Celltrion Wins Global First Approval For High-Concentration Humira Biosimilar
Yuflyma 100mg/ml Version Of Adalimumab Ready For Launch In Europe
Celltrion has received a pan-European marketing authorization for its Yuflyma high-concentration adalimumab biosimilar, making it the first firm worldwide to register a 100mg/ml rival to the blockbuster Humira brand.
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Alvotech has suffered a setback in its attempt to gain the first US FDA approval for a higher-strength biosimilar adalimumab rival to Humira, after obstacles preventing facility inspections led the agency to defer action on the firm’s AVT02 candidate.
Alvotech and Stada are on the verge of gaining the world’s second ever approval for a higher-strength Humira biosimilar, after the EMA’s CHMP endorsed the firms’ adalimumab under the names Hukyndra and Libmyris at its September meeting.