Dermatologists’ Perspectives on Biosimilars

Twenty percent of respondents would not prescribe a biosimilar for an FDA-approved indication. Respondents were most likely to prescribe a biosimilar when it is mandated by payers (55%) and for new patients (31%). Fourteen percent of respondents were not likely to prescribe a biosimilar for any patient (Figure 1).  

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 (Figure 2). Thirty-five percent of respondents felt moderately or extremely knowledgeable about biosimilar interchangeability (Table 2).

There is hesitancy by dermatologists to prescribe biosimilars for indications that have been granted FDA approval, with a fifth of respondents stating they would not prescribe biosimilars. The average time to FDA approval for biologics is 12 years, and eight for biosimilars, and both share a similar approval process.⁸ Dermatologists express a greater concern for the abbreviated FDA approval for biosimilars than other specialists, believing it impacts safety.⁷ Concerns may also stem from the recent introduction of biosimilars for skin disorders.³ Long-term safety and efficacy information for biosimilars is limited. Studies for psoriasis are limited to 52- and 55-week periods, while studies for HS are limited to international studies with small sample sizes.^9-13

Knowledge of biosimilar interchangeability and the state laws that govern biosimilar substitution is also a barrier to biosimilar adoption. Only a third of respondents endorsed feeling moderately or extremely knowledgeable about biosimilar interchangeability. Although interchangeable biosimilars have comparable efficacy to their reference product and meet additional requirements for FDA approval compared to other biosimilars, only about half of respondents were likely or very likely to prescribe a biosimilar with an FDA interchangeability indication.² Uncertainty of state laws for interchangeability and substitution limit biosimilar adoption by placing the burden of understanding prescribing and substitution guidelines on the dermatologist and the pharmacist filling the prescription.¹⁴

Our survey also identified organizational and patient factors that increased dermatologists' willingness to prescribe a biosimilar. Organizational factors include payor mandates. This may benefit patients as biosimilars cost up to 30% less than their reference biologic, which can exceed $10,000 for a single dose.¹⁵ Respondents were also more willing to prescribe a biosimilar for new patients.  Dermatologists may believe biosimilars are more effective in new patients who are treatment naïve. Alternatively, this may be evidence of dermatologists’ hesitancy to switch established patients from a biologic to a biosimilar. However, nonmedical switches from a biologic to a biosimilar for psoriasis are supported by the biosimilar working group of the International Psoriasis Council.¹⁶ In addition, nonmedical switches in psoriasis and HS do not impact clinical responses to therapy.^11,17