As the market for biosimilar products continues to grow, many biopharmaceutical companies trying to enter the space are struggling to overcome the unique challenges that developing such products presents. From navigating the complex global regulatory landscapes to ensuring optimal access, the development road for biosimilars is riddled with questions:

  • How do we ensure speed-to-market while maintaining a high quality of clinical evidence?
  • How do we maximize uptake of our biosimilar products to realize a return on our investment?
  • How do we ensure physicians and patients are comfortable with using our biosimilar products?

The potential demand for biosimilars certainly creates an enormous opportunity for biopharmaceutical companies. But unlike the development of progenitor biologics—or generic versions of chemical-based medications—biosimilar development and commercialization is a uniquely difficult endeavor requiring precision, stepwise planning to ensure timely regulatory approval and optimal market access.

Even those companies looking to protect the market share of a branded biologic product are struggling to adapt to the increased competition from biosimilars. In all cases, the uniqueness of biosimilars necessitates that an integrated, strategic development plan—which includes expert analysis and input on the key regulatory, commercial and clinical considerations—must be put in place in the very early stages of any biosimilar development program.

This paper explores further the following key messages:

  • The biosimilar market is projected to be a multi-billion dollar industry in the next few years
  • Regulatory and market access considerations must fuel biosimilar clinical development
  • Biosimilar development strategies must adapt to evolving regulatory requirements
  • Clinical development strategies must focus on patient selection and appropriate clinical endpoints
  • Commercial strategies must optimize market uptake of biosimilars.



About the Authors

Deepa Dahal, MBA, is Principal Consultant, Commercial Strategy, Biosimilar Intelligence Team, Consulting at Quintiles. Deepa Dahal brings to Quintiles Consulting over 6 years of marketing and strategic consulting experience within the pharmaceutical and life sciences industries. Her background lies in commercial strategy, market development, brand planning, product launch, life cycle management, and managed care contracting. At Quintiles, she has focused on developing commercial strategies for multiple clients in the biologics and biosimilar space, including innovator biologics as well as biosimilars in development. She has also played a leading role in defining Quintiles’ own global biosimilar strategy. Prior to joining Quintiles, Deepa was a Senior Consultant at both Campbell Alliance and IMS Health. At Campbell, she focused on Marketing and Brand Management strategy among pharmaceutical and biotech companies. At IMS, she worked on Managed Care Contracting and Compliance with pharmaceutical clients. Deepa has a bachelor’s degree in Business from the University of Idaho and an MBA from the University of New Hampshire.

   

John Doyle, Dr.P.H., MPH, is Vice President and Practice Leader for Market Access with Consulting at Quintiles. Previously, he was president and a founder of Analytica International, a global reimbursement, outcomes and market access consulting firm. He previously led the Oncology and Immunology Economics Research Group at Bristol-Myers Squibb. Since 1993, Dr. Doyle has authored over 50 original research articles and abstracts, in a variety of therapeutic areas. As a health economist and epidemiologist, he has lectured on research methodologies for academic and commercial audiences in the U.S., Canada, Europe and Latin America. He has consulted global pharmaceutical and biotech firms on strategic concerns regarding product development, pricing, reimbursement, market valuation and other commercialization issues. Dr. Doyle received a Bachelor of Science degree in Applied Economics with a concentration in the Life Sciences from Cornell University. He received a Master of Public Health degree and a Doctor of Public Health degree in Epidemiology from the Mailman School of Public Health at Columbia University.

   

Kamali Chance, MPH, Ph.D., RAC, is Senior Director, Head of Global Biosimilars Regulatory Strategy with the Biosimilar Intelligence Team at Quintiles. Dr. Chance has over 25 years of work experience in the healthcare industry, including the last 15 years in regulatory affairs at pharmaceutical and biotechnology industries. She advises pharmaceutical and biotechnology companies in the development of region specific and/or global regulatory strategy for the development of biosimilars. She is passionate about biosimilar products and to that end she has obtained extensive training on EU and US biosimilars product development as well as authored and/or co-authored number of articles on the subject matter. Dr. Chance received her PhD in Nutrition/Nutritional Biochemistry from the University of North Carolina in Greensboro and her MPH from the University of North Carolina in Chapel Hill. She obtained Regulatory Affairs Certification from Regulatory Affairs Professional Society in 2003. Dr. Chance is a member of Quintiles Biosimilars Advisory Board.