Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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

Executive Summary

Sandoz announces 'complete response' letter for its pegfilgrastim 351(k) filing, suggesting it’s a tough molecule to crack at the agency.

Advertisement

Related Content

Biosimilars' Pediatric Pressures Could Push Them Toward Interchangeability
Biosimilar Advisory Committee Features Actual Debate About Biosimilarity
Sandoz Steers Enbrel Biosimilar Away From Equivalence Quandary With Reanalysis
FDA Met Biosimilar Review Timelines But Missed Meeting Goals In 2015
Biosimilar Template Revisited: Inflectra Approval Binds And Separates From Remicade
Pending Biosimilars
Sandoz Skips Enbrel Biosimilar Patent Dance, Spurs Infringement Suit
Sandoz Files Biosimilar Neulasta In Europe, Praises EMA
Sandoz’ Neulasta Biosimilar Filing Joins Another Pending At FDA
EU Data Helps Sandoz’s U.S. Clinical Program For Filgrastim

Topics

Related Companies

Advertisement
UsernamePublicRestriction

Register

PS118802

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel