On 5 September 2019, Crohn’s and Colitis Canada announced that it had updated its position statement on the use of biosimilars for inflammatory bowel disease (IBD). The updated position statement was published after the organization reviewed its position on biosimilars particularly related to non-medical switching policy.
Canadian IBD charity updates biosimilar position statement
Biosimilars/General | Posted 13/09/2019 0 Post your comment
Crohn’s and Colitis Canada is a national, volunteer-based charity focused on finding cures for Crohn’s disease and ulcerative colitis. The research-based organization has updated its position statement based on cross-Canada surveys of patients and caregivers, gastroenterologists and IBD nurses, for which it has also released a report.
The Crohn’s and Colitis Canada Position Statement asserts that:
• Biosimilars are a safe and effective treatment for people with Crohn’s disease and ulcerative colitis (the two main forms of IBD).
• The decision to switch a patient from an originator biological to its biosimilar should be based on patient/doctor choice.
• Non-medical switching from an originator biological to its biosimilar is not in the best interest of patients.
Mina Mawani, President and CEO of Crohn’s and Colitis Canada explained that the organization’s ‘position that a non-medical switch policy is not in the best interest of patients’ is based on what the organization has ‘learned these past few months’. She added that the charity is ‘very pleased’ to share its updated position and the studies that it developed ‘to help inform policy across Canada’.
The Position Statement offers details on factors that the organization say, ‘must be considered in the event of the implementation of a non-medical switch policy’. These include:
• critical patient exemptions
• required patient supports
• extraordinary monitoring requirements
• significant communication and education needs.
Ms Mawani says that the charity has ‘serious concerns about the potential for multiple non-medical switching’, which she says that Crohn’s and Colitis Canada cannot support. The charity also understands that ‘such policies are being considered because of fiscal pressures’. However, it says that ‘should the price differential between [originator biologicals] and biosimilars be eliminated, a non-medical switch should not be considered by policymakers at all’.
Canada has one of the highest rates of Crohn’s and colitis in the world. Today, more than 270,000 Canadians have Crohn’s and colitis, a number that is expected to increase to over 400,000 within the next decade.
European IBD specialists have come out in support of switching to biosimilars following appropriate discussion between physicians, nurses, pharmacists and patients, and according to national recommendation . The European Crohn’s and Colitis Organization (ECCO) based its recommendation on the current regulatory guidance from the European Medicines Agency and the evidence about efficacy and safety of biosimilars in IBD patients.
1. GaBI Online - Generics and Biosimilars Initiative. European IBD specialists support switching to biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Sep 13]. Available from: www.gabionline.net/Biosimilars/General/European-IBD-specialists-support-switching-to-biosimilars
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Source: Crohn’s and Colitis Canada