Lupin Announces FDA Acceptance of aBLA for Pegfilgrastim Biosimilar

Goodwin
Contact

Goodwin

Global pharmaceutical company Lupin Limited recently announced that the U.S. FDA has accepted its aBLA for a proposed pegfilgrastim biosimilar (reference product Neulasta®).  Lupin reported that the aBLA submission was supported by similarity data from analytical, pharmacokinetic, pharmacodynamic and immunogenicity studies.  Company CEO Vinita Gupta commented, “FDA’s acceptance of our BLA is a significant achievement and demonstrates our commitment to delivering products which increase access in areas of substantial medical need.  This BLA expands our oncology portfolio, an area of increasing focus for Lupin.  We look forward to the opportunity to bring affordable biologic options to patients and increasing access to this important treatment.”  Lupin is headquartered in Mumbai, India and develops and commercializes a range of branded and generic pharmaceutical products.

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.