| Date | Title | Description |
| 21.04.2026 | Celltrion to present seven abstracts in inflammatory bowel disease (IBD) at 2026 Digestive Disease Week® (DDW) | Seven abstracts accepted for presentation include data from long-term follow-up studies and a post-hoc analysis of the pivotal LIBERTY studies (LIBERTY-CD and LIBERTY-UC) of ZYMFENTRA® (infliximab-dyyb)
Findings emphasize clinical decision-... |
| 19.03.2026 | Hanskin Lands in 1,400 ULTA Beauty Stores, Bringing Glass Skin Hydration to the U.S. | The Global K-Beauty Bestseller Brings Deep Hydration, Glass Skin Glow, and Next-Gen PDRN Skincare to the U.S.
CHICAGO and NEW YORK and LOS ANGELES, March 19, 2026 /PRNewswire/ -- K-Beauty skincare brand Hanskin by Celltrion Skincure is expa... |
| 16.03.2026 | Celltrion announces U.S. availability of AVTOZMA® (tocilizumab-anoh) subcutaneous (SC) formulation | AVTOZMA® (tocilizumab-anoh) is among the first wave of tocilizumab biosimilars with both intravenous (IV) and subcutaneous (SC) formulations approved and commercially available in the United States
The launch of AVTOZMA SC further diversifi... |
| 16.02.2026 | New ECCO data show subcutaneous (SC) infliximab (Remsima™ SC) effectively recaptures and maintains disease control after drug holiday | Celltrion, Inc. today announced new data from a post-hoc analysis of the pivotal LIBERTY studies (LIBERTY-CD and LIBERTY-UC), showing that subcutaneous (SC) infliximab restored and maintained response in most Crohn’s disease (CD) and ulcera... |
| 09.02.2026 | Galux: $29 Million Series B Closed For AI Protein Design In Drug Discovery | Galux, a South Korea-based biotech developing AI-driven protein therapeutics design, said it has closed a $29 million (KRW 42 billion) Series B financing, bringing the company’s total capital raised to $47 million (KRW 68 billion).
Galux sa... |
| 14.01.2026 | Celltrion presents innovative drug pipeline and U.S. manufacturing and R&D expansion strategy at the 44th Annual J.P. Morgan Healthcare Conference | Celltrion outlines a blueprint for innovative drug development built on its antibody expertise
The company highlights its business strategy to scale U.S. manufacturing and R&D capabilities, strengthening its global supply chain, product... |
| 18.12.2025 | Celltrion receives positive CHMP Opinion for SteQeyma™ (ustekinumab biosimilar) autoinjector | Celltrion, Inc. today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion of autoinjector of SteQeyma™, a biosimilar to Stelara® (ustekinumab), for t... |
| 26.11.2025 | Celltrion announces publication of post-hoc analysis of LIBERTY-CD study of ZYMFENTRA® (infliximab-dyyb), indicating consistent efficacy across disease location, including the terminal ileum in Clinic... | Findings from the post-hoc analysis of LIBERTY-CD study indicates efficacy of ZYMFENTRA® (subcutaneous infliximab) regardless of disease location, consistent across ileum-dominant and colon-dominant Crohn's disease (CD)
Findings support the... |
| 30.10.2025 | U.S. FDA grants interchangeability designation to Celltrion's denosumab biosimilars, STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) | The U.S. FDA approved STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) as interchangeable with the reference products PROLIA® (denosumab) and XGEVA® (denosumab), respectively, for all approved indications, effective as of October 2... |
| 20.10.2025 | WellsCare Partners with Celltrion Canada to Bring Advanced Wearable Pain Relief Tech to North America | SEOUL, South Korea, Oct. 20, 2025 /PRNewswire/ -- WellsCare, a South Korean medical technology startup, announced that on October 9, it signed a Memorandum of Understanding (MOU) with Celltrion Canada, a subsidiary of the global biopharmace... |
| 17.10.2025 | FDA approves expanded pediatric indications for YUFLYMA® (adalimumab-aaty) and unbranded adalimumab-aaty in the United States | YUFLYMA® (adalimumab-aaty), and its unbranded version, are now approved for two additional pediatric indications – adolescent hidradenitis suppurativa (HS) and pediatric uveitis (UV), in the U.S.[1],[2]
Pediatric UV is a rare eye inflammati... |
| 10.10.2025 | Celltrion receives U.S. FDA approval for EYDENZELT® (aflibercept-boav), biosimilar referencing EYLEA® (aflibercept) | EYDENZELT® is approved for the treatment of patients with neovascular (wet) age-related macular degeneration (wAMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR)
Celltrion... |
