FDA approves Boehringer Ingelheim’s high-concentration formulation of interchangeable Humira biosimilar
Boehringer Ingelheim has received the Food and Drug Administration’s blessing for the high-concentration, citrate-free formulation of Cyltezo (adalimumab-adbm), the company’s interchangeable biosimilar to Humira (adalimumab), to treat multiple chronic inflammatory diseases.
“With this FDA approval, we are now able to offer both high- and low-concentration, citrate-free formulations of Cyltezo, further expanding treatment access for patients living with certain chronic inflammatory diseases,” said Stephen Pagnotta, executive director and biosimilar commercial lead at Boehringer Ingelheim. “Many patients are treated with high-concentration adalimumab formulations, and we are excited to add this new option to our approved citrate-free Cyltezo and Adalimumab-adbm offerings.”
The high-concentration formulation (100 mg/ml), which is now available as a pre-filled syringe or pre-filled autoinjector, is priced at a 5% discount to Humira under the brand name Cyltezo and at an 81% discount to Humira as the unbranded product Adalimumab-adbm. The low-concentration (50 mg/ml), citrate-free formulation of Cyltezo has been commercially available since July 2023.
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“The availability of a high-concentration and citrate-free Cyltezo is welcome news for people living with certain chronic inflammatory conditions, such as Crohn’s disease and ulcerative colitis, which affect nearly 1 in 100 Americans,” said Michael Osso, president and CEO of the Crohn’s & Colitis Foundation. “The flexibility of having multiple biosimilar formulations to choose from is important to support broader patient access to biologic medicines.”
“This FDA approval is another step forward for people with chronic and often debilitating diseases such as rheumatoid and psoriatic arthritis,” said Steven Taylor, president and CEO of the Arthritis Foundation. “We stand united with our patients and healthcare providers in the effort to accelerate the adoption of biosimilars, which benefit patients as well as the larger healthcare ecosystem.”
“Biologics and biosimilars are a crucial treatment option for many living with psoriatic arthritis or psoriasis,” said Leah Howard, president and CEO of the National Psoriasis Foundation. “We welcome the introduction of this additional formulation to expand the array of options available to our community.”
[Read more: Prioritizing Lower-Priced Biosimilar Medications]