Abstract

REVIEW ON BIOSIMILARS

Dr. Virendra Kushwaha*, Dr. Pooja Agrawal, Dr. Nasreen Fatma Khan and Dr. Pradeep Gupta

Abstract

The United States Food and Drug Administration (FDA) defines a biosimilar as “a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product.” They may either mimic the natural protein‟s function or antagonize the function of the natural protein . As patents on biologic drugs expires, biosimilar drugs were developed to address this growing issue. These include monoclonal antibodies for treating various malignant and immunological disorders, growth factors like erythropoietin and granulocyte colony-stimulating factor (G-CSF), human insulins for treating diabetes mellitus, etc. Most of the biologics and the process to make them between 1990 -2005 were never patented in India. The draft guidelines thus open prospects to bring more Biosimilar brands into the market at perhaps the lowest cost Future biosimilars are anticipated to have a major impact. There will be a growing demand for affordable alternatives as more biologic medications lose their patent protection, and biosimilars are well-positioned to satisfy this need. Several elements point to a promising future for biosimilars. Including all things considered, biosimilars present a great chance to increase patient access to biological medicines while lowering medical expenses. Biosimilars are projected to become more crucial in the treatment of a wide range of illnesses as the healthcare sector continues to develop.

Keywords: Biosimilers, Biologics, drugs, patent.