FDA Approval Fuels Boehringer’s Biosimilar Challenge to AbbVie’s Humira

Boehringer Ingelheim_iStock, Sundry Photography

Pictured: Boehringer Ingelheim's office in Silicon Valley/iStock, Sundry Photography

The FDA on Wednesday approved a high-concentration and citrate-free version of Boehringer Ingelheim’s Cyltezo (adalimumab-adbm), its interchangeable biosimilar to AbbVie’s blockbuster antirheumatic treatment Humira (adalimumab).

The high-concentration version of Cyltezo, which carries a 100-mg/mL dose of the biosimilar, comes in a pre-filled syringe or autoinjector and is sold at a 5% discount to the branded reference product. An unbranded version of Cyltezo is also available at an 81% discount to Humira. A low-concentration, 50-mg/mL version of the biosimilar has been on the market since July 2023, according to Boehringer Ingelheim.

Stephen Pagnotta, biosimilar commercial lead at Boehringer Ingelheim, in a statement said that this latest Cyltezo approval will further expand “treatment access for patients living with certain chronic inflammatory diseases.”

Approved in October 2017, Cyltezo is an interchangeable biosimilar to Humira and is indicated for all the same conditions, including moderate-to-severe rheumatoid arthritis, Crohn’s disease and ulcerative colitis. With the FDA’s interchangeability designation, Cyltezo can be used in place of Humira without needing to change the patient’s prescription.

Cyltezo is backed by data from the Phase III VOLTAIRE-X comparative clinical trial, which looked at the effects of switching between Humira and the biosimilar. The study found that Cyltezo was equivalent to Humira, leading to no meaningful clinically differences in safety, efficacy and pharmacokinetic profile.

Wednesday’s FDA approval is supported by findings from the Phase I VOLTAIRE-HCLF study, which compared the bioavailability of the high- and low-concentration formulation of Cyltezo in 200 healthy volunteers.

The approval of Cyltezo’s high-concentration, citrate-free formulation comes as biosimilars claim more market ground against AbbVie’s Humira. Earlier this month, biosimilars saw a 36% surge in prescriptions after leading pharmacy benefit manager CVS Caremark took Humira off of its major national commercial formularies.

Sandoz’s biosimilar Hyrimoz (adalimumab-adaz)—which is being co-developed and commercialized by the CVS Health subsidiary Cordavis—accounted for more than 93% of the biosimilar growth. In the week ending April 5, 2024, there were nearly 8,300 new prescriptions for Hyrimoz, compared to only 640 in the week ending March 29.

In addition to Hyrimoz and Cyltezo, there are several other Humira biosimilars competing in the market, including Amgen’s Amjevita, Celltrion’s Yufly,a Alvotech and Teva’s Simlandi and Organon and Samsung Bioepis’ Hadlima.

Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

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