FDA approves first follow-on insulin glargine treatment

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The US Food and Drug Administration (FDA) announced on 16 December 2015 that it had approved Eli Lilly/Boehringer Ingelheim’s biosimilar version of Sanofi’s Lantus (insulin glargine) diabetes treatment.

Insulin 1 V13C03

The biosimilar, which will be called Basaglar in the US, is a long-acting human insulin analog used to improve glycaemic control in adult and paediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.

Basaglar is the first insulin product approved through the abbreviated approval pathway made possible by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). Although in its press announcement FDA calls the product a ‘follow-on’ version rather than a biosimilar, it goes on to state that ‘Basaglar was sufficiently similar to Lantus to scientifically justify’ the approval. The approval of Basaglar was based on data, which included two clinical trials enrolling 534 and 744 patients with type 1 and 2 diabetes mellitus, respectively.

According to the Centers for Disease Control and Prevention, approximately 21 million people in the US have been diagnosed with diabetes.

In September 2015, Eli Lilly made a settlement with Sanofi to resolve patent litigation over Basaglar. Under the terms of the agreement, Eli Lilly and Boehringer Ingelheim can only launch Basaglar in the US in December 2016 [1]. As part of the agreement Eli Lilly will pay royalties to Sanofi to enable it to manufacture and sell Basaglar in the Kwikpen injection device globally.

Lantus generated an estimated US$6.3 billion in net sales income globally for Sanofi in 2014.

Eli Lilly and Boehringer Ingelheim’s biosimilar insulin glargine Abasaglar was approved by the European Medicines Agency (EMA) in September 2014 [2]. The companies also received Japanese regulatory approval for their biosimilar insulin glargine product (LY2963016) in January 2015 [3]. While more recently Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) gave a positive recommendation for the listing of the companies’ biosimilar insulin glargine, Basaglar in the country’s Pharmaceutical Benefits Scheme (PBS) [4]. This latest regulatory approval is the 11th for Basaglar worldwide.

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1.  GaBI Online - Generics and Biosimilars Initiative. Insulin glargine biosimilar in US delayed until end 2016 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jan 8]. Available from: www.gabionline.net/Biosimilars/News/Insulin-glargine-biosimilar-in-US-delayed-until-end-2016 
2.  GaBI Online - Generics and Biosimilars Initiative. European approval for biosimilar insulin [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jan 8]. Available from: www.gabionline.net/Biosimilars/News/European-approval-for-biosimilar-insulin 
3.  GaBI Online - Generics and Biosimilars Initiative. Japanese approval for insulin glargine biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jan 8]. Available from: www.gabionline.net/Biosimilars/News/Japanese-approval-for-insulin-glargine-biosimilar 
4.  GaBI Online - Generics and Biosimilars Initiative. Australian approval for biosimilar insulin [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jan 8]. Available from: www.gabionline.net/Biosimilars/News/Australian-approval-for-biosimilar-insulin

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Source: Eli Lilly,US FDA

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