Biosimilars and interchangeable biosimilars: facts every prescriber, payor, and patient should know. Insulins perspective

ABSTRACT

Introduction

For many of the 537 million adults living now with diabetes, the cost of insulin is becoming prohibitive as the insulin prices have tripled between 2002–2013. Globally, the direct annual cost of healthcare expenditure due to diabetes will soon be US$1 Trillion. Biosimilars provide access to high-quality, affordable biologic therapy that is otherwise inaccessible due to the high costs of original biologics.

Areas covered

A primer to the development of biosimilars shows comparable structural and analytical characterization to the original biologics (e.g. insulins), with no clinically significant or meaningful differences in efficacy and safety. ‘Interchangeability’ status, a regulatory designation by the US FDA, bestowed to some biosimilars, enables confidence in high-quality, bio-equivalent biosimilar of insulin with key global approvals. This can allow rapid uptake of biosimilars by the prescribers, formulary decision-makers, and payors. Biocon-Viatris’s biosimilar Insulin Glargine (Semglee®) is the first interchangeable biosimilar insulin approved by the US FDA.

Expert opinion

The ‘interchangeable’ status can prompt faster and wider uptake of insulin biosimilars and keep the insulin expenditure under control, especially for patients who otherwise practice non-adherence or rationing of life-saving insulin. Education, support, and awareness can ensure that interchangeable biosimilars gain wider acceptance.

KEYWORDS:

• biologics
• biosimilars
• interchangeable
• regulatory
• substitution
• switching

Article highlights

• Biosimilars have comparable structural and analytical characterization to the original biologics with no clinically significant or meaningful differences in efficacy or safety.

• Biosimilars provide access to high-quality, affordable biologic therapy that is otherwise inaccessible due to high cost.

• The biosimilar denoted with an ‘interchangeable product status’ by the US FDA may be substituted for the reference/originator product after following stringent requirements to be deemed ‘interchangeable’.

• This substitution can be an ‘auto-substitution’ at the pharmacy level as is clinically practiced in the US, Canada, and Australia.OR It can be a physician-guided substitution, also called ‘switching,’ as is clinically practiced in some member states of the EU, India, Japan, and the rest of the world.

• Biocon-Viatris’s biosimilar Insulin Glargine is the first ‘interchangeable’ biosimilar insulin approved by the US FDA.

• Patient and HCP’s education and support programs play an important role in the faster and wider uptake of biosimilars.

• Insulin biosimilars with key global approvals provide value to patients and payors who are paying for expensive therapies.

Acknowledgments

The authors would like to thank Geetanjali Tonpe from Biocon Biologics Ltd for editorial assistance with this manuscript.

Declaration of interest

SR Joshi has received speaker/advisory/research grants from Abbott, Astra Zeneca, Biocon, Boehringer Ingelheim, Eli Lilly, Franco Indian, Glenmark, Lupin, Marico, Merck Sharpe & Dohme, Novartis, Novo Nordisk, Roche, Sanofi, Serdia and Zydus. S Mittra, P Raj, VR Suvarna and SN Athalye are employees of Biocon Biologics Ltd and hold stocks in Biocon. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was funded by Biocon Biologics Ltd.