Expert Review of Clinical Pharmacology最新文献_第5页

New therapies to treat nausea and vomiting: clinical need, progress towards novelty and research challenges. 治疗恶心和呕吐的新疗法：临床需要、新进展和研究挑战。

IF 3.6 3区医学

Expert Review of Clinical Pharmacology Pub Date : 2026-06-01 Epub Date: 2026-06-09 DOI: 10.1080/17512433.2026.2682294

Gareth J Sanger, John F Golding, Paul L R Andrews

{"title":"New therapies to treat nausea and vomiting: clinical need, progress towards novelty and research challenges.","authors":"Gareth J Sanger, John F Golding, Paul L R Andrews","doi":"10.1080/17512433.2026.2682294","DOIUrl":"10.1080/17512433.2026.2682294","url":null,"abstract":"Introduction: Despite the availability of drugs which prevent vomiting, treatment gaps in controlling nausea and vomiting remain. New approaches are needed.Areas covered: We identify unmet clinical needs by examining clinical reviews (last 5-years), adding our experience in drug discovery/emesis research. Mechanisms of nausea and vomiting are given. We identify emerging research and new approaches before discussing the challenges of quantifying nausea and vomiting in future trials.Expert opinion: As single agents, drugs which prevent vomiting have efficacy in some but not all groups of patients, with NK1 receptor antagonists possessing the widest spectrum of action. Drug combinations have improved efficacy in specific clinical settings. However, treatment gaps remain (e.g. gastroparesis, cyclic vomiting syndrome) and efficacy is lower against nausea compared with vomiting. The latter requires greater attention in trial design and regulatory assessments. The issue of nausea is difficult because in humans it is inadequately quantified (with high temporal resolution), there is a lack of clinical research into nausea, and animal models only measure 'nausea-like behaviours,' with challenges in translating to humans. In drug discovery, more systematic and critical analysis of the pharmacology of the diverse agents which induce or reduce nausea and vomiting may help identify new therapeutic mechanisms.","PeriodicalId":12207,"journal":{"name":"Expert Review of Clinical Pharmacology","volume":" ","pages":"535-558"},"PeriodicalIF":3.6,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148053795","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Effect of terlipressin on renal outcomes in patients with liver cirrhosis and ascites: a retrospective multicenter study. 特利加压素对肝硬化和腹水患者肾脏预后的影响：一项回顾性多中心研究。

IF 3.6 3区医学

Expert Review of Clinical Pharmacology Pub Date : 2026-06-01 Epub Date: 2026-06-21 DOI: 10.1080/17512433.2026.2679596

Yong He, Xianxian Zhang, Ting Wang, Xiaohui Fang, Na Sun, Jian Zhang, Yibing Li, Frank Tacke, Wenxiu Zhang, Yanhong Gao, Han Chen, Yunhai Wu, Lichun Shao, Xingshun Qi

{"title":"Effect of terlipressin on renal outcomes in patients with liver cirrhosis and ascites: a retrospective multicenter study.","authors":"Yong He, Xianxian Zhang, Ting Wang, Xiaohui Fang, Na Sun, Jian Zhang, Yibing Li, Frank Tacke, Wenxiu Zhang, Yanhong Gao, Han Chen, Yunhai Wu, Lichun Shao, Xingshun Qi","doi":"10.1080/17512433.2026.2679596","DOIUrl":"10.1080/17512433.2026.2679596","url":null,"abstract":"Background: Terlipressin is recommended for acute kidney injury (AKI) in cirrhosis, but its role in those with ascites but without AKI is unclear.Methods: We retrospectively enrolled 905 cirrhotic patients with ascites from three hospitals, of whom 250 received terlipressin and 655 standard medical therapy. Patients were stratified by baseline serum creatinine (Scr) into stable renal function (Scr < 133 μmol/L; n = 784) and renal dysfunction (Scr ≥ 133 μmol/L; n = 121) cohorts. Primary outcomes included AKI, renal dysfunction, and renal function improvement. Propensity score matching (PSM) was performed. Multivariable logistic regression was further performed in the stable renal function cohort to assess the independent association between terlipressin and AKI. Odds ratio (OR) was calculated.Results: In the stable renal function cohort, after PSM (n = 120), terlipressin group had lower incidence of AKI (1.67% vs. 16.67%, p = 0.004) and renal dysfunction (0% vs. 8.33%, p = 0.068); and multivariate logistic regression analysis confirmed that terlipressin was independently associated with lower incidence of AKI (OR = 0.093, p = 0.027). In the renal dysfunction cohort, after PSM (n = 34), terlipressin was associated with higher incidence of renal function improvement (70.59% vs. 23.53%, p = 0.006).Conclusion: Terlipressin may be associated with favorable renal outcomes in cirrhotic patients with ascites, regardless of baseline renal function.","PeriodicalId":12207,"journal":{"name":"Expert Review of Clinical Pharmacology","volume":" ","pages":"601-613"},"PeriodicalIF":3.6,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147987203","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Factors to consider when designing clinical trials for repurposed drugs. 设计再用途药物临床试验时应考虑的因素。

