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Sandoz Enbrel Copycat Next Biosimilar To Get Panel Treatment

 
• By Donna Young

The FDA has elected to take Sandoz Inc.'s 351(k) application for its etanercept biosimilar, which is referenced on Amgen Inc.'s tumor necrosis factor blocker Enbrel, to an advisory committee to get its advice on whether to license the product. It's only the third biosimilar to get the expert panel treatment.

While there's little insight at this point into what the FDA thinks about Sandoz Inc.'s version of Amgen Inc.'s Enbrel, it's clear, now, after regulators scheduled a July 13 advisory committee meeting the agency wants the advice of its outside experts before making a decision on whether to permit the etanercept biosimilar to enter the US market.

The agency has only convened its advisory panels twice before to examine so-called 351(k) applications for biosimilars and both of...

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