July 23, 2019 / 7:58 PM / a month ago

BRIEF-FDA Approves Ruxience (Rituximab-Pvvr), Biosimilar To Rituxan (Rituximab)

July 23 (Reuters) - U.S Food and Drug Administration:

* FDA APPROVES RUXIENCE (RITUXIMAB-PVVR), BIOSIMILAR TO RITUXAN (RITUXIMAB)

* FDA SAYS APPROVED RUXIENCE FOR TREATING ADULT PATIENTS WITH CD20-POSITIVE B-CELL NON-HODGKIN’S LYMPHOMA USED AS SINGLE AGENT/IN COMBINATION WITH CHEMOTHERAPY

* FDA SAYS APPROVED RUXIENCE FOR TREATING ADULT PATIENTS WITH CD20-POSITIVE CHRONIC LYMPHOCYTIC LEUKEMIA IN COMBINATION WITH CHEMOTHERAPY

* FDA SAYS RUXIENCE IS FIRST BIOSIMILAR APPROVED TO TREAT GRANULOMATOSIS WITH POLYANGIITIS (WEGENER’S GRANULOMATOSIS) AND MICROSCOPIC POLYANGITIS

* FDA SAYS LIKE U.S.-LICENSED RITUXAN, LABELING FOR RUXIENCE CONTAINS BOXED WARNING TO ALERT ABOUT INCREASED RISKS OF FATAL INFUSION-RELATED REACTIONS

* FDA SAYS LIKE U.S.-LICENSED RITUXAN, LABELING FOR RUXIENCE CONTAINS BOXED WARNING TO ALERT ABOUT INCREASED RISKS OF HEPATITIS B VIRUS REACTIVATION

* FDA SAYS LIKE U.S.-LICENSED RITUXAN, RUXIENCE LABELING CONTAINS BOXED WARNING TO ALERT ABOUT INCREASED RISKS OF PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY Source text: (bit.ly/2OdLUNW) Further company coverage:

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