November 26, 2018 MedicalResearch.com Interview with Abiy Agiro, PHD, HealthCore, Inc., Wilmington, Delaware
MedicalResearch.com: What is the background for this study?
Response: Biosimilar approval pathway, authorized in 2010 by the Biologics Price Competition and Innovation Act as part of the Affordable Care Act, aims to increase adoption of biosimilar products and generate significant cost savings to payers and patients alike. Biosimilar filgrastim, used to prevent febrile neutropenia, is one of the first biosimilars to be approved in the United States. A large scale, post-approval real-world analysis was needed that compares biosimilar filgrastim to the original drug for safety and efficacy.
MedicalResearch.com: What are the main findings?
Response: Biosimilar filgrastim is found to have similar rates of drug-related adverse events and febrile neutropenia complications compared to originator filgrastim, meaning that biosimilar filgrastim is equivalent to the original product in terms of safety and efficacy.
MedicalResearch.com: What should readers take away from your report?
Response: The study found an improved uptake of biosimilar filgrastim. Biosimilar filgrastim accounted for 7 percent of filgrastim users in 2014 but rose to 36 percent of filgrastim users in 2016.However, there’s potential for those numbers to grow. Studies like ours can reassure providers and patients which may result in them being more open to increased use of biosimilar filgrastim products.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: Pegfilgrastim is the most used colony-stimulating growth factors drug in the United States. Biosimilar pegfilgrastim was recently approved in June 2018. In several years’ time, it will be important to conduct a real-word comparison of safety and efficacy of biosimilar pegfilgrastim to originator pegfilgrastim.
MedicalResearch.com: Is there anything else you would like to add?
Response: Equivalency in efficacy and safety of biosimilar and originator products cannot be assumed.Therefore, additional post-approval observational studies like ours will be needed to reassure patients, oncologist and payers that biosimilar products are safe and efficacious alternative to originator drugs.
Any disclosures? None beyond what is already included in the JAMA Oncology publication.
All authors have completed and submitted the International Committee of Medical Journal Editors JE Form for Disclosure of Potential Conflicts of Interest. Xiaoxue Chen, and Drs Abiy Agiro and John Barron reported being full-time employees of HealthCore. David Debono, MD, reported being a full-time employee of Anthem and has stock and other ownership interest in Eli Lilly and Company. Mike Fisch, MD, reported being a full-time employee of AIM Specialty Health and has stock and other ownership interest in Anthem.
Citation: Chen X, Agiro A, Barron J, Debono D, Fisch M. Early Adoption of Biosimilar Growth Factors in Supportive Cancer Care. JAMA Oncol. Published online November 01, 2018. doi:10.1001/jamaoncol.2018.5090
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