Bio­con, My­lan an­nounce pos­i­tive CHMP opin­ion for Ful­phila

BioSpectrum (India) - - COMPANY NEWS -

Bio­con Ltd and My­lan N.V. has an­nounced that the Euro­pean Medicines Agency’s Com­mit­tee for Medic­i­nal Prod­ucts for Hu­man Use (CHMP) has is­sued a pos­i­tive opin­ion rec­om­mend­ing ap­proval of Ful­phila, a biosim­i­lar to Am­gen’s Neu­lasta (peg­fil­gras­tim).

The CHMP pos­i­tive opin­ion is based upon a re­view of ev­i­dence demon­strat­ing biosim­i­lar­ity. Data sub­mit­ted as part of the Mar­ket­ing Au­tho­riza­tion Ap­pli­ca­tion in­cluded sim­i­lar­ity as­sess­ment in an­a­lyt­i­cal test­ing, pre­clin­i­cal and clin­i­cal stud­ies that demon­strated biosim­i­lar­ity to the ref­er­ence prod­uct, Neu­lasta. The Phase I pro­gramme in healthy vol­un­teers and Phase III clin­i­cal study con­ducted in breast can­cer pa­tients re­ceiv­ing ad­ju­vant and neoad­ju­vant chemo­ther­apy, demon­strated no clin­i­cally mean­ing­ful dif­fer­ences in terms of phar­ma­coki­net­ics, phar­ma­co­dy­nam­ics, safety, ef­fi­cacy and im­muno­genic­ity com­pared to Neu­lasta. The CHMP pos­i­tive opin­ion will now be con­sid­ered by the Euro­pean Com­mis­sion. The de­ci­sion on ap­proval is ex­pected by Novem­ber 2018. Ful­phila was ap­proved by the U.S. Food and Drug Ad­min­is­tra­tion (FDA) ear­lier this year and is the first FDA-ap­proved biosim­i­lar for Neu­lasta in the U.S. Reg­u­la­tory ap­pli­ca­tions for Ful­phila also have been sub­mit­ted in Aus­tralia, New Zealand, Canada and sev­eral other coun­tries.

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