TY - JOUR
T1 - Prescriber Perspectives on Biosimilar Adoption and Potential Role of Clinical Pharmacology
T2 - A Workshop Summary
AU - Shubow, Sophie
AU - Sun, Qin
AU - Nguyen Phan, Ai Len
AU - Hammell, Dana C.
AU - Kane, Maureen
AU - Lyman, Gary H.
AU - Gibofsky, Allan
AU - Lichtenstein, Gary R.
AU - Bloomgarden, Zachary
AU - Cross, Raymond K.
AU - Yim, Sarah
AU - Polli, James E.
AU - Wang, Yow Ming
N1 - Funding Information:
G.H.L. was the principal investigator on research grant to institution from Amgen has consulted for Sandoz; G1 Therapeutics; Partners Healthcare; BeyondSpring; ER Squibb; MSD; Jazz Pharm; TEVA; Fresenius Kabi; and Samsung all outside the submitted work. R.K.C. has received fees for consulting and participation in advisory boards for AbbVie, Janssen, Pfizer, and Samsung Bioepis and has a research grant with Janssen. All other authors declared no competing interests for this work.
Funding Information:
This publication was supported by the Food and Drug Administration as part of a financial assistance award U01FD005946 totaling $5,000 with 100 percent funded by the FDA/Health and Human Services (HHS).
Publisher Copyright:
© 2022 The Authors. Clinical Pharmacology & Therapeutics published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.
PY - 2023/1
Y1 - 2023/1
N2 - The approval and adoption of biosimilar products are essential to contain increasing healthcare costs and provide more affordable choices for patients. Despite steady progress in the number of the US Food and Drug Administration (FDA) biosimilar approvals over the years, biosimilar adoption in the United States has been slow and gradual, largely driven by payers rather than clinicians. In order to better understand the barriers to biosimilar adoption in the clinic, the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) and the FDA jointly hosted a virtual workshop on April 13, 2022, titled “Biosimilars: A Decade of Experience and Future Directions – Strategies for Improving Biosimilar Adoption and the Potential Role of Clinical Pharmacology.” This summary documents the experiences of four leading academic clinicians with specialties in oncology, rheumatology, gastroenterology, and endocrinology and their perspectives on how to increase biosimilar adoption, including the role of clinical pharmacology. Besides systemic changes in pricing and reimbursement, there is a need for additional education of a broad range of providers, including advanced care practitioners, and patients themselves. Educational efforts highlighting the rigor of the studies that support the approval of biosimilars—including the clinical pharmacology studies—and the benefits of biosimilars, can play a major role in improving biosimilar acceptance.
AB - The approval and adoption of biosimilar products are essential to contain increasing healthcare costs and provide more affordable choices for patients. Despite steady progress in the number of the US Food and Drug Administration (FDA) biosimilar approvals over the years, biosimilar adoption in the United States has been slow and gradual, largely driven by payers rather than clinicians. In order to better understand the barriers to biosimilar adoption in the clinic, the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) and the FDA jointly hosted a virtual workshop on April 13, 2022, titled “Biosimilars: A Decade of Experience and Future Directions – Strategies for Improving Biosimilar Adoption and the Potential Role of Clinical Pharmacology.” This summary documents the experiences of four leading academic clinicians with specialties in oncology, rheumatology, gastroenterology, and endocrinology and their perspectives on how to increase biosimilar adoption, including the role of clinical pharmacology. Besides systemic changes in pricing and reimbursement, there is a need for additional education of a broad range of providers, including advanced care practitioners, and patients themselves. Educational efforts highlighting the rigor of the studies that support the approval of biosimilars—including the clinical pharmacology studies—and the benefits of biosimilars, can play a major role in improving biosimilar acceptance.
UR - http://www.scopus.com/inward/record.url?scp=85141408941&partnerID=8YFLogxK
U2 - 10.1002/cpt.2765
DO - 10.1002/cpt.2765
M3 - Article
C2 - 36251545
AN - SCOPUS:85141408941
SN - 0009-9236
VL - 113
SP - 37
EP - 49
JO - Clinical Pharmacology and Therapeutics
JF - Clinical Pharmacology and Therapeutics
IS - 1
ER -