Interchangeability rules for biosimilars are now a thing, per the FDA

The FDA just spelled out what, precisely, warrants a functional and safe facsimile biologic, so that competing biosimilar drugs can be deemed “interchangeable” with the branded counterparts. This has been a controversial and drawn-out debate.

“There’s been a bit of wavering on the agency’s part,” Anthony Maffia, vice president and head of regulatory affairs in North America for Sandoz, told STAT. 

Whether or not this will breathe new life into the stagnating biosimilar market is yet to be seen. After all, few doctors choose the still-costly biosimilars over the originals; while less pricy, they're still quite pricy. 

Read more.