Biosimilars Forum Report Calls for Changes to the US Biosimilars Market

The Biosimilars Forum and Medicines for Europe today released a joint white paper that discusses how Europe has successfully sustained its multisource biosimilars market for the past 10 years. The forum also suggests that the United States make structural changes in order to achieve similar success.

According to the white paper, despite the fact that US-led regulatory science and research made the European biosimilars market possible, the United States has yet to learn from Europe’s success in striking a balance between long-term sustainability and short-term savings. Currently, 90% of biosimilar sales take place in Europe, despite the fact that 60% of all biologic medicine sales occur in the United States.

The report explains that, as biosimilars have become available in Europe, patient access has increased while costs have dropped. In the United Kingdom, for example, after the arrival of biosimilars for infliximab, etanercept, and rituximab, prices for these therapies fell by an average of 40%, while overall volume rose by approximately 16%.

The report points to what it calls 3 key lessons from the European experience that the United States should heed: first, biosimilars are safe and effective, and this proven track record of safety and efficacy should be at the forefront of dialogue with providers and patients. Second, reducing providers’ administrative burden is crucial; the report points to the Swedish experience in which, prior to the advent of biosimilar filgrastim, 3 physicians had to approve the use of the reference product. After the advent of biosimilars, only 1 physician must authorize the use of filgrastim. Third, proactive measures to prepare the market for biosimilars are necessary. The report points to the UK commissioning framework for biologics, with its clearly defined roles and responsibilities for all stakeholders, as a notable success that has helped the nation’s health system to realize substantial savings.

The report also issues a call to action for policy makers, saying that the United States needs to support a fair market that allows lower-priced products to obtain market share; the FDA needs to provide scientifically sound, efficient, well-resourced, and timely review of biosimilars; and a framework should be implemented to align incentives across stakeholder groups.

HHS, CMS, and other payers should give biosimilars automatic priority tiering in formularies and reduced or zero-dollar copays, say the paper’s authors, and step therapy practices that require patients to fail a reference product before gaining access to a biosimilar should be banned. Switching to biosimilars should be encouraged and incentivized, stakeholders should be educated about the contribution that biosimilars can make to healthcare for all, patient groups and professional societies should use FDA educational materials in training, and commercial insurers should provide access to biosimilars with lower or zero copays.

The forum calls on the FDA to prioritize the biosimilars program, minimize the need for redundant or unnecessary clinical studies, work toward harmonization with other regulatory jurisdictions, provide clarity on interchangeability, encourage the use of real-world evidence, endorse and create educational materials, educate stakeholders, and aggressively counteract misinformation.

“A flourishing biosimilars market could save the [United States] as much as $54 [billion] 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, in a statement announcing the publication of the paper. “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.”

Julie Maréchal-Jamil, director biosimilars policy at Medicines for Europe, added, “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.”