compared to a reference product.

As indicated by the FDA, an interchangeable biosimilar has been shown to “produce the same clinical result as a reference product in any given patient.” With this draft guidance, FDA has indicated support for switching studies, providing biosimilars developers a pathway to demonstrate interchangeability.

By definition, a biosimilar has shown to have “no clinically meaningful differences” with a reference product. Agency support for interchangeability is essential to supporting this construct, reducing physician and pharmacist confusion and encouraging a greater number of biosimilars developers to enter the market, ultimately leading to greater patient access to medicines. We look forward to final guidance by the agency anticipated later this year.