IF 3.6 3区医学

Expert Review of Clinical Pharmacology Pub Date : 2026-06-01 Epub Date: 2026-05-08 DOI: 10.1080/17512433.2026.2671276

Samuel Gordon, Katarzyna Klas, Marcin Waligora

{"title":"Factors to consider when designing clinical trials for repurposed drugs.","authors":"Samuel Gordon, Katarzyna Klas, Marcin Waligora","doi":"10.1080/17512433.2026.2671276","DOIUrl":"10.1080/17512433.2026.2671276","url":null,"abstract":"Introduction: Drug repurposing is the strategy of identifying novel therapeutic uses for existing, unapproved, or failed drugs distinct from their original indications. Given the unique nature of repurposing, clinical trials for repurposed agents warrant specific design considerations.Areas covered: This article covers specific factors to consider when designing clinical trials for repurposed agents. The specific factors identified are the drug's characteristics, its clinical context, the design and methodology of the repurposing trial, the quality and management of supporting data, and other ethical and organizational concerns specific to repurposing.Expert opinion: Drug repurposing is a natural approach to reduce costs and increase the efficiency of drug development, and such trials may offer ethical advantages in terms of participant risk and social value. In the modern landscape of clinical trials, numerous barriers to initiating repurposing efforts exist. Notably, these include challenges related to intellectual property, data availability, and the unexpected and widespread consequences of off-label use and drug access. Other barriers to safe and effective repurposing will continue to challenge trialists and stakeholders, especially regarding the reuse of data, communication, documentation, and other potential confounding factors not experienced in standard trials. Thus, careful ethical assessment of trial characteristics is necessary.","PeriodicalId":12207,"journal":{"name":"Expert Review of Clinical Pharmacology","volume":" ","pages":"509-519"},"PeriodicalIF":3.6,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147835746","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Is dose adjustment of dolutegravir necessary in Chinese adults living with HIV across different body weight levels? A population pharmacokinetics analysis. 不同体重水平的中国成年HIV感染者是否需要调整多替格拉韦的剂量？群体药代动力学分析。

IF 3.6 3区医学

Expert Review of Clinical Pharmacology Pub Date : 2026-06-01 Epub Date: 2026-05-28 DOI: 10.1080/17512433.2026.2679589

Rui Chen, Renfang Zhang, Ya-Ru Xing, Jiang-Rong Wang, Li Liu, Lin Yin, Ying-Ying Li, Zheng Jiao, Lijun Zhang

{"title":"Is dose adjustment of dolutegravir necessary in Chinese adults living with HIV across different body weight levels? A population pharmacokinetics analysis.","authors":"Rui Chen, Renfang Zhang, Ya-Ru Xing, Jiang-Rong Wang, Li Liu, Lin Yin, Ying-Ying Li, Zheng Jiao, Lijun Zhang","doi":"10.1080/17512433.2026.2679589","DOIUrl":"10.1080/17512433.2026.2679589","url":null,"abstract":"Background: Dolutegravir (DTG) is an integrase strand transfer inhibitor indicated for human immunodeficiency virus (HIV) infection. Although intrinsic factors show no ethnic-specific impact on DTG pharmacokinetics, extrinsic factors may modulate its pharmacokinetic profile.Research design and methods: This study developed a population pharmacokinetic model for DTG in Chinese adults living with HIV and identified key covariates influencing its pharmacokinetics using nonlinear mixed-effects modeling.Results: A total of 302 DTG concentrations from 293 Chinese patients receiving once-daily 50 mg DTG were analyzed. A one-compartment model with first-order absorption and elimination characterized the data. The estimated parameters were as follows: an absorption rate constant of 0.222 h-1, an apparent clearance of 0.843L·h-1, and a volume of distribution of 9.32 L. Body weight (WT) was identified as a significant (p < 0.01) covariate influencing apparent clearance. Monte Carlo simulations indicated that under the standard 50 mg once-daily regimen, DTG exposure was comparable across the WT range of 40-100 kg.Conclusion: The findings may contribute to more personalized and effective treatment for Chinese adults living with HIV. In this predominantly male cohort, WT-based dose adjustment was generally not warranted among patients weighing 40-100 kg who received DTG 50 mg once daily.","PeriodicalId":12207,"journal":{"name":"Expert Review of Clinical Pharmacology","volume":" ","pages":"577-585"},"PeriodicalIF":3.6,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148014239","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Predictors of warfarin therapeutic dose across thromboembolic indications: an exploratory early clinical evaluation study using machine learning-integrated explainable artificial intelligence and Bayesian models. 华法林治疗剂量在血栓栓塞适应症中的预测因素：一项使用机器学习集成可解释人工智能和贝叶斯模型的探索性早期临床评估研究。

