Indian Providers Boast Interchangeability for Insulin Biosimilars Despite Debates in the US

Indian experts believe that interchangeable biosimilar insulin glargine is as effective and safe as the reference insulin glargine and can significantly improve insulin accessibility and affordability, highlighting the need for future efforts to enhance its availability across all Indian cities, according to a study published in Cureus.¹

The study highlights how Indian providers view interchangeability designations, which is a regulatory label specific to the US biosimilar industry. The label allows for an interchangeable biosimilar to be substituted in place of its reference agent at the pharmacy level without requiring provider permission, increasing access to biosimilars and reducing administrative burden on pharmacies.

Results showed that that Indian providers believe interchangeability is a key differentiator for biosimilars and significantly aids their acceptance and integration into health care systems. The expert opinions showed that Indian providers trust that the FDA's "interchangeability" designation boosts the adoption of insulin biosimilars, particularly benefiting patients who struggle with adherence to insulin therapy.

The findings are interesting in that interchangeability designations are a hotly debated topic in the US, where many experts believe the label does nothing to expand access or improve acceptance and is redundant considering that authorities in the European Union and the UK have declared all biosimilars as interchangeable with their reference agents.^2,3

Additionally, the FDA recently updated its interchangeability guidance, removing switching study requirements for biosimilars, making it easier than ever for companies to obtain the designation for their products.⁴ Prior to the change, only insulin biosimilars and biosimilars administered intravitreally (ranibizumab and aflibercept) were able to be deemed interchangeable without the submission of additional switching study data. However, insulin and ranibizumab biosimilar adoption remain low in the US.5

In India, poor glycemic control persists despite the use of multiple oral antidiabetic drugs, with insulin access hindered by high costs, limited availability, and market dynamics favoring expensive analogs. Biosimilar insulins could offer a cost-effective alternative, but their use is limited by market challenges and skepticism toward domestic products. Introducing interchangeable biosimilar insulin glargine could improve insulin accessibility and affordability in India, with expert input needed to bridge the gap between clinical trials and real-world practice.

However, despite the benefits, adoption of biosimilars faces several challenges. Skepticism about their efficacy, safety, and quality compared with originator biologics creates barriers for both health care professionals and patients. Concerns about immunogenicity and clinical outcomes also can hinder acceptance. Addressing these concerns through education and robust clinical evidence is crucial for wider adoption of biosimilars.

“While accessibility and affordability of insulin pose significant challenges in India,… 377 Indian experts opined that the interchangeable biosimilar insulin glargine is equally efficacious and safe to the reference insulin glargine and a viable solution, which could greatly enhance the accessibility and affordability of insulin, a crucial medicine for managing diabetes, in real-world clinical practice," the study authors wrote. "Future developments in insulin markets should focus on enhancing the accessibility of interchangeable biosimilar insulin across all tiers of cities in India.”

Between May 2023 and July 2023, 34 advisory board meetings were held across India, comprising 23 digital and 11 physical meetings, to gather expert opinions on the effectiveness of interchangeable biosimilar insulin glargine in improving insulin accessibility. Of 377 participating doctors, 210 joined digital meetings and 167 attended in person. The discussions covered the roles of biosimilars in insulin accessibility, regulatory considerations, biosimilar equivalence, switching from reference insulin, and barriers to prescribing interchangeable biosimilar insulin.

Physicians play a crucial role in initiating insulin therapy for patients with poorly controlled diabetes. The study revealed barriers to physician acceptance of biosimilars, including lack of knowledge, training, and experience, as well as concerns about hypoglycemia, weight gain, and patient compliance. Despite these challenges, the authors said physicians should encourage early insulin initiation and discuss the benefits of basal insulin’s once-daily dosing. The adoption of biosimilar insulin is also influenced by patients' socioeconomic status, and physicians should address any hesitancy and provide thorough counseling on the benefits of early insulin therapy.

Overcoming barriers to prescribing interchangeable biosimilar insulin will also involve several strategies. Educating patients about the benefits and safety of biosimilars, proper insulin pen use, and injection techniques is essential. Cost reductions can increase accessibility, and pharmaceutical companies should extend their reach to rural areas. Generating real-world evidence on biosimilar efficacy and ensuring reliable cold chain maintenance for insulin storage and transportation are also critical. Addressing these barriers will facilitate broader adoption of biosimilar insulin glargine.

References

1. Kumar KMP, Chowdhury S, Bantwal G, et al. Insulin access enhancement in India: Expert views on integrating interchangeable biosimilar insulin glargine. Cureus. 2024;16(5):e60983. doi:10.7759/cureus.60983

2. Statement on the scientific rationale supporting interchangeability of biosimilar medicines in the EU. European Medicines Agency. April 21, 2023. Accessed August 5, 2024. https://www.ema.europa.eu/en/documents/public-statement/statement-scientific-rationale-supporting-interchangeability-biosimilar-medicines-eu_en.pdf

3. Guidance on the licensing of biosimilar products. UK government. Updated November 7, 2022. Accessed August 5, 2024. https://www.gov.uk/government/publications/guidance-on-the-licensing-of-biosimilar-products/guidance-on-the-licensing-of-biosimilar-products#:~:text=5.-,Interchangeability,achieve%20the%20same%20therapeutic%20effect

4. Jeremias S. FDA draft guidance removes switching study requirements for biosimilar interchangeability. The Center for Biosimilars^®. June 20, 2024. Accessed August 5, 2024. https://www.centerforbiosimilars.com/view/fda-draft-guidance-removes-switching-study-requirements-for-biosimilar-interchangeability

5. Jeremias S. Report: Varied Biosimilar uptake speeds pose missed opportunities for cost savings. The Center for Biosimilars. January 23, 2024. Accessed August 5, 2024. https://www.centerforbiosimilars.com/view/report-varied-biosimilar-uptake-speeds-pose-missed-opportunities-for-cost-savings