WebMD

Prolia: A Biannual Injection for Osteoporosis and Bone Loss Management

Prolia is a monoclonal antibody that binds to a specific protein on osteoclasts and decreases their activity. Osteoclasts are responsible for dissolving and breaking down old or damaged bone cells. By ...
Los Angeles Business Journal

FDA to Review Amgen’s Denosumab

Amgen Inc. moved to a key stage for its potential blockbuster drug denosumab on Monday when the Food and Drug Administration announced that a panel would review the drug, which is an experimental ...
Medscape

FDA Alert: 'Substantial' Hypocalcemia Risk with Prolia Use in Dialysis Patients

The US Food and Drug Administration (FDA) issued an alert today that cited preliminary evidence for a "substantial risk" for severe and symptomatic hypocalcemia and serious outcomes related to ...
Healio

FDA investigates risk of hypocalcemia for patients on dialysis using Prolia

Please provide your email address to receive an email when new articles are posted on . The FDA is investigating the risk of severe hypocalcemia in patients on dialysis treated with the osteoporosis ...
Drug Store News

Teva’s Prolia biosimilar candidate accepted for review by FDA, EU EMA

Teva shared that the Food and Drug Administration has accepted, and the European Medicines Agency has validated, applications for TVB-009P, a biosimilar candidate to Amgen’s Prolia (denosumab). Both ...
Nature

Denosumab improves low BMD in postmenopausal women

Denosumab is a fully human monoclonal antibody that targets RANKL (the receptor activator of nuclear factor κB ligand)—a protein that acts as the primary mediator of osteoclast differentiation, ...
Monthly Prescribing Reference

Denosumab Biosimilar for Osteoporosis, Other Conditions Under FDA Review

The BLA is supported by a comprehensive data package that includes data from the phase 1/3 ROSALIA study. The Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) ...
Nasdaq

FDA Accepts RDY & ALVO's Prolia & Xgeva Biosimilar BLA for Review

Dr. Reddy’s Laboratories RDY and partner, Alvotech ALVO, announced the FDA’s acceptance of a regulatory filing, seeking the approval of AVT03, a proposed biosimilar of Amgen’s AMGN Prolia (denosumab) ...
Nasdaq

Amneal’s BLA Submissions for Two Denosumab Biosimilars Accepted for Review by U.S. FDA

BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”), a global biopharmaceutical company, and ...
AOL

Prolia: Is it covered by Medicare?

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 ...
Seeking Alpha

Teva Prolia® (Denosumab) Biosimilar Candidate is Accepted for Review by U.S. FDA and EU EMA

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 ...