Amgen and Allergan submit biologics license application for ABP 798, biosimilar candidate to Rituxan (rituximab), to U.S. FDA

FDA

19 December 2019 - Filing for ABP 798 supported by two comparative clinical studies.

Amgen and Allergan today announced the submission of a biologics license application to the U.S. FDA for ABP 798, a biosimilar candidate to Rituxan (rituximab). 

Amgen and Allergan are collaborating on four oncology biosimilar medicines, two of which have already been approved by the FDA.

Read Amgen press release

Michael Wonder

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Michael Wonder

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Medicine , US , Biosimilar , Dossier