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Pharmaceuticals / Regulatory Affairs

Novo Nordisk Petitions FDA to Require Clinical Trials for Victoza Copies

Oct. 13, 2017
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Novo Nordisk called on the FDA to require clinical trials for proposed biosimilars for its blockbuster diabetes drug Victoza.

In a citizen petition, the company argued the drug, whose patent expires in 2022, is sufficiently complex that trials are needed to establish similarity, and other existing analytical tools can’t adequately measure the similarity.

Novo Nordisk cited the nasal spray Fortical as a precedent, noting the FDA ruled the abbreviated approval path was not appropriate for a biosimilar product.

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