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Europe Drug Review Regulation

Rozanolixizumab & Biosimilar Ustekinumab Among Raft Of New Drugs Filed In EU

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Executive Summary

The European Medicines Agency’s latest list of drugs under review for potential marketing approval includes a second generalized myasthenia gravis treatment from UCB and what could become the first biosimilar version of Stelara in the EU.

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New EU Filings

Zolbetuximab, Astellas’ Claudin 18.2-targeting cancer drug, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

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Fruquintinib, Takeda/Hutchmed’s treatment for adult patients with previously treated metastatic colorectal cancer, is among the latest drugs that have been filed for review by the European Medicines Agency for potential EU marketing approval.

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Danicopan, from AstraZeneca, for the treatment of extravascular hemolysis in patients with paroxysmal nocturnal hemoglobinuria, is among the latest drugs that have been filed for review by the European Medicines Agency for potential EU marketing approval.

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