Eva Temkin Featured in Life Science Connect Q&A on Latest FDA Biosimilar Guidance
Arnold & Porter’s Eva Temkin, a partner within the Life Sciences & Healthcare Regulatory practice and former Acting Policy Staff Director at the Food and Drug Administration’s (FDA) Office of Therapeutic Biologics and Biosimilars, was recently interviewed for a Life Science Connect Q&A “FDA Draft Guidance On CES Signals More Reliance On Toxicity And PK,” published by Bioprocess Online, Biosimilar Development, and Outsourced Pharma.
In the interview, Eva discusses the FDA’s latest draft guidance revising its position on comparative efficacy studies (CES) for biosimilars, shifting its focus to other evidence of biosimilarity — namely, comparative analytical assessments. “I think what the FDA is saying now is that there is a greater presumption — this is how I read the draft guidance — that you don't need a comparative clinical efficacy study,” she said. “The guidance sets out a couple of places where it expects that a comparative clinical efficacy study might still be necessary. For example, this applies to locally acting products such as intravitreally-administered products where comparative PK isn't feasible or clinically relevant…But largely speaking, FDA is viewing analytics and PK as the new belt and suspenders under this draft guidance.”
