Regulatory comparative studies for the registration process of bio similar products in Australia and Singapore
Sri Lakshmi Sowjanya Reddy Singam, Koushik Yetukuri, Rama Rao Nadendla
The expiration of patents on many biological medicinal products has prompted the development of these products as similar biological (biosimilar) products. 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. The standard approach of demonstration of bioequivalence for chemical generic products is scientifically not applicable for biosimilar products. The biosimilar product approach, based on comparability (demonstration of similarity), should be adopted. In view of the impending submissions and to facilitate access of such products at a more affordable price in Singapore, the Regulatory Authority is Health Sciences Authority (HSA). In Australia the regulatory authority Therapeutic Goods Administration (TGA) has adopted the European Union procedure for approving biosimilars, 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. In Singapore these are approved under NDA-2, NDA-3 process. This paper aims 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 regions like Australia & Singapore.