Healio

FDA approves ‘high-concentration, citrate-free’ Yuflyma as ninth Humira biosimilar

Please provide your email address to receive an email when new articles are posted on . The FDA has approved Celltrion USA’s Yuflyma as the ninth biosimilar to adalimumab for all eligible indications ...
Dallas Morning News

Humira, the world’s top-selling drug, faces an upcoming test from low cost alternatives

If you’re one of the millions of Americans taking the prescription medication Humira, get ready to add the word biosimilars to your conversations with your doctor. Starting July 1, alternatives to the ...
Business Wire

REPEAT/Organon & Samsung Bioepis Announce US Launch of HUMIRA Biosimilar HADLIMA™ (adalimumab-bwwd) in Multiple Presentations Consistent with Originator

Autoinjector recognized by the Arthritis Foundation with Ease of Use Certification Individualized patient support program “HADLIMA For You” available including co-pay support Designed to improve ...
Pharm Exec

FDA Accepts sBLA for Interchangeability Designation for Latest Humira Biosimilar

Adalimumab-bwwd (Hadlima; Samsung Bioepis Co., Ltd. and Organon & Co.) is seeking to become the third Humira biosimilar deemed interchangeable with the reference product. The FDA has accepted a ...
Monthly Prescribing Reference

FDA Designates Yuflyma an Interchangeable Biosimilar to Humira

Credit: Celltrion. Yuflyma, a tumor necrosis factor blocker, was approved in May 2023 as a biosimilar to Humira. Similar PK, efficacy, safety, and immunogenicity data were observed between the ...
Business Wire

Organon & Samsung Bioepis Announce US Launch of HUMIRA Biosimilar HADLIMA™ (adalimumab-bwwd) in Multiple Presentations Consistent with Originator

Autoinjector recognized by the Arthritis Foundation with Ease of Use Certification Individualized patient support program “HADLIMA For You” available including co-pay support Designed to improve ...