Boehringer has already launched a branded biosimilar, Cyltezo (adalimumab-adbm), at a 5% discount and an unbranded version at an 81% markdown. However, due to low uptake, Boehringer has now switched to a hybrid marketing model that combines in-person and virtual sales for this product [1].

Cyltezo was approved in 2017 [2] and later approved as an interchangeable biosimilar in 2021 [3] for the lower concentration formulation of adalimumab in the US. With the new agreement, Boehringer will provide Quallent, a wholly owned subsidiary of the Cigna Group, with citrate-free adalimumab-adbm while continuing to commercialize both Boehringer Ingelheim-labelled Cyltezo and its unbranded Humira biosimilar adalimumab-adbm.

This comes after news that despite the influx of adalimumab biosimilars entering the market in 2023, Humira remains on top in the US. A letter published in JAMA in June 2024 [4] reported that, as of January 2024, both high and low concentrations of originator Humira, are nearly universally covered by Medicare Part D plans. However, only half of these plans cover adalimumab biosimilars. Cyltezo is covered by just over half of plans. Of the plans that covered both, only 1.5% had lower-tier placement for biosimilars. This gap in Medicare access to Humira has also been addressed in a recent article by Joshua Cohen [1].

Quallent will provide both high-concentration (40 mg/0.4 mL) and low-concentration (40 mg/0.8 mL) citrate-free formulations of adalimumab-adbm, available in pre-filled syringes or pens. The interchangeability designation for the low-concentration formulation of adalimumab-adbm will also apply to Quallent’s private-labelled 40 mg/0.8 mL version.

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 [5].

Related articles
CVS Caremark removes Humira in the US and Sandoz launches Hyrimoz in Europe

US PBMs add multiple Humira biosimilars to formularies

Humira (adalimumab) biosimilars pipeline  

References
1. 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 3]. Available from: www.gabionline.net/biosimilars/general/addressing-the-persistent-gap-in-medicare-access-to-humira-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves adalimumab biosimilar Cyltezo [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jul 3]. Available from: www.gabionline.net/biosimilars/news/FDA-approves-adalimumab-biosimilar-Cyltezo
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves adalimumab biosimilar Cyltezo as interchangeable [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jul 3]. Available from: www.gabionline.net/biosimilars/news/fda-approves-adalimumab-biosimilar-cyltezo-as-interchangeable
4. Klebanoff MJ, et al. Formulary Coverage of Brand-Name Adalimumab and Biosimilars Across Medicare Part D Plans. JAMA. Published online June 6, 2024. doi:10.1001/jama.2024.8917
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of adalimumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jul 3]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-adalimumab

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