Biologics and biosimilars: role in modern pharmacotherapy and importance of pharmacovigilance

Abstract

Biologics are highly sensitive large molecules with complex structure, difficult to characterize and reproduce, derived from living cells; used for treatment, diagnosis or prevention of disease. Examples are therapeutic hormones, vaccines, monoclonal antibodies etc. Biologicals are beneficial in the management of several health conditions which were once upon a time difficult to manage like cancer, multiple sclerosis, Alzheimer's disease, rheumatoid arthritis, diabetes etc. Biosimilars are proteins that are similar to innovator biologics but not the same as they differ slightly in structure however with no clinically significant difference. Biosimilars are not the exact replicas of originator biologic and are therefore not generics. Biosimilars for their approval are not required to undergo intense clinical trials as innovator biologic but are required to produce data that demonstrates its similarity to an original biologic in terms of clinical efficacy and safety. However, manufactures of both the biologics and biosimilars are required to submit pharmacovigilance and risk management plans as part of their application. Marketing authorization for biosimilars was for the first time framed by EMA along with the guidelines for developing them. As biologics and biosimilars are derived proteins they have immunogenic potential and risk of adverse events which cautions their use. Pharmacovigilance is needed to ensure that adverse events are quickly detected, reported and attributed to the correct product and manufacturer. Regulations are implemented to improve identification and traceability of biologics. Automatic substitution should not be permitted for biologicals.

Are acute infusion reactions after rituximab underreported?

“…12 Development of similar biologics and their distinct features as compared to the reference biopharmaceutical make it imperative that biopharmaceuticals and biosimilars are routinely and rigorously subjected to proactive pharmacovigilance even after they have been approved for marketing. 13 This study was undertaken as a pilot study to execute focused pharmacovigilance in respect of rituximab, an anti CD20 monoclonal antibody indicated for Non-Hodgkin's Lymphoma, Rheumatoid arthritis, Chronic Lymphocytic leukemia, Wegener's Granulomatosis and Microscopic Polyangiitis. 14 The overall rate of AIR observed in this study was more than 100% as all the patients experienced one or the other form of AIR.…”

Biosimilars: current scenario and challenges in india

“…The field of medicine has been able to achieve a new class of medicine, especially with the advancement in biotechnology [1][2] . These types of medicine are large sized molecules that are made in the bodies of living organisms by addition of DNA to cells.…”