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July 2026 witnessed strong momentum across the biosimilars landscape with major regulatory approvals, including Ennumo (US FDA), Garzulys (US FDA), Yesintek Autoinjector (Health Canada), and FDA/EMA acceptance of PB016, alongside commercial launches of Byooviz, Osvyrti, and Jubereq, expanding treatment options across oncology, ophthalmology, immunology, osteoporosis, diabetes, and inflammatory diseases.
Strategic collaborations and licensing agreements between Orion Pharma–Shilpa Biologicals, Polpharma–Teva, Samsung Bioepis–Teva, Formycon–OneSource Specialty Pharma, and Organon–Samsung Bioepis strengthened…
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Accord BioPharma has reported the launch of Osvyrti & Jubereq, interchangeable biosimilars to Amgen’s Prolia & Xgeva (denosumab), in the US
Osvyrti (60mg PFS) treats postmenopausal women & men with osteoporosis at high fracture risk, glucocorticoid-induced osteoporosis in both sexes, & increases bone mass in men on androgen deprivation therapy for nonmetastatic prostate cancer…
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Accord Healthcare has launched Osvyrti & Jubereq, biosimilar versions of Amgen’s Prolia & Xgeva (denosumab), following patent expiry of reference products on Nov 27, 2025
Osvyrti (60mg PFS) is indicated to treat osteoporosis in postmenopausal women & men at increased risk of fractures. It is also used to treat bone loss in pts on…
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The US FDA has approved Osvyrti and Jubereq biosimilars to Prolia and Xgeva. Accord is anticipated to commercialize OSVYRTI and JUBEREQ in 2026
The approvals were supported by a P-I study showing JUBEREQ and Xgeva had comparable PK, and a P-III study in postmenopausal women with osteoporosis demonstrating that OSVYRTI and Prolia are highly similar with no clinically meaningful differences in PK, PD, safety, or efficacy
Intas has an exclusive…
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The CHMP has recommended Osvyrti & Jubereq, biosimilar versions of Amgen’s Prolia & Xgeva (denosumab); launch expected post patent expiry of reference products in Nov 2025
Osvyrti (60mg pre-filled syringe) is indicated to treat osteoporosis in postmenopausal women & men at increased risk of fractures. It also used to treat bone loss in pts…

