US FDA Nods Boehringer Ingelheim's Cyltezo For Chronic Inflammatory Diseases

Boehringer Ingelheim Group, which is one of the world's largest manufacturers of biologic medicines, has declared that the US Food and Drug Administration (FDA) has approved its high-concentration, citrate-free formulation of Cyltezo (adalimumab-adbm). This is the company's interchangeable biosimilar to Humira (adalimumab), and it can be used to treat multiple chronic inflammatory diseases.

"With this US 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) is now available as a pre-filled autoinjector or syringe at a price that is 5 percent cheaper than Humira under the brand name Cyltezo and 81 percent cheaper than Humira as the unbranded product adalimumab-adbm. The low-fixation (50 mg/mL), sans citrate plan of Cyltezo, has been monetarily accessible since July 2023.

"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 & 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 US FDA approval is another step forward for people with chronic and often debilitating diseases such as rheumatoid and psoriatic arthritis," said Steven Taylor, president & 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."