Mechanism of Biosimilars for the Treatment of Cancer

Biosimilars are biological medications that closely resemble FDA-approved biological medications in terms of structure as well as functions and are approved according to the same standards of pharmaceutical quality, safety and efficacy that apply to all biological medicines. It works smoothly and efficiently for both acute and chronic illnesses. In the biological treatment of oncology, the high production cost causes burdensome to healthcare systems. For the quality of the treatment with biosimilars, regulatory affairs have set outlines for the production of biosimilar biologicals in terms of physicochemical characteristics, efficacy, and safety compared to the originator. The pharmaceutical industry and regulators have been using scientific principles for years to develop biosimilars. Biologics manufacturing processes are frequently modified for several reasons, such as process scalability, increased efficiency, or modernization when equipment has to be updated or replaced. Biosimilars have wide application in the medical field for the treatment of different chronic diseases like cancer, diabetes, autoimmune diseases, skin diseases, bowel diseases, and others. It is a good replacement of drugs which precipitate serious toxic effect. This chapter showing the regulatory aspects, types, and application of biosimilars in cancer therapy.