In April 2019, an advocacy group for patients with breast cancer in Canada – the Canadian Breast Cancer Network (CBCN) - published recommendations related to use of biosimilars in a white paper, entitled ‘Breast Cancer & Biosimilars Recommendations on Use, Implementation and Patient Communications’. These recommendations were informed by insights collected from virtual roundtable discussions with patients and medical oncologists.
The roundtable discussions found that breast cancer patients were generally eager to have as much control as possible over their treatment decisions, but that they trust their oncologists to use the best evidence-based treatment protocol to manage their disease. Discussions with oncologists found a range of excitement, reluctance and complacency associated with the use of biosimilars for the treatment of breast cancer. Nevertheless, the oncologists were generally confident in the decisions of Health Canada and other cancer agencies and believed that biosimilars would function in the same way as biologicals.
In light of the findings from the patient and physician discussions [1], the CBCN has five key recommendations regarding the use of biosimilars:
• Patient groups, cancer care agencies and healthcare professionals need to educate patients about biosimilars.
• Physician associations and medical institutions need to educate healthcare professionals about the role of biosimilars in breast cancer treatment, including providing research and data from other countries.
• Once more than one biosimilar is available for the treatment of breast cancer, Health Canada will need to provide guidance for issues like naming conventions, computer coding and identification of the ideal stage and type of breast cancer.
• It should be the decision of the patient and provider whether to use an originator biological or a biosimilar, and provinces should not mandate interchangeability. Patients who are being successfully treated with a reference biological should not be switched to a biosimilar.
• Health Canada should regulate provinces, institutions and biosimilar manufacturers to conduct post-marketing surveillance and disclose data on treatment outcomes.
These recommendations follow the American Society of Clinical Oncology’s 2018 position statement on biosimilars in oncology. The statement reflects the society’s views on issues such as naming, labelling, safety and efficacy, interchangeability, switching and substitution, and prescriber and patient education [2].
There are increasing efforts globally to raise awareness and encourage the use of biosimilars. The Canadian Agency for Drugs and Technologies in Health investigated initiatives to promote the use of biosimilars in Australia, New Zealand, Finland, France, Germany, The Netherlands, Norway, the UK and the US. It found several educational and awareness initiatives at the national or organization level in most of the countries studied [3].
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References
1. GaBI Online - Generics and Biosimilars Initiative. Patient and provider views on biosimilars to treat breast cancer [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 May 24]. Available from: www.gabionline.net/Biosimilars/General/Patient-and-provider-views-on-biosimilars-to-treat-breast-cancer
2. GaBI Online - Generics and Biosimilars Initiative. ASCO issues position statement on biosimilars in oncology [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 May 24]. Available from: www.gabionline.net/Biosimilars/General/ASCO-issues-position-statement-on-biosimilars-in-oncology
3. GaBI Online - Generics and Biosimilars Initiative. International promotion and education for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 May 24]. Available from: www.gabionline.net/Reports/International-promotion-and-education-for-biosimilars
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