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

Could US FDA User Fee Bill Include The Long-Sought 505(b)(2) Pathway For Biosimilars?

Executive Summary

Former FDA official says the pathway is needed to avoid wasted sponsor time and effort.

You may also be interested in...



FDA Official Foresees Reduced Biosimilar Data Burden

New guidance from UK's MHRA saying comparative clinical efficacy studies typically will not be needed is a start, but other regulators may need a few years before adopting similar rules.

Biosimilars: Deep Product Understanding Will Move Regulators To Reduce Clinical Data Requirements, US FDA Official Says

New guidance from UK's MHRA saying comparative clinical efficacy studies typically will not be needed is a start, but other regulators may need a few years before adopting similar rules.

AAM’s Leonard On Strategizing For Gene Therapies

As ‘hyper personalized’ medicines take hold, generic players need to examine the role they can play in democratizing access to gene therapies alongside complex generics and biosimilars, says AAM president and CEO Dan Leonard.

Related Content

Topics

UsernamePublicRestriction

Register

PS144356

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

Cancel