Regulatory Prototype for Biological Products in the United States
G. M. Pavithra
Department of Pharmaceutical Regulatory Affairs, Sri Ramachandra Faculty of Pharmacy, Sri Ramachandra Institute of Higher Education and Research (DU), Porur, Chennai-600116, India.
N. Venugopal
*
Department of Pharmaceutics, Sri Adichunchanagiri College of Pharmacy, Adichunchanagiri University, B G Nagar-571448, Nagamangala Taluk, Mandya District, Karnataka, India.
*Author to whom correspondence should be addressed.
Abstract
Biological products are used for the treatment of many disease, so the biological application submitted for the approval of products are also increasing. The progress of a biosimilarproduct is more difficult and expensive than a small molecule generic product. Biosimilars are not true generic drugs, but demonstrate a high degree of similarity to the reference biological product. In order to improve access to costly biological treatments, a biosimilar pathway in the US was established under the Biologics Price Competition and Innovation Act of 2009. The study highlighted the “Regulatory prospective for the registration of Biological products in US” and a brief description about the development, Manufacturing and approval process of biosimilar products. This article is also focused on the regulatory framework, Biological License Application, Purple book, and Pharmacovigilance of biological products.
Keywords: Biologicals, interchangeable products, biosimilars, pharmacovigilance, development