‘Lupin has gained significant momentum towards development of biosimilar products with primary focus on regulated markets'

Lupin Biotech, with a new-age R&D facility in Pune, is developing and commercializing biosimilars globally. The successful development of Etanercept biosimilar is a case in point. Dr Cyrus Karkaria, President-Biotechnology, Lupin divulges more details about the company’s projects in this arena, its focus areas, future plans of expansion and more, in an exclusive interview with Lakshmipirya Nair

- Lakshmipirya Nair

How is biotech propelling India Pharma Inc’s progress? How will it contribute to India Pharma Inc’s efforts to become a value-led and innovation-driven industry?

Biotechnology is the new sunrise sector in India and is poised to take the country into the next big league of internal and international investment. The Indian biopharma industry is on the brink of becoming a major global force in terms of manufacturing and research capabilities. We are witnessing dynamic changing trends such as large acquisitions by multinational companies in India, increasing investments, deeper penetration into the rural markets, growth and availability of healthcare and incentives for setting up special economic zones (SEZs). R&D in India is getting more innovative with the first set up of Made-in-India biologics approved. A well-defined regulatory framework, along with an emerging stringent IPR regime is also contributing to this trend. Foreign investment has driven clinical trial outsourcing along with strong clinical trial data management.

India is leading the global biosimilar pipeline, with the largest number of biosimilar products launched in the country and emerging economies. India alone has over 40 biosimilar products in the market. Domestic companies are also aggressively targeting entry into regulated markets. In the last three years, Indian biopharma has achieved a remarkable feat with five biosimilars approvals in EU and two approvals in the US. The final imperative for India is to create a conducive environment for global partnerships to enable joint IP generation, harmonise Indian regulatory guidelines to meet global norms and smooth movement of biologics as well as leverage better markets for biotech products and processes.

How huge is the market for biosimilars globally? What are the factors boosting its growth?