Awareness of biosimilars among U.S. specialty physicians is high but new survey identifies five major knowledge gaps.
The results of a survey show that although the majority of specialty physicians surveyed have heard about biosimilars1, there are notable gaps in their knowledge about biosimilar concepts. The survey, designed by the Biosimilars Forum and conducted by SERMO, a global social network organization for physicians, questioned 1,201 U.S. physicians across specialties that are high prescribers of biologics. The results of the Biosimilars Forum physician survey were published in the journal, Advances in Therapy, and presented on October 27 at the Drug Information Association (DIA) Biosimilars 2016 conference in Washington, D.C.
The survey showed that more than three-quarters (76.8%) of physicians had heard the term biosimilars in the month prior to the survey. However, the survey highlighted five major gaps in the knowledge of many physicians:
- Defining biologics, biosimilars and biosimilarity
- Understanding the approval process and the U.S. Food and Drug Administration's (FDA's) use of totality of evidence to evaluate biosimilars
- Appreciation that the safety profile of a biosimilar is expected to be the same as that of the originator biologic
- Understanding how decisions are made by the FDA for extrapolation2 of indications
- Defining interchangeability3 and the related rules regarding pharmacy-level substitution
"With four 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," says Hillel Cohen, Ph.D., lead study author, 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."
For example, survey questions revealed that most physicians surveyed do not clearly understand the concept of extrapolation as applied to biosimilars with only 12% of survey respondents stating that they trust extrapolation of the studied biosimilar indication(s) as the basis to obtain approval of other licensed indications of the originator product. Almost 60% of respondents correctly understood 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, but almost 80% did not agree, or potentially did 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 know that in order to be approved, FDA must find a biosimilar to be equally effective (62.3%) and safe (57.2%) when compared to the originator biologic. Fewer than half of the respondents (44.8%) believe that biosimilars will be safe and appropriate for use in existing patients as well as naïve patients.
Most physicians trust in and have high regard for the FDA with nearly three-quarters (74.5%) of survey respondents saying that they trust the FDA's biosimilar approval decisions.
Overall, the physicians surveyed expressed a general agreement that switching an existing patient to a biosimilar may be appropriate, with nine in ten (91%) saying they would consider switching a patient from an originator biologic to a biosimilar, as an effective alternative to the originator, if it would help the patient have better access to his/her medications. In addition, 82.2% believe biosimilars will expand treatment options and provide savings to patients and the health care system.
"The Biosimilars Forum launched the Partnership for Biosimilar Education and Access to provide evidence-based education for healthcare professionals, patients and the public," said Cohen. "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."
About the Survey
The 19-question survey was created by the Biosimilars Forum and conducted by SERMO, a global social network organization for physicians, from Nov. 20, 2015 to Jan. 4, 2016. The questions examined physicians' understanding and perceptions of critical quality attributes of biologics; safety and efficacy of biosimilars; biosimilarity; extrapolation; interchangeability; biosimilar approval requirements and processes; and value of biosimilars to patients. The survey also looked at intent to use biosimilars in practice; expected impact of expanded access to biologics and biosimilars on patient costs; and adherence to treatment regimens. Responses were obtained from a total of 1,201 U.S. physicians across specialties that are high prescribers of biologics, including dermatologists, gastroenterologists, hematologist-oncologists, medical oncologists, nephrologists and rheumatologists.
The Biosimilars Forum intends to conduct a similar survey in two to three years with the same design in order to monitor trends in the awareness, knowledge and perceptions of biosimilars over time.
About the Biosimilars Forum
The Biosimilars Forum is a nonprofit organization whose mission is to advance biosimilars in the United States with the intent of expanding access and availability of biological medicines, and improving health care. The founding members of the Biosimilars Forum represent the majority of companies with the most significant U.S. biosimilars development portfolios. BiosimilarsForum.org.
1 A biosimilar medicine is a biologic that is highly similar to an FDA-approved biological medicine, known as a originator biologic. A biosimilar must be (1) be highly similar to the originator biologic notwithstanding minor differences in clinically inactive components and (2) have no clinically meaningful differences in safety or effectiveness compared to the originator biologic. Biosimilars Forum. (2016, March 28). Frequently Asked Questions. Retrieved from: http://www.biosimilarsforum.org/sites/default/files/uploads/biosimilars_faqs_032816opt_0.pdf
2 Extrapolation is the process by which a biosimilar may be approved for one or more indications for which its reference biological product is licensed but for which there was no head-to-head clinical comparison. This approval is based on the extrapolation of the totality of data obtained with the biosimilar molecule in direct comparison to the originator biologic. Every indication for which extrapolation is sought must be scientifically justified. Biosimilars Forum. (2016, March 28). Frequently Asked Questions. Retrieved from: http://www.biosimilarsforum.org/sites/default/files/uploads/biosimilars_faqs_032816opt_0.pdf
3 An interchangeable biologic is a biosimilar that has been demonstrated to produce the same clinical result as its originator biologic in any given patient. In addition, for a product that is administered multiple times to an individual, the risk in terms of safety or diminished efficacy of alternating between use of the interchangeable biologic and its originator biologic is not greater than the risk of using the originator biologic alone. Designation of interchangeability requires additional supporting evidence, which will be further defined by the FDA. An interchangeable biologic may be substituted by a pharmacist for the originator biologic or vice-versa without the intervention of the healthcare professional who wrote the prescription. State laws govern the substitution process, and communication to the healthcare provider who wrote the prescription may be required after the product is dispensed. Biosimilars Forum. (2016, March 28). Frequently Asked Questions. Retrieved from: http://www.biosimilarsforum.org/sites/default/files/uploads/biosimilars_faqs_032816opt_0.pdf.
(Source: PR Newswire)