Novo Nordisk petitions FDA to require clinical trials for Victoza biosimilars Posted 27/10/2017

Danish pharmaceutical company Novo Nordisk has asked the US Food and Drug Administration (FDA) to require clinical trials for biosimilar applications for its blockbuster diabetes drug Victoza (liraglutide).

Victoza is a glucagon-like peptide-1 (GLP-1) agonist. It is an injectable prescription medicine that may improve blood sugar (glucose) in adults with type 2 diabetes when used along with diet and exercise. The drug is not recommended as the first medication to treat diabetes and is not a substitute for insulin. It is also not for people with type 1 diabetes or people with diabetic ketoacidosis.

In its citizen petition, Novo Nordisk argues that the manufacturing process for Victoza, whose patent expires in 2022, is so complex that equivalence of a biosimilar cannot be established without clinical trials. The company also added that existing analytical tools cannot adequately measure the similarity. The petition, in fact, asks FDA to refrain from approving abbreviated new drug applications (ANDAs) that reference any of its liraglutide-containing drugs. This means that it also covers Saxenda (liraglutide) and Xultophy (insulin degludec/liraglutide).

Novo Nordisk pointed out that it is not unprecedented for FDA to determine that a different manufacturing process might lead to a different result. It cites the nasal spray Fortical (calcitonin – a polypeptide hormone) as an example, saying that FDA ruled the abbreviated approval path was not appropriate for biosimilars of that product. It should be pointed out, however, that Fortical is a drug-device combination product, so possibly not such a similar case?

Israeli generics giant Teva Pharmaceutical Industries announced back in February 2017 that it had filed an ANDA with FDA seeking approval to market a generic version of Victoza (liraglutide) injection in the US. While in August 2017, Novo Nordisk announced that it had received FDA approval for a new indication for Victoza to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease.

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Source: US FDA,Novo Nordisk, Teva

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