Background

Biosimilars have become important components of contemporary biopharmaceutical care because they can increase competition and expand access to biological medicines. Their successful integration into healthcare systems, however, requires more than regulatory authorisation. Ethical challenges persist in post-marketing safety surveillance, product traceability, interchangeability, patient communication, reimbursement, and the distribution of healthcare resources.

Objective

This review critically examines the ethical and regulatory responsibilities associated with biosimilars in India, the United States (US), Canada, and the European Union (EU), focusing on patient safety, pharmacovigilance, equitable access, and accountability throughout the product lifecycle.

Methods

A critical narrative review approach was adopted to examine international biosimilar guidance, regulatory documents, pharmacovigilance recommendations, and relevant peer-reviewed literature. The comparison was organised around five domains: regulatory authorisation, post-marketing safety surveillance, interchangeability and substitution, affordability and access, and ethical accountability. International guidance and jurisdiction-specific regulatory materials were considered alongside literature addressing traceability, immunogenicity, patient autonomy, and responsible biosimilar use. This approach supports a comparative policy analysis but does not constitute a systematic review or an exhaustive assessment of every national legal provision.

Results

The comparison identifies a shared scientific foundation for biosimilar authorisation but different approaches to implementation, interchangeability, healthcare financing, and product-level safety monitoring. India’s framework is particularly relevant to the relationship between regulatory capacity, domestic manufacturing, and access. The US framework distinguishes biosimilarity from the additional designation of interchangeability under federal law, with pharmacy substitution governed by state law. The EU combines central scientific assessment with national decisions concerning pharmacy-level substitution and healthcare implementation. Canada provides federal authorisation and safety oversight, while provincial and territorial systems substantially influence interchangeability and formulary policies. Across all four jurisdictions, accurate product identification, effective adverse-event reporting, transparent patient communication, and equitable reimbursement remain important ethical priorities.

Conclusion

Responsible biosimilar governance should extend beyond market authorisation through lifecycle-based pharmacovigilance, reliable traceability, patient-centred communication, and fair access policies. A coordinated ethical governance framework could strengthen accountability while preserving regulatory flexibility and supporting sustainable healthcare.