My­lan-Bio­con com­bine get USFDA nod for biosim­i­lar peg­fil­gras­tim

Chemical Industry Digest - - News & Views -

The My­lan-Bio­con com­bine have notched up their sec­ond biosim­i­lar in the US fol­low­ing the reg­u­la­tory ap­proval given to Ful­phila, My­lan’s biosim­i­lar ver­sion of peg­fil­gras­tim, orig­i­nally sold by Am­gen un­der the brand­name Neu­lasta.

My­lan pipped other com­peti­tors in the race for this drug in the US mar­ket, when it re­ceived the US Food and Drug Ad­min­is­tra­tion’s ap­proval for Ful­phila, a biosim­i­lar it co-de­vel­oped with

Bio­con. The prod­uct is used to treat fever and other signs of in­fec­tion in pa­tients treated with chemo­ther­apy in cer­tain types of can­cer.

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