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Big Molecule Watch
April 27, 2021

Biosimilar Cyltezo® shows similar clinical outcomes to Humira® in treatment of moderate-to-severe chronic plaque psoriaris

Boehringer Ingelheim announced earlier this week that results from a phase III study showed that switching several times from Humira® (adalimumab) to Cyltezo® (adalimumab-adbm) produced similar clinical outcomes in the treatment of people with moderate-to-severe chronic plaque psoriasis.

The results support Boehringer Ingelheim’s supplemental biologics application to designate Cyltezo® as an interchangeable biosimilar to Humira®. The action date is scheduled for the 4th quarter of 2021.  Thomas Seck, Senior Vice President of Medicine and Regulatory Affairs, said that the study “further reinforces our goal to broad access to biosimilar treatment options while contributing to the quality and sustainability of healthcare systems.”  Cyltezo’s commercial license as in the United States is scheduled to begin on July 1, 2023.

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