Home / Biosimilars / General / Biosimilars of insulin lispro

Biosimilars of insulin lispro Posted 18/08/2017

Last update: 18 August 2017

Insulin glargine 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.

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

Approved by EMA in May 2017 [1]

EMA: European Medicines Agency.

*See editor’s comment

Sanofi’s insulin lispro biosimilar was approved by EMA’s Committee for Medicinal Products for Human Use on 19 May 2017 [1].

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) [2].

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.

Related article
Biosimilars of insulin glargine

References
1. GaBI Online - Generics and Biosimilars Initiative. Biologicals patent expiries [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Aug 18]. Available from: www.gabionline.net/Biosimilars/General/Biologicals-patent-expiries
2. GaBI Online - Generics and Biosimilars Initiative. Mylan and Biocon to partner on insulin products [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Aug 18]. Available from: www.gabionline.net/Biosimilars/News/Mylan-and-Biocon-to-partner-on-insulin-products

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2017 Pro Pharma Communications International. All Rights Reserved.

Source: EMA, US FDA

Comments (0)