Regulatory Perspectives And Scientific Insights On Biosimilars In India

Biologics have transferred the management of chronic and life threatening diseases such as cancer, autoimmune disorder and Diabetes. Biosimilars are playing an important role in strengthening India’s healthcare system by providing cost-effective biologic therapies and improving patient access. With support from the Central Drugs Standard Control Organization and Department of Biotechnology, India is emerging as a key centre for biosimilar research and production, helping make healthcare more affordable and widely available. This review looks at how biosimilars are changing in India, with a focus on regulatory frameworks, development challenges, market dynamics, and clinical considerations. It brings up important topics like immunogenicity, interchangeability, pharmacovigilance, and how doctors feel about it. The review also looks at how biosimilars affect the economy by making healthcare more affordable and easier to get. Even though a lot of progress has been made, there are still problems like complicated rules, a lack of knowledge, and limited infrastructure. The paper says that biosimilars are at the forefront of changing Indian healthcare and calls for a strategic approach that includes policy changes, more money for biotechnology, and educating all stakeholders. A well-planned shift to biosimilars could make healthcare in India more fair and long-lasting