Celltrion Inc

EMA approves Ronapreve (Roche) and Regkirona (Celltrion) for treating Covid-19 in patients not needing oxygen, pending EU Commission approval. Both drugs show favorable safety profiles.

DelveInsight's 'Multiple Sclerosis Pipeline Insight 2024' report highlights 75+ companies developing 80+ therapies, including promising candidates like GA Depot, Remibrutinib, and IMU 838. Key events include Immunic's positive Phase 3 ENSURE trial interim analysis, Roche's FDA approval for Ocrevus injectable, and Sanofi's mixed results for tolebrutinib in Phase III trials. The report covers global pipeline stages, product types, molecule types, mechanisms of action, and routes of administration.

Goodwin's 1,600 lawyers globally excel in complex transactions, litigation, and advisory services across tech, life sciences, real estate, private equity, and finance, uniquely serving both innovators and investors.

Skyrizi surpasses Humira in sales, causing concerns for adalimumab biosimilar market growth. Despite biosimilars capturing 22% market share by Oct 2024, Skyrizi's rise and product hopping complicate biosimilar sustainability. Clinical trials show Skyrizi's superior efficacy in psoriasis treatment, and policy reforms are advocated to enhance biosimilar access and competition.

FDA accepts Organon's aBLA for HLX14, a Prolia®/Xgeva® biosimilar, and Teva's application for its Prolia® biosimilar TVB-009P. Litigations continue between Amgen and biosimilar developers Celltrion, Samsung Bioepis, and Fresenius Kabi. Sandoz's Jubbonti®/Wyost® was approved as interchangeable with Prolia®/Xgeva®.

Organon announced FDA acceptance of its aBLA for HLX14, a biosimilar of Amgen’s Prolia®/Xgeva® (denosumab), licensed from Shanghai Henlius Biotech. Teva also announced FDA and EMA acceptance of its Prolia® biosimilar TVB-009P. These join Celltrion, Fresenius Kabi, and Samsung Bioepis’s denosumab biosimilar applications awaiting FDA approval. Litigations between Amgen and Celltrion, Samsung Bioepis, and Fresenius Kabi are ongoing. Sandoz’s Jubbonti®/Wyost® (denosumab-bddz) was FDA-approved as interchangeable with Prolia®/Xgeva®, with a U.S. market entry date by May 31, 2025, or earlier under certain circumstances.

20+ companies, including Regeneron and Sanofi, are advancing 25+ urticaria drugs through clinical trials, addressing unmet needs in treatment.

Celltrion launches biosimilar Stelkimab in Europe for autoimmune diseases, starting in Germany and the Netherlands, with plans to expand to Finland and Ireland. Stelkimab, available in IV and SC formulations, aims to leverage Celltrion's integrated structure for stable drug supply and market expansion.

Celltrion's phase 3 trial confirms Yuflyma (adalimumab, CT-P17) interchangeability with Humira for psoriasis treatment, showing comparable efficacy, safety, and pharmacokinetics. Results presented at 2024 Fall Clinical Dermatology Conference and EADV conference. The company aims for FDA approval and U.S. market expansion.

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