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FDA denies Novo Nordisk petition to block generic liraglutide Posted 02/02/2018

On 5 January 2018, the US Food and Drug Administration (FDA) denied Novo Nordisk’s October 2017 citizen petition [1] that sought to block generic versions of its insulin Victoza (liraglutide) and two other liraglutide containing products. In 2016, Victoza (liraglutide) brought the company US$3.2 billion in sales.

In the petition, the Danish multinational pharmaceutical company asked FDA not to approve abbreviated new drug applications (ANDAs) for liraglutide referencing products without clinical comparative studies that indicate the candidate has a similar safety and efficacy profile. They argued that type 2 diabetes drugs containing liraglutide are large and complex molecules and that there may be unintended consequences if it is produced by manufacturing processes that differ to those they have developed. Novo also noted that FDA has not issued guidance on qualification levels for some impurities and that, in their own analytical comparisons of Victoza with generic copies from unidentified suppliers, it found impurity profiles that differed from its own.

FDA’s letter that denies the petition notes that it issued a draft guidance in October 2017 and that this covers five peptide drug products, including liraglutide. This was issued to help potential applicants determine when a synthetic peptide that refers to a previously approved peptide of recombinant DNA (rDNA) origin should be submitted as an ANDA or a new drug application (NDA), 505(b)(2).

In February 2017, Teva filed an ANDA and hopes to have the first generic liraglutide product on the market in due course.

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1. GaBI Online - Generics and Biosimilars Initiative. Novo Nordisk petitions FDA to require clinical trials for Victoza biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Feb 2]. Available from: www.gabionline.net/Biosimilars/News/Novo-Nordisk-petitions-FDA-to-require-clinical-trials-for-Victoza-biosimilars

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