Multi-Stakeholder Collaboration Makes 2024 a Landmark Year for Biosimilars

Biologics have revolutionized treatment strategy in multiple fields, including gastroenterology and rheumatology. An important development that has revolutionized biologics themselves are biosimilars, which allow improved access of life-saving medications to patients while providing important savings to the healthcare system.

“Biologics are such great drugs, they're so effective, and they revolutionized rheumatology, for example. The saddest thing for me ever was hearing that all these patients who could have benefited from a biologic, like a TNF inhibitor, weren't able to access them because they didn't have good insurance, and then they ended up having to be handled just with the small molecule generics. That, to me, is what drives me, and drives our public health mission,” Sarah Yim, MD, director of the Office of Therapeutic Biologics and Biosimilars and Office of New Drugs at the Center for Biologics Evaluation and Research, told HCPLive®. “We want to make sure that if people need a biologic, they can get it, and biosimilars are like a direct step in that pathway. So, we want to see more of these products out there so more people can get access.”

Roadblocks to Uptake

In recent years, biosimilars’ potential impact in the United States has been stymied by several speed bumps, including physician education, insurance coverage and pharmacy benefit manager (PBM) practices, and an obfuscating interchangeability designation.

In fact, a study published in 2024 found that providers and pharmacists were statistically more likely to prescribe biosimilars when they were more informed on biosimilar’s noninferiority in terms of efficacy and safety compared with the reference drug.1 The study, although limited to a few counties in South Florida, highlights the ongoing need for education on biosimilar manufacturing pathways among pharmacists and providers.

Although the comparability between biosimilars and reference drugs has long been established, physicians can continue to be reassured by long-term studies supporting comparability as well as satisfaction with treatment when switching to biosimilars.^2,3

“I think education and letting people question and interact with [biosimilars] is so important in improving how people receive the idea of switching from their reference product to a biosimilar… We wouldn't approve products that we were worried about rheumatology patients or any other patients using. There has to be no clinically meaningful differences when you approve a biosimilar. That's the standard we use, and I would try to be as reassuring as possible on that for patients and providers who are concerned,” Yim emphasized, noting that although the message is not new, it bears repeating.

Biosimilars Have Had an Impact on Patients and Savings

A big disappointment for the field in 2023 to early 2024 was the meager uptake of biosimilars for adalimumab - the world’s top selling pharmaceutical, for which biosimilars collectively only achieved under 2% of the market share at the start of the year.⁴

“I think the underlying thought is that biosimilars have been ineffective at creating their desired outcome, and I think that we have to look at that a little bit differently. I think there are certainly examples where biosimilars, in a very short amount of time, have been able to penetrate 75-85% of the marketplace. It would be hard to say that those products are not successful. Then there are others with a share penetration of 25- 50% and people may, at first glance, say that biosimilars have been unsuccessful in their introduction. But… look at the indirect savings – [for example,] infliximab maintains about 50% of the market, but the expense… is reduced by about 70%... So yes, biosimilars didn't necessarily accrue the value that was expected of them, but the cost savings they created was significant,” Jon Martin, head of the US Biosimilar Unit at Organon, told HCPLive.

The Association for Accessible Medicines’ and Biosimilars Council’s 2024 U.S. Generic & Biosimilar Medicines Savings Report found that savings from the use of biosimilar medicines reached $12.4 billion in 2023 despite low rates of adalimumab biosimilar uptake.⁵ Notably, biosimilars also supported 495 million incremental days of therapy that patients would otherwise not have received.

Stakeholder Call to Actions Bear Fruit

Despite speed bumps, stakeholders including biosimilar sponsors, advocacy agencies such as Biosimilars Council, healthcare providers, and the FDA have all been taking action to improve the uptake of these important drugs. As a result, 2024 has been a landmark year for improving the uptake of several biosimilars, notably, adalimumab. The then 10 approved biosimilars for adalimumab have grown to 16 approved biosimilars, with market share growing from under 2% to a promising 24%.⁴ Overall, 61 biosimilars across 17 molecules have been approved by the FDA as of December 2024.

Among other healthcare providers that are proponents for increased biosimilar uptake, Jorge J. García, PharmD, MS, assistant vice president, Baptist Health South Florida and colleagues at Baptist health have been advocating for an at parity approach to biosimilars in which healthcare providers, patients, and the local market would have the freedom to choose the product that best suits their needs.

“Some payers are beginning to recognize the importance of offering a variety of biosimilar choices in their benefit design, rather than prioritizing one product for a larger rebate. By requesting smaller rebates from each company, payers can support greater access to biosimilar options while still realizing cost savings,” Garcia told HCPLive.

