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Boehringer Ingelheim has announced that Cyltezo, its biosimilar of Abbvie’s Humira, has received marketing authorisation approval from the European Commission, confirming that is comparable in safety and efficacy to its originator product.
The decision was made based on results from the Phase 3 VOLTAIRE study which confirmed Cyltezo’s clinical equivalence to Humira in patients with moderate to severely active rheumatoid arthritis.
In adults, the drug was approved for a range of multiple chronic inflammatory diseases, including:
Original Article: Boehringer celebrates EU approval of Humira biosimilarNEXT ARTICLE
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