EMA Re-Examines Decisions On Prestige’s Trastuzumab And Synchron Studies
CHMP Rejection Of Herceptin Biosimilar And Suspension Of Generics To Be Reviewed
Executive Summary
Following decisions by the EMA’s CHMP to deny Prestige Biopharma a marketing authorization for its trastuzumab biosimilar and to suspend the marketing authorizations of dozens of generics due to concerns over bioequivalence tests, the European regulator has confirmed it will review the opinions.
You may also be interested in...
Prestige And Intas Strike International Bevacizumab Deal
Prestige Biopharma and Intas Pharmaceuticals have announced a commercialization deal for Prestige’s HD204 proposed bevacizumab biosimilar, covering a range of territories including markets in the Americas, Europe, Africa and Asia.
Prestige Management Doubles Down On Share Purchase After Setbacks
Still reeling from the EMA’s recent rejection of its biosimilar trastuzumab candidate, Prestige BioPharma’s management have bought up more shares in the company, insisting that the “recent fall in stock price doesn’t reflect the potential value” of the firm.
Prestige Management Fights Back Following Biosimilar Rejection
Prestige BioPharma’s top brass are looking to restore shareholder confidence following the surprise failure of their trastuzumab biosimilar before the EMA’s CHMP.