US FDA approved second biosimilar drug Cyltezo that contains adalimumab-adbm for multiple indications. This is the second biosmilar drug approved by US FDA after the approval of Amjevita to Amgen, Inc. Cyltezo is approved for multiple indications realted to rheumatology like Crohn's disease, rheumatoid arthritis, ulcerative colitis, ankylosing spondylitis and plaque psoriasis etc. A biosimilar also termed as follow-on biologic or subsequent entry biologic is a medicinal product that is almost identical copy of original product manufactured by different company.
Cyltezo/adalimumab-adbm works by inhibiting tumor necrosis factor (TNF) via bing with tumor necrosis factor-alpha (TNFα). Normally, tumor necrosis factor-alpha (TNFα) binds with TNFα receptors to initiate inflammatory response triggered by autoimmune disease But after the administration of Cyltezo/adalimumab-adbm through subcutaneous route (SC) it readily binds with tumor necrosis factor-alpha (TNFα) and restricts its binding with TNFα receptors. This will cause a reduction in inflammatory response mediated by auto-immune disease.
Cyltezo/adalimumab-adbm is also approved for the treatment of moderately to severely active poly-articular juvenile idiopathic arthritis in children having age 4 years or more. According to US FDA, a biosimilar is very close to already approved reference product in terms of clinical effectiveness and safety profile. The only difference that can be expected or allowable is modification in inactive pharmaceutical ingredients that does not pose any change in effectiveness of the drug.
Cyltezo Side effects
According to health authorities following side effects can be expected during the therapy depending upon the factors like patient age, history and genetic predispositions.
- Increase susceptibility to infections (RTI)
- Reaction at injection site
- Anaphylaxis or serious allergic reactions
- Lupus-like syndrome
- Demyelinating disease
- Cardiovascular problems
Cyltezo Uses/Patient Information
US FDA approved this drug for multiple indications like Crohn's disease, rheumatoid arthritis, ulcerative colitis, ankylosing spondylitis and plaque psoriasis etc. Additionally, it is also approved for the treatment of moderately to severely active poly-articular juvenile idiopathic arthritis in children having age 4 years or more.
Cyltezo is will be availabe in parenteral dosage form for administration through subcutaneous route. Dosage frequency of Cyltezo is 40 mg subcutaneously every other week in case of rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis. Similarly, in case of plaque psoriasis dosage frequency will be 80mg as initial dose and then 40 mg subcutaneously every other week.