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

Sandoz EMA Trastuzumab Application Follows US Filing

European Filing For Herceptin Biosimilar Comes Shortly After FDA Submission

Executive Summary

Sandoz and EirGenix have followed their US filing for a biosimilar rival to Herceptin with a European filing for the EG12014 trastuzumab candidate.

You may also be interested in...



Sandoz Looks To Join EU Trastuzumab Party With CHMP Thumbs Up

Sandoz looks to be in line for an EU-wide approval for its trastuzumab biosimilar during 2023, with the backing of the EMA’s Committee for Medicinal Products for Human Use.

Deficient Aseptic Filling And Freeze Drying Hamstring Sandoz’s US Herceptin

Sandoz spoke to Generics Bulletin in the wake of confirming a recent complete response letter for its partnered biosimilar Herceptin candidate in the US.

Sandoz Lays Out Plan For Rebound With Top Line Stagnant In 2021

Novartis admits that its Sandoz division is not expected to enjoy turnover growth in 2022, due to a lack of material launches, but is planning for a rise in 2023 and beyond.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

GB151518

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