Roundtable Consultation on R&D Trends and Regulation for Biosimilars: Way Forward, New Delhi

The evolving biosimilars regulatory environment needs to be cognizant and sensitive to enable equitable access to low cost, safe and efficacious biosimilars-based biopharmaceuticals in the country. It was in this context, the Biotechnology Industry Research Assistance Council (BIRAC), Research Information System for Developing Countries (RIS) & Third World Network (TWN) held a roundtable to discuss how emerging trends and technological advancements drive the rapid expansion of India’s biosimilar sector. The Roundtable was held at Marigold Hall, India Habitat Centre, New Delhi.

The roundtable aimed at discussing the emerging trends in technology and recent developments in the regulatory environment and its implementation within the Indian Biosimilar Regulatory Framework, which will help to facilitate affordability and access of biotherapeutic products to patients in need of such treatments.

Objectives:

• Understand the implications of emerging trends in technology for biosimilar regulation
• Bring together policy makers, scientists, industry and CSOs to discuss the concerns of affordable access to biotherapeutics
• Summarise the current and changing biosimilar regulatory landscape globally
• Describe stakeholders’ experience with the current biosimilar regulatory process
• Identify efforts to bring changes in the Indian Biosimilar Guidelines of 2016
• Explore the possibility of a roadmap for lowering the regulatory barriers for the marketing approval of biosimilars without compromising access, quality, safety and efficacy.

The consultation brought together regulators, policy makers, biopharmaceutical developers, scientist and academic researchers. Experts discussed a roadmap for lowering the regulatory barriers for the marketing approval of biosimilars without compromising the quality, safe and efficacy and the key changes that needs to be brought in the Indian Biosimilar Guidelines of 2016.