Boehringer Ingelheim anounced that it has received FDA approval for a high-concentration, citrate-free formulation of Cyltezo® (adalimumab-adbm).

According to a press release from the company, the approval enables an expansion of treatment options for chronic inflammatory diseases. This formulation complements the low-concentration version already on the market since July 2023. Additionally, it is priced at 5% below Humira® under the Cyltezo® brand and 81% lower as adalimumab-adbm.

“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, in a press statement. “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 Crohn’s & Colitis Foundation and the Arthritis Foundation commend the approval, emphasizing its benefits for patients living with these conditions.

“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.”

The National Psoriasis Foundation also welcomed the approval.

“Biologics and biosimilars are a crucial treatment option for many living with psoriatic arthritis or psoriasis,” said Leah M. Howard, JD, President and CEO of the National Psoriasis Foundation, in a press release. “We welcome the introduction of this additional formulation to expand the array of options available to our community.”

Source: Boehringer Ingelheim Pharmaceuticals press release. May 1, 2024.