Understanding the Biosimilars as a biological Product
Biosimilars Biosimilars are a class of biological products that are highly similar to, and have no clinically meaningful differences from, existing reference biologics. They are developed to be highly comparable in terms of quality, safety, and efficacy to the reference products, which are already approved and marketed. Biosimilars offer an important opportunity to increase patient access to life-saving and life-enhancing therapies while promoting competition and reducing healthcare costs. Unlike generic versions of small-molecule drugs, which are exact copies of their reference products, Biosimilars are complex molecules produced from living organisms. They are developed through a rigorous process that involves comparing the biosimilar candidate to the reference product through extensive analytical studies, non-clinical testing, and clinical trials in order to demonstrate similarity in terms of efficacy, safety, and immunogenicity. The development of Biosimilars requires a ...