Generics Bulletin 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

Alvotech Adalimumab Biosimilar Switching Study Hits Key Date

Icelandic Firm Chasing First High-Concentration Adalimumab Biosimilar

Executive Summary

Alvotech underlined that it could “save US consumers and taxpayers billions annually,” after hitting a key landmark in its Phase III switching study for its high concentration 100mg/ml biosimilar Humira product.

You may also be interested in...



Alvotech Champions Switching Data As Clock Ticks On Adalimumab Filing

Before the month is out, Alvotech hopes to hear back from the US FDA for its AVT02 high-concentration 100mg/ml biosimilar adalimumab candidate. The Icelandic firm, which remains embroiled in litigation with originator AbbVie, has reported top-line results from its key switching study. 

What’s Next? Five Things To Look Out For In September

In the month ahead, Alvogen’s biosimilars sister company Alvotech is anticipated to receive a USFDA decision on its biosimilar Humira candidate, while Hikma’s management will meet investors to discuss prospects for its Generics business.

Interchangeable Biosimilars: Insulin Likely First But Humira May Be More Important Precedent

US FDA’s first decision on biosimilars interchangeability might have less meaning for two insulin products, but payer and prescriber responses to interchangeable biosimilars for adalimumab, which are further out on the horizon, may be more instructive regarding the importance of interchangeability status.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

GB151008

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