Biosimilars are biological medicines highly similar to an authorized reference medicine, offering substantial cost savings and increased treatment access. Despite the regulatory framework in the UK and EU facilitating their approval, the biosimilar landscape remains small compared to small-molecule drugs. This study provides a horizon scanning overview of the current biosimilar landscape, procured through horizon scanning activities.

Data were sourced from ClinicalTrials.gov and the EU Clinical Trials Register, scanned monthly to identify innovative medicines in clinical development. We included biosimilars identified through horizon scanning from April 2017 to February 2025. Supplementary data were collected from the European Medicines Agency to ascertain approval status, and additional clinical trial information was manually extracted from relevant registries.

We identified 156 unique biosimilars developed across 174 clinical trials, with sixty-four approved by the MHRA and seventy-eight by the European Medicines Agency. Adalimumab, bevacizumab, and denosumab were the reference products with the most biosimilars in development. Most biosimilar trials were at phase III. There are seventy-one biosimilars in active development.

The development landscape of biosimilars in the UK and EU show high activity levels. Continuous improvements in horizon scanning methods and regulatory frameworks are essential to support the timely adoption of biosimilars, maximizing their benefits for healthcare systems.

This study aims to evaluate the effectiveness of an adapted methicillin-resistant Staphylococcus aureus (MRSA) decolonization program in an infirmary unit in Hong Kong that was inspired by successful interventions implemented in Orange County, California.

Nasal, skin, and rectal swabs were collected to assess MRSA colonization. Decolonization involved applying 10% povidone-iodine ointment to the anterior nares twice daily for five days every other week, along with twice weekly chlorhexidine gluconate (CHG) bathing for six months. Compliance with the application of povidone-iodine and CHG bathing techniques was monitored by measuring their respective levels in the anterior nares and on the skin. Air and environmental samples were collected and analyzed over time using linear regression.

Among 60 patients in the infirmary unit (78% baseline MRSA carriers), overall MRSA colonization declined during the program, driven by significant reductions in skin colonization (65% to 29%, P < .001). Environmental contamination on high-touch patient-care equipment (bathing trolleys and slings) also significantly decreased over time (P < .001). These reductions coincided with the high-quality implementation of decolonization, evidenced by stable iodophor detection in nares during application weeks and sustained chlorhexidine levels on the skin, detectable 24 hours after bathing. In contrast, MRSA detection in air samples showed no significant change (P = .096), possibly due to dispersal by persistent carriers during care activities even as skin and environmental contamination declined.

The adapted MRSA decolonization program was effective, significantly reducing overall MRSA colonization, especially at skin sites, while achieving high compliance with the protocol.

This study compared health status and developmental skill acquisition of children aged 3–5 years with and without CHD and identified predictors of special education or early intervention plan.

Data were analysed from the 2022 National Survey of Children’s Health using complex weighted survey data procedures. Chi-square tests compared health status and developmental skill acquisition of children aged 3–5 years with and without CHD. Multivariate logistic regression identified predictors of the need for special education or early intervention plan.

11,097 National Survey of Children’s Health responses pertained to children aged 3–5 years. Children aged 3–5 years with CHD were more likely than heart-healthy peers to be born prematurely, have special healthcare needs, have parent-reported health as “fair” or “poor,” be diagnosed with anxiety, depression, or a developmental disorder, and receive special education or an early intervention plan. Children aged 3–5 years with CHD were less likely to have acquired communication, fine motor, personal social, and problem-solving skills than comparators at the time of the survey, even after adjustment for special healthcare needs. Having public plus private insurance, special healthcare needs designation, and a developmental disorder predicted children aged 3–5 years needing special education or an early intervention plan.

Children with predictors of receiving special education or an early intervention plan may benefit from early identification and support. Further research should investigate the impact of systemic disparities on developmental skill acquisition in children with CHD.

Schizophrenia (SCZ) shows marked biological heterogeneity, with negative symptoms linked to poor outcomes and hypothesised immune dysregulation. This study examined whether a peripheral cytokine–long non-coding RNA (lncRNA) panel could distinguish patients with SCZ and Brief Negative Symptom Scale (BNSS)-defined subgroups from healthy controls (HC).

Forty-one hospitalised patients with SCZ completed the BNSS and the Positive and Negative Syndrome Scale (PANSS). Twenty HCs, frequency-matched for age and sex, served as comparison samples. Severe negative-symptom subgroups were defined using two BNSS criteria: a broader (SNS1) and a more restrictive (SNS2) threshold. Serum cytokines – interleukin-6 (IL-6), tumour necrosis factor-α (TNF-α), interleukin-10 (IL-10) – and leukocyte lncRNAs (MALAT1, NEAT1, MEG3) were quantified by enzyme-linked immunosorbent assay and quantitative RT-PCR. Covariate-adjusted logistic and multinomial models (adjusting for age, sex, body mass index, and smoking) assessed discrimination using area under the receiver-operating-characteristic curve (AUC) and interquartile-range odds ratios (OR_IQR).

