Insulin Access Enhancement in India: Expert Views on Integrating Interchangeable Biosimilar Insulin Glargine

Abstract

Achieving and maintaining optimal glycemic targets is the fundamental goal of the management of diabetes. However, failure of oral antidiabetic drugs (OADs) to sustain the targeted glycemic levels in individuals with progressing disease often requires initiation of insulin therapy. This article consolidates the expert opinions of 377 doctors who participated in 34 advisory board meetings held digitally (n=23) and in person (n=11) across India. The present report underscores the need for readily available alternatives, such as biosimilar insulins, in the Indian healthcare market to make insulin accessible to every patient with diabetes. The introduction of biosimilar insulins in the Indian healthcare market is the key to making insulin accessible to every patient with diabetes. Biosimilars are biologic products that closely resemble reference/originator biologics and demonstrate no clinically meaningful differences in safety and effectiveness. The concept of interchangeability serves as a pivotal differentiator for biosimilars, underlining their reliability and safety, and plays a significant role in their broader acceptance and integration into healthcare systems. The 'interchangeability' designation by the United States Food and Drug Administration (USFDA) elevates the biosimilar concept, promoting faster and broader adoption of insulin biosimilars, especially benefiting patients prone to non-adherence to insulin therapy. Healthcare providers are encouraged to consider the option of initiating or transitioning to biosimilar insulin glargine to address the insulin accessibility challenges.

Keywords: adherence; biosimilar insulin glargine-yfgn; diabetes; originator; reference insulin glargine.

Figure 1. Definitions of Biosimilar

CDSCO: Central Drugs Standard Control Organization; DBT: Department of Biotechnology; EMA: European Medicines Agency; FDA: Food and Drug Administration; WHO: World Health Organization This figure was drawn by the authors of this article.

Figure 2. Regulatory Approval Pathway: Originator vs Biosimilar vs Interchangeable Biosimilar

This figure was drawn by the authors of this article.

Figure 3. Robust Design with Adequate Switch Periods of INSTRIDE 3 Study

This figure was drawn by the authors of this article.

Figure 4. Barriers in the Prescription of Interchangeable Biosimilar Insulin

This figure was drawn by the authors of this article.