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


FDA Biosimilars Guidances Address Immunogenicity Studies, European Bridge Data, Analytics

This article was originally published in The Pink Sheet Daily

Executive Summary

The agency’s first three draft guidances on biosimilar product development describe how to characterize biosimilar and reference products and extrapolate data on one condition of use to another. FDA says interchangeability is difficult to determine now and will require a switching study.

You may also be interested in...

Biosimilar Guidances: Broader Populations Permitted; More Immunogenicity Requested

New draft Q&A and three final guidances from FDA offer pros and cons for sponsors of biosimilar applications.

Neupogen Off-Label Use Complicates Data Extrapolation For Sandoz’s Biosimilar

Amgen’s biologic is often used off-label in healthy stem cell donors; advisory committee members distinguished between some Neupogen indications in discussing whether extrapolation was appropriate.

What Will Biosimilar Labeling Look Like? Stakeholders Await FDA Guidance, Approvals

Unknowns include whether labeling will include reference product’s clinical data, and how absence of data for particular indications or populations will be handled; labeling decisions for 351(k) approvals will have important ramifications for advertising and promotion of both the biosimilar and reference product.

Related Content


Related Companies

Latest News
See All



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