FDA clears orphan drug backlog
14-09-2017
Apotex ordered to provide 180 days’ biosimilar notice to Amgen
15-12-2015
xtock / Shutterstock.com
The US Food and Drug Administration (FDA) has denied Amgen’s petition asking that the so-called patent dance between a biosimilar maker and the product’s innovator be a mandatory requirement.
You need a subscription to continue reading this content.
Start a subscription today to access the LSIPR website.
To access the full archive, digital magazines and special reports you will need to take out a paid subscription.
News stories up to a week old and feature articles on the day of publication are accessible with a BASIC FREE ACCOUNT.
Register here for free content, or subscribe for access to archive.
If you have already subscribed please login.
If you have any technical issues please email tech support.
For access to the complete website, archive, and to receive print publications, choose '12 MONTH SUBSCRIPTION'. For a free, two-week trial with full access, select ‘TWO WEEK FREE TRIAL’; and for basic access to the latest news on the website and weekly email news alerts choose the 'BASIC FREE ACCOUNT' registration.
Amgen, Sandoz, FDA, Zarxio, patent dance
