title: Administration of Biosimilar Insulin Analogs: Role of Devices.
abstract: With the expiration of patent protection for several originator insulin analog molecules, the availability of insulin analog copies is set to increase. Many regulatory authorities have developed, and continue to refine, guidelines for the approval of biosimilar insulin analogs. Aspects such as the structure, pharmacokinetics and pharmacodynamics, efficacy, safety, and immunogenicity of biosimilar insulin analogs are extensively addressed in these guidelines, but how the biosimilar insulin analog is administered to people with diabetes is not usually a topic. The aim of this article is to highlight that the delivery device-drug combination is of particular importance. Regulatory, legal, and practical aspects of the delivery device, be it a syringe, pen, or pump, have to be considered in the context of biosimilar insulin analogs. Although the safety and efficacy of biosimilar insulin analogs per se are of primary importance for physicians and people with diabetes, functions and features of the devices used for administration also require attention from a practical point of view. Unfortunately, although there are several clinical studies investigating the technical aspects of and patient preference for the originator insulin analog pens, there are currently very little published data for nonoriginator or biosimilar insulin analog pens. In addition, it is not known if it is safe to assume that a biosimilar insulin analog cartridge is compatible with an existing originator insulin analog pen. We believe that there is a need for more discussion on the role of devices for administration of biosimilar insulin analogs.
authors.affiliation: 1 Science & Co. , Düsseldorf, Germany .
authors.forename: Lutz
authors.initials: L
authors.lastname: Heinemann
authors.affiliation: 2 Device Development, Sanofi , Frankfurt, Germany .
authors.forename: Ingo
authors.initials: I
authors.lastname: Fritz
authors.affiliation: 3 Escala Therapeutics, a subsidiary of Fortress Biotech, New York, New York.
authors.forename: Hootan
authors.initials: H
authors.lastname: Khatami
authors.affiliation: 4 Division of Endocrinology and Metabolism, University of California San Diego , San Diego, California.
authors.forename: Steven V
authors.initials: SV
authors.lastname: Edelman
mesh_terms: D059451:Biosimilar Pharmaceuticals / Q000008:administration & dosage* / Q000627:therapeutic use; D003920:Diabetes Mellitus / Q000188:drug therapy*; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D007328:Insulin / Q000008:administration & dosage* / Q000031:analogs & derivatives* / Q000627:therapeutic use; D007332:Insulin Infusion Systems; D013594:Syringes
chemical_list: D059451:Biosimilar Pharmaceuticals; D007004:Hypoglycemic Agents; D007328:Insulin
keywords: Biosimilar insulin; Insulin analog; Insulin pen; Originator insulin; Regulatory