Open AccessRegulatory Prototype for Biological Products in the United States
Author(s) -
G. Pavithra,
N. Venugopal
Publication year - 2021
Publication title -
journal of pharmaceutical research international
Language(s) - English
Resource type - Journals
ISSN - 2456-9119
DOI - 10.9734/jpri/2021/v33i28b31539
Subject(s) - biosimilar , biological drugs , license , pharmacovigilance , business , risk analysis (engineering) , product (mathematics) , competition (biology) , new product development , microbiology and biotechnology , computer science , pharmacology , marketing , medicine , disease , biology , drug , operating system , ecology , geometry , mathematics , pathology
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.