Am­gen catch­es a break as FDA re­jects Neu­las­ta knock­off; Zaf­gen gets a new CEO as Hugh­es moves to top sci­ence job

→ Am­gen caught a break to­day on its block­buster fran­chise drug Neu­las­ta. The FDA has re­ject­ed an ap­pli­ca­tion from Bio­con and My­lan for a knock­off of the bi­o­log­ic af­ter cit­ing man­u­fac­tur­ing is­sues at the In­di­an com­pa­ny that need to be re­solved. No­var­tis was re­cent­ly hand­ed a CRL for its biosim­i­lar of Neu­las­ta as well, con­serv­ing a multi­bil­lion-dol­lar mar­ket for Am­gen. Bio­con, though, says it doesn’t ex­pect a de­lay in its com­mer­cial launch plans.

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