European Medicines Agency Recommends Marketing Authorization of AVT03, Alvotech’s Proposed Biosimilar to Prolia® and Xgeva®

Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for ...
Targeted Oncology

FDA Clears 2 New Denosumab Biosimilars in Osteoporosis and Cancer-Related Bone Events

Earlier this month, the FDA approved Bildyos and Bilprevda (denosumab-nxxp), 2 additional denosumab biosimilars for Prolia ...
CURE

FDA Approves Bosaya and Aukelso Biosimilars for Solid Tumor Care

The FDA approved Bosaya and Aukelso, biosimilars of Prolia and Xgeva, respectively, for the treatment of solid tumors, like ...
Pharmabiz

Dr Reddy’s receives positive CHMP opinion from EMA for AVT03, a proposed biosimilar of Prolia and Xgeva

Dr Reddy’s receives positive CHMP opinion from EMA for AVT03, a proposed biosimilar of Prolia and Xgeva: Our Bureau, Bengaluru Tuesday, September 23, 2025, 13:30 Hrs [IST] Dr Re ...

Dr Reddy’s biosimilar gets nod from European Medical Agency’s panel

CHMP recommends AVT03 biosimilar for marketing authorization in the EU and UK by the European Commission and MHRA.
Reuters

FDA approves Amgen's Prolia for new use

(Reuters) - Amgen Inc, the world's largest biotechnology company, said U.S. health regulators approved its Prolia injection for a new use as a treatment to increase bone mass in men with osteoporosis ...

Biocon Biologics secures USFDA approval for Bosaya and Aukelso biosimilars to treat osteoporosis and bone loss

USFDA approved affordable biosimilars Bosaya and Aukelso approved by Biocon Biologics Ltd, offering treatment options for ...

Biocon Biologics Receives U.S. Food and Drug Administration Approval for Bosaya™ and Aukelso™, Denosumab Biosimilars

Biocon Biologics Ltd. (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd. (BSE: 532523, NSE: BIOCON), today announced that the U.S. Food and Drug Administration (FDA) ...

Health Canada approves Celltrion’s Stoboclo® and Osenvelt®(CT-P41), denosumab biosimilars for the treatment of all indications approved for the reference products, Prolia ...

Stoboclo and Osenvelt are Celltrion’s sixth biosimilars approved in Canada after receiving the company’s approval of Remdantry™/ Remsima ® SC (infliximab), Yuflyma ® (adalimumab), Vegzelma ® ...
Medical Dialogues

Dr Reddy's Labs receives positive EMA Committee opinion for proposed biosimilar of Prolia, Xgeva

Hyderabad: Dr Reddy's Laboratories Ltd., has announced that the European Medicines Agency's (EMA) Committee for Medicinal ...