HDMA report explores biosimilar marketplace potential in the U.S.
ARLINGTON, Va. — A new study published Thursday by the Center for Healthcare Supply Chain Research (HDMA’s nonprofit 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 United States.
“In a little more than five years, about $55 billion of the U.S.’s original biologics will lose exclusivity,” said Karen Ribler, EVP 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 road map 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:
A minimum threshold of physician acceptance, which is linked to their understanding of the category, is necessary for prescribing biosimilar medications. This behavior varies by country, disease state and type of treatment;
Substitutability does accelerate adoption in markets where it exists, but market players are able to achieve high adoption of biosimilar use even where substitutability is not an option;
Payers influence uptake in adoption through aggressive use of various tactics like utilization quotas;
Commercial support, including sales force and patient services, is often necessary to obtain biosimilar uptake;
More entrants, while increasing competitive intensity and price pressures, also typically result in higher publicity, which boosts market penetration; and
Biobetters may limit biosimilar uptake when they offer better convenience, lower cost or an enhanced drug profile in terms of safety or efficacy.
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 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.