Research & Development
US FDA grants approval to Sandoz's Hyrimoz
1 November 2018 -

The US Food and Drug Administration (FDA) has granted approval to Sandoz, a division of Novartis, for Hyrimoz (adalimumab-adaz), its biosimilar of AbbVie's Humira (adalimumab) intended for use in all indications as the reference medicine, it is reported today.

The approval allows the use of the product in the treatment of rheumatoid arthritis, juvenile idiopathic arthritis in patients four years of age and older, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis.

The approval was based on analytical, preclinical and clinical research data which proved the biosimilar equivalence of the Sandoz drug to the reference medicine in terms of safety, efficacy and quality.

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