IL-6 correlated with PANSS Total (ρ = 0.48, p = 0.001) and Negative (ρ = 0.34, p = 0.032) scores and was higher in SCZ than HC (p = 0.033), with further increases in SNS subgroups. NEAT1 was significantly reduced only within BNSS-defined subgroups (p ≤ 0.025). The dual-marker pattern (IL-6 ↑, NEAT1 ↓) showed the strongest discrimination for SNS1 versus HC (AUC = 0.85) and the steepest multinomial contrasts for SNS2 (IL-6 OR_IQR = 4.98; NEAT1 OR_IQR = 0.11).

Elevated IL-6 and decreased NEAT1 define a peripheral signature linked to negative-symptom severity in SCZ and may support biologically informed stratification and longitudinal research.

Emerging evidence suggests that metabolic and hormonal disturbances in polycystic ovary syndrome (PCOS) may increase vulnerability to neurodegenerative disorders. However, the link between PCOS and Alzheimer’s disease (AD)-related pathology remains unclear.

In this cross-sectional study, plasma levels of β-amyloid (Aβ40, Aβ42), phosphorylated tau (p-tau181), neurofilament light chain (NfL) and glial fibrillary acidic protein (GFAP) were quantified in women with PCOS and age-matched controls. Homeostasis model assessment of insulin resistance (HOMA-IR), inflammatory cytokines (IL-6, TNF-α) and hormonal parameters were assessed. Mediation and moderation analyses were conducted to explore metabolic and hormonal pathways underlying biomarker alterations.

Among 400 women (200 PCOS, 200 controls), age and BMI were comparable (P > 0.05). Compared with controls, PCOS participants had increased Aβ40, p-tau181, NfL and GFAP, a slightly higher Aβ42, and a lower Aβ42/40 ratio (all P < 0.05). p-tau181 correlated positively with HOMA-IR (r = 0.41) and IL-6 (r = 0.36), while Aβ42/40 ratio correlated negatively with HOMA-IR (r = –0.27). In multivariable analysis, p-tau181 (aOR = 1.34, 95% CI 1.05–1.71), IL-6 (aOR = 1.19) and TNF-α (aOR = 1.14) were independent predictors of insulin resistance. Mediation analysis indicated that HOMA-IR, IL-6 and TNF-α jointly mediated ∼ 71% of the PCOS–p-tau181 association, suggesting a metabolic–inflammatory pathway linking PCOS to AD-related tau pathology.

PCOS is linked to peripheral markers of early Alzheimer’s pathology, largely mediated by insulin resistance and inflammation. PCOS may provide a clinical context to explore metabolic–inflammatory contributors to early neurodegenerative changes.

The bidirectional Glenn surgery is an important staging procedure for patients with single ventricle physiology. Approximately 1000 children are born each year in the United States with this subset of CHD. There is limited data regarding optimal post-operative management for these children. We surveyed paediatric cardiac intensive care providers surrounding their management strategies after the bidirectional Glenn surgery.

An anonymous survey was distributed via email to paediatric cardiac intensive care providers. The survey included anonymised demographic data and focused on post-operative physiologic targets for patients recovering after the bidirectional Glenn surgery.

Thirty-five paediatric cardiac intensive care providers responded to an anonymous 12-question survey. Subjects were mostly comprised of paediatric cardiac intensive care attendings (80%), with an average of 7.86 years of training. The respondents primarily practised in settings with medical trainees, and all practised in settings with extracorporeal membrane oxygenation capabilities.

Respondents were asked to complete a web-based survey. Five of the survey questions were devoted to background demographic data, and seven questions were aimed at identifying physiologic targets. Two of the seven questions were in relation to a provided clinical vignette.

This survey demonstrated that there is a lack of consensus in the management of patients after the bidirectional Glenn surgery. Specifically, granular SpO2, mean arterial pressure, and pH Goals were all less than 75% consensus. This survey highlights the variable practice patterns in providers taking care of patients after the bidirectional Glenn surgery, and further demonstrates the need for physiologic and outcome-driven targets to optimise the post-operative care.

Surveillance activities are emerging as exemplar use cases for large language models (LLMs) in health care. The aim of this study was to evaluate the potential for LLMs to support the expansion of surveillance activities to include cardiovascular implantable electronic device (CIED) procedures.