| 02.10.2025 | Celltrion launches AVTOZMA® (tocilizumab-anoh) intravenous (IV) formulation in the United States | The AVTOZMA® (tocilizumab-anoh) intravenous (IV) formulation was approved in January 2025 by the FDA to treat the same conditions as the reference product ACTEMRA® (tocilizumab)
AVTOZMA is Celltrion's fifth immunology biologic and seventh b... |
| 06.08.2025 | FDA approves expanded indication for AVTOZMA® (tocilizumab-anoh) intravenous (IV) formulation in cytokine release syndrome (CRS) | Approval of AVTOZMA® (tocilizumab-anoh) intravenous infusion expands label to include treatment of adults and pediatric patients aged 2 years and older with cytokine release syndrome (CRS) [1]
AVTOMZA received FDA approval in January 2025, ... |
| 08.07.2025 | Celltrion USA announces U.S. launch of denosumab biosimilars, STOBOCLO® and OSENVELT® (denosumab-bmwo) | STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) are approved by FDA for all indications of PROLIA® (denosumab) and XGEVA® (denosumab) respectively[1],[2]
STOBOCLO and OSENVELT, among the first wave of biosimilars referencing PROLI... |
| 19.06.2025 | Big Pharma Under Fire: A Taxing Debate in the Senate | The Senate floor is heating up. Two Democratic lawmakers, Sen. Elizabeth Warren and Rep. Jan Schakowsky, are shining a spotlight on the pharmaceutical giants. Pfizer, Johnson & Johnson, Merck, AbbVie, and Amgen are in the crosshairs. Th... |
| 16.06.2025 | Celltrion announces U.S. FDA approval of additional presentation of STEQEYMA® (ustekinumab-stba), expanding dosing options for pediatric patients | Approval of 45mg/0.5mL solution in a single-dose vial for subcutaneous injection expands dosing flexibility for pediatric patients with plaque psoriasis (PsO) or psoriatic arthritis (PsA) under 60kg
The FDA previously approved STEQEYMA® 45m... |
| 26.05.2025 | YUFLYMA®: A Game Changer in the Biosimilar Landscape | In the ever-evolving world of pharmaceuticals, the recent announcement from Celltrion, Inc. has sent ripples through the biosimilar market. The U.S. Food and Drug Administration (FDA) has granted an expanded interchangeable designation for ... |
| 24.05.2025 | Celltrion's YUFLYMA® (adalimumab-aaty) receives FDA interchangeability designation for all its approved dosage forms and strengths | YUFLYMA® (adalimumab-aaty) is a high-concentration (100mg/mL) and citrate-free formulation of Humira® (adalimumab) biosimilar[1]
Celltrion previously received interchangeability (IC) designation for YUFLYMA® (adalimumab-aaty) in prefilled s... |
| 24.05.2025 | /DISREGARD RELEASE: Celltrion/ | We are advised by Celltrion that journalists and other readers should disregard the news release, Celltrion's YUFLYMA® (adalimumab-aaty) receives FDA interchangeability designation for all its approved dosage forms and strengths, issued 21-... |
| 22.05.2025 | Celltrion's YUFLYMA® (adalimumab-aaty) receives FDA interchangeability designation for all its approved dosage forms and strengths | YUFLYMA® (adalimumab-aaty) is a high-concentration (100mg/mL) and citrate-free formulation of Humira® (adalimumab) biosimilar[1]
Celltrion previously received interchangeability (IC) designation for YUFLYMA® (adalimumab-aaty) in prefilled s... |
| 17.05.2025 | Redica Systems and Hyundai ADM Bio: Navigating the Future of Life Sciences | In the fast-paced world of life sciences, two companies are making headlines for their strategic maneuvers. Redica Systems, a quality and regulatory intelligence firm, has secured funding to enhance its innovative platform. Meanwhile, Hyund... |
| 13.05.2025 | Hyundai ADM Bio Voluntarily Withdraws IND for Clinical Study of Docetaxel Combination Cancer Therapy to Focus on Immunotherapy Strategy | Declares a strategic pivot to lead the post-patent immunotherapy combination era
SEOUL, South Korea, May 13, 2025 /PRNewswire/ -- Hyundai ADM Bio (KOSDAQ symbol 187660) today announced the voluntary withdrawal of its Investigational New Dru... |
| 28.04.2025 | Celltrion to present six abstracts in inflammatory bowel disease (IBD) at 2025 Digestive Disease Week® (DDW) | Six abstracts accepted for presentation includes post hoc analyses and real-world evidence for ZYMFENTRA® (infliximab-dyyb)
Findings reinforce clinical decision-making in long-term management of moderate-to-severe Crohn's disease and ulcera... |
| 02.04.2025 | Roche’s Top-Selling Drug’s New High-Dose Version Fails in Study | (Bloomberg) -- Roche Holding AG said a high-dose version of Ocrevus, its best-selling multiple sclerosis drug, failed to outperform the original in a large study, potentially reducing the drugmaker’s ability to fend off cheaper copies.
