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


Further Victory For Celltrion and Teva, As Their Trastuzumab Biosimilar, Herzuma, Receives FDA Approval

Executive Summary

Less than a month after the FDA greenlit their Truxima (rituximab-abbs) biosimilar, partners Celltrion and Teva are toasting approval for their Herzuma (trastuzumab-pkrb) biosimilar, albeit with a limited set of indications; a date for market entry is also unclear at this stage.

You may also be interested in...

Celltrion And Teva Catch Up On Canadian Trastuzumab

Celltrion and Teva have now received a Health Canada approval for their Herzuma trastuzumab biosimilar. However, notices of compliance have already been granted for rival biosimilars from Mylan and Pfizer.

Celltrion Enlists Lonza To Help Make Its Remsima

Lonza will help Celltrion to satisfy increasing global demand for biosimilar infliximab after signing a deal to manufacture the drug substance for Remsima.

FDA Approves Pfizer's Trastuzumab Biosimilar

Pfizer’s approval for trastuzumab in the US marks the fourth FDA nod for a biosimilar rival to Genentech’s Herceptin original. However, while two of those biosimilar sponsors continue to be engaged in patent litigation with the originator, Pfizer and Mylan have both struck settlement deals.

Related Content


Latest News
See All



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