Insulin biosimilar wins first-ever interchangeable designation from FDA
For the first time ever, the FDA on Wednesday green-lighted an interchangeable biosimilar, capping a decade-long quest for such an approval since the pathway was opened up by Obamacare. The announcement means that Mylan’s new Lantus biosimilar may be substituted for Sanofi’s reference product without the intervention of a prescriber.
The US is the only country in the world to use these congressionally-created, so-called “interchangeable” designations. The US still fails to adopt biosimilars as quickly or as consistently as its European counterparts, where all biosimilars are considered interchangeable.
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