Celltrion launches Humira biosimilar in US
South Korean biopharmaceutical company Celltrion has announced that its US branch – Celltrion USA – has launched a Humira (adalimumab) biosimilar, providing an alternative treatment option for patients.
Yuflyma (CT-P17 adalimumab-aaty) is a recombinant fully human anti-tumour necrosis factor α (anti-TNFα) monoclonal antibody. It comes in a high-concentration (100mg/mL), low volume and citrate-free formulation indicated for use in patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis and hidradenitis suppurativa.
Tom Nusbickel, chief commercial officer at Celltrion USA, stated: “The launch of Yuflyma is a critical milestone not only for Celltrion USA, but for patients, healthcare providers and payers. We are committed to providing a patient-centric approach with a focus on increased access to innovative, high-quality biologics in the US. Celltrion has a demonstrated track record of commercial, regulatory and manufacturing success globally and our dedicated immunology commercial team is ready to leverage their experience and market knowledge in the US.”
Professor Jonathan Kay of UMass Chan Medical School, said: “The launch of Yuflyma provides patients with one of only a few FDA-approved adalimumab biosimilars that has a high-concentration, citrate-free formulation. This formulation can reduce injection discomfort for patients with chronic conditions like rheumatoid arthritis, thereby improving adherence to treatment.”
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