[LY2963016 insulin glargine: The first biosimilar insulin

Presse Med · Oct 2018

Review Comparative Study

[LY2963016 insulin glargine: The first biosimilar insulin approved in the European Union].

Biosimilars are not generics. They are similar, but not exactly identical to the biological reference product. The development plan of a biosimilar should assess the physical, chemical and biological properties (quality), as well as toxicological (safety), pharmacodynamic, pharmacokinetic, and clinical (efficacy and safety) characteristics of the biosimilar developed. ⋯ Abasaglar®, a biosimilar of insulin glargine, is the first insulin biosimilar approved in the European Union. Phase III studies, ELEMENT 1 in patients with type 1 diabetes mellitus and ELEMENT 2 in patients with type 2 diabetes mellitus, showed LY2963016 insulin glargine to have similar efficacy and a comparable safety profile to the insulin glargine Lantus®. Policies for interchangeability/substitutability between a biosimilar and the reference product are decided at national level in Europe (LFSP, ANSM).

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- Jean-Jacques Altman, Nicolas Chevalier, Brigitte Delemer, Florence Travert, and Imane Benabbad.
- Hôpital européen Georges-Pompidou, 75015 Paris, France. Electronic address: jean-jacques.altman@aphp.fr.
- Presse Med. 2018 Oct 1; 47 (10): 854866854-866.
AbstractBiosimilars are not generics. They are similar, but not exactly identical to the biological reference product. The development plan of a biosimilar should assess the physical, chemical and biological properties (quality), as well as toxicological (safety), pharmacodynamic, pharmacokinetic, and clinical (efficacy and safety) characteristics of the biosimilar developed. The development of generics requires bioequivalence studies in healthy volunteers. Abasaglar®, a biosimilar of insulin glargine, is the first insulin biosimilar approved in the European Union. Phase III studies, ELEMENT 1 in patients with type 1 diabetes mellitus and ELEMENT 2 in patients with type 2 diabetes mellitus, showed LY2963016 insulin glargine to have similar efficacy and a comparable safety profile to the insulin glargine Lantus®. Policies for interchangeability/substitutability between a biosimilar and the reference product are decided at national level in Europe (LFSP, ANSM).Copyright © 2018 The Authors. Published by Elsevier Masson SAS.. All rights reserved.

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[LY2963016 insulin glargine: The first biosimilar insulin approved in the European Union].

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