FDA reverses, plans to pull interchangeability statement from labels of interchangeable biosimilars

The FDA on Fri­day re­leased new draft guid­ance that re­vers­es pri­or guid­ance and says that in­ter­change­able biosim­i­lars should no longer in­clude a de­scrip­tion of their des­ig­na­tion on their la­bels.

The agency said it’s mak­ing the move as an ex­pla­na­tion of the in­ter­change­abil­i­ty stan­dard in the la­bel “is not like­ly to be use­ful to pre­scribers, who can pre­scribe both biosim­i­lar and in­ter­change­able biosim­i­lar prod­ucts in place of the ref­er­ence prod­uct with equal con­fi­dence that they are as safe and ef­fec­tive as their ref­er­ence prod­ucts.”

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