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: How To Design A Multiple-Switch Study

Executive Summary

US FDA guidance lays out two types of study design recommendations: a dedicated study to demonstrate interchangeability, and an integrated study intended to support determinations of both biosimilarity and interchangeability.

You may also be interested in...



Biosimilar Interchangeability Switching Studies May Use Foreign Comparators, US FDA Says

But scientific bridging required for non-US reference products might be more extensive than in other contexts, agency cautions; easing of the US comparator-only recommendation is one of several changes from the 2017 draft guidance that could make pursuing an interchangeability designation easier.

Humira Biosimilar Interchangeability: The Race Begins

Boehringer Ingelheim announcement is first public disclosure of interchangeability trial since US FDA draft guidance was released.

Humira Biosimilar Interchangeability: The Race Begins

Boehringer Ingelheim announcement is first public disclosure of interchangeability trial since US FDA draft guidance was released.

Related Content

Topics

UsernamePublicRestriction

Register

PS119859

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