FDA Accepts Fresenius Kabi Pegfilgrastim Biosimilar Candidate for Review

Goodwin
Contact

Goodwin

Fresenius Kabi announced on May 27, 2020 that the FDA “accepted for review the company’s Biologics License Application (BLA) for MSB11455,” a biosimilar candidate of NEULASTA (pegfilgrastim).  According to the press release, this is Fresenius Kabi’s first biosimilar candidate submitted to the FDA.

Fresenius Kabi also received acceptance for review of its submission for Marketing Authorization Application for the same biosimilar candidate from the EMA earlier this month.

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

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

This website uses cookies to improve user experience, track anonymous site usage, store authorization tokens and permit sharing on social media networks. By continuing to browse this website you accept the use of cookies. Click here to read more about how we use cookies.