Biosimilar and Follow-on Insulin: The Ins, Outs, and Interchangeability

Abstract

Objective: To provide an overview of the differences between biosimilars and generics, and to summarize regulatory requirements and outstanding issues related to biosimilar insulins in the United States, including the issue of interchangeability. Data Sources: References were obtained using MEDLINE searches, the bibliographies of articles identified during the searches, review articles, and general Internet searches. Key words included the following: diabetes, insulin, biosimilar, regulatory, follow-on, and interchangeability. Study Selection and Data Extraction: Articles, studies, regulatory documents, and opinion pieces that addressed issues around biosimilar/follow-on insulins and interchangeability of insulins in people with diabetes were selected for inclusion in this narrative review. Data Synthesis: There is understandable interest in the potential for new copies of existing insulins—termed biosimilar insulins or follow-on insulins—to reduce the substantial and growing costs associated with managing the diabetes epidemic and to improve access, as has been achieved with conventional generic drugs. However, biosimilars or follow-on insulins are not generics. There are critical differences between biologic products and conventional chemical drugs, which present specific challenges to manufacturers, regulators, and clinicians. Conclusions: Health care providers and payers need to be aware of the issues surrounding biosimilar and follow-on insulins as they become more widely available in the coming years. In particular, in the face of limited data on comparative safety and efficacy, careful consideration needs to be given when interchanging between originator and biosimilar drugs, when switching patients from one biosimilar drug to the other.

MYL1501D Insulin Glargine: A Review in Diabetes Mellitus

“…The 2015 expiration of the patent for reference insulin glargine 100 U/mL opened up the market to biosimilars/followon biologicals [15,16]. LY2963016 insulin glargine was the first of these, being approved in the EU as a biosimilar and in the USA as a follow-on biological to reference insulin glargine 100 U/mL [17].…”

“…Given the growing prevalence of diabetes and the ever increasing cost of healthcare, it is hoped that the introduction of biosimilar or follow-on biological insulins will increase market competition and thus lower costs [1,15,16]. Well-designed cost-effectiveness analyses of the use of biosimilar or follow-on biological insulin glargine would be of interest.…”

Pharmacovigilance of biosimilars – Why is it different from generics and innovator biologics?

“…[8] While the precision of dosing is a key concern for insulin biosimilars, ease of use, comfort, and convenience of the device are important factors that could potentially influence patient adherence, and so they have an impact on efficacy. [9]…”

The Application of Electrospray Tandem Mass Spectrometry for <i>de novo</i> Sequencing of Reduced Insulins

“…The heavy financial burden associated with diabetic treatment has been a common obstacle for many countries, particularly developing countries. The good news is that the patents for a series of insulin products are due to expire shortly, which represents an opportunity to provide patients with access to more affordable follow-on drugs [5].…”

“…Potential immunoreactions include insulin allergies, antibody-mediated insulin resistance, and others [8] [9]. The occurrence of immunoreactions is attributable to many factors, such as the drug's amino acid sequence, spatial structure, and other characteristics that are influenced by the manufacturing process [5]. Three different manufacturing processes based on recombinant DNA technology have been developed, two of which use E. coli as an expression system, while the third uses yeast cells [10].…”