What Physicians Need to Know About Biosimilars

Biologics are complex proteins derived from living organisms that have been used successfully in treating many different diseases. As some biologics approach patent expiration, the development of drugs that are similar to the approved biological agents, known as biosimilars, has gained significant interest, primarily as a more affordable option for patients. Because of the structural complexity of large proteins and the inherent heterogeneity associated with culturing and manufacturing conditions, biosimilars are highly similar, but not identical to the approved 'reference' agents. Any subtle changes in the manufacturing processes may result in altered function and immunogenicity of the biosimilars, potentially affecting their efficacy and safety profile. Thus, stringent regulatory framework and requirements are necessary to ensure biosimilars are comparable in quality, efficacy, and safety with the reference agents and suitable for clinical use. As this field continues to evolve and more biosimilars are expected to become available in the near future, physicians will need to make informed decisions in the clinical use of biosimilars to ensure that high-quality, safe, and affordable drugs are accessible to patients. This article summarises current considerations, regulatory processes, and challenges in this rapidly evolving field.