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

Biosimilar Interchangeability: NOR-SWITCH-Type Study Not Enough For US FDA

Executive Summary

Norwegian single-transition study would not satisfy agency's requirements for demonstrating interchangeability but could boost patient confidence in general concept of switching between reference product and biosimilar.

Advertisement

Related Content

Biosimilar Interchangeability: How To Design A Multiple-Switch Study
NOR-SWITCH Results ‘Concerning’ In Crohn’s Disease, Says Janssen
Biosimilars: Sandoz Pegfilgrastim Review, Amgen Adalimumab Launch Extended To 2018
Biosimilar Guidance Development Timelines Criticized By Docs And Patients
Biosimilars Switching Debate Escalates After Remicade and Remsima Match In Landmark Study
How Risky Is Pfizer’s Launch Of Its Remicade Biosimilar?
J&J Maintains Strategy For Biosimilar Remicade As Inflectra Nears
Sandoz's Multi-Switch Biosimilar Trials: A View To Interchangeability?
Biosimilar Non-Medical Switching: Advocacy Groups, FDA Advisors Push For Action
Biosimilar Interchangeability Requirements Pushed At Inflectra Review

Topics

Related Companies

Related Deals

Advertisement
UsernamePublicRestriction

Register

PS119433

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

All set! This Question has been sent to 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