The Current State of Dermatologists’ Familiarity and Perspectives of Biosimilars for the Treatment of Psoriasis: A Global Cross-Sectional Survey
April 2017 | Volume 16 | Issue 4 | Original Article | 336 | Copyright © April 2017
Iviensan F. Manalo MD,a Kathleen E. Gilbert MD,b and Jashin J. Wu MDc
aGeorgia Regents University Medical College of Georgia, Augusta, GA bIndiana University School of Medicine, Indianapolis, IN cDepartment of Dermatology, Kaiser Permanente Los Angeles Medical Center, Los Angeles, CA
BACKGROUND: Biologic patent expiration, accelerated approval pathways, and business interests of third party payers and the biopharmaceutical industry are driving the development of biosimilars to treat immune-mediated disorders like psoriasis. No studies have investigated dermatologists’ familiarity and perspectives of biosimilars.
OBJECTIVES: To assess: (1) dermatologists’ familiarity with biosimilars and interchangeability and (2) their perspectives toward biosimilar properties, including interchangeability, indication extrapolation, and immunogenicity risk.
METHODS: For this prospective survey study, we distributed electronic and paper questionnaires to dermatologists from selected societies and attendees at the 73rd annual American Academy of Dermatology meeting between March 20, 2015 and May 30, 2015. Primary outcome was dermatologists’ familiarity with biosimilars. Secondary aims included dermatologists’ confidence in biosimilar efficacy and safety, familiarity concerning the concept of interchangeability and perspectives regarding indication extrapolation, interchangeability, and immunogenicity risk.
RESULTS: Of the 116 total dermatologists who completed the questionnaire, 73 (62.9%) were slightly to very unfamiliar with biosimilars. On a 5-point Likert scale, dermatologists were somewhat to very concerned with the practice of interchangeability (3.4±1.1) and slightly uncomfortable to fairly comfortable in prescribing biosimilars for an extrapolated indication (3.3±1.0).
CONCLSUIONS: Our survey identified that the majority of dermatologists were unfamiliar with biosimilars. Dermatologists were consistently concerned regarding safety issues surrounding the practice of interchangeability without provider knowledge.
J Drugs Dermatol. 2017;16(4):336-343.
The application of biologics to treat moderate-to-severe psoriasis has proven safe and ef cacious but their cost has been prohibitive for more widespread use.1 As patents on these (‘reference’, ‘originator’) biologic therapies end, the production and use of biosimilars (‘follow-on biologics’) will inevitably become more common. Per the Biologics Price Competition and Innovation (BPCI) Act, an abbreviated licensure pathway under the United States (U.S.) Affordable Care Act (ACA), a biosimilar “is a biological product that is highly similar to the reference product notwithstanding minor differences in clinically inactive components and that there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.”2 Guidelines for developing biosimilar drugs are available from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA).3,4,5 Conceptually, biosimilars are anticipated to introduce significant bene ts to the healthcare industry.Their increased cost savings potential could grant accessibility and adherence to a large population of patients who previously could not afford biologics, including those in developing countries.1 For the U.S. Medicare program alone, the application of biosimilars in healthcare is expected to result in a cost savings of $9 billion to $12 billion over the next decade.1,6Biosimilars, while likened to generic pharmaceuticals, are unlike small molecule pharmaceuticals. The International Psoriasis Council has released guidelines for standardizing pre-clinical assessments of emerging biosimilars via the development of a biosimilar index.7 Biologic pharmaceuticals are large complex organic biopolymers that cannot be replicated entirely identical to their reference biologics due to the nature of variability in the living systems and manufacturing techniques they are produced in.8 These inherent characteristic differences in biosimilars are the source of concern for potential safety and efficacy issues involving their pharmaceutical quality and properties of indication extrapolation, interchangeability, and immunogenicity (Table 1). Extrapolation of clinical data allows a biosimilar to be approved for therapeutic indications for which it has not been clinically