Could Cyltezo Be the First Interchangeable Biosimilar in the United States?

In the United States, biosimilars have to meet certain requirements outlined by the Biologics Price Competition and Innovation Act in order to be considered interchangeable. Receiving this status would be a great benefit to biosimilars; pharmacists would be able to fill prescriptions with biosimilars instead of the originator product without consulting the prescribing physician.

However, while the FDA has approved 29 biosimilars, none of them have received interchangeable designation, which would require a second FDA review. The lack of interchangeable biosimilars in the United States has been cited as one barrier to the uptake of biosimilars, despite the fact that they are “highly similar” to originator brands and just as safe and efficacious.

Cyltezo, an adalimumab biosimilar from Boehringer Ingelheim (BI), may be the first. The company believes that results of VOLTAIRE-X, a phase 3 randomized study comparing pharmacokinetic properties for the adalimumab reference product (Humira) with those of Cyltezo in patients with moderate-to-severe chronic plaque psoriasis, has put the product on the path toward gaining interchangeable status.

Although Cyltezo was approved in 2017, it has not launched yet. As a result of a settlement with AbbVie, the maker of Humira, Cyltezo won’t launch in the United States until July 1, 2023, but BI anticipates the FDA will make a decision on the interchangeability application by the end of 2021, according to The Center for Biosimilars^®, a part of The American Journal of Managed Care^®.

The findings were presented at the American Academy of Dermatology Virtual Meeting Experience. In the study, 238 patients were randomized to either the switching (n = 118) or continuous treatment (n = 120) arms. Patients in the switching arm were switched multiple times between the reference product and the biosimilar. Patients in the continuous treatment arm received the reference product.

The researchers found that patients in the switching arm had similar clinical outcomes in terms of pharmacokinetics, efficacy, immunogenicity, and safety. Learn more about the study and its results.

A poll from The Center for Biosimilars® found that readers believe all biosimilars should automatically be interchangeable when they are approved (62%), while 31% believe interchangeable status should continue to be granted upon secondary FDA review, and 6% believe only insulin biosimilars should have automatic interchangeable status.

When Semglee, an insulin glargine biosimilar, was launched on the US market in August 2020, Biocon Biologics and Mylan said they hoped the product would be declared a full-fledged biosimilar to Lantus and also receive interchangeability status.

Reference

Menter A, McCabe D, Lang B, et al. Phase III, randomized trial comparing clinical outcomes between patients with moderate-to-severe chronic plaque psoriasis receiving adalimumab reference product continuously versus those who switched between BI 695501 and adalimumab RP. Presented at: American Academy of Dermatology 2021; April 23-25, 2021. Poster 27381.