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FDA Approves Celltrion’s YUFLYMA (adalimumab-aaty), a Biosimilar to HUMIRA

Today Celltrion announced that the FDA approved its biosimilar product, YUFLYMA (adalimumab-aaty), a high-concentration (100mg/mL) and citrate-free formulation of HUMIRA.  YUFLYMA is approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa.  As we previously reported, Celltrion…

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Alvotech Begins Confirmatory Study on EYLEA® Biosimilar

Last week Alvotech announced that it has initiated a confirmatory study for its biosimilar candidate to EYLEA®, AVT06 (aflibercept).  EYLEA® is indicated for treating a variety of eye disorders including wet AMD, macular edema, and diabetic retinopathy.  According to Alvotech, the study “is a randomized, double-masked, parallel-group, multicenter, therapeutic equivalence…

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