Affiliation:
1. Capital Health Cancer Center, Hopewell, NJ 08534, USA
2. The Center for Cancer & Blood Disorders, Fort Worth, TX 76104, USA
Abstract
Biosimilars can provide choices for patients and may provide cost savings; however, their uptake has been slow in the USA, in part due to limited knowledge. To provide additional confidence in US pegfilgrastim biosimilars, this narrative review compared the safety profiles of biosimilar pegfilgrastims, currently approved or filed for approval in the USA, with the EU- and US-approved reference pegfilgrastims. Headache and bone pain were common to biosimilars and reference products and occurred at a similar incidence. Clinical trial data on the safety profiles of biosimilar pegfilgrastims and reference products have demonstrated similarity and comparability, with no unexpected safety outcomes. Overall, the safety profiles of biosimilar pegfilgrastims and reference pegfilgrastims demonstrated a high degree of similarity and comparability.
Subject
Cancer Research,Oncology,General Medicine
Reference58 articles.
1. Design Rationale and Development Approach for Pegfilgrastim as a Long-Acting Granulocyte Colony-Stimulating Factor
2. Neuroprotective Effect of Granulocyte-Colony Stimulating Factor
3. Granulocyte colony-stimulating factor receptor signaling in severe congenital neutropenia, chronic neutrophilic leukemia, and related malignancies
4. US Food and Drug Administration. Highlights of Prescribing Information Neulasta® (Pegfilgrastim) (2015). https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125031s180lbl.pdf
5. US Food and Drug Administration. Orphan Drug Designations and Approvals (2013). https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=413013
Cited by
2 articles.
订阅此论文施引文献
订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献