Dr Kimberly Maxfield Highlights FDA's Education Efforts to Increase Biosimilar Comfort

Kimberly Maxfield, PhD, of the FDA explained how the FDA is uplifting the US biosimilar industry. Maxfield expanded upon the biosimilars topic during the AMCP Nexus session, "Biosimilar Operational Readiness: Marketplace Trends and Regulatory Considerations" on October 17.

At the FDA, Maxfield currently serves as the scientific lead on the Biosimilar User Fee Act (BsUFA) III regulatory research pilot program in the Office of Therapeutic Biologics and Biosimilars (OTBB).

Transcript

What do you wish more people understood about what the FDA is doing to uplift the US biosimilar industry?

The biosimilar lifecycle includes many pieces of the health care market and industry. We have the development, we have the marketing, we have the formulary access, we have the clinician comfort. FDA is purview in sort of that lifecycle, at the development phase, and in that education phase.

The regulatory science program is very focused on the time and cost of licensure, so it's very focused on the actual development program, the data package that's submitted as part of a 351(k) application.

However, the FDA is also doing a lot of educational efforts that are targeting patients, that are targeting providers, that are targeting pharmacists to inform them about what a biosimilar is and how it is different from a generic; that's just to increase comfort.

There's a lot of confusion between biosimilarity and interchangeability, and even in FDA's efforts to streamline the development process, we're never compromising on the statutory requirements or the safety and efficacy. Everything we're doing is trying to build on our experience, to build on others' experience. In the product quality information for biosimilars, every biosimilar and every interchangeable is exactly the same.