Biologics, biosimilars, intended copies and the era of competitive medicine

Biologics have helped treatment of diseases including cancers, rheumatoid arthritis, etc. in entirely new ways. Because they are expensive, there is a demand for generic versions (biosimilars). Biologicals and biosimilars consist of large complex molecular entities difficult to characterize. An innovator and a biosimilar will never be entirely identical because their manufacturing processes are different; hence both need to be evaluated for potential adverse effects and clinical impact, and thus require a separate regulatory approval process. Biosimilar manufacturing has to follow a similar process as biologics, but may not produce exactly identical result. Hence, there can be variations owing to differences in cell line, transfection and the process in fermentation or purification. Also since biosimilars approval is on limited preclinical and clinical data, it is essential to have a comprehensive post-marketing surveillance to detect safety risks, immunogenic, or adverse reactions. Currently, several products labelled as “biosimilars” are approved in some developing countries, which, at the time of approval, did not have a formal regulatory processes in line with EMA and US-FDA. These products should be considered “intended copies” rather than biosimilars. Physicians should know the difference among biologic, biosimilar, bio-better and an ‘intended copy’ to make an informed prescribing decision or substitution.