AbbVie’s Humira (adalimumab) has retained more than 80% of patients in the last year (Q3/2023 to Q2/2024), despite the availability of nine lower-priced rival products available in the US. This raises questions among drug pricing experts and analysts about whether the market for prescription biosimilars can survive in its current form.
Humira, priced at nearly US$7,000 a month in the US, is the first leading drug to face competition from a range of 10 biosimilars of AbbVie's blockbuster arthritis drug. Six of these biosimilars come in the more popular high-concentration version, and all are citrate-free, see Table 1. The three largest pharmacy benefit managers (PBMs) have included two to three of these biosimilars on their lists of covered drugs for 2024.
Adalimumab is a human monoclonal antibody treats autoimmune diseases including rheumatoid arthritis, juvenile idiopathic and psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis and ulcerative colitis [1].
| Table 1: Biosimilar adalimumab launched in the US*
|
| Product name
|
Company
|
Launched in the US
|
Interchangeable
|
High concentration
|
Citrate free
|
| Abrilada (adalimumab-afzb)
|
Pfizer
|
Oct 2023
|
Yes
|
No
|
Yes
|
| Amjevita (adalimumab-atto)
|
Amgen
|
Jan 2023
|
No
|
Yes
|
Yes
|
| Cyltezo (adalimumab-adbm)
|
Boehringer Ingelheim
|
Jul 2023
|
Yes
|
No
|
Yes
|
| Hadlima (adalimumab-bwwd)
|
Organon/Samsung Bioepis
|
Jul 2023
|
No
|
Yes
|
Yes
|
| Hulio (adalimumab-fkjp)
|
Biocon
|
Jul 2023
|
No
|
No
|
Yes
|
| Hyrimoz (adalimumab-adaz)
|
Sandoz
|
Jul 2023
|
Yes
|
Yes
|
Yes
|
| Idacio (adalimumab-aacf)
|
Fresenius Kabi
|
Jul 2023
|
No
|
No
|
Yes
|
| Simlandi (adalimumab-ryvk)
|
Alvotech/Teva
|
May 2024
|
Yes
|
Yes
|
Yes
|
| Yuflyma (adalimumab-aaty)
|
Celltrion
|
Jul 2023
|
No
|
No
|
Yes
|
| Yusimry (adalimumab-aqvh)
|
Coherus Biosciences
|
Jul 2023
|
No
|
No
|
Yes
|
*Data updated 30 July 2024.
Note: High-concentration versions of Hyrimoz, Hadlima and Yuflyma were available on launch, but those versions of Amjevita and Cyltezo only became available in 2024. The Cost Plus Drug Company started offering Yusimry at US$569.27 plus dispensing and shipping fees in July 2024.
|
The first adalimumab biosimilar, Amgen’s Amjevita, was approved in the US in 2016 [2], and since then, eight more have been approved. However, they were only launched in 2023 due to patent expiry extensions and agreements between AbbVie and the biosimilars companies [3, 4].
Since its launch, the uptake of the products has been slow, despite being offered at discounted prices through PBMs [5]. From Q3/2023 to Q2/2024, AbbVie filled a total of more than 3,316,804 prescriptions for Humira, while all its competitors combined filled just over 131,793 prescriptions of their biosimilars. The data exclude sales of Teva/Alvotech’s Humira biosimilar, Simlandi, which became available in the US only in May 2024.
Despite the sharply discounted prices of biosimilars, CVS Caremark did not remove Humira from its list of covered drugs [6] until April 2024. This marked the beginning of an increase in the uptake of adalimumab biosimilars. Starting in June 2024, CVS began covering a Sandoz biosimilar and a co-branded Humira, both through its new Cordavis pharmaceutical unit.
Stacie Dusetzina, a health policy professor at Vanderbilt University, has noted that regulatory reform is needed so patients can more easily access biosimilars and attract rival drugmakers to develop them. ‘It's not clear to me there's any incentive at all for companies to spend their time and money creating biosimilars. And if no one will, then the price of the brand drug would never come down,’ she said.
In addition, a recent article by Dr Joshua Cohen discusses the challenges facing the adoption of biosimilars in the US, particularly focusing on Medicare beneficiaries’ access to these lower-cost alternatives to brand-name biologicals like Humira [7].
Related articles
FDA approves interchangeable adalimumab biosimilar Simlandi
The latest biosimilars agreements
References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of adalimumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jul 30]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-adalimumab
2. GaBI Online - Generics and Biosimilars Initiative. FDA approval for Amgen’s adalimumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jul 30]. Available from: www.gabionline.net/biosimilars/news/FDA-approval-for-Amgen-s-adalimumab-biosimilar
3. GaBI Online - Generics and Biosimilars Initiative. Amgen’s adalimumab biosimilar will only be launched in US in 2023 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jul 30]. Available from: www.gabionline.net/biosimilars/news/Amgen-s-adalimumab-biosimilar-will-only-be-launched-in-US-in-2023
4. GaBI Online - Generics and Biosimilars Initiative. AbbVie and Samsung Bioepis reach patent deal over Humira biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jul 30]. Available from: www.gabionline.net/biosimilars/general/AbbVie-and-Samsung-Bioepis-reach-patent-deal-over-Humira-biosimilar
5. GaBI Online - Generics and Biosimilars Initiative. US PBMs add multiple Humira biosimilars to formularies [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International [cited 2024 Jul 30]. Available from: www.gabionline.net/biosimilars/general/us-pbms-add-multiple-humira-biosimilars-to-formularies
6. GaBI Online - Generics and Biosimilars Initiative. CVS Caremark removes Humira in the US and Sandoz launches Hyrimoz in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International [cited 2024 Jul 30]. Available from: www.gabionline.net/biosimilars/general/cvs-caremark-removes-humira-in-the-us-and-sandoz-launches-hyrimoz-in-europe
7. GaBI Online - Generics and Biosimilars Initiative. Addressing the persistent gap in Medicare access to Humira biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International [cited 2024 Jul 30]. Available from: www.gabionline.net/biosimilars/general/addressing-the-persistent-gap-in-medicare-access-to-humira-biosimilars
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