A large range of biosimilars of the anti-inflammatory drug Humira (adalimumab) are expected to flood the market in 2023. There could be as many as 10+ biosimilar competitors on the market by the end of 2023, based on current US Food and Drug Administration (FDA) approvals and pending applications [1].
Adalimumab, sold under the brand name Humira, is the monoclonal antibody used to treat a range of inflammatory conditions including rheumatoid arthritis, psoriatic arthritis and inflammatory bowel disease (IBD) [2, 3].
Since first launching in the US in 2003, Humira® as a product has evolved in many ways including new concentrations, citrate-free versions, latex-free delivery devices, and smaller needle gauges. Given the numerous product attributes that have arisen over the last 18 years, understanding what to anticipate from a product differentiation standpoint is a challenging task.
Table 1 shows the Humira (adalimumab) biosimilars in the pipeline that are approved to launch in 2023.
| Table 1: FDA approved Humira (adalimumab) biosimilars pipeline
|
| Date of anticipated launch
|
Biosimilar brand name
|
Manufacturer
|
| 31 Jan 2023
|
Amjevita
|
Amgen
|
| 1 Jul 2023
|
Cyltezo
|
Boehringer Ingelheim
|
| Hadlima
|
Organon/Samsung Bioepis
|
| Yusimry
|
Coherus
|
| 31 Jul 2023
|
Hulio
|
Viatris/Biocon
|
| 30 Sep 2023
|
Hyrimoz
|
Sandoz
|
| 20 Nov 2023
|
Abrilada
|
Pfizer
|
Note: Data reflect biosimilar pipeline information as of January 2022.
FDA: US Food and Drug Administration.
|
As indicated in Table 1, Amgen is developing a Humira biosimilar (Amjevita), which it plans to launch on the US market in January 2023 [4].
Cyltezo is also currently one of seven FDA-approved adalimumab biosimilars that are lined up to hit the market in 2023. With multiple other candidates in development, and various product attributes associated with each one, competition is expected to be strong.
Although Cyltezo is the first adalimumab biosimilar to achieve interchangeability status, it is not expected to be the last. Alvotech/Teva, Pfizer, Amgen and Organon/Samsung Bioepis have all revealed that they are pursuing interchangeability designation for their adalimumab candidates as well.
Other biosimilars, CT-P17 (Yuflyma) from Celltrion or AVT02 from Alvotech/Teva are pending for approval and the date of anticipated launch is in some cases still to be determined, see Table 2.
| Table 2: Pending approval Humira (adalimumab) biosimilars pipeline
|
| Estimated launch
|
Biosimilar brand name
|
Manufacturer
|
| 1 Jul 2023
|
SB5-CH
|
Organon
|
| 30 Sep 2023
|
Idacio
|
Fresenius Kabi
|
| 1 Jul 2023
|
ATV-02*
|
Teva
|
| 1 Jul 2023
|
CT-P17 (Yuflyma)
|
Celltrion
|
| To be determined
|
ABP-501 HC
|
Amgen
|
*Alvotech and AbbVie have entered into a settlement agreement that will allow Alvotech and commercialization partner Teva to launch in the US on or after 1 July 2023.
Last updated: 13 June 2022.
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The market entrance of adalimumab biosimilars will serve as one of the most significant events to impact US healthcare costs in recent history.
Between 2023 and 2029, there will be 37 or more biosimilars of different molecules in the therapeutic areas of ophthalmology, supportive care, immunology and bone health to be launched [5].
Related articles
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Celltrion updates on Remsima and Yuflyma
Approval and launch dates for US biosimilars – 2021
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References
1. GaBI Online - Generics and Biosimilars Initiative. New adalimumab biosimilars prepare to launch in Canada, US and Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Nov 18]. Available from: www.gabionline.net/biosimilars/news/new-adalimumab-biosimilars-prepare-to-launch-in-canada-us-and-europe
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of adalimumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Nov 18]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-adalimumab
3. GaBI Online - Generics and Biosimilars Initiative. Switching from adalimumab originator and ABP501 to SB5 in arthritis patients [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Nov 18]. Available from: www.gabionline.net/biosimilars/research/switching-from-adalimumab-originator-and-abp501-to-sb5-in-arthritis-patients
4. GaBI Online - Generics and Biosimilars Initiative. Amgen predicts a steady flow of biosimilar launches [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Nov 18]. Available from:
www.gabionline.net/biosimilars/general/amgen-predicts-a-steady-flow-of-biosimilar-launches
5. GaBI Online - Generics and Biosimilars Initiative. New and upcoming biosimilars launches in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Nov 18]. Available from: www.gabionline.net/reports/new-and-upcoming-biosimilars-launches-in-the-us
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