A biosimilar is a biological product that has been demonstrated to be highly similar to another existing FDA-approved biological product. It should have no clinically meaningful differences in terms of safety and effectiveness from the reference product. Biosimilars are usually manufactured by a concurrent company after the patent for the original product has expired.
How Cyltezo works
RA is a chronic inflammatory disease with an unknown cause that triggers the immune system to attack the joints, leading mainly to joint inflammation.
Cyltezo is an antibody that works by binding specifically to tumor necrosis factor alpha (TNF-alpha), blocking its interaction with its receptors. TNF-alpha is a naturally occurring cytokine (protein) produced by immune cells that are involved in normal inflammatory responses. In RA patients, elevated levels of TNF are found in the synovial, or joint, fluid, contributing to both inflammation and joint destruction, hallmarks of this disease.
Cyltezo in clinical trials
The FDA approved Cyltezo based on pharmacological, nonclinical, and clinical data showing that it is a biosimilar of Humira.
Cyltezo’s effectiveness and safety were assessed in five randomized, double-blind clinical trials in 2,468 patients ages 18 and over with active RA. Adalimumab was studied primarily in placebo-controlled trials and in long-term follow-up studies for up to 36 months.
Patients had at least six swollen and nine tender joints, and Cyltezo was administered under the skin in combination with either methotrexate, widely used to treat RA, or other disease-modifying anti-rheumatic drugs (DMARDs), or on its own.
The results showed that Cyltezo, alone or in combination with methotrexate or other nonbiologic DMARDs, helps patients with RA by reducing signs and symptoms of the disease, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function.
In addition to RA, Cyltezo can also be used to treat a range of diseases, including juvenile arthritis (JA), psoriatic arthritis (PA), ankylosing spondylitis (AS), plaque psoriasis, Crohn’s disease, and active ulcerative colitis.
Cyltezo is not yet available commercially, but Boehringer Ingelheim is currently engaged in patent litigation with AbbVie. The company will also seek approval for an auto-injector of Cyltezo, as another delivery option for patients.
The most frequent adverse events are infections, injection-site reactions, headache, and rash.
The European Medicines Agency (EMA) is also expected to provide an opinion on the marketing authorization application for Cyltezo during 2017.
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