EMA Backs Six Drugs, One Biosimilar for EU Approval
By Michael Mezher -
Published 10 November 2017
The European Medicines Agency (EMA) on Friday said that its Committee for Medicinal Products for Human Use (CHMP) is recommending six new drugs, a biosimilar and three generic medicines for EU approval.
Categories: News, Europe, EMA, Biologics and biotechnology, Drugs, Submission and registration
Tags: Marketing Authorization Applications, CHMP, Accelerated Assessment, Orphan Designation, Biosimilar, Jorveza, Prevymis, Ocrevus, Adynovi, Fasenra, Intrarosa, Mvasi
FDA Approves First Biosimilar Cancer Treatment
By Zachary Brennan -
Published 14 September 2017
The US Food and Drug Administration (FDA) on Thursday approved Amgen’s biosimilar to Roche’s cancer treatment Avastin (bevacizumab). Amgen's biosimilar was approved under the brand name Mvasi (bevacizumab-awwb).
Categories: News, US, FDA, Biologics and biotechnology, Drugs, Submission and registration
Tags: Amgen, Mvasi, Avastin biosimilar