Tagged as: Alvotech

Alvotech Announces Positive Topline Results From Confirmatory Clinical Study for its Proposed Golimumab Biosimilar

On April 23, 2024, Alvotech announced “positive topline results from a confirmatory clinical study for AVT05,” Alvotech’s proposed golimumab biosimilar to Janssen Biotech, Inc.’s SIMPONI(R) and SIMPONI ARIA(R).  According to Alvotech, the confirmatory clinical study (NCT05842213) was a randomized, double-blind, two-arm, multicenter clinical study designed to investigate the therapeutic equivalency…

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Biocon Settles with Janssen, Securing U.S. Market Entry Date for Ustekinumab Biosimilar

On February 29, Biocon Biologics Ltd announced that it signed a settlement and license agreement with Janssen Biotech Inc. and Johnson & Johnson (“J&J”) regarding Bmab 1200, Biocon’s proposed biosimilar to STELARA.  The agreement allows Biocon to launch in the United States in February 2025, pending FDA approval.  As part…

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Teva and Alvotech’s Adalimumab Biosimilar Receives Interchangeable Status at FDA

On February 23rd, 2024, Alvotech and Teva announced FDA’s approval of SIMLANDI (adalimumab-ryvk), the first high-concentration and citrate-free biosimilar interchangeable with Humira. SIMLANDI injection was approved for nine indications—rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s Disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurative, and uveitis. The approval follows…

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