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Pharmaceuticals / Regulatory Affairs

Novartis Urges FDA to Flag Common Misconceptions About Biosimilars

Nov. 28, 2018

Piggybacking on a petition from Pfizer, Novartis called on the FDA to debunk common myths about biosimilars and better educate consumers about their safety and efficacy.

Pfizer petitioned the agency in August to release a final version of 2017 draft guidance aimed at preventing misleading communications from reference drug sponsors on the effectiveness of biosimilars, citing numerous misleading claims that biosimilars were inferior.

In its comment on the petition, Novartis suggested the agency create a “Facts about Biosimilars” website to combat misinformation about the drugs.

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