Rituximab biosimilar recommended for European approval
medwireNews: The EMA has adopted a positive opinion recommending approval of a new rituximab biosimilar, rituximab-pvvr, for a number of indications including rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis, and pemphigus vulgaris.
This decision is based on data demonstrating that the biosimilar has similar quality, safety, and efficacy profiles to originator rituximab reference.
The biosimilar will be administered by intravenous infusion and available as 100 mg and 500 mg concentrates. As with the reference product, the EMA recommends that rituximab-pvvr “should be administered under the close supervision of an experienced healthcare professional, and in an environment where full resuscitation facilities are immediately available.”
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