The issue of “biosimilar” medications has been under debate for years. Now, the U.S. Food and Drug Administration (FDA) is on the cusp of approving the first biosimilar. In case you don’t know, biosimilars are less expensive versions of already approved biological medications used for cancer, autoimmune, and other diseases. Biologic medications are typically large complex molecules manufactured in living systems. The biosimilars are almost (but not exactly) the same medication as the original biologic.
Earlier this month, an FDA advisory panel moved forward the potential that a biosimilar for Neupogen® could be approved in the near future (perhaps in May). The biosimilar for Neupogen would be made by Sandoz (an arm of Novartis) and called Zarxio. Neupogen enhances immune function and fights infection during cancer treatment.
Biosimilars are not the same as generic versions of medications. During the advisory panel, experts contended that Zarxio is very similar to Neupogen in terms of toxicology, safety, and effectiveness. This similarity is necessary to meet the definition of being a biosimilar. The Novartis biosimilar of Neupogen has already been used in Europe for many years with a good safety and effectiveness profile.
The FDA panel’s unanimous vote in favor of this biosimilar makes it likely that Zarxio will become available as a cheaper version of the more expensive Neupogen. This could lead to significant savings for both patients and payers. Biosimilars are generally sold at a price point 20-30% lower than the brand-name medication they mimic. By one estimate, biosimilar versions of Neupogen and Remicade (a rheumatoid arthritis drug) could save nearly $23 billion over the next decade.
Stephen C. Vogt, Pharm.D.
President and CEO
BioPlus Specialty Pharmacy
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Burton TM. The FDA moves a step closer to approving its first biosimilar drug in the U.S. Wall Street Journal January 7, 2015.
Ledford H. First biosimilar drug set to enter US market. Nature January 15, 2015;517(7534):253-4.