학술논문
[LY2963016 insulin glargine: The first biosimilar insulin approved in the European Union].
Document Type
Academic Journal
Author
Altman JJ; Hôpital européen Georges-Pompidou, 75015 Paris, France. Electronic address: jean-jacques.altman@aphp.fr.; Chevalier N; CHU de Nice, département d'endocrinologie, diabétologie & médecine de la reproduction, 06202 Nice, France.; Delemer B; CHU de Reims, service d'endocrinologie, maladies métaboliques, pôle digestif, 51100 Reims, France.; Travert F; Hôpital Bichat, 75877 Paris, France.; Benabbad I; Lilly France, 92521 Neuilly-sur-Seine, Paris, France.
Source
Publisher: Elsevier Masson Country of Publication: France NLM ID: 8302490 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2213-0276 (Electronic) Linking ISSN: 07554982 NLM ISO Abbreviation: Presse Med Subsets: MEDLINE
Subject
Language
French
Abstract
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. 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.)
(Copyright © 2018 The Authors. Published by Elsevier Masson SAS.. All rights reserved.)