India's biosimilar adoption policy encompasses a comprehensive regulatory framework guided by the Central Drugs Standard Control Organization (CDSCO) and the Department of Biotechnology (DBT). The 2016 Guidelines on Similar Biologics outline stringent preclinical, clinical, and post-marketing requirements to ensure biosimilar safety and efficacy. Market access is enhanced through pricing regulation by the National Pharmaceutical Pricing Authority (NPPA) and increasing insurance coverage. Intellectual property laws balance innovation with accessibility. Moving forward, India aims to harmonize its regulations with global standards, introduce fast-track approvals, and invest in training and infrastructure. Public awareness programs, insurance reforms, R&D incentives, and collaborative research are vital for enhancing market access and fostering innovation. Legal reforms and efficient dispute resolution mechanisms are necessary to balance innovation and access. These efforts will bolster India’s biosimilar sector, addressing domestic health needs and establishing India as a global biosimilar leader.