An overview of biosimilars for cancer, diabetes mellitus, rheumatoid arthritis and other immune-mediated diseases approved between 2016 and 2021

Abstract

The steep rise in the cost of brand name biologics and expiration of their patents led to the arrival of several new biosimilars in the United States (US) and European Union (EU) markets. Indian pharma companies have also taken initiatives for bringing lower cost similar biologics to the market and made them accessible to the patients who are under the treatment of life-threatening diseases such as cancer. In this paper, we have compiled and compared the biosimilars approved between the year 2016 and 2021 by United States Food and Drug Administration (USFDA), European Medicines Agency (EMA) and Central Drugs Standard Control Organization (CDSCO), India, for the treatment of cancer, diabetes mellitus and immune-mediated inflammatory diseases (IMID) such as rheumatoid arthritis, psoriasis, psoriatic arthritis, ankylosing spondylitis, etc. Despite the fact that currently India has approved only lesser number of biosimilar therapeutics in comparison with US and EU, the innovation in biomanufacturing technologies and reducing the complexity of regulation pathways are expected to increase the availability of biosimilars in future.