The U.S. Food and Drug Administration (FDA) has approved Boehringer Ingelheim‘s Cyltezo— a biosimilar of Abbvie’s Humira (adalimumab) — to treat Crohn’s disease, ulcerative colitis and a host of other diseases ranging from rheumatoid arthritis to ankylosing spondylitis.
Cyltezo is the German company’s first FDA-approved biosimilar and “marks an important step towards our goal of providing new and more affordable treatment options to healthcare providers and patients,” Ivan Blanarik, senior vice-president and head of Boehringer Ingelheim’s therapeutic area biosimilars, said in a press release.
The FDA’s Aug. 29 decision is the second biosimilar of Humira after the approval of Amgen’s Amjevita in September 2016. Another biosimilar of Humira, Imraldi by Samsung Bioepis, won approval by the European Medicines Agency (EMA) on Aug. 24.
The FDA granted its approval based on pharmacological, non-clinical and clinical data showing that Cyltezo is a biosimilar of Humira. The EMA is also expected to provide an opinion this year.
A biosimilar is a drug that is shown to be “highly similar” to another existing biological drug, according to the FDA. It should have no clinically meaningful differences in terms of safety and effectiveness from the reference product. It is usually manufactured by a concurrent company after the patent for the original product has expired.
As with Humira, warnings include risks of serious infections and malignancies, with reports of lymphomas in children and adolescent patients treated with anti-TNF therapy. Most reported adverse effects are infections, injection-site reactions, headaches and rash.
It is not known if Cyltezo is effective in people who stopped responding or could not tolerate previous anti-TNF therapy, as stated in the product’s medication guide.
Cyltezo is available as a pre-filled syringe at a dose of 40 mg per injection. Another delivery option, an auto-injector, is currently seeking approval.
Cyltezo is a TNF-alpha inhibitor. It acts by blocking the pro-inflammatory cytokine TNF-alpha, involved in many inflammatory diseases. It is also indicated in a range of diseases, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis and plaque psoriasis.
The FDA’s full report is available here. No information has been released yet on the drug’s commercial availability, but lawsuits are ongoing between Abbvie and Boehringer Ingelheim that may delay the product’s launch.