On 13 May 2024, Boehringer Ingelheim (Boehringer) announced an agreement with Quallent Pharmaceuticals, a private label pharmaceutical distributor, to help expand patient access to citrate-free adalimumab-adbm, Boehringer’s biosimilar to AbbVie’s Humira (adalimumab) in the US.
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 the first product approved in 2017 [2] and later approved as an interchangeable biosimilar in 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].
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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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