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Biosimilar Knowledge Lacking Among Biologic-Prescribing Physicians

Physicians may lack knowledge about fundamental information regarding biosimilars.
 
Published Online: Nov 09,2016
Laurie Toich, Assistant Editor
Results from a recent survey indicate that a majority of specialty physicians have knowledge gaps when it comes to biosimilars.

While a majority of the physicians heard about the drugs, further knowledge was not shared by all physicians included in the survey. The survey, which was created by the Biosimilars Forum and published in Advances in Therapy, asked 1201 physicians 19 questions regarding biosimilars.

These physicians had specialties in disease states that are high prescribers of biologic drugs, such as dermatologists, gastroenterologists, hematologist-oncologists, medical oncologists, nephrologists, and rheumatologists. They discovered that 76.8% of physicians had heard about biosimilars within a month before the survey.

However, serious knowledge gaps were also prevalent. According to the survey, there were 5 major gaps:
  • defining biologics, biosimilars, and biosimilarity
  • understanding the FDA approval process of biosimilars
  • the safety profile of the biosimilar is the same as the reference product
  • understanding how the FDA extrapolates indications
  • defining interchangeability and substitution rules
Extrapolation is the process in which a biosimilar gains approval for indications that the reference product has, despite the lack of clinical comparison. The approval is based on extrapolating data obtained with the biosimilar in comparison with the reference product, and each indication sought must be justified. 

Only 12% of respondents said they trusted the extrapolation of the biosimilar indications as the basis to receive approval of other licensed indications of the reference product, the researchers reported.

A majority (60%) of physicians understood that interchangeability meant that the biosimilar was considered safe and effective to be switched without resulting in negative outcomes. Nearly 80% of physicians also did not believe that interchangeability allows pharmacists to switch between the biosimilar and the reference product.

More than half of the physicians also responded that they had knowledge of the FDA finding the biosimilar to be as safe and effective as the reference product. Approximately 44.8% responded that biosimilars are safe and clinically appropriate for use in patients who are treatment-experienced and those who are treatment-naïve, according to the study.

Overall, 74.5% of physicians said that they trust the FDA and their biosimilar approvals. The physicians all seemed to agree that switching a patient to a biosimilar may be appropriate, with 91% saying they would do so if the biosimilar would help patients access their treatments easier.

Since biosimilars are generally not as costly as the reference products, a recent report has disclosed that the introduction of biosimilars could save as much as $110 billion in the US and Europe by 2020. With various research findings that biosimilars can save billions, it is no surprise that 82.2% of respondents said that biosimilars would expand treatment options, and save patients and the health care system money. 

These findings suggest that more educational information is needed among physicians in specialties that prescribe biologics.

“With 4 biosimilars approved by the FDA and more than 60 in development, the survey highlights the need for greater biosimilars education for physicians and healthcare professionals,” said lead study author Hillel Cohen, PhD, executive director, Scientific Affairs, Sandoz Inc. “Education will help physicians and healthcare professionals have a better understanding and knowledge of biosimilars, so that they feel comfortable about administering biosimilars to patients when appropriate.”