IF 3.6 3区医学

Expert Review of Clinical Pharmacology Pub Date : 2026-06-01 DOI: 10.1080/17512433.2026.2682286

Kannan Sridharan, Gowri Sivaramakrishnan

{"title":"Predictors of warfarin therapeutic dose across thromboembolic indications: an exploratory early clinical evaluation study using machine learning-integrated explainable artificial intelligence and Bayesian models.","authors":"Kannan Sridharan, Gowri Sivaramakrishnan","doi":"10.1080/17512433.2026.2682286","DOIUrl":"10.1080/17512433.2026.2682286","url":null,"abstract":"Background: Warfarin dosing varies widely due to genetic, demographic, and clinical factors, but it is unknown whether the importance, equilibrium, and prediction uncertainty of established pharmacogenetic predictors (VKORC1 and CYP2C9) differ between arterial (AF/stroke) and venous (DVT/PE) thromboembolic indications.Research design and methods: This exploratory study (early clinical evaluation) synthesizes findings from the International Warfarin Pharmacogenetics Consortium dataset. We evaluated five machine learning (ML) models, and SHapley Additive exPlanations (SHAP) and Bayesian Additive Regression Trees (BART) analyses were carried out.Results: Random Forest demonstrated slightly better predictive performance than other ML models. SHAP analysis quantified feature contributions, revealing that VKORC1 G/G genotype as the most influential in AF/Stroke, while VKORC1 A/A genotype followed by age in the DVT/PE group. BART provided probabilistic predictions and identified indication-specific uncertainty drivers. Age possibly has an interaction effect in the requirements of reduced warfarin doses with AF/Stroke.Conclusions: Our findings reveal that while core genetic and anthropometric predictors of warfarin dose transcend thromboembolic indication, the equilibrium among these factors and sources of prediction uncertainty possibly differ between arterial and venous disease. Integration of ML with SHAP offers a roadmap for personalized warfarin dosing, though prospective validation is needed before clinical implementation.","PeriodicalId":12207,"journal":{"name":"Expert Review of Clinical Pharmacology","volume":" ","pages":"587-600"},"PeriodicalIF":3.6,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148053739","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Prophylaxis for inherited factor X deficiency: a systematic review. 预防遗传性因子X缺乏症：一项系统综述。

IF 3.6 3区医学

Expert Review of Clinical Pharmacology Pub Date : 2026-06-01 Epub Date: 2026-06-08 DOI: 10.1080/17512433.2026.2683094

Vitor José Poletto Ferreira, Alessandra Fatima da Costa, Renan Souza, Ricardo Mesquita Camelo

