ISSN: 2642-6315
Authors: Lakshmi P and Rajakumari KS*
Recombinant human insulin, the first genetically designed biologic pharmaceutical product approved in the United States, was approved in 1982, and since then, innumerable biologic drugs have been approved to treat a variety of ailments, many of which are difficult to treat or treat efficiently. Their popularity has grown over time owing to its ability to cure serious and chronic diseases like cancer, inflammatory disorders, and diabetes. Biologics are significantly more complex to design and manufacture compared to small-molecule medications, and they are also significantly more expensive. Market forces combined with recent regulatory developments have led to the rise in interest and popularity of a new type of biologic drug: the Biosimilars. A Biosimilars, also known as follow-on biologic or a subsequent entry biologic, is a pharmacological product that is nearly identical to a distinct company’s original product. Biosimilars are FDA-approved versions of initial “innovator” products which can be manufactured after the patent on the original product expires. The approval process includes a reference to the innovator product. Although Biosimilars are expected to reduce the cost of modern therapies, there are some issues that need to be discussed among physicians at this time, including the differences between Biosimilars and generics of traditional chemical drugs, the need for appropriate regulations, and the identification of potential Biosimilars problems. This review examines the differences between generics and Biosimilars, the current state of problems and opportunities, effects, as well as the attempt to demonstrate the difficulties in establishing regulatory guidelines and those associated with the introduction of these drugs into clinical practice.
Keywords: Pharmaceuticals; Biologics; Biosimilars; Generics; Innovators; Disorders
