Biopharmaceutical drugs or biologicals have become an essential part of
modern pharmacotherapy. Biosimilars or similar biologics have been defined
as drugs that have shown to have comparable quality, safety and efficacy to
the original biopharmaceutical drugs. The past decade has seen a significant
increase in interest in these products from the biotechnology industry. Major
developments in order to establish a regulatory path for approval of these
products have taken place . In order to understand how the different quality
attributes of a biosimilar impact its safety and efficacy we need further efforts.
India is globally regarded to have great potential for development and
commercialization of biosimilars.