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


No Comparison: FDA Draws Bright Line Between BLA, Biosimilar Pathways In Tbo-filgrastim Review

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Teva’s tbo-filgrastim could have been the first review under FDA’s new biosimilars pathway, but Teva gambled that transplanting its successful European biosimilar G-CSF submission to the U.S. as a regular BLA had better odds. FDA used the review to make clear that it would be rigorous in distinguishing between 351(a) and 351(k) requirements.


Related Content

Review Of Reviews: Drug Review Profiles 2013
Where Are The Biosimilars?
Teva’s G-CSF Product Clears FDA, Leaving Appeal Of Biosimilar Pathway Uncertain
FDA Biosimilars Guidances Address Immunogenicity Studies, European Bridge Data, Analytics


Related Companies




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