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Q&A with Dr Chelsee Jensen: FDA Policy Shifts, Biosimilar Development Hurdles, and Market Access in 2026
03 Feb 2026 03:23 GMT
… senior pharmacy specialist and pharmaceutical formulary manager at … those in human trials and therefore reduce … , because denosumab is predominantly a medical benefit drug, though … manufacturer for both Prolia and Xgeva (denosumab; Amgen) biosimilars. However, …
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Shanghai Henlius Biotech Announces FDA Acceptance of aBLA for Proposed Avastin® Biosimilar HLX04
02 Feb 2026 21:46 GMT
… 2026, Shanghai Henlius Biotech announced the FDA acceptance of an … Amgen / Allergan’s Mvasi® (bevacizumab-awwb), FDA-approved … Prolia® / Xgeva® (denosumab) biosimilars Bildyos® / Bilprevda® (denosumab-nxxp) (previously reported FDA Approves Prolia …
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Real-World Comparability of Antiresorptive Osteoporosis Treatment Groups Among Treatment-Naïve and Treatment-Experienced Women Ages 55 and Older in the United States
02 Feb 2026 13:58 GMT
… treatment-experienced women (eg, RD for influenza vaccine for denosumab … Clinical Trials. Springer; … fda.gov/drugs/;news-events-human-drugs/fda-approves-first-interchangeable-biosimilars-prolia … in treatment among users of osteoporosis medications: …
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Silver Economy Boom: Investing in Healthcare's Aging Tailwinds
03 Feb 2026 22:03 GMT
… investment opportunities across pharmaceuticals, medical devices, home care … as demand for critical treatments, pharmaceuticals and procedures stays stable … In bone health, Prolia and EVENITY remain cornerstone … through 2024–2025.
Amgen continues to emphasize …
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Trial Data Support Equivalence of Denosumab Biosimilar in Postmenopausal Osteoporosis
16 Jan 2026 14:31 GMT
… to Prolia and Xgeva (reference denosumab) are increasingly shaping treatment access … by both the FDA and the European Medicines Agency.
The … to enrollment.
The trial included 2 co-primary … common limitation in osteoporosis trials of relatively short duration. …
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Denosumab Biosimilar Updates: Boncresa™ / Oziltus™ Approval, AVT03 Complete Response Letter
09 Jan 2026 22:22 GMT
… the nineth biosimilars of Amgen’s Prolia® / Xgeva® (denosumab).
On December 31 … which was accepted by the FDA in March 2025. The CRL … the FDA in October 2024.
Amgen reported FY24 U.S. sales for Prolia …
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FDA Approves Amneal Denosumab Biosimilars, Capping Year of Market Expansion
06 Jan 2026 14:32 GMT
… receiving treatment frequently experienced … repetitive clinical trials. This … medicine in the US.
References
1. Amneal announces FDA approval of denosumab … biosimilars referencing Prolia and Xgeva. News release. Amneal Pharmaceuticals …
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Amgen acquires cancer drugmaker Dark Blue Therapeutics for up to $840 mn
07 Jan 2026 14:05 GMT
… biotech Amgen has announced the acquisition of UK-based cancer drugmaker … 47;3-targeting medicines to clinical … to overcome treatment resistance and … Prolia, Xgeva, (denosumab) Repatha (evolocumab) and Evenity (romosozumab), the California-based biotech …
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<![CDATA[FDA Approves Denosumab-Mobz as Biosimilar for Prolia, Xgeva]]>
05 Jan 2026 19:12 GMT
… our Affordable Medicines segment.”
Denosumab is in a class of medication called … morbidity, and for the treatment of hypercalcemia of malignancy refractory … Gallagher A. FDA approves denosumab-desu as biosimilar to Prolia, Xgeva. Drug Topics. November 20 …
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Icelandic BioTech Alvotech secures €100 million term loan facility to bolster liquidity and R&D investment
02 Jan 2026 07:45 GMT
… BioTech company specialising in the development and manufacture of biosimilar medicines … an existing approved biologic medicine, or reference product. Biosimilars … ), Eylea® (aflibercept) and Prolia®/Xgeva® (denosumab).
Its current development pipeline …