Indigence for Robust Pharmacovigilance in Biosimilars: A review

Treatments with biologics drugs have become the order of the day for many diseases and ailments including cancer. Unlike the availability of small molecule generics at lower costs, generic versions of biologics are not available at costs that are affordable to the patients in the developing countries. This is mainly due to factors such as immunogenicity, interchangeability, and difficulties in the manufacturing and characterisation of these biosimilars. These factors also raise a question on the conductance of pharmacovigilance programme, since each version of biologic is different. In this review, we analyse the major issues and the regulatory mandates concerning biosimilars and discuss some recommendations for the pharmacovigilance programme.