This week’s endocrinology news delivers the latest updates, developments, and progress from leading biopharma companies.
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🦴 EC clears AVT03, denosumab biosimilar to Prolia/Xgeva [1] [EU • 24 Nov 2025]
https://www.globenewswire.com/news-release/2025/11/24/3193283/0/en/Alvotech-Announces-Approval-of-AVT03-a-Biosimilar-to-Prolia-and-Xgeva-denosumab-in-the-European-Economic-Area.html
Context: Commercialized with STADA (Kefdensis/Zvogra) and Dr. Reddy’s (Acvybra/Xbonzy); totality-of-evidence included PK/PD and comparative efficacy studies (n not stated here).
Key point: European Commission approved AVT03 as a biosimilar to Prolia 60 mg and Xgeva 70 mg across reference indications.
Implication: Introduces competition that may affect pricing and formulary access.
🧠 AI-led DPP matches human coaching in prediabetes RCT [2] [US • 28 Nov 2025]
https://www.medscape.com/viewarticle/ai-directed-diabetes-prevention-program-effective-human-2025a1000xam
Context: JAMA trial; mobile app plus Bluetooth scale, asynchronous engagement; higher initiation and completion in AI arm.
Key point: In 368 adults with prediabetes and overweight/obesity, AI-led DPP achieved the 12-month composite outcome at 31.7% vs 31.9% for human-led, meeting noninferiority.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
❤️ Diabetes tied to higher early stent complications after PCI [3] [Sweden – 28 Nov 2025]
https://healthcare-in-europe.com/en/news/diabetes-complications-stent-surgery.html
Context: 2010–2020 registry; first-month incidence 9.27 vs 4.34 per 100 person-years (type 1 vs no diabetes); published in Diabetes Care.
Key point: Among >160,000 recipients of drug-eluting stents, type 1 diabetes had >2× risk of stent complications vs no diabetes; type 2 also elevated.
Implication: May influence prescriber choice and payer reviews pending full data.
🤰 Maternal thyroid dysfunction linked to higher ASD risk [4] [Israel • 25 Nov 2025]
https://www.healio.com/news/endocrinology/20251125/thyroid-dysfunction-during-pregnancy-linked-to-higher-autism-risk-for-offspring
Context: Retrospective cohort of 51,296 births; aHRs reported for hypothyroidism combinations; confounders like iodine status not assessed.
Key point: Chronic plus gestational thyroid dysfunction associated with increased offspring ASD diagnoses; risk rose with each additional trimester of dysfunction.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
🧪 Biomarker watch: isthmin-1 signals renal decline in T2D [5] [28 Nov 2025]
https://bioengineer.org/ishtmin-1-levels-indicate-renal-decline-in-diabetes/
Context: Reported in BMC Endocrine Disorders; details on n and effect sizes not stated; authors call for validation in larger, diverse cohorts.
Key point: Elevated serum isthmin-1 associated with progression of renal function decline in type 2 diabetes.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
🧬 Thyroid cancer: targeting syndecan-2 curbs invasiveness [6] [29 Nov 2025]
https://bioengineer.org/targeting-syndecan-2-reduces-thyroid-cancer-invasiveness/
Context: BMC Endocrine Disorders report; in vitro and in vivo evidence; translational relevance to be tested clinically.
Key point: In PTC models, syndecan-2 inhibition reduced cell invasion and de-differentiation, with smaller tumors and fewer metastases in mice.
Implication: Signals pipeline investment and modality expansion.
📱 Meta-review: AI-enhanced wearables in T2D/prediabetes [7] [US – 20 Nov 2025]
https://medicine.buffalo.edu/news_and_events/news/2025/11/fraser-wearable-devices-prediabetes-24345.html
Context: 60 studies synthesized from ~5,000 screened; heterogeneity in devices, models, benchmarks; issues with data integration and workflow.
Key point: NPJ Digital Medicine meta-review finds AI-enabled wearables can predict glucose trends 1–2 hours ahead, but transparency and validation gaps remain.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
🦴 Samsung Bioepis to roll out OBODENCE/XBRYK in EU [8] [EU • 01 Dec 2025]
https://www.businesswire.com/news/home/20251130748101/en/Samsung-Bioepis-Announces-Launch-of-Denosumab-Biosimilars-OBODENCE-and-XBRYK-in-Europe
Context: Company’s 10th and 11th EU biosimilars; direct sales expansion into endocrinology and oncology.
Key point: OBODENCE 60 mg and XBRYK 120 mg denosumab biosimilars will be available in Europe starting Dec 2025–Jan 2026 across approved indications.
Implication: Introduces competition that may affect pricing and formulary access.
