Biosimilars—highly similar and cost-effective alternatives to original biologic medicines—have been transforming medical treatment for over two decades, providing critical therapies for various diseases. However, as scientific advancements accelerate, India’s current regulatory framework for biosimilars is becoming outdated.
Initially designed based on the scientific and technical standards of the time, existing guidelines no longer reflect the rapid progress in biosimilar development. To ensure continued safety, affordability, and accessibility of these vital medicines, India must update its regulatory policies. A modernized framework will not only keep pace with innovation but also foster greater patient access to high-quality biosimilar therapies.