Pegfilgrastim Biosimilars: Where Are We Now?
Christopher Selby,(1) PharmD, BCOP, Breanne Peyton-Thomas,(2) PharmD, BCOP, and Parnian Eslami,(3) PharmD
From (1)Texas Tech University Health Sciences Center Jerry H. Hodge School of Pharmacy, Dallas, Texas; (2)Ochsner Medical Center, New Orleans, Louisiana; (3)St. Joseph Health, Irvine, California
Authors’ disclosures of conflicts of interest are found at the end of this article.
Correspondence to: Christopher Selby, PharmD, BCOP, 5920 Forest Park Road, Dallas, TX 75235. E-mail: firstname.lastname@example.org
J Adv Pract Oncol 2021;12(5):541–547 |
© 2021 Harborside™
In 1991, the U.S. Food & Drug Administration (FDA) approved rmetHuG-CSF for human use. This recombinant methionyl human granulocyte colony-stimulating factor, or filgrastim, saw use in over 1 million patients in its first 5 years on the market. In 2002, the FDA approved a version of filgrastim with covalent linkage to a monomethoxypolyethylene glycol, increasing the molecular size and half-life to replace multiple days of dosing with a single injection. These medications remained standard of care for neutropenia until the Biologics Price Competition and Innovation Act of 2009 created an abbreviated pathway to licensure for biologic products. Practitioners now have their pick of numerous and expanding options for pegfilgrastim biosimilars.
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