Biosimilar medications are all but a sure thing. Earlier this year, I discussed the topic in Biosimilars: Close to the Real Thing, since the U.S. Food and Drug Administration (FDA) seemed to be on the cusp of approving the first biosimilar. Biosimilars – which are less expensive versions of already approved biological medications used for cancer, autoimmune, and other diseases – are actually different than generics. They tend to be large complex molecules manufactured in living systems that are almost (but not exactly) the same medication as the original biologic.
The first biosimilar on track to become available September 2, 2015 is Zarxio (filgrastim) from Sandoz (an arm of Novartis), which mimics Neupogen®. Both medications enhance immune function to fight infections that can develop in the course of treating cancer. Zarxio will come at a lower price point than Neupogen and it has already been used in Europe for many years with a good safety and effectiveness profile.
Following on the heels of Zarxio might be a biosimilar of the popular rheumatoid arthritis medication Enbrel®. This biosimilar, currently named SB4, was recently shown to be as effective as Enbrel in a study in the Annals of the Rheumatic Diseases. In this study, SB4 produced clinical responses on par with Enbrel in patients with severe rheumatoid arthritis. It’s likely that this medication will enter the European market first, with some hurdles remaining before a U.S. launch would be cleared.
What does seem clear; however, is this: biosimilars continue to make headway in rulings by the Federal Circuit court and there will likely be more available to patients in the near future.
Emery P, Vencovsky J, Sylwestrzak A, et al. A phase III randomised, double-blind, parallel-group study comparing SB4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy. Ann Rheum Dis July 6, 2015 [epub ahead of print].
Rosenthal M. First U.S. biosimilar prepared to launch after early September. Specialty Pharmacy Continuum July 22, 2015.