Humira (adalimumab) biosimilars pipeline

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.

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].

Celltrion updates on Remsima and Yuflyma

Approval and launch dates for US biosimilars – 2021

LATIN AMERICAN FORUM

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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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