India needs to update its regulations surrounding biosimilars to ensure the availability of safe, effective, and affordable treatments for patients, experts say. Biosimilars, which are biologic medical products highly similar to an already approved reference biologic, have the potential to significantly reduce healthcare costs while providing treatment options for conditions like cancer, diabetes, and autoimmune diseases.

However, experts warn that the current regulatory framework in India may not be sufficiently robust to address the complexities involved in biosimilar approvals. Unlike generic drugs, biosimilars are not exact copies but are instead similar to the reference biologics. This means that the regulatory process must account for variations in production, efficacy, and safety profiles between the biosimilar and the reference product.

One of the key concerns raised by healthcare professionals is the need for a more rigorous evaluation process for biosimilars, which includes comprehensive clinical trials to assess safety and effectiveness. Additionally, there is a growing call for greater transparency and consistent post-market surveillance to monitor the long-term effects of biosimilars once they are in use by the general population.

India’s current regulatory guidelines, though evolving, still face challenges in keeping pace with global advancements in biosimilar development. Countries like the U.S. and European Union have already established more comprehensive and detailed biosimilar approval processes, which ensure that only the safest and most effective biosimilars reach the market. By aligning its regulatory standards with these international practices, India can improve patient outcomes and enhance confidence in biosimilar treatments.

Moreover, improving access to biosimilars in India can help reduce the financial burden on patients. Biologics, especially cancer and autoimmune treatments, are often extremely costly, and biosimilars can provide a more affordable alternative without compromising on quality. By making the regulatory framework more stringent, India can strike the right balance between affordability, safety, and effectiveness.

As India continues to emerge as a global leader in pharmaceutical production, updating biosimilar regulations will be a crucial step toward providing patients with high-quality, cost-effective medicines. The government, regulatory bodies, and healthcare stakeholders must collaborate to ensure that India’s biosimilar landscape is strengthened to benefit public health.