The Future of Biosimilars: Learning from Prior Mistakes

More biosimilars continue to be developed, and as they come to market, they should help lower costs. Systemic barriers continue to limit access, and therefore, savings. Market manipulation by drug manufacturers, complexities caused by formulary placement by large pharmacy benefits managers (PBMs), administrative hurdles, and an array of variations in biosimilar products led to patient and physician confusion and lack of adoption. As a result, high-cost brand biologics continue their market dominance.

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The 2 previous articles in this series explored these challenges and their impact. The barriers they created have been obvious in the lack of update of lower cost alternatives to adalimumab (Humira; AbbVie) that has been a blockbuster drug for more than a decade since its launch. Cheaper and equally effective alternatives to this expensive brand drug are being held back by the very systems meant to make medications accessible. With other high-cost biologics—most immediately, ustekinumab (Stelara; Janssen Immunology)—set to face similar biosimilars competition,¹ the issue is about to get much bigger.

Without deliberate resolve and decisive action, it will not stop with ustekinumab. Biosimilars for treatments ranging from cancer to diabetes will face the same uphill battle, leaving patients, employers, and, indeed, the entire health care system stuck with higher costs that could be avoided. The risk is that some manufacturers may even decide that investing in biosimilar development is no longer viable. However, there is still an opportunity to change course.

SEIZING A NEW OPPORTUNITY WITH USTEKINUMAB BIOSIMILARS

The next major brand biologic to face significant competition from multiple biosimilars, starting in January 2025, is ustekinumab, which is widely prescribed for inflammatory diseases, and is second only to adalimumab in market dominance for a broad range of conditions.^1,2 This presents one more opportunity to lower the cost for plan sponsors, patients, and the health care system without sacrificing efficacy or safety.²

Making the most of this savings opportunity is particularly important because these 2 therapies work through different pathways to treat inflammation.³ That means trial and failure with 1 drug does not limit the opportunity for treatment with the other. Having biosimilar alternatives for both adalimumab and ustekinumab offers plan sponsors—and the 45% of pharmacy benefits plan members using these medications—a cost-effective, clinically appropriate formulary lineup.

Although the potential is clear, the path forward is not. If the same barriers that held back adalimumab biosimilars, such as delayed formulary placement and entrenched rebate structures, are not addressed, ustekinumab biosimilars may struggle to make a meaningful impact. There is reason to be hopeful. In the last few months, some PBMs have taken important steps to include biosimilars more quickly on their formularies, providing a glimmer of hope for greater adoption. The lessons learned from the adalimumab experience provide an opportunity to make necessary changes. Adopting a proactive approach to formulary management and biosimilar inclusion gives these new treatments the best chance to succeed.

PREPARING FOR WHAT IS NEXT

Ustekinumab is just the tip of the iceberg. The next few years will bring an influx of biosimilars for high-cost biologics across a wide range of therapeutic areas, including oncology and diabetes. If systemic issues that have hindered biosimilar adoption so far are not addressed, these alternatives will continue to be priced out of competition or trapped in administrative limbo, and billions in potential savings will remain out of reach.⁴

Providers will once again face the frustration of knowing there’s a better, more affordable option while being unable to offer it due to complex policies and entrenched financial interests. Meanwhile, patients and plan sponsors will be stuck with higher costs, missing out on the potential savings that biosimilars could bring.

BUILDING A ROADMAP FOR CHANGE

What would help prevent a repeat of the consequences of inaction that were seen with adalimumab?

1. First, PBMs must accelerate how quickly they evaluate biosimilars for formulary inclusion. Currently, many PBMs lock in their strategies years in advance, meaning it's too late to make adjustments when a biosimilar hits the market. For biosimilars to succeed, PBMs need to be nimble, proactive, and ready to incorporate these alternatives as soon as they become available.
2. Next, a level playing field is essential. Biosimilars can’t compete fairly when brand name drugs benefit from aggressive rebate structures and marketing strategies that lock them into preferential positions. Biosimilar preference—not just formulary parity—should be a presumption. Taking the branded drug off formulary altogether should be a serious consideration. Voluntary—or mandatory, if required—reforms are needed to break these barriers and create a space where biosimilars can compete based on their cost and clinical efficacy rather than being sidelined by financial incentives.
3. Finally, improving competition will make it easier for providers to prescribe and pharmacists to facilitate dispensing biosimilars. Providers are responsible for making the initial prescribing decisions, and pharmacists play a key role when it comes to medication substitution, especially for interchangeable biosimilars where allowed by state law.⁵ Providers often face both formulary limitations and administrative burdens when trying to switch patients to lower-cost biosimilars.5 Removing these barriers and empowering health care providers to make cost-effective choices will help biosimilars gain the foothold they need in the market.

THE STAKES WILL CONTINUE TO RISE

The biosimilar pipeline is expanding. In the next few years, a wave of biosimilars could revolutionize how chronic diseases and serious conditions are treated.⁴ But without the right systems in place, future biosimilars will suffer a similar fate as those already launched and the cost of repeating the same mistakes and doing nothing is just too high.

REFERENCES

1. Jeremias S. Amgen’s Stelara biosimilar delayed until 2025 after settling with J&J. The Center for Biosimilars. May 29, 2023. Accessed October 2, 2024. https://www.centerforbiosimilars.com/view/amgen-s-stelara-biosimilar-delayed-until-2025-after-settling-with-j-j

2. FDA approves interchangeable biosimilar for multiple inflammatory diseases. News release. FDA. October 31, 2023. Accessed October 2, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-interchangeable-biosimilar-multiple-inflammatory-diseases

3. Danapilis S. Stelara vs. Humira: What You Should Know. Healthline. April 12, 2024. Accessed October 2, 2024. https://www.healthline.com/health/drugs/stelara-vs-humira

4. Humphreys S, Gluckman R, Bahou E M. Biosimilars in Focus: Advancing Implementation in Health Care Systems. AJMC. September 16, 2024. Accessed October 2, 2024. https://www.ajmc.com/view/biosimilars-in-focus-advancing-implementation-in-health-care-systems.

5. FDA. 9 Things to Know About Biosimilars and Interchangeable Biosimilars. June 20, 2024. Accessed October 3, 2024. https://www.fda.gov/drugs/things-know-about/9-things-know-about-biosimilars-and-interchangeable-biosimilars