Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Amgen Exec Backs WHO’s ‘Biological Qualifier’, Says First Ones Could Be Issued By End Of 2017

Executive Summary

An Amgen executive says that the WHO should press ahead with its “biological qualifier” proposal, and suggests that the first BQs could be issued towards the end of 2017.

You may also be interested in...



Biological Product Suffix Submissions Limited To 10 Candidates By US FDA

Increasing cap on number suffixs that sponsors can submit from three to 10 will increase review efficiency, agency says, but evaluation will still stop after finding first acceptable suffix as part of final guidance on distinguishable nonproprietary names for novel biological products and biosimilars.

Biological Product Suffix Submissions Limited To 10 Candidates By US FDA

Increasing cap on number suffixs that sponsors can submit from three to 10 will increase review efficiency, agency says, but evaluation will still stop after finding first acceptable suffix as part of final guidance on distinguishable nonproprietary names for novel biological products and biosimilars.

WHO To Pilot ‘Biological Qualifier’ Scheme Despite Protests From Biosimilars Industry

The World Health Organization has decided to pursue its “Biological Qualifier” scheme despite concerns that it may conflict with other traceability systems. Calls by the European biosimilars industry to put the scheme on ice appear to have fallen on deaf ears.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS119524

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