Pink Sheet is part 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

Biosimilar Interchangeability: Stakeholders Want More FDA Guidance, Fewer Hurdles

Executive Summary

The limited discussion of interchangeability in FDA’s initial biosimilar draft guidances has left some stakeholders clamoring for more details. Others say the agency’s demand for a “higher standard” of evidence to show interchangeability is misplaced and will inhibit use of the 351(k) pathway.

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.

FDA Wants Biosimilar Naming Guidance Released Before Approving An Application

The agency’s policy, planning and legislation chief says FDA hopes a draft guidance is released before the first application is reviewed.

Biosimilars: Does Low BsUFA Fee Revenue Suggest Sponsor Interest Has Stalled?

Halfway through the first year of the biosimilar user fee program, fee payments have not lived up to the expectation in President Obama’s FY 2013 budget request. Initial meetings continue to grow but at a slow pace, suggesting sponsors may remain hesitant about the pathway.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS054399

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