Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Sandoz’ Omnitrope Approved

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA notes that approval of the Genotropin follow-on does not establish a pathway for follow-on protein products regulated under the Public Health Service Act.

You may also be interested in...



FDA Cites Immunogenicity Concerns In “Not Approvable” Letter For Momenta/Sandoz’s Lovenox Generic

Firm is “confident” no immunogenicity differences will arise, Momenta CEO Wheeler says.

FDA Cites Immunogenicity Concerns In “Not Approvable” Letter For Momenta/Sandoz’s Lovenox Generic

Firm is “confident” no immunogenicity differences will arise, Momenta CEO Wheeler says.

Sandoz Will Launch Biosimilar Epoetin Alfa In Europe At Up To 30 Percent Discount To Branded Products

EU approval further demonstrates need for U.S. follow-on pathway, Sandoz VP-Global Head of Biopharma Development Ajaz Hussain tells “The Pink Sheet” DAILY.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS064259

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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