Biosimilars and Generics: A New Class Needed for Hormonal and Herbal Preparations

Abstract

Strict regulations are in place for the manufacture and approval of pharmaceutical products. Specific drugs such as biological products are governed by specific rules, which take cognizance of the extra diligence required for their production. This communication describes two classes of drugs: hormones and herbal products, which should be subject to stringent regulations. It explains the rationale behind this, and calls for added vigilance in regulatory oversight.