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

Author:

Chen Brian123,Nagai Sumimasa4,Armitage James O.5,Witherspoon Bartlett6,Nabhan Chadi1,Godwin Ashley C.1,Yang Y. Tony7,Kommalapati Anuhya8,Tella Sri Harsha8,DeAngelis Carlo9,Raisch Dennis W.10,Sartor Oliver11,Hrushesky William J.212,Ray Paul S.1,Yarnold Paul R.1,Love Bryan L.1,Norris LeAnn B.1,Knopf Kevin113,Bobolts Laura1415,Riente Joshua3,Luminari Stefano1617,Kane Robert C.1,Hoque Shamia1,Bennett Charles L.12183

Affiliation:

1. South Carolina Center of Economic Excellence for Medication Safety, College of Pharmacy, University of South Carolina, Columbia, South Carolina, USA

2. Arnold School of Public Health, University of South Carolina, Columbia, South Carolina, USA

3. William Jennings Bryan Dorn VA Medical Center, Columbia, South Carolina, USA

4. Translational Research Center, The University of Tokyo Hospital, Tokyo, Japan

5. University of Nebraska School of Medicine, Omaha, Nebraska, USA

6. College of Medicine, Medical University of South Carolina, Charleston, South Carolina, USA

7. Center for Health Policy and Media Engagement, George Washington University, Washington, D.C., USA

8. School of Medicine, University of South Carolina, Columbia, South Carolina, USA

9. Sunnybrook Health Sciences Center, Toronto, Ontario, Canada

10. College of Pharmacy, University of New Mexico, Albuquerque, New Mexico, USA

11. Tulane University School of Medicine, New Orleans, Louisiana, USA

12. Department of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina, USA

13. Alameda Health System, Oakland, California, USA

14. Oncology Analytics Inc., Plantation, Florida, USA

15. Nova Southeastern University College of Pharmacy, Fort Lauderdale, Florida, USA

16. Hematology, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy

17. Department of Diagnostic, Clinical and Public Health Medicine, University of Modena and Reggio Emilia, Reggio Emilia, Italy

18. Hollings Cancer Center, Medical University of South Carolina, Charleston, South Carolina, USA

Abstract

Abstract 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.

Publisher

Oxford University Press (OUP)

Subject

Cancer Research,Oncology

Reference90 articles.

1. Colony-stimulating factors for febrile neutropenia;Bennett;N Engl J Med,2013

2. Biosimilar filgrastim use in the United States versus the European Union and Japan: Why does it lag behind and what can be done?;Qureshi;JAMA Oncol,2018

3. Friction in the path to use of biosimilar drugs;Chen;N Engl J Med,2018

4. Challenges to biosimilar subsitution;Chen;JAMA,2017

5. Regulatory and clinical considerations for biosimilar oncology drugs;Bennett;Lancet Oncol,2014

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