Dermatologists’ Perspectives on Biosimilars

April 2024 | Volume 23 | Issue 4 | 277 | Copyright © April 2024


Published online March 27, 2024

Priscila Arellano Zameza MSa, Christina Kontzias BAa, Keith Flanders MBAb, Peter Sonnenreich MAc, Steven R. Feldman MD PhDa,d,e

aCenter for Dermatology Research, Department of Dermatology, Wake Forest University School of Medicine, Winston-Salem, NC
bLEO Pharma, Ballerup, Denmark 
cKikaku America International, Bethesda, MD 
dDepartment of Pathology, Wake Forest University School of Medicine, Winston-Salem, NC 
eDepartment of Social Sciences & Health Policy, Wake Forest University School of Medicine, Winston-Salem, NC

Abstract
Background: Biosimilars are biologic agents the Food and Drug Administration (FDA) has deemed to have no clinical difference from their reference biologics. In dermatology, biosimilars are approved for the treatment of psoriasis and hidradenitis suppurativa. Although dermatologists are high prescribers of biologics, they are more reluctant to prescribe biosimilars than other specialists. This survey-based study sought to characterize dermatologists' current perspectives on biosimilars. 
Methods: A 27-question survey was distributed via email to dermatologists between September and October of 2022. 
Results: Twenty percent of respondents would not prescribe a biosimilar for an FDA-approved indication. When asked about the greatest barriers to biosimilar adoption, 61% had concerns about biosimilar safety and efficacy, 24% reported uncertainty about state laws for interchangeability and substitutions, and 20% had concerns about biosimilar safety without concerns about efficacy. Thirty-five percent of respondents felt moderately or extremely knowledgeable about biosimilar interchangeability. 
Conclusion: Biosimilars are safe and effective for treating approved dermatological conditions and may lower patient costs compared to their reference products. Patients are not always offered biosimilar therapy as an option, which may be due to unfamiliarity among dermatologists. This survey suggests a need for more research and educational initiatives, such as modules and workshops that focus on biosimilar safety, efficacy, and interchangeability guidelines. 

J Drugs Dermatol. 2024;23(4):277-280. doi:10.36849/JDD.7755

INTRODUCTION

Biologics are protein-based pharmaceuticals derived from living organisms that can treat autoimmune and inflammatory conditions.1 Biosimilars are biologic agents the Food and Drug Administration (FDA) has deemed to have no clinical difference from their reference biologics.2 Biosimilars are developed when the patent for the reference product expires. 

The first biosimilar was approved by the FDA in 2015.3 Currently, there are 39 biosimilars available, 11 of which are approved for psoriasis and hidradenitis suppurativa (HS), including biosimilars to adalimumab, etanercept, and infliximab.4 Of these, only Cyltezo (adalimumab-adbm) is considered interchangeable with its reference product, Humira (adalimumab). Interchangeable biosimilars are FDA-approved to be substituted for their biologic at the pharmacy without input from the prescriber, although this is subject to state laws and regulations.5 Although dermatologists are high prescribers of biologics, they are more reluctant to prescribe biosimilars than other specialists.6,7 This survey-based study sought to characterize dermatologists' current perspectives on biosimilars. 

MATERIALS AND METHODS

A 27-question survey was distributed via email to dermatologists who subscribe to the Dermatologist Magazine and those registered with IQVIA between September and October of 2022. Fifty-two dermatologists responded.

RESULTS

Survey Respondent Characteristics
Respondents' clinical practices focused on medical dermatology (71%), surgical dermatology (23%), pediatric dermatology (13%), cosmetic dermatology (13%), or a combination of all the above (27%). Most dermatologists worked in a single-specialty group practice with fewer than five offices (46%), followed by solo dermatology practice (31%) (Table 1). Sixty-four percent of practice revenue was derived from medical office visits and consults, followed by