Biologics Vs Biosimilars: Addressing Affordability And Access In Indian Healthcare

Biologics have revolutionised treatment of cancer, diabetes, rheumatoid arthritis, and other chronic diseases by offering targeted and effective therapies. However, their high-cost limits access, particularly in developing countries like India where out-of-pocket healthcare expenses are significant. Biosimilars, which are highly similar versions of approved biologics, provide a safe, effective, and more affordable alternative, often at 30-70% lower prices. India has made early progress with over 100 approved similar biologics and updated regulatory guidelines, yet challenges in manufacturing complexity, regulatory enforcement, pharmacovigilance, and stakeholder confidence persist. This review examines the science of biologics and biosimilars, India’s regulatory framework, market status, key challenges, opportunities, and recommendations. A full shift towards quality assured biosimilars is essential to improve patient access, reduce financial burden, strengthen India’s biopharmaceutical industry, and position the country as a global hub for affordable biologics. Robust regulation, investment in infrastructure, education, and real-world evidence generation will be critical for success.