A Regulatory Perspective of Biosimilars in Emerging Markets
Track:
Regulatory Affairs and Submissions
Day & Time:
June 25, 8:00AM - 9:30AM
Session Number:
212
Room Number:
253B
Level:
Intermediate
Type:
Session
Title:
A Regulatory Perspective of Biosimilars in Emerging Markets
Chair(s):
Linda F. Bowen, MS,RAC
Head of US Regulatory Policy and Intelligence
Sanofi, United States
Description:
With a number of innovator biologicals going off patent, biosimilars present a promising opportunity and a high market potential. However, unlike small molecules, which have known chemical structures, structure activity relationships and well-defined chemical synthesis processes, biosimilars are complex proteins requiring multistep multifaceted manufacturing processes. Hence the development of biosimilars presents unique and complex challenges which need to be strategically planned.
As pharmaceutical business interests spread to Latin America and the Asia Pacific regions, understanding aspects of the regulatory environment in those regions became a critical success factor. This session will provide high-level insight into the regulatory framework for biosimilar product development in key Latin America and Asia Pacific markets. There will be a discussion of a practical case study involving different marketed biosimilar formulations of a known innovator biological product and the practical implications thereof.
Learning Objective(s):
Identify the key regulatory instruments related to the development and approval of biosimilar products in key markets of the Latin America (Brazil, Argentina and Mexico) and Asia Pacific (India, China, Korea) regions; Recognize the similarities and differences in the regulatory requirements in these markets.
Presentation(s) & Speaker(s):
Biosimilar Regulatory Environment in the Asia Pacific Region
Sonica Sachdeva Batra, DrMed
Director, Medical and Scientific Affairs
Jubilant Clinsys Ltd., India
Biosimilar Regulatory Environment in Latin America
Oliver Cox, MSc
Consultant
PAREXEL International, United Kingdom