Volume: 5, Issue: 1
ABSTRACT
Biologics have revolutionized the treatment of serious medical conditions, such as cancer and autoimmune diseases, which kill people prematurely and make them sick for a long time. In India, the high cost of advanced synthetic drugs has limited their uses, making it inaccessible to millions of people living in the country. Biosimilars may be a potential solution to this problem. Essentially, these are authorized medications that closely resemble biologics and show no clinically significant differences. India is frequently referred to as the pharmacy of the world. India, as the pharmacy of the world, is in a good situation to increase the uptake and development of biosimilars with a view to enhancing patient access and making the health system more resilient. In India, the biosimilars and biologics sector has gained unprecedented traction recently. The papers have elaborated on scientific merit, therapeutic significance, regulatory environment, commercial potential and cost. Biosimilars are difficult to develop due 35 to manufacturing complexity, a lack of regulatory harmonisation, physician confidence, pharmacovigilance, and public awareness. According to the article, a change in strategy regarding biosimilars can permit innovating for cheaper medicines and make future medicines affordable to the Indian people. Through strengthening focuses of research, policy, industry, and education, India can be established as a global leader in biosimilars and a model for equitable health care delivery.
Biologics; Biosimilars; Healthcare affordability; India; Regulatory pathway; Patient access


