Clinicians' Perceptions and Adoption of Oncology Biosimilars in India: Results from a National Survey

Abstract

Biosimilars enhanced access to advanced therapies by providing cost-effective alternatives to reference biologics. However, their adoption in clinical practice remains limited due to concerns regarding efficacy, safety, and data reliability. This survey aimed to assess Indian clinicians' perspectives on biosimilars and identify factors influencing their adoption. A questionnaire-based online survey was conducted from July to August 2024. Fifty-two medical, radiation, and surgical oncologists across India provided a complete response. Questionnaires addressed prescription patterns, confidence in biosimilars, and clinical decision-making criteria. Descriptive statistics were performed. Among 52 respondents, 34.6% of clinicians prescribed biosimilars to >60% of patients, while 17.3% prescribed to <20%. Safety (27.1%), efficacy (35.6%), and pharmacokinetics (21.2%) were key determinants for biosimilar adoption; 76.9% of clinicians rejected biosimilars with biomolecular deviation; 65.4% of clinicians opposed data extrapolation without clinical trial evidence; and 76.9% lacked confidence in biosimilars before peer-reviewed publication. Clinicians stressed the importance of rigorous statistical analysis in biosimilar trials, with 46.2% hesitant without intention-to-treat/per-protocol analyses, 69.2% concerned about deviations beyond 80% to 125% margins, and 63.5% accepted efficacy differences within ± 20% of the noninferiority range. Clinicians' concerns and limited evidence hinder biosimilar adoption, despite their potential to improve access. Larger trials, transparent reporting, and real-world evidence may improve confidence.

Keywords

biosimilars - clinical practice - survey - oncology - adoption

Data Availability Statement

The data that support the findings of this study are available from the corresponding author upon reasonable request.

Authors' Contributions

The author confirm that they are the sole author of this manuscript. The author meet the criteria for authorship as outlined in the journal's guidelines and that the manuscript represents honest and original work.

Ethical Approval

Ethical approval is not required under the Common Rule, as this is a survey study and de-identified data were used.

Patients' Consent

Patient consent is not required.

Publication History

Article published online:
11 September 2025

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