Introduction of biosimilar insulins in Europe

Abstract

Regulatory approval of the first biosimilar insulin in Europe, LY2963016 insulin glargine (Abasaglar®), in 2014 expanded the treatment options available to people with diabetes. As biosimilar insulin products come to market, it is important to recognize that insulin products are biologicals manufactured through complex biotechnology processes, and thus biosimilar insulins cannot be considered identical to their reference products. Strict regulatory guidelines adopted by authorities in Europe, the USA and some other countries help to ensure that efficacy and safety profiles of biosimilar insulins are not meaningfully different from those of the reference products, preventing entry of biological compounds not meeting quality standards and potentially affecting people's glycaemic outcomes. This review explains the concept of biosimilar medicines and outlines regulatory requirements for registration of biosimilar insulins in Europe, which is illustrated by the successful development of LY2963016 insulin glargine and MK‐1293 insulin glargine (Lusduna®). Preclinical and clinical comparative studies of the biosimilar insulin glargine programmes include in vitro bioassays for insulin and insulin‐like growth factor 1 receptor binding, assessment of in vitro biological activity, evaluation of pharmacokinetic/pharmacodynamic profiles in phase I studies and assessment of long‐term safety and efficacy in phase III studies. The emergence of biosimilar insulins may help broaden access to modern insulins, increase individualized treatment options and reduce costs of insulin therapy.

ISPAD Clinical Practice Consensus Guidelines 2018: Insulin treatment in children and adolescents with diabetes

“…With the biosimilar Glargin Insulin LY2963016 from Lilly and Boehringer, a first biosimilar insulin has been approved in several countries also for pediatric use and others may be coming soon (ie, biosimilar insulin lispro). In contrast to common generic drugs, insulin molecules are much larger molecules.…”

“…Premixed insulins with regular (or rapid acting): NPH in different ratios, for example, 10:90, 15:85, 20:80, 25:75, 30:70, 40:60, 50:50 are available in various countries from different manufacturers. Premixed insulins are suitable for use in pen injector devices.16 | BIOSIMILAR INSULINWith the biosimilar Glargin Insulin LY2963016 from Lilly and Boehringer, a first biosimilar insulin has been approved in several countries also for pediatric use94 and others may be coming soon (ie, biosimilar insulin lispro). In contrast to common generic drugs, insulin molecules are much larger molecules.…”

New Insulins, Biosimilars, and Insulin Therapy

“…Once the first reviews, systematic reviews, and metaanalysis about a given topic are published, this can be regarded as a sign of a certain maturity in this area of research. One review reflected mainly on the introduction of BioIns in the EU (15). A U.S. team recently published a systematic review of five different BioIns for which studies have shown no difference between the BioIns and the originator insulins (16).…”

Biosimilar vs originator insulins: Systematic review and meta‐analysis

“…The widespread availability of generic products has substantially improved access to medicines in low‐ and middle‐income countries . Biosimilar insulins have expanded treatment options for diabetes and can potentially reduce medical costs . LY2963016 insulin glargine, MK‐1293 insulin glargine, Mylan's insulin glargine, and SAR342434 insulin lispro have been approved as biosimilar insulins …”

“…Biosimilar insulins have expanded treatment options for diabetes and can potentially reduce medical costs . LY2963016 insulin glargine, MK‐1293 insulin glargine, Mylan's insulin glargine, and SAR342434 insulin lispro have been approved as biosimilar insulins …”