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 ...
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 ...
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 ...
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 ...