Awareness of Biosimilars High Among Irish Specialist Physicians, Pharmacists; Less So Among GPs

A new survey assessing awareness of and attitudes about biosimilars among medical specialists and pharmacists in Ireland found that a majority of such experts say that they are familiar or very familiar with the term “biosimilar,” but many general practitioners (GPs) were either unable to define or had never heard the term. Study authors Joan O’Callaghan, School of Pharmacy, University College, Cork, Ireland, and colleagues published the results of their survey online in the June 27, 2017 issue of Regulatory Toxicology and Pharmacology.

The study’s authors invited physicians to complete a questionnaire during April and May of 2016, and community pharmacists received a postal questionnaire in August of 2015. Responses were received from 268 GPs, 109 medical specialists, and 143 community pharmacists. The final analysis included responses from 102 medical specialists, 254 GPs, and 125 community pharmacists. Medical specialists included dermatologists, endocrinologists, gastroenterologists, hematologists, nephrologists, neurologists, oncologists, and rheumatologists.

Many medical specialists claimed to be very familiar, with a complete understanding (44%), or familiar, with a basic understanding (41%), of the term “biosimilar.” Although familiarity among medical specialists was high, the researchers found that this level of familiarity was not consistent across the 3 professions surveyed. GPs were the least familiar with the term, with 1 in 4 saying that they had never heard the term biosimilar—possibly because GPs are not directly involved in the prescribing of biological drugs. “However, GPs are certainly involved in the treatment of patients receiving biological medicines; therefore it is important that GPs are informed about biosimilars,” the authors note.

With 1 in 5 healthcare professionals who had previously heard the term “biosimilar” responding that they believed biosimilars to be the same thing as generic medications, the authors questioned the level of understanding of biosimilars among some healthcare professionals, and said that the survey exposed some misconceptions about fundamental regulatory principles concerning biological drugs and biosimilars that should be better communicated to Irish healthcare professionals.

The specialists indicated they had concerns about biosimilars that range from slight to extreme in relation to:

• traceability (62%)
• quality (73%)
• safety profile (78%)
• efficacy profile (79%)
• immunogenicity (81%)
• efficacy in extrapolated indications (84%)

Most specialists surveyed (>95%) opposed pharmacist-led substitution of biological drugs, though some thought it could be appropriate if agreed to by the clinician in advance. In addition, specialists who prescribe biosimilars (n = 43) were more likely to do so on treatment initiation (67%) rather than in a switch from an originator medication to a biosimilar (28%).

The authors noted that, in Ireland, unlike other countries, there is currently no national guidance in relation to switching from an innovator drug to a biosimilar; if biosimilar uptake is to be encouraged in Ireland, further guidance about switching and how best to manage this practice may be needed. “Notably, 19% of medical specialists who currently prescribe biosimilars indicated that they would be likely to switch to a biosimilar when a patient's response to the reference medicine was inadequate,” the authors said. This response highlights the need to inform prescribers that biosimilars are equivalent treatments to their reference medicines, offering comparable patient outcomes.

Another challenge that the survey exposed is that only 14% of pharmacists stated that they were comfortable with substitution without prescriber agreement. As pharmacists are ultimately responsible for the implementation of substitution policies at the pharmacy level, the survey results suggest that pharmacists have reservations about assuming responsibility for substitution without prescriber agreement, which is a situation that must be addressed.

The study’s authors conclude that targeted communication to medical specialists via professional societies, published literature, and educational events could help to reduce the information gap about biosimilar medicines. The most appropriate communication channels for GPs and community pharmacists are not as clear, but communication with professional societies may facilitate the transfer of knowledge to these professionals.