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.
Rheumatologists want to evaluate long-term safety of biosimilars
Biosimilars/General | Posted 27/03/2015 0 Post your comment
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
Related article
UK outlines process for developing biosimilars guidances
Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.
Copyright – Unless otherwise stated all contents of this website are © 2015 Pro Pharma Communications International. All Rights Reserved.
Source: BSR
Research
Long-term real-world safety experience of biosimilars confirms concept of biosimilarity
Budget impact analysis of Rixathon introduction in Chile for non-Hodgkin lymphoma
Most viewed articles
The best selling biotechnology drugs of 2008: the next biosimilars targets
Global biosimilars guideline development – EGA’s perspective
Comments (0)
Post your comment