EMA accepts for review Mylan’s MAA for a proposed biosimilar trastuzumab

Share on facebook
Share on twitter
Share on linkedin
Share on email
Share on print

MYLAN N.V. and Biocon LTD said the European Medicines Agency accepted for review Mylan’s Marketing Authorization Application for a proposed biosimilar trastuzumab, which is used to treat certain HER2-positive breast and gastric cancers. This filing includes analytical, functional and pre-clinical data, as well as results from the pharmacokinetics and confirmatory efficacy/safety global clinical trials for...

To access this subscriber-only content please log in or subscribe.

If your institution has a site license, log in with IP-login or register for a sponsored account.*
*Not all site licenses are enrolled in sponsored accounts.

Login Subscribe
Table of Contents

YOU MAY BE INTERESTED IN

As NCI paylines drop to 4%, cancer centers are tapping into their institutional funds to provide “bridge funding,” typically in $50,000 to $100,000 increments, to enable investigators to keep their labs open until better times return—next year God willing.

Never miss an issue!

Get alerts for our award-winning coverage in your inbox.

Login