Tagged as: Celltrion

Adalimumab Biosimilars Ready To Enter Australian, Korean, Japanese and European Markets

On March 29, Samsung Bioepis announced the launch of its adalimumab biosimilar HadlimaTM, referencing AbbVie’s HumiraTM, in Australia in partnership with Merck & Co.  HadlimaTM is approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult and paediatric Crohn’s disease, ulcerative colitis, hidradenitis suppurativa and…

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Recent Adalimumab Biosimilar Updates

On February 15, 2021, Celltrion Healthcare announced that the European Commission granted marketing authorization for Yuflyma™ (CT-P17), an adalimumab biosimilar, on February 11, 2021.  Yuflyma™ was approved across all thirteen intended indications covered by the reference biologic, Humira®.  Yuflyma™ is a high concentration, low-volume and citrate-free adalimumab biosimilar, which, according…

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Celltrion begins Phase 3 trial of aflibercept biosimilar

Celltrion Inc. has begun a Phase 3 clinical trial of CT-P42, an aflibercept biosimilar referencing Regeneron’s Eylea.  The trial will enroll 300 patients with diabetic macular edema, and aims to compare CT-P42’s efficacy, safety, pharmacokinetics, and immunogenicity against Eylea. Celltrion adds CT-P42 to its pipeline of other investigational biosimilars, including…

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Biosimilar Market Updates: Samsung Biologics, Celltrion, and Alvotech

Samsung Biologics’ third quarter report disclosed that it had suspended its research and development of its SAIT101, a biosimilar of Rituxan.  As we previously reported, the rituximab product was being developed through Archigen Biotech, a joint venture with AstraZeneca.  According to a report in Korea Biomedical Review, a Samsung Biologics…

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Celltrion’s Trastuzumab Biosimilar Earns WHO Prequalification Status

Celltrion recently announced that its trastuzumab biosimilar, Herzuma, has met the World Health Organization’s (WHO) prequalification standards.  WHO prequalification status is based on an assessment of the quality, safety, and efficacy of a medicine and enables the recipient to participate in UN procurement tenders.  Herzuma has been commercially available in Europe since May 2018,…

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BREAKING NEWS: Celltrion Prevails Over Janssen in Infliximab Biosimilar Appeal

Today, the Federal Circuit issued a Rule 36 affirmance of the district court’s judgment of non-infringement in the litigation involving Celltrion’s infliximab biosimilar.  The court heard oral argument in the appeal yesterday.  As we previously reported, Janssen had appealed the district court’s order granting Celltrion’s motion for summary judgment of non-infringement of…

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