Generics BulletinHBW InsightIn VivoMedtech InsightPink SheetScrip

Generics Bulletin

Medtech Insight

Biosimilars Still Flummoxed By Neulasta: Sponsors Now 0 For 2 At FDA

19 Jul 2016

• By Derrick Gingery

SandozNorvatisDiv_1200

Related Content

Sandoz Files Biosimilar Neulasta In Europe, Praises EMA

11 Feb 2016

Biosimilar Advisory Committee Features Actual Debate About Biosimilarity

14 Jul 2016

Biosimilar Sponsors May Be Going Overboard On Clinical Data, FDA Says

13 Jul 2016

Sandoz’ Neulasta Biosimilar Filing Joins Another Pending At FDA

18 Nov 2015

Sandoz Skips Enbrel Biosimilar Patent Dance, Spurs Infringement Suit

01 Mar 2016

FDA Met Biosimilar Review Timelines But Missed Meeting Goals In 2015

25 Apr 2016

Pending Biosimilars

07 Mar 2016

EU Data Helps Sandoz’s U.S. Clinical Program For Filgrastim

12 Jan 2015

Biosimilar Template Revisited: Inflectra Approval Binds And Separates From Remicade

06 Apr 2016

Biosimilars' Pediatric Pressures Could Push Them Toward Interchangeability

15 Jul 2016

Sandoz Steers Enbrel Biosimilar Away From Equivalence Quandary With Reanalysis

11 Jul 2016

Related Companies

Novartis AG

Amgen, Inc.

Novartis AG

Apotex Inc.

Celltrion, Inc.

Johnson & Johnson

AbbVie Inc.

Additional Topics

United States Review Pathway Regulation Drug Review Biosimilars BioPharmaceutical

More from Review Pathways

More from Pathways & Standards

Twitter feed RSS feed RSS feed

About UsOpens in new window
Meet the TeamOpens in new window
RSS FeedOpens in new window

Contact Us
Customer Service
Subscribe
AdvertisingOpens in new window
Feedback

Terms and ConditionsOpens in new window

Privacy PolicyOpens in new window

Copyright © 2025 Pharma Intelligence UK Limited (Citeline), a Norstella company Pharma Intelligence UK Limited is a company registered in England and Wales with company number 13787459 whose registered.