🦴 Sandoz launches Wyost/Jubbonti denosumab in Europe [9] [EU • 01 Dec 2025]
https://www.webdisclosure.com/press-release/sandoz-group-ag-etr-sandoz-launches-denosumab-biosimilars-in-europe-providing-affordable-treatment-option-for-cancer-related-bone-disease-and-osteoporosis-for-millions-of-patients-hK5hylw1Ysr
Context: Part of broader 2025 biosimilar rollout; targets oncology supportive care and osteoporosis markets in Europe.
Key point: European launch of Wyost 120 mg and Jubbonti 60 mg as among the first denosumab biosimilars across all reference indications.
Implication: Introduces competition that may affect pricing and formulary access.
Why it matters
- Denosumab biosimilar wave in Europe could lower costs and widen access in osteoporosis and oncology supportive care.
- AI modalities in diabetes prevention and monitoring show parity with human-led approaches, with scalability potential.
- Cardiovascular outcomes in diabetes remain fragile post-PCI, especially early, underscoring risk-tailored follow-up.
- Maternal thyroid hormone management may have neurodevelopmental implications for offspring.
- Emerging biomarkers and targets, like isthmin-1 and syndecan-2, may refine risk stratification and therapy design.
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FAQ
What is AVT03 and who will market it in Europe?
AVT03 is Alvotech’s denosumab biosimilar to Prolia/Xgeva. STADA will market as Kefdensis/Zvogra, and Dr. Reddy’s as Acvybra/Xbonzy in the EEA, Switzerland, and UK [2].
When will Samsung Bioepis’ OBODENCE and XBRYK be available?
Per the company, OBODENCE 60 mg starts in Dec 2025 and XBRYK 120 mg in Jan 2026, across Europe, covering Prolia/Xgeva indications [8].
Are Sandoz’s Wyost and Jubbonti launched across all reference indications?
Yes. Wyost 120 mg and Jubbonti 60 mg launched in Europe with approvals mirroring Xgeva and Prolia indications, respectively [9].
Did AI actually match human-led DPP outcomes?
Yes. In a JAMA RCT, the AI-led program was noninferior to human-led for a composite of A1c and weight/physical activity targets at 12 months, with similar achievement rates and higher engagement in AI arm [5].
How strong is the link between maternal thyroid dysfunction and ASD?
In a 51,296-mother cohort, combined chronic and gestational thyroid dysfunction was associated with higher ASD diagnoses in offspring, with risk increasing by trimester exposure. Retrospective design and unmeasured confounders limit inference [3].
Which diabetes patients face the highest early stent risk?
Those with type 1 diabetes had more than double the risk of stent complications versus non-diabetes, with highest incidence in the first month post-implantation [4].
Entities / Keywords
Denosumab biosimilars; AVT03 (Alvotech); Prolia/Xgeva (Amgen); Kefdensis/Zvogra (STADA); Acvybra/Xbonzy (Dr. Reddy’s); Wyost/Jubbonti (Sandoz); OBODENCE/XBRYK (Samsung Bioepis); Diabetes Prevention Program; AI-enabled wearables; continuous glucose monitor; isthmin-1 biomarker; papillary thyroid cancer; syndecan-2; stent thrombosis/restensosis; gestational hypothyroidism; autism spectrum disorder.
References
- https://www.globenewswire.com/news-release/2025/11/24/3193283/0/en/Alvotech-Announces-Approval-of-AVT03-a-Biosimilar-to-Prolia-and-Xgeva-denosumab-in-the-European-Economic-Area.html
- https://www.medscape.com/viewarticle/ai-directed-diabetes-prevention-program-effective-human-2025a1000xam
- https://healthcare-in-europe.com/en/news/diabetes-complications-stent-surgery.html
- https://www.healio.com/news/endocrinology/20251125/thyroid-dysfunction-during-pregnancy-linked-to-higher-autism-risk-for-offspring
- https://bioengineer.org/ishtmin-1-levels-indicate-renal-decline-in-diabetes/
- https://bioengineer.org/targeting-syndecan-2-reduces-thyroid-cancer-invasiveness/
- https://medicine.buffalo.edu/news_and_events/news/2025/11/fraser-wearable-devices-prediabetes-24345.html
- https://www.businesswire.com/news/home/20251130748101/en/Samsung-Bioepis-Announces-Launch-of-Denosumab-Biosimilars-OBODENCE-and-XBRYK-in-Europe
- https://www.webdisclosure.com/press-release/sandoz-group-ag-etr-sandoz-launches-denosumab-biosimilars-in-europe-providing-affordable-treatment-option-for-cancer-related-bone-disease-and-osteoporosis-for-millions-of-patients-hK5hylw1Ysr