BIOSIMILARS: A BRIEF OVERVIEW

Dhanashree SANAP, Anil Kumar DINDIGALA

Journal of Research in Pharmacy - 2026;30(1):134-144

Department of Pharmaceutics, Assistant Professor of Pharmaceutics Bharati Vidyapeeth's College of Pharmacy, University of Mumbai, Navi Mumbai, India

 

In a world of high competition, expensive health care costs and the need for patient access to various biologic treatments lead to the development of biosimilars. A biosimilar is a biological product that is highly similar to a reference biologic drug, with no clinically meaningful differences in terms of safety, purity, and potency . Companies become eligible to manufacture biosimilars once the exclusive patent on the reference biological product has expired. They are approved according to the same standards of pharmaceutical quality. As they are comparatively cheaper than biological products, they have better reach among many patients. Biosimilars are primarily designed to target non -communicable diseases, including oncological disorders (e.g., cancer), respiratory conditions (e.g., asthma), and inflammatory diseases (e.g., rheumatoid arthritis). The escalating prevalence of non -communicable diseases in developing countries underscores the growing significance of biosimilars as a therapeutic option. Versavo is a classic example of a biosimilar product launched in India which is referenced from Roche's Avastin which has shown its effectiveness in the treatment of various types of cancers. Even though biosimilars accomplish the same results as branded drugs, they have a different composition and their development period is longer than the generic drugs. The future outlook for biosimilars is promising, offering benefits such as expanded access to biological therapies, cost -effective treatment options and the market potential for biosimilars is expected to grow as more biologics lose patent exclusivity, creating opportunities for biopharmaceutical companies.