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

Samsung Bioepis And Organon Get First High-Concentration Adalimumab Nod In US

Firms Receive First FDA Approval For Higher-Strength 100mg/ml Humira Biosimilar

Executive Summary

Samsung Bioepis and Organon have broken new ground for Humira biosimilars in the US after receiving the first FDA approval for a higher-strength 100mg/ml adalimumab biosimilar.

You may also be interested in...



Sandoz Gets EU Nod For Higher-Strength Adalimumab

Sandoz has received a positive opinion from the EMA’s CHMP recommending that its high-concentration 100mg/ml adalimumab biosimilar be granted a pan-European marketing authorization. Three generics were also endorsed at the CHMP’s January meeting, including a rival to Forxiga.

Samsung Bioepis Set To Join High-Concentration Humira Party In Canada

Samsung Bioepis has confirmed launch plans for its citrate-free, high-concentration Hadlima (adalimumab) biosimilar after it was waved through the Canadian healthcare regulator.

Humira In 2023: The $17bn Biosimilar Opportunity

The advent of US biosimilar competition to Humira in 2023 represents the largest ever loss-of-exclusivity opportunity for the off-patent industry, with the first adalimumab rival expected to hit the US market at the end of this month. But with a host of other biosimilars expected to launch throughout the year, how will competition play out in the long term?

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

GB152096

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