Elderly patients in US lack knowledge on biosimilars

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Elderly patients in US lack knowledge on biosimilars

Home/Reports | Posted 10/10/2014 0 Post your comment

A survey conducted by patient advocacy group RetireSafe finds that seniors are largely unaware of biosimilars and that they overwhelmingly support strong patient safeguards and notification of patients and physicians when biosimilar substitution takes place.

The survey, which was carried out in July 2014, questioned 1,467 senior Americans concerning their knowledge of biosimilars.

The results showed that almost all respondents did not know that biosimilars could be substituted for the originator drug (92%) or that they were not exact copies of the originator biological (93%). Almost all respondents (93%) were also not aware that the US Food and Drug Administration (FDA) was considering whether to accept extrapolation of indications for biosimilars [i.e. to approve the biosimilar for the same conditions, e.g. arthritis, cancer, as the originator biological even though it has not been tested in all conditions].

Most respondents thought that in order to ensure safety, biosimilars developers should conduct trials in humans (86%), be required to test the biosimilar in all indications (92%), and give the biosimilar a different name to the originator biological to enable tracking of adverse events (90%).

Most respondents also believed that the physician should be notified when a biosimilar is substituted for the originator biological they prescribed for their patient (91%) and that the patient should also be notified (94%).

Nevertheless, the survey questions had simple yes or no answering options and did not present alternative options. For example, in the case of naming, in the European Union, where biosimilars have been on the market since 2006, both the brand name and International Nonproprietary Name (INN) are used to identify the specific biological product, whether it is an originator product or a biosimilar. To date, EU Member States report that it is not problematic to identify which biological product is subject to which adverse reaction report [1, 2]. This was not given as an alternative to different names for biosimilars in the survey.

The results do, however, show the lack of knowledge surrounding biosimilars in this elderly population and highlight the need for education. Lack of knowledge generally leads to distrust, which could lead to lack of uptake for biosimilars in the US.

References
1. GaBI Online - Generics and Biosimilars Initiative. EU majority says same INNs for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Oct 10]. Available from: www.gabionline.net/Biosimilars/General/EU-majority-says-same-INNs-for-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. Calls for biosimilars to have same INN at WHO meeting [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Oct 10]. Available from: www.gabionline.net/Biosimilars/General/Calls-for-biosimilars-to-have-same-INN-at-WHO-meeting

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Source: RetireSafe