FDA’s back-to-back punch­es against biosims from Cell­tri­on, No­var­tis leave Roche’s big Rit­ux­an fran­chise un­touched

A month af­ter the FDA kicked backed Cell­tri­on’s ap­pli­ca­tion to mar­ket a biosim­i­lar for Roche’s big block­buster Rit­ux­an, the agency made it a clean sweep Thurs­day by do­ing the same for No­var­tis’ copy­cat.

No­var­tis didn’t say why San­doz’s ap­pli­ca­tion got the boot, re­mark­ing on­ly that it “stands be­hind the ro­bust body of ev­i­dence.” The FDA nev­er re­marks on its re­jec­tions.

Roche, mean­while, will do some qui­et cel­e­brat­ing. The phar­ma gi­ant has been hus­tling up new meds like Hem­li­bra to fill the gap that will be cre­at­ed as cheap­er gener­ic ver­sions of their bi­o­log­ics eat in­to their fran­chise rev­enue for Rit­ux­an, Her­ceptin and Avastin. It’s been feel­ing the heat in Eu­rope, where biosim­i­lars are far more ad­vanced in com­pet­ing with the brand­ed orig­i­nals.

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