Generics maker Mylan has started two US phase III clinical trials for a biosimilar version of French drugmaker Sanofi’s diabetes drug Lantus (insulin glargine).
The studies are designed as non-inferiority studies and will evaluate the efficacy and safety of Mylan’s biosimilar insulin glargine compared with Lantus in Type 1 (INSTRIDE 1) and Type 2 (INSTRIDE 2) diabetes mellitus patients.
The trials, which are currently recruiting participants, according to ClinTrials.gov, are both multicentre, open-label, randomized, active controlled, parallel-group studies. For both trials Mylan plans to evaluate the change in HbA1c (glycated haemoglobin – a measure of blood sugar level) from baseline to 24 weeks in patients with diabetes. Secondary objectives for the trials include an assessment of the immunogenicity and rate of hypoglycaemic events and hypoglycaemia occurrence of Mylan’s biosimilar insulin glargine compared to Lantus. For the INSTRIDE 1 trial 500 patients with type 1 diabetes will be recruited, while for the INSTRIDE 2 trial 600 patients with type 2 diabetes will be recruited.
Both trials will be carried out in Texas, and started recruiting patients, aged 18 years and above, in August 2014 and are expected to be completed by June 2016.
Mylan made a deal with India-based Biocon to develop and market Biocon’s biosimilar versions of three insulin analogue products in February 2013 [1].
Mylan is not the only company aiming to produce biosimilar insulin glargine. Merck and Samsung Bioepis made a deal to develop and commercialize biosimilars, including insulin glargine (MK-1293), back in February 2013 [2]. The companies have two phase III trials also currently recruiting patients, which are expected to be completed by early 2015. While partners Eli Lilly and Boehringer Ingelheim received European Commission approval for their biosimilar insulin glargine product, Abasria (LY2963016), on 10 September 2014 [3].
The patent for Lantus is expected to expire in both Europe and the US in 2014 [4]. Lantus sales were Euros 5.7 billion during 2013, making it a lucrative target for biosimilars developers.
Insulin glargine is not the only biosimilar that Mylan has in its sights. The company launched its trastuzumab ‘similar biologic’ Hertraz in the Indian market in February 2014 [5].
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 EU. 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 articles
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Merck and Samsung Bioepis collaborate on biosimilar insulin
Biosimilars approved in Europe
References
1. GaBI Online - Generics and Biosimilars Initiative. Mylan and Biocon to parter on insulin products [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Oct 3]. Available from: www.gabionline.net/Biosimilars/News/Mylan-and-Biocon-to-partner-on-insulin-products
2. GaBI Online - Generics and Biosimilars Initiative. Merck makes biosimilars deal with Samsung Bioepis [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Oct 3]. Available from: www.gabionline.net/Biosimilars/News/Merck-makes-biosimilars-deal-with-Samsung-Bioepis
3. GaBI Online - Generics and Biosimilars Initiative. European approval for biosimilar insulin [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Oct 3]. Available from: www.gabionline.net/Biosimilars/News/European-approval-for-biosimilar-insulin
4. GaBI Online - Generics and Biosimilars Initiative. US$67 billion worth of biosimilar patents expiring before 2020 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Oct 3]. Available from: www.gabionline.net/Biosimilars/General/US-67-billion-worth-of-biosimilar-patents-expiring-before-2020
5. GaBI Online - Generics and Biosimilars Initiative. Mylan launches trastuzumab ‘similar biologic’ in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Oct 3]. Available from: www.gabionline.net/Biosimilars/News/Mylan-launches-trastuzumab-similar-biologic-in-India
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Source: ClinTrials.gov, Sanofi
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