BIOAVAILABILITY AND BIOEQUIVALENCE OF BIOSIMILARSAbstract
Biosimilars are the most promising medicines for treating complex diseases. The first biosimilar was approved in India in 2000, and since then, there is no looking back. CDSCO in collaboration with DBT has developed new guidelines in 2012, which were revised in 2016 for pre and post-marketing approval of biosimilars in India. India is one of the leading manufacturers of biosimilars catering to domestic and international market. Soon it will have a vast opportunity to develop more similar biologics as the patent of many biologics is scheduled to expire by the year 2020. India has emerged well in global market of biosimilars. India started its journey with near about US$ 250 million biosimilar market in 2015 and it is estimated to reach around US$ 40 billion in India while US$ 240 billion in world by 2030. Biosimilars are the boon in treating patients.
A. Arora * and A. Parle
Department of Quality Assurance, Delhi Institute of Pharmaceutical Sciences and Research, New Delhi, India.
15 April 2020
19 August 2020
12 September 2020
01 April 2021