PBMs, which have done a lot of damage to the progress of biosimilar uptake in recent years, may be changing their tunes and recognizing the cost-saving opportunity offered by biosimilars. This year, some of the biggest PBMS, including CVS Caremark, Evernorth, and GoodRx, have announced plans to either add biosimilars to formulary list or replace the originator with a biosimilar option.^6,7,8 Costco, the Mark Cuban Cost Plus Drug Company, and others have also made deals with manufacturers to offer adalimumab biosimilars at a low cost to patients.^9,10

Companies developing biosimilars themselves, such as Organon, have also learned lessons helping to, and recognizing more opportunities to, streamline biosimilar development.

“I think there's a couple of things [we’ve learned] are when we have kind of an alignment of incentives, they're aligned around lower cost therapies, we see greater uptake of biosimilars,” Martin said. “There are opportunities, I think, for the system to continue to evolve to greater align incentives around lower cost therapies to the system and payer, as well as ensuring patients are part of the value equation. I think [those] are core drivers of biosimilar regularization.”

Another advocacy front has been led by Julianna Reed and the Biosimilars Council, for which she serves as executive director. The council, several months ago, called on the FDA to help streamline biosimilar development by publishing a position paper outlining their suggestions, with the goal of enhance access, affordability, and efficiency by bringing biosimilars to market faster.¹¹

The Interchangeability Question

A big focus of the Biosimilars Council’s paper is the confusion surrounding interchangeability, a designation that requires additional data reflecting how the biosimilar may be used in the marketplace with patients and allowing the biosimilar to be substituted at the pharmacy for the reference product without intervention of the prescribing health care provider.¹² The FDA recognizes that the designation, introduced in 2009, may not have a place in today’s market.

“We would like to see the categories simplified into 1 determination, but that’s up to Congress. In the meantime, we continue to approve high-quality biosimilars and interchangeables, but there really isn't much of a difference between the 2. The only real difference is how pharmacies may use them—pharmacies can substitute interchangeables, and biosimilars have to be prescribed by name,” Yim clarified.

Putting the interchangeability designation to bed would certainly resolve the current confusion between interchangeable and not interchangeable biosimilars, but until that time, the Biosimilars Council calls for streamlined regulations for attaining the almost-arbitrary designation.

FDA Revamps Biosimilars Action Plan

In addition to interchangeability, the regulatory agency has been working to revitalize its Biosimilars Action Plan (BAP) in ways that address many stakeholder concerns.¹³ The BAP’s goals are to (1); improve the efficiency of the biosimilar and interchangeable product development and approval process; (2); to maximize scientific and regulatory clarity for the biosimilar product development community; (3); continuing and improving communication and education for physicians and patients; and (4); supporting a competitive workplace.

“Clinical data is the most expensive and time-consuming part of a biosimilar program, and unless it is necessary to resolve a specific question, it can add significant cost without providing substantial benefits. This is a major focus area for us right now,” Yim stressed.

The FDA is also working to address calls for more global cooperation when it comes to comparability studies between reference and biosimilar products.

“Comparative efficacy studies are a big one, where most countries have the flexibility to not require them if they don’t think they need them for a scientific reason. We think that the efforts we’re doing there are potentially really important for making biosimilar development more feasible for the development community, and hopefully that’ll get more products out and increase access for patients,” Yim said. “That’s the ultimate goal, right? To get more of these products out and have more people be able to get biologics if they need them.”

Looking Forward

Biosimilars have already made a difference in patient care and savings to the healthcare system and seem poised to make an even greater wave in the years to come. The continuing change is supported by efforts from physicians, advocates, companies, and the FDA; and patients, physicians, and even PBMs are starting to listen.

“When you look at what the future potential could be for biosimilars in the United States, being a pro-competition market, it leads you to believe that over time the biosimilars will be one of the solutions to help address the affordability in the US both from the system perspective as well as patients,” Reed said.

“Can we create an environment where incentives are aligned? …I think there's opportunities for shared savings, where another odd way, where users of biosimilars would be rewarded for using lower-cost therapies in terms of what they were able to share in terms of savings, I think looking towards pathways where we can ensure patients, youth who use biosimilars have lower co pays across the market, I think is certainly a benefit that we've learned from the generic market that could be applied to biosimilars,” Martin added.

While the future seems bright, Yim did have a word of caution to add about the growth of the biosimilar market and its uncertain sustainability.

