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BioRationality: The Urgency of Removing Clinical Efficacy Studies
Biosimilar associations advocate for lower development costs and streamlined regulations to enhance patient access to affordable biosimilars.
Associations established to support biosimilars are currently represented by three entities: the Biosimilars Forum, the Biosimilar Council (part of the Association of Affordable Medicines), and the significant pharma representation by Bio.org. The memberships of these 3 entities are highly diverse, with the Biosimilar Council being the smallest of the bunch.
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Juliana Reed, executive director of the Biosimilar Forum, stated when she took over the role, “I am extremely excited to lead the most influential organization for the biosimilars industry at such a critical time. My top priority will be to work with our members, Congress, and the FDA as a voice for our industry and patients. I will advocate for commonsense policy solutions that give more patients access to life-saving, lower-cost biosimilars.”1
I will analyze this perspective and offer advice on bringing this conviction to reality.
Unpacking the Core Issues: Beyond the Advertising Hype
The most common statements made by both biosimilar associations center on the roles of PBMs, prescriber and patient understanding, hurdles in distribution channels, and, to a lesser extent, development cost hurdles. They mainly advertise how much biosimilars are saving without adequately highlighting a crucial point: only a small number of biologicals are available as biosimilars because of the high cost of their development.2 This reality keeps smaller companies out of the market and large companies focused only on high-market products, as their development announcements can significantly affect their stock.
If we can bring down the development cost closer to the pathway for abbreviated new drug applications or 505(b)(2) filings, there will be little left to promote to make biosimilars accessible. I believe this is the fundamental challenge to biosimilar success.
Reconsidering Current Approaches: Where Advocacy Falls Short
The Biosimilar Council regularly references IQVIA reports, stating that only a few molecules have biosimilars available. However, I don’t think this view fully grasps that it is not in IQVIA's interest to reduce testing in patients; they are, after all, an excellent company to conduct these trials. My point here is that we should be questioning the necessity of all that testing, not just reporting on its current state.
The Biosimilar Council also remains engaged in the Inflation Reduction Act, where they argue that the reference product must not sell at a lower price; otherwise, biosimilars will have less incentive to enter the market. This is, in my opinion, a position that misunderstands the dynamics of market incentive for biosimilars.
A Clear Path Forward: Learning from International Success
Reed has spoken clearly that we must lower the cost of biosimilars, and that can only be achieved if we work together to convince the FDA to follow what the UK’s Medicines and Healthcare products Regulatory Agency has already done. The European Medicines Agency is about to remove clinical efficacy testing. As a long-time advisor to the FDA, I have published another paper highlighting the urgency for the FDA to consider removing CESs.3
This is another agenda that I believe the Biosimilar Council and Biosimilar Forum should take up. In this opinion column, I am asking them to promote this motivation to the FDA. I hope my paper will also help these associations understand my position that a lot of the issues facing the biosimilar space will be addressed once we address development costs.
References
1. Juliana M. Reed named executive director of the Biosimilars Forum. Press release. Biosimilars Forum; January 31, 2022. Accessed June 1, 2025. https://biosimilarsforum.org/2022/01/31/juliana-m-reed-named-executive-director-of-the-biosimilars-forum/
2. Munz K. Despite uptake barriers, real-world biosimilar data demonstrate safety, efficacy, cost-effectiveness. AJMC®. April 17, 2024. Accessed June 2, 2025. https://www.ajmc.com/view/despite-uptake-barriers-real-world-biosimilar-data-demonstrate-safety-efficacy-cost-effectiveness
3. Niazi, S.K. Scientific justification and policy recommendations to the US Food and Drug Administration for waiving comparative efficacy studies. Pharmaceuticals. 2025;18:779. doi:10.3390/ph18060779
Eye on Pharma: Interchangeability Labels and Expanded Biosimilar Partnerships
May 29th 2025The FDA designates 2 biosimilars as interchangeable, enhancing access to treatments for inflammatory diseases and multiple sclerosis, while 2 other companies expand their biosimilar partnership to include more products.
Escaping the Void: All Things Biosimilars With Craig & G
May 4th 2025To close out the Festival of Biologics, Craig Burton and Giuseppe Randazzo from the Association for Accessible Medicines and the Biosimilars Council tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
What Stands in the Way of Biosimilar Use Across MENA Countries?
May 21st 2025Despite the clear promise of cost savings and expanded access, the path to integrating generics and biosimilars across the Middle East and North Africa (MENA) region is tangled in a web of distrust, inconsistent policies, and deep-rooted cultural preferences for branded drugs.
