THE US Food and Drug Administration has approved Amjevita (adalimumab-atto) as a biosimilar to Humira (adalimumab) for multiple inflammatory diseases.
Amjevita is approved for a range of indications including rheumatoid arthritis, psoriatic arthirits, ankylosing spondylitis, Crohn's disease, ulcerative colitis and plaque psoriasis in adult patients, as well as polyarticular juvenile idiopathic arthritis in patients four years of age and older.
Amjevita, manufactured by Amgen, is the fourth FDA-approved biosimilar, with the approval based on a review of evidence including structural and functional characterisation, animal study data, human pharmacokinetic and pharmacodynamics data and clinical immunogenicity data demonstrating biosimilarity.
The above article was sent to subscribers in Pharmacy Daily's issue from 26 Sep 16
To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 26 Sep 16
