Generics Bulletin 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


Biosimilar Suffixes Appear Superfluous In Adverse Event Reporting

Executive Summary

Nearly all adverse event reports received by US FDA include brand name of biosimilar, raising questions as to whether suffix on nonproprietary name is necessary for pharmacovigilance.

Related Content

Biosimilar Education Needed To Eliminate 'Nocebo' Effect, Pfizer Says
New CDER No. 2 May Impact FDA's Safety Monitoring Aspirations
Novel Biologics Will Get Suffixes (Or At Least One Did)
Biosimilars: US FDA Education Campaign Is Non-Committal On Non-Medical Switching
FDA’s Burden Estimate On Biologic Naming Ignores Downstream Costs, Critics Say
Biosimilar Suffix Detractors Hope Private Studies Build Their Case
Sentinel For Biosimilars? Biologics Post-Market Monitoring Is Focus Of New Consortium
FDA Biosimilar Education Campaign Will Need To Be Targeted


Related Companies

What to read next




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