FDA Approves First ‘Interchangeable’ Biosimilar for Humira
/By Pat Anson, PNN Editor
People living with rheumatoid arthritis, psoriasis and other arthritic conditions will finally have a cheaper alternative to an expensive biologic drug — but they’ll have to wait a couple of years before its available.
The Food and Drug Administration has approved Cyltezo (adalimumab-adbm) as the first “interchangeable” biosimilar product to treat chronic inflammatory diseases, making it eligible to be substituted for Humira (adalimumab). Cyltezo won’t be on the U.S. market until 2023.
An interchangeable biosimilar may be substituted without the prescriber having to change the prescription. The substitution may occur at the pharmacy, similar to how cheaper generic drugs are often substituted for brand name drugs by insurers.
Biologic drugs are derived from living organisms such as animal cells or bacteria, and are expensive to manufacture. Biosimilars are “highly similar” to biological products, clinically just as effective, and cheaper to make.
The cost savings will probably be significant for switching from Humira to Cyltezo. Humira is an injectable drug that costs $7,389 for a one-month supply, or about $88,000 a year.
Cyltezo is also injected and citrate-free, which results in less pain on injection. Cyltezo is expected to cost about 30% less than Humira.
"As the first interchangeable biosimilar of Humira, Cyltezo represents an important step toward bringing patients more affordable treatment options for complex, and often expensive, biologic reference products," Martin Alan Menter, MD, chair of the Division of Dermatology at Baylor University Medical Center, said in a statement on behalf of Boehringer Ingelheim, Cyltezo’s manufacturer.
"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."
Although Cyltezo was first approved by the FDA in 2017, its commercial launch was delayed by legal actions taken by AbbVie, Humira’s manufacturer. Humira is Abbvie’s top selling drug, and generated revenues of $4.8 billion in the first quarter of 2021.
Boehringer Ingelheim reached a settlement with AbbVie in 2019, agreeing to pay AbbVie royalties and delaying Cyltezo’s release until July 1, 2023.
The FDA has approved 31 biosimilar medications since 2015, but only about 60% have made it to market due patent disputes and legal maneuvers.
“The biosimilar and interchangeable approval pathway was created to help increase access to treatment options for patients with serious medical conditions,” said acting FDA Commissioner Janet Woodcock, MD, said in a statement. “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.”
Cyltezo is approved for the following conditions in adult patients:
Moderate to severe rheumatoid arthritis
Psoriatic arthritis
Ankylosing spondylitis
Crohn’s disease
Moderate to severe ulcerative colitis
Moderate to severe chronic plaque psoriasis.
Cyltezo is also approved for moderate to severe active polyarticular juvenile idiopathic arthritis in children two years of age and older, and in pediatric patients six years of age or older with Crohn’s disease.
"We are proud to be the company driving the advancement of biosimilars and delivering the first and only Interchangeable biosimilar with Humira. It is a true milestone and an important step forward for broader adoption in the U.S. and for patient access to affordable medicines," Thomas Seck, senior vice president at Boehringer Ingelheim, said in a statement.
