Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Posted 10 November 2017 | By Michael Mezher
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.
The six medicines the agency is recommending are:
CHMP also recommended Amgen's Mvasi (bevacizumab) biosimilar for Roche's Avastin (bevacizumab). Amgen had originally submitted two marketing authorization applications for Avastin biosimilars, but in October the company withdrew its application for the other biosimilar "for marketing reasons."
Additionally, CHMP recommended two generics for Janssen's HIV drug Prezista (darunavir) both made by Slovenia-based Krka, and Mylan's generic of AstraZeneca's breast cancer drug Faslodex (fulvestrant).
CHMP also said that it is maintaining its negative opinion for two drugs, Fanaptum (iloperidone) and Onzeald (etirinotecan pegol), following requests from the drugs' sponsors to re-examine the committee's earlier decision.
Tags: Marketing Authorization Applications, CHMP, Accelerated Assessment, Orphan Designation, Biosimilar, Jorveza, Prevymis, Ocrevus, Adynovi, Fasenra, Intrarosa, Mvasi
Regulatory Focus newsletters
All the biggest regulatory news and happenings.