Novo Nordisk granted exclusivity on GLP-1 agonist Victoza until 2023

Generics and biosimilars Initiative

Building trust in cost-effective treatments

Inscribirse
eng / esp

Novo Nordisk granted exclusivity on GLP-1 agonist Victoza until 2023

INICIO/Noticias Farmacéuticas | Posted 12/04/2019 0 Post your comment

Novo Nordisk has announced a settlement with Teva Pharmaceuticals (Teva) giving the company at least four years before it has to compete with biosimilar versions of its diabetes injectable Victoza (liraglutide).

Victoza is an injectable drug used for the treatment of type 2 diabetes and obesity, developed by Danish pharmaceutical firm Novo Nordisk.

Victoza mimics the hormone GLP-1, which increases the secretion of insulin and thereby reduces blood glucose levels. Victoza is used in patients whose diabetes cannot be controlled by other, more commonly used medications such as metformin. It can also be used for weight management in adults with a BMI above 30 kg/m²(or 27 kg/m² if the patient also has high blood pressure, type 2 diabetes or dyslipidaemia).

Novo Nordisk’s patent on Victoza is set to expire in 2022. Back in 2017, Israeli generics firm Teva filed an abbreviated new drug application (ANDA) with the US Food and Drug Administration (FDA) to market a biosimilar version of the drug.

Soon after, Novo Nordisk petitioned FDA to require clinical trials for biosimilars of Victoza, citing its complex manufacturing process [1]. The petition was rejected by FDA [2]. The agency highlighted draft guidance released in October 2016, which covered liraglutide and four other peptide drugs.

The most recent settlement between Teva and Novo Nordisk, announced on 18 March 2019, means Teva cannot launch a generic version of Victoza until 22 March 2023 at the earliest and likely not until 22 December 2023.

Novo Nordisk could also be granted a paediatric extension for Victoza, which would extend the above deadline by six months (to June 2024). The remainder of the agreement remains confidential and is subject to review by the US Federal Trade Commission and the US Department of Justice.

Jesper Brandgaard, Executive Vice President and Head of Biopharm and legal affairs for Novo Nordisk, said the settlement reflects the comprehensive US patent portfolio for liraglutide, adding ‘Novo Nordisk will continue to defend our broad intellectual property portfolio for innovative drugs against challenges’.

The company is currently developing an oral version of Victoza, aiming for FDA approval before the end of 2019. They have also launched a weekly GLP-1 agonist (Semaglutide, marketed as Ozempic) in an attempt to fend off competition.

References
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 2019 Apr 12]. Available from: www.gabionline.net/Biosimilars/News/Novo-Nordisk-petitions-FDA-to-require-clinical-trials-for-Victoza-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. FDA denies Novo Nordisk petition to block generic liraglutide [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Apr 12]. Available from: www.gabionline.net/Generics/General/FDA-denies-Novo-Nordisk-petition-to-block-generic-liraglutide

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Source: Novo Nordisk