On March 25th, the Journal of the Generics and Biosimilars Initiative (GaBI Journal) published a whitepaper entitled Policy recommendations for a sustainable biosimilars market: lessons from Europe. The paper was authored by ASBM Executive Director Michael Reilly and Advisory Board Chair Philip Schneider.

The biosimilar market in Europe is the largest in the world, representing approximately 60% of global biosimilar use. Several studies, research papers and position statements have been published that offer insight into elements that led to the successful introduction of biosimilars into Europe. The whitepaper examines these studies, along with real-world policy and procurement examples from European countries.
When comparing the findings and recommendations from these papers, several key conditions to achieve sustainable biosimilar markets can be identified and may be considered as ‘must haves’ for the long-term success of these markets. These are:
  1. Physicians should have the freedom to choose between off-patent originator biologicals and available biosimilars and to act in the best interest of their patients based on scientific evidence and clinical experience.
  2. Tenders should be designed to include multiple value-based criteria beyond price, e.g. education, services, available dose strengths, and provide a sufficient broad choice (multi-winner tenders versus single-winner tenders) to ensure continuity of supply and healthy competition.
  3. A level playing field between all participating manufacturers is the best way to foster competition; mandatory discounts which place artificial downward pressure on manufacturers do not engender a sustainable market environment.
Reilly expressed his hope that the paper will aid in the international development of robust biosimilar markets:
“As countries around the world look to replicate the success of biosimilars in Europe, it is our hope that this paper will serve as a guide, identifying the common factors and specific policies embraced by many European countries which made that success possible.”

The paper will also appear in Volume 9, issue 2 of the Gabi Journal 2020 print edition to be published in June.


Read the whitepaper here.