FDA Considering Biosimilars ‘Guardrails’
US Agency May Take Steps To Prevent Misinformation In Communications
Agency wants to ensure patients ‘aren’t unnecessarily or unfairly scared off or intimidated’ from taking biosimilars, Office of Therapeutic Biologics and Biosimilars' acting policy director Eva Temkin tells the FDA/CMS Summit; Temkin says recent guidance on biosimilar insulins shows agency is trying to be flexible on interchangeability data requirements.
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Two agencies to take action against false or misleading communications about biosimilars, impediments to sampling, and anticompetitive patent settlement agreements; to hold public workshop in March.
In a move that will likely be welcomed by industry, the US FDA issued draft guidance stating that sponsors will generally not need to conduct comparative clinical immunogenicity studies in developing biosimilar/interchangeable products.
Payers are driving the selection of reference products or biosimilars, creating an ‘artificial interchangeability’ unlikely to be affected by the actual regulatory designation, industry reps say; former FDA commissioner Scott Gottlieb says misinformation campaigns around biosimilar and interchangeable products may lead to enforcement by the FDA and Federal Trade Commission.