Insulin glargine biosimilar in US delayed until end 2016

Biosimilares/Novedades | Posted 23/10/2015 post-comment0 Post your comment

Pharmaceutical majors Eli Lilly and Sanofi announced on 28 September 2015 that the two companies had agreed to end the legal dispute over biosimilar insulin glargine in the US and to discontinue similar disputes worldwide.

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The two companies have made a deal to resolve patent litigation brought by Sanofi against Eli Lilly and its partner, Boehringer Ingelheim (BI), regarding their insulin glargine product, Basaglar.

Under the terms of the agreement Eli Lilly and BI will be able to launch Basaglar in the US on 15 December 2016. As part of the agreement Eli Lilly will pay royalties to Sanofi to enable it to manufacture and sell Basaglar in the Kwikpen device globally.

This is quite a delay, considering the fact that the patents on the originator product, Lantus, expired in the US and Europe in 2014 [1]. Investors had also assumed that Eli Lilly would launch Basaglar at the latest in the US in June 2016, once the 30-month stay under the Hatch-Waxman Act triggered due to the patent litigation had expired.

Eli Lilly and BI’s biosimilar insulin glargine Basaglar was approved by the European Medicines Agency in September 2014 [2]. Eli Lilly has filed for a similar approval for its biosimilar insulin glargine product, Basaglar, in the US.

The settlement, according to Sanofi’s statement, does not cover the drug packaged in vials or any Lantus combination products.

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1.   GaBI Online - Generics and Biosimilars Initiative. Biological patent expiries []. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Oct 23]. Available from:
2.   GaBI Online - Generics and Biosimilars Initiative. European approval for biosimilar insulin []. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Oct 23]. Available from:

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Source: Eli Lilly, Reuters, Sanofi

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