First biosimilar in the United States launches, hurdles still remain

Biosimilars — less expensive versions of costly biologic specialty drugs — can be marketed after the original drug’s patent has expired. Costing 10 to 30 percent less than the original medicines, biosimilars could create opportunities for price competition and savings on overall pharmacy costs.

Zarxio launched on September 3, 2015, making it the first biosimilar available in the United States.

While the federal appeals court’s decision paved the way for the U.S.’s first biosimilar, some uncertainties remain.

The FDA has not issued rules on how biosimilars may be substituted for a brand name biologic. Studies on Zarxio have shown that it produces similar results to Neupogen. But, Zarxio is not biologically the same as Neupogen. Zarxio was approved for use in Europe in 2009.2 

Neupogen is a drug that treats neutropenia, a condition resulting in abnormally low count of a white blood cell to fight off infections. It affects about half of all cancer patients.

At this time, a pharmacist cannot automatically substitute Zarxio for Neupogen. The pharmacist would first need authorization from the member’s doctor.

Naming conventions for biosimilars aren’t final. The FDA recently proposed a rule suggesting both the biologic product and its biosimilar share the same core name.3 To better identify each drug, every product — including the original biologic — would have a unique suffix assigned by the FDA. If a biosimilar does not have the same generic name as the reference product, it could create confusion for doctors and members.

These issues may raise unnecessary concerns about safety among both doctors and their patients. It could limit how broadly biosimilar drugs are used, which would result in reduced savings for both health plans and consumers. Prime is working with industry associations to send comments to the FDA.

The price of some biologics is as high as $50,000 to $90,000 for a single course of treatment.4 Zarxio is priced at a 15 percent discount off Neupogen's price.

If uncertainties continue, approval and adoption of biosimilars could lag. Pete Clagett, Prime’s senior vice president for integrated care and specialty, sees that translating to lower-than-projected savings. “Prime urges regulators and legislators to carefully consider their decisions on these complex issues. As an industry, we need to take full advantage of the opportunities biosimilars offer as one way to help solve the unsustainable growth in health care costs.”

With more than 40 biosimilars in the pipeline today, Prime is monitoring progress and preparing for release dates. Prime is also working with regulators and lawmakers to bring attention to the needs of the market and consumers.

Next story: How Prime works to improve your employees' experience

  1. “Amgen Can't Block Sandoz Biosimilar At Fed. Circ.” By Jeff Overley. Law 360. Portfolio Media Inc.  Accessed at:   http://www.law360.com/articles/698456/amgen-can-t-block-sandoz-biosimilar-at-fed-circ
  2. “FDA approves Zarxio, its first biosimliar drug.” By Sabrina Tavernise and Andre Pollack.  March 6, 2015. The New York Times Company.  Accessed at: http://www.nytimes.com/2015/03/07/health/fda-approves-zarxio-first-biosimilar-drug.html?_r=0
  3. McDermott Will & Emery. 2015. FDA Releases Long-Awaited Biological Naming Draft Guidance and Proposed Rule. Accessed at: http://www.mwe.com/FDA-Releases-Long-Awaited-Biological-Naming-Draft-Guidance-and-Proposed-Rule-09-09-2015/
  4. Prime Therapeutics. (2013). A PBM perspective on the evolving biosimilars landscape. Retrieved from: user/220a4eb2-dd7f-4520-ab96-7cfb9e87326b/8e648f20-2a6c-4610-9b15-849b37ce4f51/File/3da0a2273ffa0dea4bd52b670f03eaa3/ wp_biosimilars_april_2013.pdf

Drug names are the property of their respective owners.

 

 

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