Biosimilars

Pharma covigilance challenges in Biosimilars

Since 2000, biosimilars have been sold in India. Similar to biologics, biosimilars are made in live organisms and have a huge size, intricate structure, and difficult production procedure. It demands specialist administration equipment and more stringent temperature control to prevent degradation. Because of the shortened development process for biosimilars, adverse incidents (AEs) an unidentified during a clinical trial could be found after marketing. India has seen a considerable rise in pharmacovigilance awareness following the January 2018 implementation of the pharmacovigilance guidance. However, to assure their safety, biologics need more rigorous surveillance efficiency, too. The significance of pharmacovigilance for biosimilars is discussed in this review article along with how it differs from generic vigilance. Proposals for educating doctors and scientists about the need for a new strategy to improve pharmacovigilance. Pharmacovigilance for innovator biologics and biosimilars is equally as vital as for generic drugs