FDA to review insulin biosimilar

Biosimilars/News | Posted 31/01/2014 post-comment0 Post your comment

Eli Lilly and Boehringer Ingelheim announced on 20 December 2013 that the US Food and Drug Administration (FDA) had accepted their New Drug Application (NDA) for a biosimilar insulin product.

Insulin 1 V13C03

The biosimilar (LY2963016) is an investigational basal (long-acting) insulin for the treatment of type 1 and type 2 diabetes. The product is a biosimilar of Lantus (insulin glargine), which is produced by Sanofi.

The NDA was filed through the 505(b)(2) regulatory pathway, which allows FDA to reference their previous findings of safety and efficacy data for an already-approved insulin glargine product, in addition to the studies of LY2963016. Another advantage for Eli Lilly and Boehringer Ingelheim of using this pathway instead of the biosimilars pathway is that the applicant may qualify for three, five or even seven years of market exclusivity.

Eli Lilly and Boehringer Ingelheim studied LY2963016 in a comprehensive clinical development programme, which included comparative pharmacokinetic and pharmacodynamic studies as well as phase III studies in patients with type 1 and type 2 diabetes. Lantus (insulin glargine) was used as the active comparator.

During 2013, Lantus had worldwide sales of Euros 5 billion (US$6.6 billion) making it Sanofi’s top-selling product. Worldwide, Lantus accounts for around 80% of the market for long-acting or basal insulins used to treat diabetes. The US and European patents for Lantus are expected to expire in 2014 [1], opening up the market for competition from biosimilars.

Around 24.4 million Americans suffer from diabetes, and Dr Gwen Krivi, Vice President, Eli Lilly Diabetes Product Development said that ‘the US regulatory submission for our new insulin glargine product demonstrates our progress in bringing another option to the millions of Americans with diabetes who require long-acting insulin as an integral part of their treatment plan’.

In July 2013, the companies also announced that the marketing application for their biosimilar insulin product (LY2963016) had been accepted by the European Medicines Agency (EMA) [2], and to date it remains on the list of biosimilars under review [3].

Related articles

Sanofi starts biosimilar insulin trials

Positive results from phase I study with biosimilar insulin glargine

Boehringer Ingelheim joins other Big Pharma going into biosimilars


1.  GaBI Online - Generics and Biosimilars Initiative. US$67 billion worth of biosimilar patents expiring before 2020 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jan 31] Available from: www.gabionline.net/Biosimilars/General/US-67-billion-worth-of-biosimilar-patents-expiring-before-2020

2.  GaBI Online - Generics and Biosimilars Initiative. EMA reviewing biosimilar insulin application [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jan 31] Available from: www.gabionline.net/Biosimilars/News/EMA-reviewing-biosimilar-insulin-application

3.  GaBI Online - Generics and Biosimilars Initiative. Biosimilars applications under review by EMA – 2013 Q4 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jan 31]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-applications-under-review-by-EMA-2013-Q4 

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Source: Eli Lilly

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