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News about "Celltrion"
Celltrion Gets FDA Nod for 300mg OMLYCLO, the First Interchangeable Xolair Biosimilar
The US FDA has approved 300 mg/2 mL prefilled syringe formulation of OMLYCLO (omalizumab-igec), expanding dosing options for patients with certain allergic diseases and supporting more personalised treatment. OMLYCLO—the first and only biosimilar interchangeable with XOLAIR (omalizumab)—previously received approval for its 75 mg and 150 mg strengths.
Celltrion | 03/12/2025 | By Dineshwori
US-based biotechnology company Kaigene has signed an exclusive global licensing agreement with South Korean biopharmaceutical giant Celltrion to develop and commercialise two of its nonclinical-stage antibody assets, KG006 and KG002.
Celltrion | 04/11/2025 | By Dineshwori | 354
FDA Expands Indications for Celltrion's YUFLYMA to Include Pediatric and Adolescent Patients
Celltrion has announced that the US Food and Drug Administration (FDA) has approved expanded indications for YUFLYMA (adalimumab-aaty) and its unbranded version to include the treatment of hidradenitis suppurativa (HS) in adolescent patients aged 12 years and older, and uveitis (UV) in pediatric patients aged 2 years and older.
Celltrion | 17/10/2025 | By Dineshwori | 268
Celltrion Receives US FDA Approval for EYLEA Biosimilar EYDENZELT
Celltrion has received approval from the US Food and Drug Administration (FDA) for EYDENZELT (aflibercept-boav), a biosimilar to EYLEA (aflibercept), for the treatment of neovascular (wet) age-related macular degeneration (wAMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR).
Celltrion | 11/10/2025 | By Dineshwori | 216
Hikma, Celltrion Deepen Ties to Boost Biosimilar Access in Middle East and North Africa
British multinational pharmaceutical company Hikma Pharmaceuticals has signed new exclusive licensing agreements with its long-standing partner, South Korea’s Celltrion, covering the Middle East and North Africa (MENA) region.
Celltrion | 06/10/2025 | By Dineshwori | 265
Celltrion Launches Tocilizumab Biosimilar AVTOZMA IV in the US Market
AVTOZMA is Celltrion's fifth immunology biologic and seventh biosimilar approved by the US FDA. It will be available in the same presentations as its reference product, Actemra (tocilizumab).
Celltrion | 03/10/2025 | By Dineshwori | 279
Prometheus Laboratories Collaborates with Celltrion for Anser Testing
Prometheus is the first specialty lab to validate TDM testing for both intravenous and subcutaneous infliximab, supporting the growing demand for at-home treatment options.
Celltrion | 28/08/2025 | By Dineshwori | 106
Celltrion Secures US FDA Approval for Expanded Indication for AVTOZMA
Celltrion has received FDA approval for an expanded indication of AVTOZMA IV (tocilizumab-anoh) to treat cytokine release syndrome (CRS), achieving full indication parity with reference biologic ACTEMRA IV in the US.
Celltrion | 07/08/2025 | By Mrinmoy Dey | 108
Celltrion to Acquire US Biologics Plant to Counter Potential Pharma Tariffs
Celltrion has been selected as the preferred bidder to acquire a large biologics manufacturing plant in the United States —a strategic move aimed at insulating the company from potential US pharmaceutical tariffs.
Celltrion | 30/07/2025 | By Dineshwori | 434
Celltrion Announces Three-Stage Strategy to Counter Trump's Pharma Tariff Plan
Celltrion has announced its response strategy to US President Donald Trump’s plan to impose tariffs on pharmaceuticals.
Celltrion | 10/07/2025 | By Dineshwori | 434
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