{"title":"Prophylaxis for inherited factor X deficiency: a systematic review.","authors":"Vitor José Poletto Ferreira, Alessandra Fatima da Costa, Renan Souza, Ricardo Mesquita Camelo","doi":"10.1080/17512433.2026.2683094","DOIUrl":"10.1080/17512433.2026.2683094","url":null,"abstract":"Background: Hereditary factor X (FX) deficiency (FXD) leads to bleeds. Therapy is based on treating (episodic) or preventing (prophylaxis) bleeds with procoagulants. We aimed to evaluate the efficacy/effectiveness and safety of prophylaxis in people with FXD (PwFXD) compared to on-demand treatment or prophylaxis with a different procoagulant.Research design and methods: A systematic review was conducted based on database searches on 6 May 2024, and 11 August 2025. Two reviewers independently selected publications according to the research question. Additionally, prophylaxis-referenced citations from included studies and excluded reviews since 2014 were screened. Efficacy/effectiveness was evaluated using bleeding-related outcomes. Study quality and risk of bias were assessed using Joanna Briggs Institute checklists.Results: Fifteen publications involving 78 PwFXD were included, of whom 47 (60%) received prophylaxis. Most studies were case reports from Europe or North America. Prophylaxis regimens included prothrombin complex concentrate and plasma-derived FX, with follow-up from 22 weeks to 15 years. Control groups received on-demand treatment. Individual annualized bleeding rates ranged from 0-2.2 during prophylaxis versus 2.3-136.8 during on-demand periods. Study quality was mostly low (31%) to intermediate (56%).Conclusion: Prophylaxis appears more effective than on-demand treatment; however, better-designed studies are needed to confirm this evidence.Prospero registration: CRD42024535021.","PeriodicalId":12207,"journal":{"name":"Expert Review of Clinical Pharmacology","volume":" ","pages":"567-576"},"PeriodicalIF":3.6,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148143279","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Novel biomarkers driving treatment selection in metastatic castration-sensitive prostate cancer: fundamentals of personalized clinical decision making. 新的生物标志物驱动转移性去势敏感前列腺癌的治疗选择：个性化临床决策的基础。

IF 3.6 3区医学

Expert Review of Clinical Pharmacology Pub Date : 2026-06-01 Epub Date: 2026-05-22 DOI: 10.1080/17512433.2026.2677891

Lilia Bardoscia, Federico Camilli, Luca Triggiani, Elisa Ciurlia, Federico Iori, Eleonora Festa, Marco Trovò, Andrea Lancia, Beatrice Detti, Gianluca Ingrosso

{"title":"Novel biomarkers driving treatment selection in metastatic castration-sensitive prostate cancer: fundamentals of personalized clinical decision making.","authors":"Lilia Bardoscia, Federico Camilli, Luca Triggiani, Elisa Ciurlia, Federico Iori, Eleonora Festa, Marco Trovò, Andrea Lancia, Beatrice Detti, Gianluca Ingrosso","doi":"10.1080/17512433.2026.2677891","DOIUrl":"10.1080/17512433.2026.2677891","url":null,"abstract":"Introduction: Prostate cancer is well known to be androgen-dependent, with growth directly relying on the androgen receptor signaling pathway. In fact, androgen deprivation therapy, with or without Docetaxel and/or newer hormonal drugs such as Abiraterone acetate, Enzalutamide, Apalutamide, and Darolutamide, remains the most effective systemic treatment for metastatic disease. Beyond PSA detection, there is a lack of standardized biohumoral markers to understand the biology of metastatic castrate-sensitive prostate cancer (mCSPC), predict response to newer therapies such as immunotherapy, and identify a true oligometastatic state.Areas covered: A comprehensive, non-systematic literature review across Scopus, Google Scholar, Medline, EMBASE, and the Cochrane Library was conducted. New evidence was identified, gathered, and screened for relevance, limited to English-language publications. Information and recommendations on the emerging mCSPC biomarkers, their possible integration, and application for care decisions were evaluated. Our work aimed to summarize the current understanding of molecular characterization of mCSPC and the evidence on the role of emerging molecular biomarkers in guiding personalized treatment for mCSPC.Expert opinion: The integration of data extracted from imaging with the molecular and genetic profiles of a specific tissue, using artificial intelligence, will help assess the genetic and biochemical makeup of living tissue.","PeriodicalId":12207,"journal":{"name":"Expert Review of Clinical Pharmacology","volume":" ","pages":"521-534"},"PeriodicalIF":3.6,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147971878","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Integrating homologous recombination deficiency and replication stress: converging strategies unlocking new frontiers in precision oncology. 整合同源重组缺陷和复制压力：聚合策略解锁精准肿瘤学新领域。

IF 3.6 3区医学

Expert Review of Clinical Pharmacology Pub Date : 2026-05-01 Epub Date: 2026-04-28 DOI: 10.1080/17512433.2026.2665447

Tugba Y Ozmen, Connor M Frankston, Matthew J Rames, Furkan Ozmen, Galip G Yardimci, Gordon B Mills