“I think we’re making good progress, and I just hope that we can sustain that progress over the next decade and get more of these products out for patients, and that more people are interested in developing biosimilars. That's my hope. We're going to try to make it as smooth as possible from our side, but there are a lot of other people who need to also join in those efforts,” she said.

Reaching the full potential of biosimilars and avoiding unsustainable pricing may not be possible without more systemic change in the US healthcare and insurance system – but perhaps we’ll leave 2024 on a high note and poke that beast next year.

REFERENCES:

1. Qahtani MA, Al-Jedai A, Wertheimer A. Factors that Influence Healthcare Professionals' Intentions towards Biosimilars. Innov Pharm. 2024;15(1):10.24926/iip.v15i1.5922. Published 2024 Mar 18. doi:10.24926/iip.v15i1.5922
2. Young D, Harris C, Rahmany S, et al. A randomised, crossover trial exploring the patient perspective and effectiveness of biosimilar adalimumab transition: IBD reference and biosimilar adalimumab cross over study (iBaSS). Int J Clin Pharm. Published online May 11, 2024. doi:10.1007/s11096-024-01739-5
3. Birck MG, Lukusa L, Choquette D, Boire G, Maksymowych WP, Singh H, Afif W, Bernatsky S. Incidence of serious infection among etanercept and infliximab initiators: safety comparison between biosimilars and bio-originators with Canadian population-based data. BMC Rheumatol. 2024 Sep 27;8(1):47. doi: 10.1186/s41927-024-00415-5. PMID: 39343928; PMCID: PMC11441163.
4. Samsung Bioepis biosimilar market dynamics 7th edition, Q4 2024. Samsung Bioepis. October 10, 2024. Accessed October 11, 2024. https://www.samsungbioepis.com/en/etc/gadown.do?filename=SB+Biosimilar+Market+Report+Q4+2024.pdf&utm_source=pdfClick&utm_medium=filedown&utm_campaign=marketReport
5. 2024 Savings Report. 2024 U.S. Generic & Biosimilar Medicines Savings Report. AAM. September 5, 2024. https://accessiblemeds.org/resources/blog/2024-savings-report
6. CVS Caremark accelerates biosimilars adoption through formulary changes. CVS Health. News release. January 3, 2024. https://www.cvshealth.com/news/pbm/cvs-caremark-accelerates-biosimilars-adoption-through-formulary-changes.html
7. Evernorth announces Humira biosimilar available at $0 out of pocket for Accredo patients in June. Evernorth. News release. April 25, 2024. https://www.prnewswire.com/news-releases/evernorth-announces-humira-biosimilar-available-at-0-out-of-pocket-for-accredo-patients-in-june-302128023.html
8. Boehringer Ingelheim and GoodRx announce exclusive patient affordability initiative for Adalimumab-adbm injection, Boehringer's biosimilar to Humira®. News release. Boehringer Ingelheim. July 18, 2024. https://www.prnewswire.com/news-releases/boehringer-ingelheim-and-goodrx-announce-exclusive-patient-affordability-initiative-for-adalimumab-adbm-injection-boehringers-biosimilar-to-humira-302199865.html
9. Celltrion USA announces incorporation of adalimumab-aaty, a Humira® biosimilar, to the Costco Member Prescription Program. News release. Celltrion USA. August 12, 2024. https://www.prnewswire.com/news-releases/celltrion-usa-announces-incorporation-of-adalimumab-aaty-a-humira-biosimilar-to-the-costco-member-prescription-program-302220446.html?tc=eml_cleartime
10. Mark Cuban Cost Plus Drug Company joins forces with Coherus to make YUSIMRY™, a HUMIRA® biosimilar, available to patients. News release. Mark Cuban Cost Plus Drug Company. June 1, 2023. https://investors.coherus.com/news-releases/news-release-details/mark-cuban-cost-plus-drug-company-joins-forces-coherus-make
11. Biosimilars Council. Streamlining the Development of Biosimilar Medicines. Biosimilars Council. May 30, 2024. Accessed June 5, 2024. https://biosimilarscouncil.org/wp-content/uploads/2024/05/202405-BiosimilarsCouncil-Streamlining-Development-Biosimilar-Medicines.pdf
12. Biosimilars: Overview for Healthcare Professionals. FDA. Updated August 1, 2024. https://www.fda.gov/drugs/biosimilars/overview-health-care-professionals
13. Biosimilars Action Plan. FDA. Updated April 26, 2024. https://www.fda.gov/drugs/biosimilars/biosimilars-action-pla