Regulatory and Clinical Experiences with Biosimilar Filgrastim in the U.S., the European Union, Japan, and Canada.

Autor:	Chen B; South Carolina Center of Economic Excellence for Medication Safety, College of Pharmacy, University of South Carolina, Columbia, South Carolina, USA.; Arnold School of Public Health, University of South Carolina, Columbia, South Carolina, USA.; William Jennings Bryan Dorn VA Medical Center, Columbia, South Carolina, USA., Nagai S; Translational Research Center, The University of Tokyo Hospital, Tokyo, Japan., Armitage JO; University of Nebraska School of Medicine, Omaha, Nebraska, USA., Witherspoon B; College of Medicine, Medical University of South Carolina, Charleston, South Carolina, USA., Nabhan C; South Carolina Center of Economic Excellence for Medication Safety, College of Pharmacy, University of South Carolina, Columbia, South Carolina, USA., Godwin AC; South Carolina Center of Economic Excellence for Medication Safety, College of Pharmacy, University of South Carolina, Columbia, South Carolina, USA., Yang YT; Center for Health Policy and Media Engagement, George Washington University, Washington, D.C., USA., Kommalapati A; School of Medicine, University of South Carolina, Columbia, South Carolina, USA., Tella SH; School of Medicine, University of South Carolina, Columbia, South Carolina, USA., DeAngelis C; Sunnybrook Health Sciences Center, Toronto, Ontario, Canada., Raisch DW; College of Pharmacy, University of New Mexico, Albuquerque, New Mexico, USA., Sartor O; Tulane University School of Medicine, New Orleans, Louisiana, USA., Hrushesky WJ; Arnold School of Public Health, University of South Carolina, Columbia, South Carolina, USA.; Department of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina, USA., Ray PS; South Carolina Center of Economic Excellence for Medication Safety, College of Pharmacy, University of South Carolina, Columbia, South Carolina, USA., Yarnold PR; South Carolina Center of Economic Excellence for Medication Safety, College of Pharmacy, University of South Carolina, Columbia, South Carolina, USA., Love BL; South Carolina Center of Economic Excellence for Medication Safety, College of Pharmacy, University of South Carolina, Columbia, South Carolina, USA., Norris LB; South Carolina Center of Economic Excellence for Medication Safety, College of Pharmacy, University of South Carolina, Columbia, South Carolina, USA., Knopf K; South Carolina Center of Economic Excellence for Medication Safety, College of Pharmacy, University of South Carolina, Columbia, South Carolina, USA.; Alameda Health System, Oakland, California, USA., Bobolts L; Oncology Analytics Inc., Plantation, Florida, USA.; Nova Southeastern University College of Pharmacy, Fort Lauderdale, Florida, USA., Riente J; William Jennings Bryan Dorn VA Medical Center, Columbia, South Carolina, USA., Luminari S; Hematology, Arcispedale Santa Maria Nuova, Istituto di Ricovero e Cura a Carattere Scientifico, Reggio Emilia, Italy.; Department of Diagnostic, Clinical and Public Health Medicine, University of Modena and Reggio Emilia, Reggio Emilia, Italy., Kane RC; South Carolina Center of Economic Excellence for Medication Safety, College of Pharmacy, University of South Carolina, Columbia, South Carolina, USA., Hoque S; South Carolina Center of Economic Excellence for Medication Safety, College of Pharmacy, University of South Carolina, Columbia, South Carolina, USA., Bennett CL; South Carolina Center of Economic Excellence for Medication Safety, College of Pharmacy, University of South Carolina, Columbia, South Carolina, USA bennettc@cop.sc.edu.; Arnold School of Public Health, University of South Carolina, Columbia, South Carolina, USA.; Hollings Cancer Center, Medical University of South Carolina, Charleston, South Carolina, USA.; William Jennings Bryan Dorn VA Medical Center, Columbia, South Carolina, USA.
Jazyk:	angličtina
Zdroj:	The oncologist [Oncologist] 2019 Apr; Vol. 24 (4), pp. 537-548. Date of Electronic Publication: 2019 Mar 06.
DOI:	10.1634/theoncologist.2018-0341
Abstrakt:	Biosimilar filgrastims are primarily indicated for chemotherapy-induced neutropenia prevention. They are less expensive formulations of branded filgrastim, and biosimilar filgrastim was the first biosimilar oncology drug administered in European Union (EU) countries, Japan, and the U.S. Fourteen biosimilar filgrastims have been marketed in EU countries, Japan, the U.S., and Canada since 2008, 2012, 2015, and 2016, respectively. We reviewed experiences and policies for biosimilar filgrastim markets in EU countries and Japan, where uptake has been rapid, and in the U.S. and Canada, where experience is rapidly emerging. U.S. regulations for designating biosimilar interchangeability are under development, and such regulations have not been developed in most other countries. Pharmaceutical substitution is allowed for new filgrastim starts in some EU countries and in Canada, but not Japan and the U.S. In EU countries, biosimilar adoption is facilitated with favorable hospital tender offers. U.S. adoption is reportedly 24%, while the second filgrastim biosimilar is priced 30% lower than branded filgrastim and 20% lower than the first biosimilar filgrastim approved by the U.S. Food and Drug Administration. Utilization is about 60% in EU countries, where biosimilar filgrastim is marketed at a 30%-40% discount. In Japan, biosimilar filgrastim utilization is 45%, primarily because of 35% discounts negotiated by Central Insurance and hospital-only markets. Overall, biosimilar filgrastim adoption barriers are small in many EU countries and Japan and are diminishing in Canada in the U.S. Policies facilitating improved U.S. adoption of biosimilar filgrastim, based on positive experiences in EU countries and Japan, including favorable insurance coverage; larger price discount relative to reference filgrastim pricing; closing of the "rebate trap" with transparent pricing information; formal educational efforts of patients, physicians, caregivers, and providers; and allowance of pharmaceutical substitution of biosimilar versus reference filgrastim, should be considered. IMPLICATIONS FOR PRACTICE: We reviewed experiences and policies for biosimilar filgrastims in Europe, Japan, Canada, and the U.S. Postmarketing harmonization of regulatory policies for biosimilar filgrastims has not occurred. Acceptance of biosimilar filgrastims for branded filgrastim, increasing in the U.S. and in Canada, is commonplace in Japan and Europe. In the U.S., some factors, accepted in Europe or Japan, could improve uptake, including acceptance of biosimilars as safe and effective; larger cost savings, decreasing "rebate traps" where pharmaceutical benefit managers support branded filgrastim, decreased use of patent litigation/challenges, and allowing pharmacists to routinely substitute biosimilar for branded filgrastim. Competing Interests: Disclosures of potential conflicts of interest may be found at the end of this article. (© AlphaMed Press 2019.)
Databáze:	MEDLINE
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