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UCB announced that it has gained EU marketing approval for Bimzelx® (bimekizumab), an IL-17A and IL-17F inhibitor indicated for the treatment of adults with moderate to severe plaque psoriasis.

The UK’s MHRA granted conditional marketing authorisation for REGEN-COV®/Ronapreve® (casirivimab and imdevimab antibody cocktail) to prevent and treat acute COVID-19 infection.

Australia’s TGA granted approval for AbbVie’s Skyrizi® (risankizumab) in a higher, 150mg/mL  concentration formulation. Skyrizi® is indicated for plaque psoriasis in adults.

Novartis announced that China’s NMPA has expanded its approval of Cosentyx® (secukinumab) to include the treatment of plaque psoriasis in paediatric patients.

Novartis announced the results of its Ph III trials of Beovu® (brolucizumab) versus aflibercept in patients with diabetic macular edema, reporting that Beovu® demonstrated superiority versus aflibercept in key endpoints.

The FDA announced the Biosimilar User Fee Act rates for the 2022 fiscal year. The new rates will apply from 01 October 2021.