Why we need to low­er U.S. reg­u­la­to­ry bar­ri­ers around biosim­i­lar ap­provals now

The FDA’s in­ter­nal re­view on Am­gen’s biosim­i­lar of Hu­mi­ra reads like a prod­uct en­dorse­ment. Post­ed on Fri­day, the agency in­sid­ers es­sen­tial­ly said: Let’s give it a quick kiss on both cheeks and ap­prove this knock­off. It’s good to go on every in­di­ca­tion Ab­b­Vie has in the U.S., which is the lynch­pin to its glob­al, $14 bil­lion fran­chise.

The le­gal war still has to play out, but the re­al les­son here is that now that the ap­pli­ca­tions are com­ing, the agency ex­perts are hav­ing no trou­ble rec­om­mend­ing a green light to these bi­o­log­ic twins. The da­ta pack­ages they’re de­liv­er­ing are de­ci­sive. And years of watch­ing law­mak­ers and reg­u­la­tors play a tug-of-war over the rules around biosim­i­lar de­vel­op­ment have come down to this:

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