Rising biosimilars in the Indian biopharmaceutical industry: emerging challenges and way forward

ABSTRACT

Biopharmaceuticals have the potential to contribute immensely towards improving the health and quality of life of people. However, there is a gap in the availability of medical services in India and inequality in disseminating health benefits to the poor. Several issues are associated with biopharmaceuticals, such as increasing cost of treatments, access, affordability, safety, efficacy, quality, and intellectual property rights. Hence, the present paper addresses the crucial questions on the emerging challenges in the Indian biopharmaceutical industry regarding the patent cliff and biosimilars. What are the technological and institutional challenges faced by the biosimilars producing firms? Whether biosimilars could meet the regulatory requirements of safety, efficacy, and whether they will meet global regulatory standards? This article further analyses the regulatory pathways for commercial approval of biosimilars.

KEYWORDS:

• Biosimilars
• safety
• efficacy
• regulatory framework

Disclosure statement

No potential conflict of interest was reported by the author(s).

Notes

1 A biosimilar is a biologic medicine that is highly similar to another already approved reference biologic product.

2 ICH is known as the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use. It brings together pharmaceutical industries and regulatory authorities to discuss scientific and technical aspects of drug registration. It has 16 members and 32 observers.

Additional information

Funding

This work was supported by the Department of Science and Technology, Centre for Policy Research (DST-CPR), Government of India [Grant Number DST/PRC/CPR-04/2014].

Notes on contributors

Pallavi Singh

Pallavi Singh is Research Scientist at DST-Centre for Policy Research, Babasaheb Bhimrao Ambedkar University (BBAU), Lucknow, India. She holds her PhD degree in Science Policy from Centre for Studies in Science Policy (CSSP), Jawaharlal Nehru University (JNU), New Delhi, India. She has done her masters in Sociology from JNU and has completed her graduation in Commerce from DDU University, India. Her expertise lies in Science Technology and Innovation Policy Perspectives, Technology Foresight, IPR and Innovation Management, Regulatory Issues, International Trade, Technology and Development, and Science Diplomacy. She has gained six years of research experience while working with several research organizations on numerous national and international projects funded by European Union, UNEP, GEF, Ministry of Environment and Forest, Department of Science and Technology, etc. She has varied experience in analyzing socio-economic, techno-ethical, regulatory aspects of several cross cutting technologies. She has published several papers in national and international journals.

Pranav N. Desai

Pranav N. Desai is currently Director, Centre for Research in Environment, Science and Technology Policy (CREST), New Delhi and Member, South Asia Sustainability Hub & Knowledge Network (SASH&KN), Transdisciplinary Research Cluster on Sustainability Studies (TRCSS), Jawaharlal Nehru University, New Delhi. He is a former professor at the Center for Studies in Science Policy (CSSP), Jawaharlal Nehru University (JNU), India and was engaged in teaching analysis in science and technology policy and technology futures analysis. He received his PhD in Science Policy Studies from JNU and has conducted research in diverse areas of science policy studies including emerging technologies, intellectual property rights, energy and environment related issues. He specializes in science, technology and international affairs. He has contributed to various national and international journals and has published several books.

Venkatesh Dutta

Venkatesh Dutta is Coordinator, DST-Centre for Policy Research, BBAU, Lucknow and Professor, Department of Environmental Science, BBAU, Lucknow, India. He holds Ph.D from Centre for Regulatory & Policy Research, TERI University, New Delhi with major research focus on urban water systems. He completed his M.Sc. in Environmental Management from GGS Indraprastha University, Delhi and B.Sc. in Environmental Sciences from Ramjas College, University of Delhi. He has also completed an advanced course on sustainable development and role of technology from EPFL, Lausanne. Dr. Dutta’s research interests span environmental management with particular emphasis on integrated water resources management, river restoration, land-use planning, and regulatory policy modeling in the environment sector. He is also interested in spatial patterns, process, cause and consequence of urban sprawl vis-à-vis environmental impacts. He has about ten years of professional experience in areas of environmental management, development planning and advocacy.