On Friday, March 6th, 2015 the FDA approved Sandoz’s Zarxio, the first official biosimilar that will be made available in the U.S.
Zarxio, a recombinant granulocyte colony-stimulating factor used to boost white blood cells after cancer treatments, is the long-awaited biosimilar for filgrastim (Amgen’s Neupogen).
The FDA noted in their briefs that Zarxio was “highly similar” to the brand biologic and had “no clinically meaningful differences between the proposed product and the reference product in terms of safety, purity, and potency”. The FDA stated that “robust” pharmacokinetic and pharmacodynamic comparative studies supported biosimilarity with the original filgrastim.
I’ll admit it, as a pharmacist the topic of biosimilars peaks my interest. Europe has been marketing biosimilars for years now, and the Food and Drug Administration (FDA) is developing long-awaited standards so that this process can be initiated in the U.S. And it looks like this week, the process is finally starting.
But there are many questions still to be answered:
- What biologics are in-line to be the first approved biosimilars?
- Where will health care providers find information about biologic interchange with biosimilars?
- How much cheaper will a biosimilar be as compared to its brand counterpart?
- Can pharmacists automatically make a switch between a biologic and a biosimilar without prescriber approval?
The current state of biosimilars, and their FDA standards, is still in process in the U.S.