January 6th, 2015
On Wednesday, January 7th, the FDA Oncologic Drugs Advisory Committee unanimously recommended approval of Sandoz’s EP2006, a biosimilar for filgrastim (Neupogen). EP2006 is a recombinant granulocyte colony-stimulating factor used to boost white blood cells after cancer treatments that deplete these necessary infection-fighting cells. If FDA-approved, this would be the first true biosimilar in the U.S. and would have a brand name of Zarxio. The FDA noted that EP2006 was “highly similar” to the original drug 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. Legal action over patent protection may still interfere with the launch.
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: What is the current biosimilar status is in the U.S? What biologics are in-line to be the first approved biosimilars? Where will health care providers find information about biologic interchange with biosimilars? Will a biosimilar still be as expensive as its brand counterpart? Can pharmacists automatically make a switch between a biologic and a biosimilar?
Here’s a quick overview:
- In a nutshell, a biosimilar is a biological product that is highly similar to a U.S.-licensed reference biological. The key word here is similar.
- Manufacturing of large molecule biologics is complex. Proteins can be altered when manufacturing processes change, and there is concern that this may alter how the biosimilar product performs clinically in the patient. Studies will be done to address these concerns.
- Once biosimilars are approved in the U.S., a pharmacist cannot automatically substitute the biosimilar for the reference biologic unless it is deemed “interchangeable”. The Purple Book, not unlike The Orange Book, will be the go-to resource to answer these questions.
- Costs of biologics and biosimilars will lead to policy debates in health care. How might this affect the patient?
- Biosimilars have been available in Europe since 2005, and the U.S. has much to learn from their experiences.
The current state of biosimilars is still in process in the U.S. Take a look at our article to review the pressing issues, learn some facts, and see upcoming biologics in line for biosimilar approvals down the road.