In Vivo 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

Canadian Decision On Biological Names Leaves US As The Outlier

Executive Summary

Health Canada’s decision to not add a suffix to non-proprietary names for biologics, including biosimilars, has left the US as the only major territory to operate such a convention. The move has been welcomed by the Canadian generics industry.

You may also be interested in...



FTC Warns FDA That Biologic Suffixes Will Curb Competition

The US Food and Drug Administration should abandon its suffix-based naming proposals for biosimilars, according to local competition regulator the Federal Trade Commission, citing a dampening effect on the market and the likelihood of confusion.

IGBA Still Sees A Path To Change FDA’s Mind On Biologic Suffixes

In the second of three exclusive interviews with IGBA secretary general Suzette Kox and chair Jim Keon, Kox provides the latest update on worldwide issues around biosimilars, particularly naming conventions.

Petition Piles Pressure On FDA Over Biosimilar Suffix

A citizen petition filed by biosimilars industry veteran Sarfaraz Niazi has once again urged the FDA to reconsider its approach on biosimilar naming, along with suggesting changes to language used by the regulator to describe biosimilars.

Related Content

Topics

UsernamePublicRestriction

Register

SC027449

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