US Physicians Still Need Education on Biosimilars
SERMO poll highlights knowledge gaps.
Nine out of ten speciality physicians in the United States would switch an existing patient from an original biologic to a biosimilar, says a survey of 1,201 US specialty physicians.
Conducted by doctor portal SERMO on behalf of the non-profit Biosimilars Forum, the survey found that 91% of respondents would consider switching if it helped the patient gain access to medication while 82% believed biosimilars will expand treatment options and provide savings to patients and the healthcare system.
Cost is inevitably an issue with high-priced therapies like biologics, says Hillel Cohen, Executive Director, Scientific Affairs for Novartis’ generics subsidiary Sandoz, and lead study author of the study. “These are expensive products – there’s no question about that – and we’re hopeful that, by bringing biosimilars to the market, there will be competition,” he adds. “Good things happen when you have competition. Clearly, the reason for the existence of biosimilars is to increase access and to make these products more affordable to the masses.”
The 19-question survey examined physicians’ understanding and perceptions of critical quality attributes of biologics, safety and efficacy, biosimilarity, extrapolation, interchangeability, approval requirements and processes, and value to patients.
While the majority of healthcare stakeholders were familiar with the concept of biosimilars – over three-quarters (77%) of respondents had heard the term in the month prior to the survey – the survey identified notable gaps in their knowledge.
Importantly, the survey found that many respondents did not understand various key concepts around development, application and use of biosimilars, and highlighted five major knowledge gaps:
- Defining biologics, biosimilars and biosimilarity
- Understanding the approval process and the totality of the evidence used to evaluate biosimilars
- Appreciation that the safety of biosimilars is expected to be the same as the originator biologic
- Understanding how decisions are made for extrapolation of indications
- Defining interchangeability and the related rules regarding pharmacy-level substitution.
“Education will help physicians and healthcare professionals have a better understanding and knowledge of biosimilars, so that they feel comfortable about administering them to patients when appropriate,” says Cohen.
One area where more education is needed is around the concept of extrapolation – the process by which a biosimilar may be approved in indications where its reference biological product is already licensed without head-to-head clinical comparison.
While 60% of survey respondents understand that to be approved as ‘interchangeable’, a biosimilar must be shown to be safe and effective for back-and-forth switching with no negative impacts to safety or efficacy. However, only 12% of the physicians trusted extrapolation and almost 80% do not agree – or do not realize – that an FDA designation of interchangeable may enable a pharmacist to switch between the originator biologic and biosimilar, and vice versa.
A little more than half of physicians surveyed knew that, in order to be approved, the US Federal Drugs Administration (FDA) must find a biosimilar to be equally effective (62.3%) and safe (57.2%) when compared with the originator biologic. Fewer than half of the respondents (44.8%) believed that biosimilars were safe and appropriate for use in existing patients as well as naïve patients.
Despite this, nearly three-quarters (74.5%) of survey respondents trusted the FDA’s biosimilar approval decisions, an important factor considering that four biosimilars have already been approved and there are more than 60 in development.
To tackle the education of healthcare professionals, the Biosimilars Forum launched the Partnership for Biosimilar Education and Access, providing evidence-based education for healthcare professionals, patients and the public. “The Forum will use the survey results to provide education on the key concepts of biosimilars, as we advance our mission to encourage awareness, access and adoption of these important medicines,” says Cohen.
He stresses the forum’s interest in working with stakeholders across the healthcare sector, including patient groups and professional organizations. “We will provide them with non-biased, science-based information about the biosimilar pathway and various concepts, which will hopefully help to educate those groups so they, in turn, can educate their membership. It is something that’s going to take some time but many of us feel that there’s already been some movement.”
Cohen argues that, from a patient perspective, it is vital to maintain associated patient services when switching to a biosimilar, as patients value this level of service.
Meanwhile, as physicians gain more experience of working with biosimilars, Cohen is hoping they will spread the word. “We would like to think that physicians will be sharing their experiences. Over time, it creates a sense within the physician community of what other peer physicians think about these products and what their experiences have been,” he says.
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