Current Trends in Biosimilars

Abstract

Recombinant technology has brought a wide availability of the treatment options for many life-threatening diseases. Consistent with the great inventions in the area of biotechnology, biopharmaceuticals have become the fastest growing area of the pharmaceutical industry. The recent expiration of many innovator biopharmaceutical products has triggered the development of alternate versions of originators biologic drugs. Unlike generic drugs, these new biological products are not the identical copies of innovator products. Thus, these alternate versions are referred to as ‘follow-on biologics’ or ‘biosimilar drugs’. Slight changes in starting materials or modification in the manufacturing processes have significant impact on the final structure of the biologic molecule. Thus, the exact structure of the originator’s biologic molecule cannot be duplicated. This makes these biosimilars very unique molecules necessitating the need for elaborate characterisation and consistent pharmacovigilance.