- Earlier this month, Sandoz, a division of Novartis, made history when it became the first company to receive an FDA approval for a biosimilar—in this case, Zarxio (filgrastim-sndz), a biosimilar of Amgen's Neupogen.
- Amgen plans to appeal the decision, which was given down by U.S. District Judge Richard Seeborg of San Francisco.
- Novartis had previously agreed to delay its U.S. launch until the court's decision on the preliminary injunction, or until April 10, whichever came first.
This case is being seen as a precedent and being closely watched by all companies with a stake in the biosimilars market. Right now, there is a lot of uncertainty. For example, it's not clear how long the appeal process will take for Amgen.
One thing that contributes to overall uncertainty is that biosimilars are made in living cells and are therefore not exact duplicates of the reference product. The trend seems to favor the approval of more and more biosimilars, as payers look for discounted prices for biologics, which tend to be expensive. Plus, there's the fact that biosimilars have been approved and used in the E.U. since 2006. At this point, it seems that the U.S. is starting to catch up.