FDA approves high-concentration, citrate-free form of interchangeable biosimilar Cyltezo
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The FDA has approved a citrate-free, high-concentration formulation of the interchangeable adalimumab biosimilar Cyltezo to treat multiple chronic inflammatory diseases, according to the manufacturer.
As with the low-concentration (50 mg/mL) version of Cyltezo (adalimumab-adbm, Boehringer Ingelheim), the high-concentration formulation is approved for Crohn’s disease and ulcerative colitis, as well as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, juvenile arthritis, hidradenitis suppurativa and chronic plaque psoriasis.
“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, said in a press release. “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 FDA based its approval, in part, on data from the phase 1 VOLTAIRE-HCLF study that compared the FDA-approved 50 mg/mL dosage with the citrate-free, 100 mg/mL formulation. The study met all the primary objectives, demonstrating comparable pharmacokinetics as well as similar safety and immunogenicity between the two formulations.
“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,” Michael Osso, president and CEO of the Crohn’s & Colitis Foundation, said in the release. “The flexibility of having multiple biosimilar formulations to choose from is important to support broader patient access to biologic medicines.”
In 2021, Cyltezo was approved as the first interchangeable biosimilar to treat certain inflammatory diseases, allowing pharmacists to substitute it for Humira (adalimumab, AbbVie) without the need for the prescriber to alter the prescription.
“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. “We stand united with our patients and health care providers in the effort to accelerate the adoption of biosimilars, which benefit patients as well as the larger health care ecosystem.”
Leah M. Howard, JD, president and CEO of the National Psoriasis Foundation, echoed these sentiments, noting that “biologics and biosimilars are a crucial treatment option for many living with psoriatic arthritis or psoriasis. We welcome the introduction of this additional formulation to expand the array of options available to our community.”
According to the company, the high-concentration formulation of Cyltezo is currently available as a prefilled syringe or autoinjector, and competitively priced compared with Humira: The high-concentration formulation is set at a 5% discount as brand name Cyltezo and an 81% discount as unbranded adalimumab-adbm.
Perspective
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Shubha Bhat, PharmD, MS, FCCP, BCACP
The introduction of high-concentration, citrate-free reference adalimumab was a game-changer for many patients with immunologic conditions, condensing the total volume of medication administered and reduced burning or pain at the injection site after administration.As a result, this formulation makes up approximately 80% of total adalimumab prescriptions. Adalimumab biosimilars have been introduced as a mechanism to provide the same therapeutic benefits at a reduced cost.
Although the low concentration of Cyltezo, originally approved by the FDA in 2021, was citrate-free, administration may take slightly longer since these devices contain more volume compared with the high-concentration formulations (0.8 mL vs. 0.4 mL).
Cyltezo was also the first adalimumab biosimilar to obtain interchangeability designation, which permits a pharmacist to automatically dispense this biosimilar in place of a reference product as prescribed without involving the prescribing provider (subject to specific pharmacy state laws).
The introduction of a high-concentration, citrate-free Cyltezo offers patients and providers with more options and may be preferred, as the majority of patients are already on high-concentration, citrate-free reference adalimumab.
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