FDA Approves High-Concentrate, Citrate-Free Formulation of Biosimilar Adalimumab-adbm

Credit: US Food and Drug Administration

The US Food and Drug Administration (FDA) has approved the high-concentrate, citrate-free formulation of subcutaneous adalimumab-adbm (Cyltezo), an interchangeable biosimilar to the reference product, adalimumab (Humira), according to a press release from Boehringer Ingelheim.¹ The tumor necrosis factor (TNF) blocker has been approved to treat multiple chronic inflammatory diseases, including moderate to severe rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and hidradenitis suppurativa.

“This FDA approval is another step forward for people with chronic and often debilitating diseases such as rheumatoid and psoriatic arthritis,” Steven Taylor, president and CEO of the Arthritis Foundation, said in a statement. “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.”¹

Originally approved as the first interchangeable biosimilar to Humira in October 2021, the safety and efficacy of the drug was demonstrated in part due to results from the phase 3 randomized VOLTAIRE-X clinical trial, which studied the effects of multiple switches from adalimumab to adalimumab-adbm compared with continuous treatment with the reference product.²

The current approval is based on the phase 1 VOLTAIRE-HCLF clinical trial, which examined the bioavailability of high-concentration (100 mg/mL) and low-concentration (50 mg/mL) formulations of adalimumab-adbm. The pre-filled syringe or pre-filled autoinjectors are priced at an 81% discount to reference adalimumab.

“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,” Stephen Pagnotta, Executive Director and Biosimilar Commercial Lead at Boehringer Ingelheim, stated. “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.”¹

References

1. ^{Boehringer Ingelheim Pharmaceuticals Inc. US FDA approves high-concentration, citrate-free formulation of Cyltezo® (Adalimumab-ADBM) injection, Boehringer Ingelheim’s interchangeable* biosimilar to Humira®. Accessed May 1, 2024. https://www.prnewswire.com/news-releases/us-fda-approves-high-concentration-citrate-free-formulation-of-cyltezo-adalimumab-adbm-injection-boehringer-ingelheims-interchangeable-biosimilar-to-humira-302132457.html}
2. ^{Butera A. FDA approves Adalimumab-adbm as first interchangeable biosimilar with Adalimumab. HCP Live. October 18, 2021. Accessed May 1, 2024. https://www.hcplive.com/view/fda-approves-adalimumab-adbm-interchangeable-biosimilar.}