Biologics and Biosimilars: Differences and Clinical Implications.

ABSTRACT

Biologics or biopharmaceuticals are drugs derived from living organisms by recombinant technology. Biologics have made a significant contribution to the management of certain chronic diseases such as cancer, rheumatoid, arthritis, ankylosing spondylitis, psoriasis and other immune mediated disorders. Biologics are produced by genetically modifying cells and, are highly complex and expensive to manufacture. Many of them are now facing patent expiry which has paved the way for the development of biosimilars. Biosimilars are biologic medicine that is similar in terms of quality, safety and efficacy but not the same as a registered innovator biologic. The manufacturing of biosimilars has many complexities, such as consistency of manufacturing process, conformation of manufacturing standards and demonstration of product consistency Also, powered clinical trials have to be executed to demonstrate similarity to the innovator biologic. Registration of biosimilars requires a more stringent evaluation than that is required for conventional generics. Biosimilars have the potential to be the molecules of the future as long as they are developed strictly in accordance with comparative procedures mandated by regulatory authorities such as EMA and USFDA. It is believed that the advent of biosimilars will improve patient access to expensive biologics for chronic illnesses. However, it is important that clinicians distinguish between innovator biologics and biosimilars. Physicians should avoid substituting biosimilars for innovators as well as avoid interchangeability as biosimilars are not generics. In addition, pharmacovigilance will be the need of the hour to track down any safety and efficacy problems arising from the use of biosimilars.