Rajkiran Kolakota1 and I. Jhansi Lakshmi*2
1-2Department of Pharmaceutical Regulatory Affairs, Sri Sivani College of Pharmacy, NH-16, Chilakapalem Jn, Srikakulam-532402, A.P.
A B S T R A C T
The main aim is to facilitate the regulatory requirements for the approval process of Biosimilar in Regulated and Emerging markets by establishing the foundation for a harmonized regulatory standard to meet common demands of a region. ‘Biosimilar’ denotes a biological medicine which is highly similar to an already authorized reference biological medicine and also referred to as Bio therapeutic products, Follow on biologics, Subsequent entry biologics, with respect to different Ministry of health. Depends on type of country regulations, and approval process of generic version of biopharmaceuticals is specified. In Health Canada these are approved under new drug submission, In European Union, Centralized Procedure is mandatory for Biosimilar and fall within the scope of Regulation EC 726/2004; Food drug & administration is still in the process of developing guidelines regarding these types of products. Till now case by case approval process is going on in United States. 505 (b) (2) under Food Drug and Cosmetic Act, Biological License Application under 351 Public Health Service Act, Biological Price Competition and Innovation Act provides the regulatory framework for application process of follow- on biologics. In Singapore these are approved under NDA-2, NDA-3 process. In India these products comes under new drugs, and follows the Biological drugs submission requirements and should be submitted in Common technical document.
Keywords: Biosimilars, Regulations, Emerging markets, Biological License etc.