Biosimilars of insulin lispro

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Last update: 26 January 2018

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.

Insulin 1 V13C03

The originator product, Eli Lilly’s Humalog (insulin lispro), was approved by the US Food and Drug Administration (FDA) in June 1996 and by the European Medicines Agency (EMA) in April 1996 [1]. Humalog generated an estimated US$2.8 billion in net sales income globally for Eli Lilly in 2016.

Humalog no longer has effective exclusivity through patent protection or data protection in either Europe or the US. Some of the insulin lispro biosimilars and non-originator biologicals approved or in development are presented in Table 1.

Table 1: Biosimilars and non-originator biologicals* of insulin lispro approved or in development

Company name, Country Product name Stage of development
Biocon/Mylan, India*/USA - ‘Similar biologic’ currently under preclinical/ scale-up development
Sanofi, USA Insulin lispro Sanofi (EU)/Admelog (US) Approved by EMA in May 2017 [2]. Approved by FDA in December 2017 [3]

EMA: European Medicines Agency.

*See editor’s comment

Sanofi’s insulin lispro biosimilar was approved by the EMA’s Committee for Medicinal Products for Human Use (CHMP) on 19 May 2017 [2]. Admelog (insulin lispro) was approved by the FDA on 11 December 2017 [3].

Generics giant Mylan and India-based Biocon have made an agreement to develop and market Biocon’s biosimilar versions of three insulin analogue products, which include Lantus, as well as Eli Lilly’s Humalog (insulin lispro) and Novo Nordisk’s NovoLog (insulin aspart) [4].

Editor’s comment
It should be noted that ‘similar biologics’ approved in India might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the European Union. The EMA (European Medicines Agency) regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.

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Biosimilars of insulin glargine

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. EMA approval for insulin and rituximab biosimilars []. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jan 26]. Available from:
3.   GaBI Online - Generics and Biosimilars Initiative. FDA approves follow-on insulin lispro Admelog []. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jan 26]. Available from:
4.   GaBI Online - Generics and Biosimilars Initiative. Mylan and Biocon to partner on insulin products []. Mol, Belgium: Pro Pharma Communications International; [cited 2017 May 23]. Available from:

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Source: EMA, US FDA

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