Scrip 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

Mylan's Next Up For A Shot At Neulasta Biosimilar After Coherus CRL

Executive Summary

FDA issued a complete response letter to Coherus' application for a biosimilar version of Amgen's Neulasta (pegfilgrastim), giving Amgen a reprieve, though Mylan has an application pending at the US agency.

Advertisement

Related Content

Spectrum Gears Up To File Rolontis, Stresses Patient Access
Finance Watch: Six More IPO Filings As Three More Biopharmas Go Public In The US
Finance Watch: Lilly Cuts 3,500 Jobs Globally To Drive Growth
Complex Products At US FDA: Adamis' Epi-Pen Alternative OKed; Sandoz Advair ANDA Accepted
Complex Products At US FDA: Adamis' Epi-Pen Alternative OKed; Sandoz Advair ANDA Accepted
Apotex Moves To Block Coherus' Neulasta Biosimilar; Asks FDA To Require Patient Studies
Biosimilars: Sandoz Pegfilgrastim Review, Amgen Adalimumab Launch Extended To 2018

Topics

Related Companies

Advertisement
UsernamePublicRestriction

Register

SC098919

Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

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