Pink Sheet is part of the Informa 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


Industry May Like FDA's Biosimilar Guidance Withdrawal, But Not The New Information Vacuum

Executive Summary

Sponsors may have to rely even more on the advice they receive from formal meetings as FDA decides to rewrite draft guidance on statistical approaches to evaluate analytical similarity for biosimilars.


Related Content

Biosimilars: US FDA Favors Quality Range Testing For Comparative Analytical Assessments
Clinical Trial Reform Is A Focus For CDER's 2019 Guidance Agenda
Biosimilar Hearing Will Consider Whether 'Umbrella' Exclusivity Policy Warranted
Biosimilar Hearing Will Consider Whether 'Umbrella' Exclusivity Policy Warranted
Suffix Smackdown: Gottlieb Calls Issue 'Red Herring' For Biosimilars
US FDA's Biosimilars Program: Five Years In, Complete Response Letters Still Outnumber Approvals
US FDA Biosimilar Guidance Update Will Relax Interchangeability Standards
Biosimilar Sponsors Seek Statistical Flexibility When Reference Products Change
Biosimilars Statistical Guidance Reflects Early Development Approach
Biosimilars: Postmarketing Data Alone Not Enough For Interchangeability





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