October 16, 2014
ARLINGTON, Va. — A new study published by the Center for Healthcare Supply Chain Research (HDMA’s non-profit research foundation) — Biosimilars: Lessons from Europe and Strategies for the U.S. — identifies factors, based on an analysis of European models, that may affect the American launch of biosimilars and their marketplace potential in the U.S.
“In a little more than five years, about $55 billion of the U.S.’s original biologics will lose exclusivity,” said Karen J. Ribler, Executive Vice President and COO of the Center for Healthcare Supply Chain Research. “As the U.S. market awaits FDA guidance on biosimilars, it is useful to look at Europe for a roadmap of how these products can be adopted in the U.S.”
By reviewing the European experience, the publication found that the commercialization and adoption of biosimilars varied throughout five countries — including France, Germany, Italy, the United Kingdom and Romania — but the amount of regulation in place and stakeholder alignment both tended to shape the overall uptake of these products. Among the factors found to drive European biosimilar adoption:
The report then applies the lessons learned from Europe to the U.S. healthcare environment, taking into account stakeholder influence, payer structure and marketplace dynamics. With many determinants for biosimilars being unknown, the report methodically offers a discussion based on the present, as well as scenarios for possible commercialization. Areas discussed include: interchangeability, substitutability, the use of international data, naming conventions and stakeholder influence.
Jeff Herzfeld, PharmD, Senior Vice President, U.S. Trade Relations, Specialty Medicines, TEVA Pharmaceuticals, said, “This report provides a comprehensive analysis of today’s European and U.S. biosimilar landscape.”
HDA is the national association representing primary healthcare distributors, the vital link between the nation’s pharmaceutical manufacturers and healthcare providers. Each business day, HDA member companies ensure that over 15 million prescription medicines and healthcare products are delivered safely and efficiently to more than 200,000 pharmacies, hospitals, long-term care facilities, clinics and others nationwide. HDA and its members work daily to provide value and achieve cost savings, an estimated $42 billion each year to our nation’s healthcare system.