With a view to push the growth of biosimilars which are fast emerging as a key segment of the Indian pharma industry, the Centre has proposed a number of measures including a National Biosimilar Centre, likely to be headquartered at Bengaluru.

Besides, the proposal also includes setting up of three regional biosimilar centres at Chandigarh, Hyderabad and Ahmedabad, according to sources. The expected cost for the four centres would be Rs.60 crore, but it is still at the proposal stage, sources added.

The first generation of biological drugs, which have introduced many revolutionary treatments to life-threatening and rare illnesses, is currently facing patent expiration. As a result, research-based and generics pharmaceutical companies alike are pursuing the opportunity to develop “generic” substitutes to original biologics, which are also known as biosimilars.

“The research infrastructure, talent pool and academic network in India are at the nascent stage so far as biosimilars industry is concerned. The regulatory hurdles are both at domestic as well as global level. The costs and technology related challenges for biosimilar are also higher. In view of above facts, to facilitate the growth of biosimilar industry, the proposal has been made to set up the national and the regional centres,” sources said.

The centres will take up consultancy on issues related to IPR and other regulatory aspects like, regulations of different countries on biosimilars. Domestic and international registration requirements etc. would be discussed and expert groups would be there to guide the industry. There would be expert groups for guidance related to issues on clinical trials and testing and approval process of biosimilar.

They will also provide common infrastructure. The centres will thus have the equipments, which could be used by industry or academia for carrying out basic research work requiring high precision instruments. This will help in reducing the cost of development of biosimilars.