Celltrion Bags FDA Approval For High-Concentration Humira Rival
Yuflyma, Ninth US Adalimumab Biosimilar, Will Be Marketed Directly By Korean Firm
Celltrion has won US FDA approval for its Yuflyma 100mg/ml adalimumab biosimilar, making it the third high-concentration version approved in the US and the ninth Humira rival overall.
You may also be interested in...
Biocon Pumps Up For Adalimumab US Debut Amid Payer ‘Steady State’
Biocon is confident of its “four channel strategy” for the upcoming debut of biosimilar Humira in the US and also asserts it’s well positioned to compete when price cuts come into play for Sanofi’s Lantus next year.
Celltrion Goes It Alone With First Solo US Biosimilar Launch
Celltrion is taking a major step forward in the US with its first direct launch of a biosimilar through its own front-end operation. The Korean firm’s Vegzelma rival to Avastin will be looking to compete with multiple other versions of bevacizumab already in the market.
Alvotech’s Latest FDA Knockback Cuts It Fine For Humira Rival
Alvotech has received a further complete response letter from the US FDA relating to its AVT02 proposed adalimumab biosimilar rival to Humira. The latest BsUFA goal date disclosed for the product is now just a few days ahead of a potential US launch.