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

AJMC October 22, 2023
Brooke McCormick

Kimberly Maxfield, PhD, of the FDA reflected upon how the FDA is uplifting the US biosimilar industry.

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...

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