Cell­tri­on re­ceives CRLs for Rit­ux­an, Her­ceptin biosim­i­lars

Cell­tri­on has re­ceived com­plete re­sponse let­ters (CRLs) from the FDA for two bi­o­log­ics li­cense ap­pli­ca­tions for rit­ux­imab and trastuzum­ab biosim­i­lars, a Cell­tri­on spokesman told Fo­cus on Thurs­day.

The CRLs fol­low an FDA warn­ing let­ter is­sued to Cell­tri­on in Jan­u­ary, which the spokesman said “was di­rect­ly re­lat­ed to the re­ceipt of the CRL. Cell­tri­on is mak­ing progress ad­dress­ing these con­cerns and is com­mit­ted to work­ing with the agency to ful­ly re­solve all out­stand­ing is­sues with the high­est pri­or­i­ty and ur­gency.”

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