A validated machine learning-based infection flagging tool was applied to a cohort of VA CIED procedures from 7/1/2021 to 9/30/2023; cases with ≥10% probability of CIED infection underwent manual review. Then, a weighted random sample of 50 infected and 50 uninfected cases was reviewed with generative artificial intelligence (GenAI) assistance. GenAI prompts were iteratively refined to extract and classify all components of infection-related variables from clinical notes. Data extracted by GenAI were compared with manual chart reviews to assess infection status and extraction consistency.

Among 12,927 CIED procedures, 334 (2.58%) had ≥10% probability of CIED infection. Among 100 sampled cases, 50 of 50 uninfected cases were correctly categorized. Among 50 infection cases, GenAI identified all CIED infections, but the timing of events and the attribution to a preceding procedure were incorrect in 7 of 50 cases. The overall specificity of the GenAI-assisted process was 100% and the sensitivity for accurately classifying timing and attribution of CIED infection events was 82%. Errors in timing improved with iterative prompt updates. Manual chart reviews averaged 25 minutes per chart; the GenAI-assisted process averaged 5–7 minutes per chart.

LLMs can help streamline the review process for healthcare-associated infection surveillance, but manual adjudication of output is needed to ensure the correct timeline of events and attribution.

Major depression (MDD) is linked to neuro-immune, metabolic, and oxidative stress (NIMETOX) pathways. The gut microbiome may contribute to these pathways via leaky gut and immune-metabolic processes.

To identify gut microbial alterations in MDD and to quantify functional pathways and enzyme gene families and integrate these with the clinical phenome and immune–metabolic biomarkers of MDD.

Shotgun metagenomics with taxonomic profiling was performed in MDD versus controls using MetaPhlAn v4.0.6, and functional profiling was conducted using HUMAnN v3.9, aligning microbial reads to species-specific pangenomes (Bowtie2 v2.5.4) followed by alignment to the UniRef90 v201901 protein database (DIAMOND v2.1.9).

Gut microbiome diversity, both species richness and evenness, is quite similar between MDD and controls. The top enriched taxa in the multivariate discriminant profile of MDD reflect gut dysbiosis associated with leaky gut and NIMETOX mechanisms, i.e., Ruminococcus gnavus, Veillonella rogosaem and Anaerobutyricum hallii. The top four protective taxa enriched in controls indicate an anti-inflammatory ecosystem and microbiome resilience, i.e., Vescimonas coprocola, Coprococcus, Faecalibacterium prausnitzii, and Faecalibacterium parasitized. Pathway analysis indicates loss of barrier protection, antioxidants and short-chain fatty acids, and activation of NIMETOX pathways. The differential abundance of gene families suggests that there are metabolic distinctions between both groups, indicating aberrations in purine, sugar, and protein metabolism. The gene and pathway scores explain a larger part of the variance in suicidal ideation, recurrence of illness, neurocognitive impairments, immune functions, and atherogenicity.

The gut microbiome changes might contribute to activated peripheral NIMETOX pathways in MDD.

To investigate the extent to which the associations of socio-economic position (SEP) with stunting and wasting are mediated by minimum acceptable diet (MAD) and a family care indicator (FCI) in Sri Lanka.

Secondary data analysis of children from the 2016 Sri Lanka Demographic and Health Survey. The outcomes were stunting and wasting, the exposure was a composite measure combining maternal education and household wealth, and the mediators were binary MAD and FCI variables (adequate v. inadequate). Analyses were performed using counterfactual mediation models adjusted for age, sex and place of residence.

A nationally representative sample of children from Sri Lanka.

Mothers/caregivers of children under 36 months (4325).

Twenty per cent of children were stunted, and 14 % were wasted. Lower SEP was associated with higher odds of stunting and wasting and inadequate MAD and FCI. Inadequate FCI was associated with higher odds of stunting (OR = 1·47, 95 % CI = 1·24, 1·74) but not wasting (OR = 1·14, 95 % CI = 0·94, 1·38), whereas MAD was not associated with stunting or wasting. Neither MAD nor FCI significantly mediated the relationship between SEP and stunting and wasting. All mediation estimates were statistically non-significant at the 5 % level. For example, the proportion mediated by FCI on the association between the lowest composite SEP and stunting was 13 % (mean difference = 0·13, 95 % CI = < 0·00, 0·26).

We did not find consistent or strong evidence that the associations of SEP with childhood stunting and wasting in Sri Lanka are mediated by MAD and FCI. Research with larger samples is needed for more precise estimates.