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REGENXBIO Sues Sarepta Therapeutics for Patent Infringement on Gene Therapy Product

Last week REGENXBIO Inc. and the Trustees of the University of Pennsylvania filed suit in Delaware against Sarepta Therapeutics, Inc., Sarepta Therapeutics Three, LLC, and Catalent, Inc., alleging that the defendants’ adeno-associated virus (“AAV”) technology gene therapy product has infringed or will infringe U.S. Patent No. 11,680,274 (“the ‘274 Patent”)….

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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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