Tagged as: SIMLANDI

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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Alvotech and Bioventure Announce Approval of ADALIMUMAB Biosimilar in Saudi Arabia

On January 24, Alvotech and Bioventure, a subsidiary of GlobalOne Healthcare Holding LLC, announced that the Saudi Food & Drug Authority has approved SIMLANDI, a biosimilar referencing HUMIRA (adalimumab), in Saudi Arabia. According to the press release, Bioventure is Alvotech’s exclusive strategic partner for the commercialization of SIMLANDI in the…

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Alvotech and JAMP Pharma Receive Marketing Authorization for SIMLANDI in Canada

On January 10, 2022, Alvotech Holdings S.A. (“Alvotech”) and JAMP Pharma Group (“JAMP Pharma”) announced that Health Canada granted marketing authorization to JAMP Pharma for a high-concentration biosimilar to Humira® (adalimumab) developed by Alvotech.  The biosimilar, also referred to as AVT02, will be marketed in Canada as SIMLANDI (100 mg/mL…

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