Generics Bulletin 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 Pulled Up Over Anti-Biosimilar Pegfilgrastim Promotion

FDA Cautions Originator Over ‘Misleading’ Claims On Neulasta Onpro

Executive Summary

Amgen has been rebuked by the FDA over promotion for its unique Neulasta Onpro on-body injector version of pegfilgrastim, in which the firm made false or misleading claims about its benefit compared to a pre-filled syringe formulation of pegfilgrastim, where biosimilar competition exists.

You may also be interested in...



Pfizer And Amgen Strike A Deal To Settle US Pegfilgrastim Tussle

Pfizer’s Nyvepria biosimilar was the fourth pegfilgrastim biosimilar approved by the FDA, despite ongoing litigation from originator Amgen. The biosimilar sponsor has cleared any niggling legal issues by settling litigation over a US patent directed at methods of protein purification.

Amgen Optimistic Over Inflammation Biosimilars Ahead Of Ustekinumab

Amgen has once again touched on its impending expansion into US inflammation/immunology biosimilars, with launches for adalimumab and ustekinumab scheduled for the coming years.

Waiting For Inspections, Biocon Seeks US FDA Stance On Mutual Recognition Agreement Route

Biocon needs a pre-approval inspection for insulin aspart at its facility in Malaysia, but the surge in COVID-19 cases in the Southeast Asian nation may cloud timelines. The Indian firm is also pursuing a mutual recognition agreement route with the agency for a generic product approval.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

GB151094

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