Doub... |
| 31.03.2025 | Bridging Innovation and Accessibility: The New Era of AI and Healthcare Solutions | In the fast-paced world of technology and healthcare, two recent developments stand out. One is the appointment of Ajay Anand at the Wharton School, focusing on artificial intelligence (AI) and analytics. The other is the introduction of Ce... |
| 27.03.2025 | Celltrion's STEQEYMA® (ustekinumab-stba), now added to the Costco Member Prescription Program | STEQEYMA® (ustekinumab-stba) is Celltrion's biosimilar to STELARA® (ustekinumab), which was launched on March 12, 2025
Celltrion's adalimumab-aaty was previously added to the Costco Member Prescription Program in August 2024
JERSEY CITY, N.... |
| 13.03.2025 | STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA® (ustekinumab), now available in the United States | STEQEYMA®, one of the first-wave biosimilars to STELARA®, is now available in the U.S.
Approved for the same indications as the reference product, STEQEYMA will be priced with a wholesale acquisition cost (WAC) list price at an 85% discount... |
| 10.03.2025 | U.S. FDA approves Celltrion's OMLYCLO® (omalizumab-igec) as the first and only biosimilar with interchangeability designation referencing XOLAIR® | OMLYCLO® (omalizumab-igec) is the first and only omalizumab biosimilar approved by the FDA
Regulatory approval for interchangeability was supported by positive phase III data demonstrating comparable efficacy and safety profile with the ref... |
| 04.03.2025 | Celltrion receives U.S. FDA approval for STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) biosimilars referencing PROLIA® and XGEVA® | STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) are approved by FDA for all indications of reference products PROLIA® (denosumab) and XGEVA® (denosumab) respectively[1], [2]
The FDA approval is based on robust clinical evidence, w... |
| 15.01.2025 | Celltrion unveils strategic vision for advancing its innovative drug pipeline at the 43rd Annual J.P. Morgan Healthcare Conference | Celltrion unveils strategic roadmap for the first time outlining its innovative drug development strategy and its plan to submit 13 Investigational New Drug (IND) application by 2028
Company reinforces its commitment to a two-pillar growth ... |
| 31.10.2024 | ZYMFENTRA® (infliximab-dyyb) coverage continues to increase through partnership with top 3 Pharmacy Benefit Managers (PBMs) | Celltrion USA has expanded access to ZYMFENTRA® (infliximab-dyyb), the first and only FDA-approved subcutaneous (SC) infliximab, to a significant share of the U.S. market
The availability of ZYMFENTRA will support greater patient access and... |
| 30.08.2024 | /DISREGARD RELEASE: Celltrion USA/ | We are advised by Celltrion USA that journalists and other readers should disregard the news release, Celltrion USA partners with Express Scripts and Cigna Healthcare to expand access to ZYMFENTRA® (infliximab-dyyb), the first and only FDA-... |
| 29.08.2024 | A New Era in Treatment: Celltrion USA's ZYMFENTRA® Partnership with Cigna and Express Scripts | In the ever-evolving landscape of healthcare, partnerships can pave the way for innovation and accessibility. Celltrion USA has recently made headlines by teaming up with Cigna Healthcare and Express Scripts. This collaboration aims to broa... |
| 29.08.2024 | Celltrion USA partners with Express Scripts and Cigna Healthcare to expand access to ZYMFENTRA® (infliximab-dyyb), the first and only FDA-approved subcutaneous infliximab on their medical benefit form... | JERSEY CITY, N.J., Aug. 29, 2024 /PRNewswire/ -- Celltrion USA announced today that it has signed an agreement with Cigna Healthcare, the health benefits provider of the Cigna Group and Express Scripts, the pharmacy benefits services busine... |
| 28.08.2024 | Celltrion USA partners with Express Scripts and Cigna Healthcare to expand access to ZYMFENTRA® (infliximab-dyyb), the first and only FDA-approved subcutaneous infliximab on their medical benefit form... | JERSEY CITY, N.J., Aug. 28, 2024 /PRNewswire/ -- Celltrion USA announced today that it has signed an agreement with Cigna Healthcare, the health benefits provider of the Cigna Group and Express Scripts, the pharmacy benefits services busine... |
