This morning, Boehringer Ingelheim Pharmaceuticals announced that its drug Cyltezo (adalimumab-adbm), a biosimilar to Humira, has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of multiple chronic inflammatory diseases.
Adalimumab binds to tumor necrosis factor-alpha (TNFa), a protein involved in the inflammatory response of several autoimmune diseases. Cyltezo is the first biosimilar from Boehringer Ingelheim to have been approved by the FDA.
In a pre-filled syringe, Cyltezo may now be administered for the following conditions:
- Active psoriatic arthritis
- Active ankylosing spondylitis
- Moderate-to-severe active adult Crohn’s disease
- Moderate-to-severe plaque psoriasis
- Moderate-to-severe polyarticular juvenile idiopathic arthritis
- Moderate-to-severe active rheumatoid arthritis
- Moderate-to-severe active ulverative colitis
Cyltezo is not yet commercially available, but the FDA approval was based on an all-inclusive data package including analytical, pharmacological, non-clinical and clinical development studies that show the drug is biosimilar to Humira.
"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," said Ivan Blanarik, Senior Vice President and Head of Therapeutic Area Biosimilars at Boehringer Ingelheim in a press release
. "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."
Boehringer Ingelheim has plans to seek approval for an auto-injector of Cyltezo as a secondary delivery option for patients.
Cyltezo is indicated, either alone or in combination with another therapy, for the following indications:
- Treating non-infectious intermediate, posterior and panuveitis in adult patients
- Reducing signs and symptoms, and maintaining clinical remission, in patients 6 years and older with moderately-to-severely active Crohn's disease who have had an inadequate response to corticosteroids or immunomodulators such as azathioprine, 6-mercaptopurine, or methotrexate
- Reducing signs and symptoms of moderately-to-severely active polyarticular juvenile idiopathic arthritis in patients 2-to-4 years of age
- Treating moderate-to-severe hidradenitis suppurativa
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