​U.S. FDA grants interchangeable designation to YUFLYMA, Celltrion's biosimilar to Humira

YUFLYMA(adalimumab-aaty) is a high-concentration (100mg/mL) and citrate-free formulation of Humira(adalimumab) biosimilar, that is now interchangeable Interchangeable designation ofYUFLYMAissupported by positive data from the Phase III interchangeability study in patients with moderate-to-severe plaque psoriasis [Press Release] INCHEON,South Korea,April 14, 2025 -- Celltrion(셀트리온), Inc. today announced that the U.S. Food and Drug Administration (FDA) has designated YUFLYMA(adalimumab-aaty), as an interchangeable biosimilar to Humira(adalimumab). YUFLYMAis an FDA-approved, high-concentration (100mg/mL) and citrate-free formulation of Humirabiosimilar, approved for multiple inflammatory indications. With this new designation, YUFLYMA is further positioned to help more patients gain access to and afford the therapy they need, saidThomas Nusbickel, Chief Commercial Officer at CelltrionUSA. YUFLYMA has the same dosage form, route of administration, and dosing regimen as the reference product. Thepharmacists ability to substitute the biosimilar directly at the pharmacy without the hassle ofa new prescription and without the patient having to learn a new method of administration can be a game changer in increasing patient access to adalimumab. The interchangeable designation was supported by data from the Phase III interchangeability study, which demonstrated similar outcomes in terms of pharmacokinetics, efficacy, safety and immunogenicity in patients with moderately to severely active plaque psoriasis who received reference adalimumab (ADA) continuously and those who alternated between reference ADA and YUFLYMA during the dosing interval of Week 25-27. The result of the interchangeability study was presented at the European Academy of Dermatology Venereology (EADV) 2024. FDA-approved interchangeable biosimilars may be substituted for the reference product at the pharmacy without the intervention of the prescribing health care provider, subject to state laws. The high-concentration form of YUFLYMA was FDA-approved inMay 2023and is currently available as 20mg, 40 mg and 80mg solution for injection in a prefilled syringe and in an autoinjector pen. YUFLYMA was introduced into the US commercial market onJuly 2, 2023. YUFLYMA is available in two pricing options to help provide more affordable options for patients. Adalimumab-aaty, the unbranded version, is priced at an 85% discount to the current wholesale acquisition cost (WAC) list price of Humira (adalimumab), providing economic benefits for patients and overall healthcare system. The branded version is priced at a 5% discount to the current WAC of Humira (adalimumab). News provided byCelltrion

Lunit Study in Radiology Highlights Trust Gap Between Radiologists and AI in Breast Cancer Screening

Despite strong performance from AI, fewer recalls from AI-flagged cases point to challenges in human-AI collaboration [Press Release] SEOUL, South Korea,April 9, 2025-- Lunit(루닛), a leading provider of AI-powered solutions for cancer diagnostics and therapeutics, today announced the publication of a new study inRadiology(RSNAs flagship journal), highlighting how radiologists interact with AI in real-world breast cancer screening. Lunits AI identified more cancers, but radiologists recalled fewer of those caseshighlighting a trust gap in clinical decision-making. The study, based on the prospectiveScreenTrustCAD trial, is the first large-scale, population-based trial to evaluate how radiologists interact with AI in an operational breast cancer screening setting. Conducted at Capio St Gran Hospital inStockholm, Sweden, the trial enrolled about 55,000 women and implemented Lunit INSIGHT MMG as an independent third reader alongside two radiologists. The findings suggest that radiologists were significantly less likely to recall patients flagged by AIeven though those cases were more likely to be cancerouspointing to a trust gap between human clinicians and AI tools. This study isnt just about how well the AI performsits about what happens when AI enters the decision-making process, saidBrandon Suh, CEO of Lunit. The findings point to a gap between AI input and human response, and thats where real-world impact is made or lost. Human-AI Collaboration The study showed that: -When only AI flagged a case, just 4.6% were recalled by radiologists. -When only a radiologist flagged a case, 14.2% were recalled. -When two radiologists flagged a case, 57.2% were recalledbut when AI and one radiologist both flagged it, the recall rate dropped to 38.6%. Despite being blinded to AI scores during the initial review, radiologists consistently recalled fewer patients from AI-flagged casesraising questions about how AI findings are weighed in clinical judgment. This isnt a question of whether AI can detect cancer. Its about how AI findings are interpreted and acted on by the people making clinical decisions, said Dr. Karin Dembrower, lead author of the study and radiologist atKarolinska Institutet. Clinical Performance of Lunit INSIGHT MMG While the studys central focus was on decision-making dynamics, it also confirmed the strong diagnostic performance of Lunit INSIGHT MMG: -Among women recalled after screening, 22% of AI-only flagged cases were diagnosed with cancer. -In contrast, just 3.4% of single-radiologist flags and 2.5% of two-radiologist flags resulted in a cancer diagnosis. -When both AI and one radiologist flagged a case, the cancer yield was highest at 25%. These results highlight AIs ability to detect cancers that may go unnoticed in standard double-reading workflowsparticularly in early or less obvious presentations. These findings suggest that while the AI system correctly identified high-risk cases, many of those cases were not recalled by radiologistsindicating a potential gap in trust or confidence in AI-generated findings. The AI clearly shows strong diagnostic performance, Suh added. What this study reveals is that realizing that potential in daily clinical practice depends on how AI and humans work together. News provided by Lunit