{"title":"Integrating homologous recombination deficiency and replication stress: converging strategies unlocking new frontiers in precision oncology.","authors":"Tugba Y Ozmen, Connor M Frankston, Matthew J Rames, Furkan Ozmen, Galip G Yardimci, Gordon B Mills","doi":"10.1080/17512433.2026.2665447","DOIUrl":"10.1080/17512433.2026.2665447","url":null,"abstract":"Introduction: Homologous recombination (HR) deficiency (HRD) and replication stress (RS) are increasingly recognized as interconnected hallmarks of genomic instability in cancer, offering promising avenues for therapeutic targeting. As novel combination therapies targeting these hallmarks continue to emerge, understanding how these processes interact in therapeutic contexts and comparing the relative efficacy and toxicity of combination therapy is critical in advancing precision oncology.Areas covered: We investigate current and emerging assays that assess HRD and RS in cancer treatment and provide an exploration of related pathways. We also provide a high-level comparative pan-cancer analysis from results available on clinicaltrials.gov for common mono poly(ADP-ribose) polymerase inhibitor (PARPi), RS, and immune checkpoint blockade (ICB) therapies as well as their pairwise combinations, demonstrating efficacy and toxicity of current combination therapies.Expert opinion: Integrating functional assessment of HRD and RS with immune contexture and considering these processes as outputs of their interconnected pathways in response to targeted agents could establish a unified therapeutic axis. Targeting this collective axis comprehensively may provide a promising foundation for next-generation, functionally guided treatment strategies capable of achieving durable responses with acceptable toxicity across diverse cancer types.","PeriodicalId":12207,"journal":{"name":"Expert Review of Clinical Pharmacology","volume":" ","pages":"429-446"},"PeriodicalIF":3.6,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147766780","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Immunotherapy in limited-stage small cell lung cancer: riding the ADRIATIC wave toward precision. 有限期小细胞肺癌的免疫治疗：乘着亚得里亚海浪潮走向精准。

IF 3 3区医学

Expert Review of Clinical Pharmacology Pub Date : 2026-05-01 Epub Date: 2026-05-09 DOI: 10.1080/17512433.2026.2669256

Serena Eccher, Adele Bonato, Marco Sposito, Ilaria Mariangela Scaglione, Jessica Insolda, Michele Milella, Sara Pilotto, Lorenzo Belluomini

引用次数: 0

Biosimilars for chronic plaque psoriasis: a 2026 update. 慢性斑块型银屑病的生物仿制药：2026年更新

IF 3.6 3区医学

Expert Review of Clinical Pharmacology Pub Date : 2026-05-01 Epub Date: 2026-05-03 DOI: 10.1080/17512433.2026.2667342

Martina Maurelli, Andrea Danese, Paolo Gisondi, Giampiero Girolomoni

{"title":"Biosimilars for chronic plaque psoriasis: a 2026 update.","authors":"Martina Maurelli, Andrea Danese, Paolo Gisondi, Giampiero Girolomoni","doi":"10.1080/17512433.2026.2667342","DOIUrl":"10.1080/17512433.2026.2667342","url":null,"abstract":"Introduction: Biosimilars have emerged as a key strategy to improve access to biologic therapies in moderate-to-severe psoriasis, addressing long-standing limitations related to treatment costs and availability.Areas covered: This narrative review summarizes the current evidence on biosimilars approved for psoriasis, including tumor necrosis factor inhibitors and ustekinumab, focusing on efficacy, safety, interchangeability, and pharmacoeconomic impact. A literature search was conducted in PubMed/MEDLINE and Embase to identify relevant clinical trials, real-world studies, and pharmacoeconomic analyses published between January 2015 and January 2026. Available data consistently demonstrate that biosimilars are highly similar to their reference biologics, with no clinically meaningful differences in efficacy, safety, or immunogenicity. Pharmacoeconomic studies across Europe confirm substantial cost savings and reduced cost-per-responder, supporting broader and earlier access to biologic therapy.Expert opinion: Biosimilars should be considered as first-line biologic options when appropriate, not only as cost-saving alternatives. Their wider use may enable earlier intervention, potentially reducing long-term disease burden and improving health system sustainability.","PeriodicalId":12207,"journal":{"name":"Expert Review of Clinical Pharmacology","volume":" ","pages":"447-455"},"PeriodicalIF":3.6,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147766824","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0