THE CLINICAL AND REGULATORY STATUS OF BIOSIMILARS

Pharmaceutical businesses, both based and generic, are vying for the chance to develop new products. Biosimilars are "generic" versions of original biologics. However, the procedure of launching a biosimilar to an innovator product is significantly more complicated than the process of introducing a biosimilar to an existing product. The procedure of introducing a generic copy to an innovator product is quite basic. Predicated on the discovery of a novel chemical entity. Biosimilars aren't allowed to be referred Generics are a type of medication that is used to treat a wide range of words used to describe pharmaceutical goods that signify "Similarity" between products.

Keywords: Biosimilars, Clinical trials, Regulatory science.