Readout from the 2024 Festival of Biologics

Wednesday April 24, 2024

Last week’s Festival of Biologics in San Diego came during a critical time for our industry when unfolding challenges and opportunities are shaping the future of the biosimilar market. I was pleased to join the Biosimilars Council team at the annual event, presenting and meeting with colleagues across the biosimilars industry.

Several themes stood out throughout the meeting. Above all, speakers highlighted the need to ensure future sustainability of biosimilar competition. This included discussions on what a sustainable biosimilar market could and should look like, challenges to sustainability, and how stakeholders can work together to ensure that biosimilars continue to deliver increased patient access and savings. You’ll recall that we released our Hatch-Waxman white paper earlier in the year touching on this theme of sustainability in the generic and biosimilar industries, and calling for legislative and regulatory action to preserve and enhance generic and biosimilar competition and sustainability.

The other hot topic at the Festival was, unsurprisingly, Humira. Despite price discounts of greater than 80 percent, adoption of biosimilar versions of Humira has been disappointingly slow. Earlier this month we released a new report with IQVIA highlighting the strategy created by pharmacy benefit managers (PBMs) to protect $2 billion in profits by suppressing adoption of the biosimilar. IQVIA found that adalimumab biosimilars offer up to $6 billion in potential savings to the U.S. healthcare system, but at a loss of profits to PBMs.

And in an example of health systems leading the charge with biosimilars, we had the opportunity to sit in on presentations by leaders at Kaiser Permanente and the Mayo Clinic, both of whom talked about their respective successful adoption of biosimilars, and how other systems can replicate their strategies to realize pharmaceutical savings from increased biosimilar utilization.

We also discussed biosimilar interchangeability. We’ve long known that once a biosimilar is approved by the FDA, there is no need for a separate process or designation for interchangeability, which only slows patient access and increases prices. There is an emerging science-based consensus, consistent with FDA’s insights, that there is no difference between biosimilar and interchangeable medicines.

Finally, patient education continues to be a critical aspect to driving biosimilar uptake. The Council has long been committed to increasing patient understanding of the safety and efficacy of biosimilars. We heard from stakeholders in the patient and provider community about how consumers want to receive education and resources about biosimilars, who they trust and want to hear from about new treatment options, and the persistence of myths and misconceptions around biosimilars. As more biosimilars become available to patients in new therapeutic areas, it is incumbent upon industry to continue our outreach to stakeholder communities to ensure they understand the tremendous value these biosimilars can have on their health and on their wallets. We’re proud to be a part of these discussions and look forward to continuing to work with stakeholders to expand patient access to lower cost biosimilars.

– Craig Burton, Executive Director, Biosimilars Council and Senior Vice President, Policy & Strategic Alliances, Association for Accessible Medicines

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October 21–23, 2024 | Rockville, MD

GRx+Biosims™ 2024 is the leading regulatory science and policy event for the U.S. generics and biosimilars industry. Access the most recent information straight from experts at the Food and Drug Administration, grasp the latest policies shaping the industry, and acquire valuable insights to propel your professional development.