Endocrinology Video Recap—December 2, 2025

This biweekly endocrinology video recap highlights major shifts in bone and endocrine therapeutics, including accelerating biosimilar competition, early regenerative platforms, and new evidence shaping treatment pathways.

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Week 18–24 November 2025
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Transcript

Welcome to the latest edition of Endocrinology Updates, covering the latest breakthroughs. Brought to you by LucidQuest, this update highlights:

The EMA’s CHMP issued positive opinions for two biosimilars, Ondibta insulin glargine and Osqay denosumab, moving both to European Commission review. Ondibta matched Lantus in phase 3 and clamp studies per committee summary. Osqay met EMA biosimilarity criteria for Prolia across fracture-risk indications, with specific endpoints not detailed. The likely effect is added competition that could influence pricing and formulary access.

Skeletalis raised 8 million dollars in seed funding led by Pillar VC to advance SKE-001 and the Oasis bone-surface delivery platform for post-menopausal osteoporosis. The company positions its approach around FDA’s Sabre recognition of bone mineral density as an approval endpoint, although trial specifics were not stated. The round signals investor confidence in bone-targeted, localized therapeutics.

A prospective multicenter Dexa analysis from Belgium and Italy reported that 186 women on romosozumab experienced significant 12-month BMD gains at the lumbar spine and hip, independent of age. Fracture outcomes and safety were not assessed in this analysis. The finding may influence prescriber choice and payer reviews, pending fuller outcomes data.

Pluristyx and Breakthrough T1D announced a project of up to 1.4 million dollars to engineer an immune-cloaked, safety-switch-enabled iPSC starting line for off-the-shelf islet replacement. The program integrates iACT immune cloaking and the FailSafe drug-inducible safety switch into the FDA DMF-registered PSXi013 line. Clinical timelines were not stated, but the platform aims to reduce reliance on chronic immunosuppression.

The European Commission approved AVT03 as a biosimilar to Prolia 60 mg and Xgeva 70 mg across reference indications. Commercialization will occur with Stada and Dr. Reddy’s under multiple brand names, supported by a totality of evidence including PK and PD plus comparative efficacy in osteoporosis. This approval introduces another competitor that could affect EU pricing and access.

Preclinical work reported that targeting syndecan-2 in papillary thyroid cancer models curtailed invasion and de-differentiation, yielding smaller tumors and fewer metastases in mice. The study, published in BMC Endocrine Disorders, is early stage. Translational and clinical studies are pending.

Samsung Bioepis announced EU rollout plans for denosumab biosimilars Obodence 60 mg and XBRYK 120 mg. Indications align with Prolia and Xgeva labeling. Market entry is expected to increase competition and potentially broaden access.

Sandoz launched Jubbonti 60 mg and Wyost 120 mg across EU indications as among the first denosumab biosimilars. The launch is part of Sandoz’s broader biosimilar expansion in oncology and immunology. As with other entrants, this may influence pricing and formulary decisions.
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🗓️ Explore weekly details and sources

Week 18–24 November 2025
Week 25 November–1 December 2025

📚 See the full Endocrinology archive on our research hub page.

Why it matters

Denosumab biosimilars from multiple sponsors could shift EU pricing and broaden access for osteoporosis and oncology supportive care.
FDA’s SABRE framework and real-world BMD data may accelerate development and uptake of anabolic and targeted bone therapies.
Immune-evasive iPSC starting materials aim to remove chronic immunosuppression as a barrier for islet replacement in T1D.

FAQ

What did CHMP recommend for diabetes and bone health?

CHMP issued positive opinions for Ondibta (insulin glargine biosimilar) and Osqay (denosumab biosimilar), moving them to EC review for EU authorization [1].

Which denosumab biosimilars are now approved or launching in Europe?

AVT03 received EC approval with commercialization by STADA and Dr. Reddy’s [5]. Samsung Bioepis plans EU availability of OBODENCE/XBRYK from Dec 2025–Jan 2026 [7]. Sandoz launched Jubbonti/Wyost across EU indications [8].

Does age limit response to romosozumab?

A prospective multicenter DEXA study reported significant BMD gains after 12 months that did not vary by age among older women. Safety and fracture outcomes were not evaluated in that analysis [3].

What is Skeletalis developing with its new funding?

Bone-targeted, localized therapeutics for post-menopausal osteoporosis using the Oasis platform, funded by an $8M round led by Pillar VC [2].

How might the Pluristyx–Breakthrough T1D project impact T1D therapies?

By providing an immune-cloaked, safety-switch-enabled iPSC starting line intended for allogeneic islet replacement, potentially reducing reliance on chronic immunosuppression (clinical timelines not stated) [4].

Entities / Keywords

Denosumab biosimilars; Osqay (Theramex); AVT03 (Alvotech); Jubbonti/Wyost (Sandoz); OBODENCE/XBRYK (Samsung Bioepis); Ondibta (insulin glargine, Gan & Lee); Prolia/Xgeva (Amgen); romosozumab (Evenity); Skeletalis; SKE-001; Oasis platform; SABRE; Pluristyx; Breakthrough T1D; iPSC; iACT; FailSafe.