A new US Food and Drug Administration draft guidance aims to lay out an efficient route by which biosimilar product sponsors can add new or previously protected reference product indications to their labeling.
Biosimilar and interchangeable product sponsors may submit supplemental applications for additional indications in advance so that approval will coincide with expiration of a reference product’s
In addition, the FDA will aim to review such supplements in a six-month timeframe, four months quicker than the 10-month target period provided under the second