| 13.08.2024 | Celltrion USA announces incorporation of adalimumab-aaty, a Humira® biosimilar, to the Costco Member Prescription Program | Adalimumab-aaty was first approved by the Food and Drug Administration on May 23, 2023 and became commercially available among key distributors across the U.S. on July 2, 2023
Adalimumab-aaty's inclusion creates greater accessibility to tre... |
| 12.08.2024 | Celltrion USA announces incorporation of adalimumab-aaty, a Humira® biosimilar, to the Costco Member Prescription Program | Adalimumab-aaty was first approved by the Food and Drug Administration on May 23, 2023 and became commercially available among key distributors across the U.S. on July 2, 2023
Adalimumab-aaty's inclusion creates greater accessibility to tre... |
| 06.07.2024 | 14 Celltrion Legacy products acquired by CBC-Backed Hasten Biopharmaceutical | The South Korean biopharmaceutical company Celltrion has successfully sold the asset rights to 14 branded products for use across Pan-Asia countries and regions to Hasten Biopharmaceutical (Hasten), an innovative biopharmaceutical company. ... |
| 10.05.2024 | Celltrion USA's adalimumab-aaty biosimilar to HUMIRA® now available at low wholesale acquisition cost | Adalimumab-aaty will be priced at an 85% discount to HUMIRA® (adalimumab)
Branded and unbranded versions of Celltrion USA's adalimumab biosimilar help provide more affordable options for patients
JERSEY CITY, N.J., May 10, 2024 /PRNewswire/... |
| 09.05.2024 | Celltrion USA's adalimumab-aaty biosimilar to HUMIRA® now available at low wholesale acquisition cost | Adalimumab-aaty will be priced at an 85% discount to HUMIRA® (adalimumab)
Branded and unbranded versions of Celltrion USA's adalimumab biosimilar help provide more affordable options for patients
JERSEY CITY, N.J., May 9, 2024 /PRNewswire/ ... |
| 24.01.2024 | WuXi XDC and Celltrion Sign MOU for Integrated Services for Antibody-Drug Conjugates (ADCs) | SHANGHAI and INCHEON, South Korea, Jan. 24, 2024 /PRNewswire/ -- WuXi XDC(2268.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO) focused on ADC and the other types of bioconjugate market, and Celltr... |
| 28.04.2022 | Celltrion USA Recalls Certain Point of Care DiaTrust COVID-19 Ag Rapid Test Kits Which May Have Been Distributed to Unauthorized, Non-CLIA-Certified Users | The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product
Product Name: Celltrion DiaTrust COVID-19 Ag Rapid Test
Product Codes: 83QKP
Lot Nu... |
| 28.11.2018 | FDA approves Celltrion, Teva’s Rituxan biosimilar, but with a narrow label | The biosimilar is approved as a single agent in patients with relapsed or refractory low-grade or follicular B-NHL; combined with first-line chemotherapy in patients with first-line follicular lymphoma and also as a single-agent maintenance... |
| 11.10.2018 | Teva-partnered Celltrion biosimilar scores FDA adcomm recommendation for a second shot at shaking up Roche's Rituxan franchise | After repeated run-ins with the FDA in the past few months regarding site inspections and biosimilar filings, Celltrion might finally be turning things around with an unanimous thumbs up for its Rituxan copycat from the ... |
| 01.02.2018 | UCB, investors back a neurosciences startup called Syndesi; Germany's Biofrontera increases US IPO pricing range | Dhavalkumar Patel, UCB
→ UCB and a syndicate of Belgian and international investors have joined hands to launch a new biotech called Syndesi Therapeutics. The Belgian startup gained a €17 million A round, which will be use... |
| - | FDA approves Celltrion, Teva’s Rituxan biosimilar, but with a narrow label | The Food and Drug Administration has approved the first biosimilar version of a drug commonly used to treat the most widespread forms of lymphoma.
The agency said Wednesday that it had approved Truxima (rituximab-abbs), a biosimilar version... |
