Te­va-part­nered Cell­tri­on biosim­i­lar scores FDA ad­comm rec­om­men­da­tion for a sec­ond shot at shak­ing up Roche's Rit­ux­an fran­chise

Af­ter re­peat­ed run-ins with the FDA in the past few months re­gard­ing site in­spec­tions and biosim­i­lar fil­ings, Cell­tri­on might fi­nal­ly be turn­ing things around with an unan­i­mous thumbs up for its Rit­ux­an copy­cat from the FDA ad­vi­so­ry com­mit­tee.

All 16 on­co­log­ic drug ex­perts on the pan­el en­dorsed CT-P10 for three of the eight in­di­ca­tions on Rit­ux­an’s la­bel — as ei­ther stand­alone or main­te­nance ther­a­py for B-cell non-Hodgkin lym­phoma.

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