By Marcus. A. Banks
Biosimilars generated $12.4 billion in savings in 2023, bringing the total savings since their introduction in 2015 to $36 billion. But in the case of biosimilar versions of Humira (adalimumab, AbbVie), payor incentives that sometimes favor the innovator product have kept even more cost reductions from being realized, speakers noted at AMCP Nexus 2024, in Las Vegas.

Nine Humira biosimilars launched in 2023, including the first, Amjevita (adalimumab-atto, Amgen), introduced in January, the speakers noted. In February 2024, the FDA approved a tenth Humira biosimilar, Simlandi (adalimumab-ryvk). Simlandi joins Pfizer’s Abrilada (adalimumab-afzb) and Boehringer Ingelheim’s Cyltezo (adalimumab-adbm) as the only three biosimilars that are interchangeable with Humira. (Interchangeable or interchangeability means that the biological product may be substituted for the reference product without the intervention of the prescribing health care provider).

Despite this profusion of Humira biosimilars, purchasing the branded version cost an estimated $6 billion in extra spending in 2023, per the Association for Accessible Medicines (U.S. Generic & Biosimilar Medicines Savings Report, September 2024). Leaders of the association, an advocacy organization, argue that rebates between pharmacy benefit managers (PBMs), health systems and other entities sometimes incentivize providing Humira and not its lower-cost biosimilars.

“Progress is never swift and easy,” said Nexus speaker Sophia Humphreys, PharmD, MHA, BCBBS, the director of formulary management and clinical programs at Sutter Health, in Sacramento, Calif.
Regulatory changes that align incentives among health systems, PBMs, payors and patients are needed to maximize cost savings from Humira biosimilars, Dr. Humphreys said. Similar efforts are also needed for biosimilars treating cancer, autoimmune diseases and other conditions, she added.


Generics Versus Biosimilars

Generic medications often are cited as the model for reducing drug spending. But that model only goes so far in the case of biosimilars. Because biologics are larger-molecule proteins with more complex structures, Dr. Humphreys explained, generics are not possible. Thus, biosimilars are the only lower-cost alternatives to these biologic agents. But it can cost up to $300 million to develop a new biosimilar, she added, citing a study she co-authored (J Manag Care Spec Pharm 2024;16:1-8).

Although it is important to extract more savings from biosimilars when possible, Justin Bioc, PharmD, BCPS, BCGP, the head of clinical pharmacy at Devoted Health, in Waltham, Mass., offered one caveat during the Nexus session: Regulations that drive the cost of biosimilars too low could have unintended consequences, “including discouraging manufacturers from developing them.” 

There are many success stories in the biosimilars space, with biosimilar versions of Remicade (infliximab, Janssen) a case in point. These biosimilars were introduced in 2016, with little immediate market penetration. But by 2023, infliximab biosimilars garnered almost half the market share (IQVIA Market Prognosis, September 2023; IQVIA Institute, November 2023).

“Patience and persistence win the race,” Dr. Bioc said, and ideally with thoughtful regulatory reforms that encourage more biosimilar development.

Dr. Bioc reported no relevant financial disclosures. Dr. Humphreys reported a consultantship with Boehringer Ingelheim.