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The FDA approved Cyltezo as the first interchangeable biosimilar to adalimumab (Humira), with indications ranging from rheumatoid arthritis (RA) to inflammatory bowel disease, late on Friday.

Of note, however, the biosimilar will not be commercially available in the U.S. until July 2023.

Interchangeable biosimilars have the advantage of being able to be substituted for their reference product without need for a prescription change (similar to generic drugs), and these substitutions can occur at the pharmacy level in some states.

"The biosimilar and interchangeable approval pathway was created to help increase access to treatment options for patients with serious medical conditions," Acting FDA Commissioner Janet Woodcock, MD, said in a on Monday. "We continue to be steadfast in our commitment to provide patients with alternative high-quality, affordable medications that are proven to be safe and effective."

In adults, Cyltezo -- a tumor necrosis factor (TNF) inhibitor -- has approved indications in RA, psoriatic arthritis, ankylosing spondylitis, Crohn's disease or ulcerative colitis, and plaque psoriasis. In children, the biosimilar is approved for polyarticular juvenile idiopathic arthritis in those 2 years and up, and for Crohn's disease in those ages 6 years and up.

Cyltezo was originally approved in 2017, and will be available in pre-filled single-dose syringes at two dose levels (40 mg/0.8 mL, 20 mg/0.4 mL).

Support for Friday's interchangeability approval came from the phase III VOLTAIRE-X trial, a study that tested the effects of multiple switches between Cyltezo and its reference biologic Humira, versus a control group that received continuous Humira. The randomized trial showed equivalence between study groups, with no meaningful differences in terms of efficacy or safety, pharmacokinetics, and immunogenicity.

The approval "represents an important step toward bringing patients more affordable treatment options for complex, and often expensive, biologic reference products," said Martin Alan Menter, MD, of Baylor University Medical Center in Dallas, in a press release from Boehringer Ingelheim. "This is incredibly important for patients, who can be confident that once available, citrate-free Cyltezo has the same efficacy and safety as the originator medicine with the added benefit of cost savings."

Labeling for Cyltezo, like Humira, includes a boxed warning due to increased risks for serious infections, as well as lymphoma and other cancers. Common adverse events include headache, injection site reactions, upper respiratory and sinus infections, and rash.

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