Newswise — Chicago (March 2015): The Hematology/Oncology Pharmacy Association (HOPA) is encouraged by the Food and Drug Administration’s (FDA) approval of the first biosimilar product, Zarxio (filgrastim-sndz), in the United States, but strongly urges the FDA to develop a naming policy for approved biosimilars. HOPA believes that naming is important to avoid prescribing and dispensing errors and that biosimilars must be able to be easily tracked to monitor safety and quality. For this approval, the FDA has designated the placeholder nonproprietary name for this product as “filgrastim-sndz” which the FDA states does not reflect the agency’s decision on a comprehensive naming policy for biosimilar and other biological products. The FDA has plans to issue draft guidance in the near future on how current and future biological products marketed in the United States should be named. HOPA recommends a naming policy that uses the current generic name associated with the innovator, and modified with a prefix.
“HOPA strongly feels that individuals with cancer should have increased access to biologic medications that offer significant advances in the treatment and cure of cancer,” says HOPA President Michael Vozniak, PharmD BCOP. “Biosimilars have the potential to increase access to life-saving therapy by reducing the financial barriers that exist for many of the current high-cost cancer therapies and once available, biosimilars also have the potential to reduce the nation’s healthcare costs for patients with cancer and other diseases that are treatable by biologic medications.”
Zarxio was approved through an abbreviated licensure pathway for biological products created through The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) that was passed as part of the Affordable Care Act in March 2010. The abbreviated licensure pathway was created specifically for biological products shown to be “biosimilar” to or “interchangeable” with an FDA-licensed biological product, called the “reference product.” The high cost of cancer medications is frequently a barrier to patients receiving the latest and most promising cancer therapies.
HOPA closely monitors developing issues related to biosimilars and last fall released an issue brief with recommendations for ensuring appropriate access to, and safe use of biosimilars. Additional recommendations can be found on HOPA’s website.
HOPA:HOPA is a nonprofit professional organization formed in 2004 to help oncology and hematology pharmacy practitioners and their associates provide the best possible cancer care. HOPA supports research, conducts educational conferences to advance knowledge, encourages professional development and advocates for health policy issues that improve patient care. HOPA has more than 2,200 members and includes oncology pharmacists, as well as pharmacy interns, residents, nurses, technicians, researchers, and administrators specializing in hematology/oncology practice. To learn more about HOPA, visit www.hoparx.org.
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