BREAKING NEWS: FDA Expected to Approve Amgen’s Humira Biosimilar Today

Goodwin
Contact

According to a report this morning from Seeking Alpha, FDA is expected to approve Amgen’s application for a biosimilar version of AbbVie’s Humira (adalimumab) today.  If approved, it will be the first biosimilar adalimumab product approved by FDA, and the fourth product to be approved under the BPCIA’s abbreviated approval pathway for biosimilars (first was Sandoz’s Zarxio (filgrastim) biosimilar to Amgen’s Neupogen, second was Celltrion’s Inflectra, a biosimilar to Janssen’s Remicade (infliximab), and third was Sandoz’s Erelzi, a biosimilar to Amgen’s Enbrel (etanercept)).

Amgen’s adalimumab product is currently the subject of pending litigation in AbbVie v. Amgen.

 

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Goodwin | Attorney Advertising

Written by:

Goodwin
Contact
more
less

PUBLISH YOUR CONTENT ON JD SUPRA NOW

  • Increased visibility
  • Actionable analytics
  • Ongoing guidance

Goodwin on:

Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
- hide
- hide