FDA approves Humira-biosimilar Cyltezo

SILVER SPRING, Md. — The Food and Drug Administration last week approved Boehringer Ingelheim's Cyltezo (adalimumab-adbm) subcutaneous injection, a new biosimilar to AbbVie's Humira (adalimumab).

"Cyltezo is the first biosimilar from Boehringer Ingelheim to be approved by the FDA and marks an important step towards our goal of providing new and more affordable treatment options to healthcare providers and patients," stated Ivan Blanarik, SVP and head of therapeutic area biosimilars at Boehringer Ingelheim. "Chronic inflammatory diseases collectively affect 23.5 million people in the U.S., and Cyltezo has the potential to deliver significant benefits to many of these individuals."

The FDA approval is based on a comprehensive data package comprised of analytical, pharmacological, non-clinical and clinical development studies demonstrating that Cyltezo is biosimilar to Humira.

Cyltezo is not commercially available at this time, however. Boehringer Ingelheim is currently engaged in patent litigation with AbbVie. Boehringer Ingelheim will also seek approval for an auto-injector of Cyltezo, as another delivery option for patients.

The first Humira biosimilar, Amgen's Amjevita (adalimumab-atto), was approved by the FDA in September 2016.

Cyltezo is a recombinant tumor necrosis factor blocker and is indicated to treat adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, moderately to severely active Crohn's disease, moderately to severely active ulcerative colitis and moderate-to-severe plaque psoriasis.

In pediatric patients, Cyltezo is indicated to treat moderately to severely active juvenile idiopathic arthritis in children over the age of four.

Cyltezo will be available as 40mg/0.8mL strength pre-filled glass syringes in 2-count cartons.

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