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

FDA's Biosimilar Strategy Will Rely On "Fingerprint" Technology To Limit Trials

This article was originally published in The Pink Sheet Daily

Executive Summary

European experiences with "totality of the evidence" method also seem to be shaping policy, according to FDA article in NEJM.
Advertisement

Related Content

Sandoz Steers Enbrel Biosimilar Away From Equivalence Quandary With Reanalysis
Sandoz Steers Enbrel Biosimilar Away From Equivalence Quandary With Reanalysis
FDA Biosimilars Guidances Address Immunogenicity Studies, European Bridge Data, Analytics
FDA, EMA Seek Biosimilar Pathway Convergence
Practice Makes Good: FDA, EMA Focus On CROs As GCP Info Sharing Improves
How Should FDA Collect The Biosimilar Product Development Fee?
FDA “Busy” With Biosimilars; Sponsors Already In Pre-IND Meetings
FDA Searches For Clinical Trial Middle Ground At Biosimilar Hearing
FDA Searches For Clinical Trial Middle Ground At Biosimilar Hearing
FDA Signals Interest In Requiring Unique Biosimilar Names

Topics

Advertisement
UsernamePublicRestriction

Register

PS072725

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