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Sanofi receives tentative FDA approval for insulin lispro biosimilar Posted 15/09/2017

Pharma giant Sanofi announced on 1 September 2017 that it had received tentative approval for Admelog, its insulin lispro biosimilar, from the US Food and Drug Administration (FDA).

Insulin lispro is a fast acting insulin analogue used to treat people living with type 1 or type 2 diabetes. Insulin lispro has one primary advantage over regular insulin for postprandial glucose control. It has a shortened delay of onset, allowing slightly more flexibility than regular insulin, which requires a longer waiting period before starting a meal after injection. Both types should be used in combination with a longer acting insulin for good glycaemic control.

Admelog is a proposed biosimilar to Eli Lilly’s Humalog (insulin lispro), which had worldwide sales of US$2.8 billion in 2016. Humalog no longer has effective exclusivity through patent protection or data protection in either Europe or the US [1].

The tentative approval is based on physicochemical, non-clinical and clinical similarity to another insulin lispro 100 units/mL as currently approved in the US, including data from a clinical development programme involving more than 1,000 adults living with type 1 or type 2 diabetes. Admelog is contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to insulin lispro or one of its other ingredients.

With the tentative approval, FDA concluded that Admelog met all necessary regulatory requirements for approval in the US, pending any patent issues that are yet to be resolved.

Sanofi started phase I clinical development for both insulin lispro and insulin aspart biosimilars back in 2013 [2]. The move into biosimilars is seen as an attempt to broaden its diabetes portfolio. The French drugmaker also makes an originator insulin product, Lantus (insulin glargine). According to Stefan Oelrich, Senior Vice President and Head, Global Diabetes Franchise, Sanofi, the tentative approval will not only broaden their portfolio, but also ‘help people living with diabetes manage their blood sugar’.

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1. Derbyshire M. Patent expiry dates for biologicals: 2016 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2017;6(1):27-30. doi:10.5639/gabij.2017.0601.006
2. GaBI Online - Generics and Biosimilars Initiative. Sanofi starts biosimilar insulin trials [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 15]. Available from: www.gabionline.net/Biosimilars/News/Sanofi-starts-biosimilar-insulin-trials

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Source: Sanofi

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