India an emerging hub for biologics and biosimilars: Report

Clarivate Analytics has released a new report together with the Department of Biotechnology (DBT), Biotechnology Industry Research Assistance Council (BIRAC) and ABLE (Association of Biotechnology Led Enterprises). Entitled ‘India: The emerging hub for biologics and biosimilars’, the report features analysis based on insights from Cortellis Deals Intelligence and Cortellis Competitive Intelligence.

The report was released at the Global Bio-India 2019 in New Delhi by Dr Harsh Vardhan, Union Minister for Science and Technology, Earth Sciences, and Health and Family Welfare, Dharmendra Pradhan, Minister for Petroleum & Natural Gas and Steel, Dr Renu Swarup, Secretary, DBT and other luminaries including Prof Vinod K Paul, Member NITI Aayog and Dr Kiran Mazumdar Shaw, Chairperson and Managing Director, Biocon.

The report examines the transformation of the pharmaceutical/biotech industry from small molecule therapeutics to biotherapeutics (biologics and biosimilars), driven by unmet clinical needs, the inherent advantages of biotherapeutics, and commercial potential. Of the top 10 blockbuster molecules in 2018, only two were small molecule therapeutics and eight were biological therapeutics.

The Indian pharmaceutical/biotech industry is well placed to capitalize on the substantial opportunity offered by biotherapeutics and includes companies with an extensive pipeline of biosimilars under active development.  So far, Indian pharmaceutical companies have launched 123 biosimilars and currently have 201 active biosimilars covering multiple indications in the development pipeline. It is likely that drug development will continue to accelerate thanks to the steps taken by the government of India to support the biopharmaceutical industry with the necessary infrastructure, funding, global collaborations to bridge the technical knowledge gap, and further development of regulatory guidelines.

Dr Renu Swarup, Secretary, Department of Biotechnology said, “India is predicted to be one of the world’s ‘fastest-growing bio-hubs’ in the next few years. India’s growing biosimilars industry is the primary driver of this growth. India has 95 approved biosimilars in the domestic market, more than any other country, and market penetration, which is currently relatively low and expected to increase quickly in coming years with the increase in demand by middle-class patients.”

Kiran Mazumdar, Chairperson and Managing Director, Biocon, said, “Technological innovation, coupled with economies of scale, are driving India’s emergence as a global hub for biologics and biosimilars. We are already serving the needs of millions of patients globally, by assuring the supply of safe and efficacious biosimilars on an embedded platform of affordability. In enabling affordable access to high-quality biosimilars worldwide, India’s biopharma sector can emulate the global leadership achieved in generic drugs and vaccines.”

Dr Cyrus S. Poonawalla, Chairman and Managing Director, Serum Institute of India, said, “India’s contribution and heft in the health sector is growing through novel technologies and innovative science, supported by economies of scale and cutting-edge manufacturing infrastructure to drive new frontiers in health science.”

“Efforts by industry and the government will help position India as a leader in biotechnology-based research and a hub for biotech innovation and commercialization,” said Arvind Pachhapur, Vice President, Clarivate Analytics. “We are honored to support these efforts to help accelerate the pace of innovation in the region.”