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Recently, a new tumor necrosis factor
(TNF) blocker has been FDA approved for rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA) patients.
As per the recent announcement of an established global generic and specialty pharmaceuticals company and a biopharmaceutical company on 09, July,2020, FDA has approved of a novel tumor necrosis factor (TNF) blocker, which is a biosimilar to adalimumab which was first approved on 31 December, 2002.
This new tumor necrosis factor (TNF) blocker has been found to be effective for reducing reducing signs/symptoms in rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), Psoriatic arthritis (PsA), ankylosing spondylitis (AS), adult crohn disease (CD), ulcerative colitis (UC) and plaque psoriasis (PsO).
This drug approval has been in accordance with inclusive analytical, preclinical and clinical module, comprising ARABESC study. As per the study results, no clinically meaningful differences between the biosimilar and the reference product in patients with RA, concerning efficacy, safety and immunogenicity was found.
This novel drug is expected to launch in US market in July,2023 obtainable as a 40mg/0.8mL solution in single-dose prefilled pens and prefilled injects plus 20mg/0.4mL solution in single-dose prefilled inject.
Biosimilar Hulio Gets FDA Approval
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