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

Pfizer’s EPO Biosimilar Stalls In US On Hospira Compliance Woes

Executive Summary

US FDA hands Pfizer its second complete response letter for its proposed biosimilar to Epogen/Procrit, citing manufacturing compliance concerns at a legacy Hospira manufacturing facility in Kansas that was the target of a February warning letter. Issue “is not directly related to EPO itself,” Pfizer’s Salomon Azoulay says.

Advertisement

Related Content

US FDA's Biosimilars Program: Five Years In, Complete Response Letters Still Outnumber Approvals
US FDA's Biosimilars Program: Five Years In, Complete Response Letters Still Outnumber Approvals
Pfizer’s Retacrit Finally Clears US FDA, But Biosimilar’s Launch Date Is Still Unclear
Pfizer’s Retacrit Finally Clears US FDA, But Biosimilar’s Launch Date Is Still Unclear
Pfizer Excludes EU Biosimilar Experience From US Epoetin Application
Biosimilar Advisory Committees Getting Smoother, Even As Worries Stay The Same
Hospira's Epogen Biosimilar Appears Poised For Quick Advisory Cmte. OK
Pfizer Suffered 'Significant Loss Of Control' At McPherson Plant, US FDA Warning Letter Says
Pfizer Warning Letter Trips Up Sandoz/Momenta’s Expected Glatopa Launch
Biosimilar Denied: Hospira's Retacrit Could Head Back To FDA In First Half 2016

Topics

Related Companies

Advertisement
UsernamePublicRestriction

Register

PS120935

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