Biosimilars and Pharmaceuticals

Biosimilar Pharmacovigilance

Biosimilars are biological products that are highly similar to an already approved biologic reference product, known as the originator or reference biologic. Biosimilars are developed to be comparable in terms of safety, efficacy, and quality to the reference product. To gain approval, biosimilars undergo a comprehensive comparability exercise, which includes extensive analytical studies and clinical trials, to demonstrate that they are highly similar to the reference biologic.

Biologics are a class of medicinal products derived from living organisms or their components. They are produced using advanced biotechnology techniques and are typically large and complex molecules, such as proteins, antibodies, or nucleic acids. Biologics are used to treat various diseases, including autoimmune disorders, cancer, and chronic diseases like diabetes. Unlike traditional small molecule drugs, which are chemically synthesized, biologics are manufactured using living cells or organisms, such as bacteria or yeast.