プレスリリース発表元企業：Organon & Co. Prolia ® とXgeva ® （デノスマブ）との第3相比較臨床試験でバイオシミラー候補HLX1 4が主要評価項目を達成 （SHANGHAI, China & JERSEY CITY, N.J.）- （ビジネスワイヤ） -- シャンハイ・ヘンリウス・バイオテック（2696.HK）と ...

--Amgen today announced new data from a real-world study of nearly half of a million postmenopausal women with osteoporosis in the U.S. medicare program showing Prolia ® injection reduced fracture ...

Both applications, a Biologics License Application (BLA) in the U.S., seeking interchangeability, and a Marketing Authorization Application (MAA) in the European Union (EU), include all indications ...

SHANGHAI, China & JERSEY CITY, N.J.--(BUSINESS WIRE)--Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) announced that the phase 3 comparative clinical trial for the investigational ...

Amgen has announced the submission of a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for Prolia (denosumab) for the treatment of patients with ...

Original Medicare (Part A and Part B), Part D, and Medicare Advantage typically offer coverage for the osteoporosis drug Prolia. However, individuals must meet certain requirements for Part B coverage ...

SHANGHAI, China & JERSEY CITY, N.J.--(BUSINESS WIRE)-- Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) announced that the phase 3 comparative clinical trial for the investigational ...

Generic drugmaker Sandoz (OTCQX:SDZNY) announced Tuesday that the FDA had approved two of its biosimilar products targeting Amgen’s (AMGN) blockbuster bone therapies, Prolia and Xgeva, collectively ...

REYKJAVIK, ICELAND (November 25, 2025) — Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today ...

Shanghai Henlius Biotech and Organon have received permission from the Food and Drug Administration for Bildyos (denosumab-nxxp) injection 60 mg/ml and Bilprevda (denosumab-nxxp) injection 120 mg/1.7 ...