New Biosimilars Forum and Medicines for Europe research details how the EU created a competitive, multisource biosimilars market that increases patient access, creates cost-savings
The Biosimilars Forum and Medicines for Europe released a joint report recently exploring how European countries have successfully instituted and sustained a multi-source, competitive biosimilars market over the last decade. The report also lays out a roadmap for United States (U.S.) policymakers to ensure that patients have access to the treatments they need and that the healthcare system at-large achieves the significant potential for cost-savings associated with a vibrant biosimilars market.
The last decade of the European experience with biosimilars confirms that these important treatments represent an equally safe, equally effective, and a lower-cost alternative to specialty biologics. Although anti-competitive behaviors and other market dynamics have discouraged market uptake of biosimilars in the U.S., the report examines how adequate market preparedness and streamlining administrative processes can lead to the rapid adoption of biosimilars.
The report proposes a series of recommendations for U.S. stakeholders, including Congress, Health and Human Services (HHS), Centers for Medicare and Medicaid Services (CMS), the Food and Drug Administration (FDA), and commercial payers that can help ensure immediate and successful market uptake of biosimilars, including:
Giving biosimilars, just like generics, automatic priority tiering in formularies and reduced or zero-dollar copays for patients;
Banning fail first policies with the reference product before a biosimilar can be prescribed because these are always contrary to the ethical practice of medicine and create dangers for patients;
Proactively encouraging and incentivizing switching to biosimilars by physicians in order to increase access and affordability and assessing shared savings models that can foster this.
“A flourishing biosimilars market could save the U.S. as much as $54B over the next decade, but to realize these savings, policymakers must effectively address the barriers to biosimilars uptake,” said Juliana Reed, President of the Biosimilars Forum. “This report analyzed and thoughtfully put forth numerous lessons from the experiences of European countries -- which have successfully overcome similar barriers that the U.S. is currently facing -- that can be leveraged to cultivate a vibrant biosimilars marketplace and help cut billions in healthcare costs.”
“Our analysis shows that biosimilars were able to thrive quickly in Europe because the market was thoughtfully prepared, the treatments proved to be as safe and effective as the reference product, and the government provided clear guidelines to healthcare providers. While work is still required in the EU to achieve a sustainable framework over time, these principles can be replicated to lower healthcare costs by creating a competitive marketplace where providers, physicians and patients have access to cost-effective biosimilars treatment options,” said Julie Maréchal-Jamil Director Biosimilars Policy, Medicines for Europe.