Rheumatologists want to evaluate long-term safety of biosimilars

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Rheumatologists want to evaluate long-term safety of biosimilars

Biosimilars/General | Posted 27/03/2015 0 Post your comment

One of the biggest challenges for biosimilar companies is to convince physicians to use biosimilars instead of their well-known biological counterparts. One of the issues that physicians see as a concern is the long-term safety of biosimilars, a concern that is thought could slow down the adoption of biosimilars. This issue has even prompted certain organizations to embark on programmes that seek to provide definitive evidence on the issue.

The British Society of Rheumatology (BSR) is calling for clinicians to register patients with the BSR Biologics Registers in order to develop the long-term evidence base required to provide patients and clinicians with the necessary assurances on safety and effectiveness of biosimilars coming on to the UK market.

BSR maintains two patient registers for biologicals, one for patients with rheumatoid arthritis and the other for patients with ankylosing spondylitis. BSR is recommending that all patients starting or switching to biosimilars should be registered with the BSR Biologics Registers to allow the capture of the same robust systematic data on adverse effects that have been collected for the reference medicines. The data, says the society, will ultimately allow clinicians and patients to make informed choices about treatment options.

The BSR recommendation comes as part of its position statement on biosimilars, which the society released in February 2015, and in which the BSR recommends against switching to biosimilars. The society does, however, admit that the ‘introduction of biosimilars has the potential to provide patients with access to a wider range of more cost-effective treatments to manage their conditions’. Although it also states that ‘their introduction also comes with a degree of uncertainty’.

The BSR position statement recommends:

Prescription by brand name
Prescription for clinical reasons
Substitution only with the consent of the prescribing clinician
Decisions made in partnership with the patients
Registration with the BSR Biologic Registers
The need for awareness raising on biosimilars
Biosimilars should undergo robust technology appraisals
The need for better information sharing across the care pathway
Local tenders involving biosimilars should seek to source a range of products

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Source: BSR