The September 2013 issue of Conquering the Cancer Care Continuum, funded by Teva Pharmaceuticals, contained errors. In the article by Beth Faiman, PhD(c), MSN, APRN-BC, AOCN, titled “The Role of Biosimilars in Oncology: A Nurse’s Perspective,” the FDA approval language and indication for GRANIX™ (tbo-filgrastim) was incorrect, as was the package insert information cited in reference 7. Also, in the article by Steve Stricker, PharmD, MS, BCOP, titled “The Role of Biosimilars in Oncology: A Pharmacist’s Perspective,” Dr. Stricker mistakenly refers to tbo-filgrastim as a biosimilar. The correct approval language, indication, and reference are provided below.
GRANIX (tbo-filgrastim) was approved by the FDA on August 29, 2012, through a Biologics License Application and is therefore not a biosimilar as stated in the article.
GRANIX (tbo-filgrastim) is a leukocyte growth factor indicated for reduction in the duration of severe neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.
Reference 7 should be listed as follows: Granix [package insert]. North Wales, PA: Teva Pharmaceuticals USA, Inc; 2013.
Teva Pharmaceuticals did not have any control or involvement in the content development of this newsletter.
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