The key topic was ‘the science of extrapolation of indications’, with many related subjects also being covered by the conference [1]. Other topics included the basic principles of biologicals, the EMA overarching guideline, harmonization efforts on biosimilar clinical trials, naming/labelling of biosimilars, the WHO Biological Qualifier proposal, strategic approaches on uptake of biosimilars in France, Germany, Italy, Spain, Sweden and the UK (see separate reports from different countries published in GaBI Journal), Norway’s biosimilar infliximab experience [2], and the global view of biosimilars regulatory approval, with a focus on Brazil, Canada [3] and the US.

Mr Didier Laloye from Hospira France gave a presentation covering biosimilars uptake in France, which highlighted the complexity of the situation in the country regarding reimbursement, pricing, substitution and incentives for biosimilars.

A presentation by Dr Peter Richardson, Head of Quality Office, Specialised Scientific Disciplines Department, at EMA, explored the use of statistical methodology for comparative assessment of quality attributes, global development and the increasing use of non-EU comparators, and the variety of clinical approaches proposed to demonstrate biosimilarity. A global development approach was proposed in 75% of the scientific advice requests for biosimilars in 2014.

In a presentation by Dr Jian Wang from Health Canada titled ‘Biosimilars in Canada: learning from the approval of the first mAb and future outlook’, the reasons for the agency’s refusal to extrapolate inflammatory bowel disease indications to the infliximab biosimilar (Remsima/Inflectra) [4] were outlined.

In the session chaired by Dr Sumant Ramachandra on ‘The evolving biosimilar paradigm: from a science-driven conceptual approach to a science-driven knowledge-based approach’ the science of extrapolation was also discussed and highlighted as a critical issue for biosimilars makers.

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References

1. Derbyshire M. European biosimilars conference highlights extrapolation as key issue. Generics and Biosimilars Initiative Journal (GaBI Journal). 2015;4(3):149. doi:10.5639/gabij.2015.0403.032
2. Asbjørn M. Norway, biosimilars in different funding systems. What works? Generics and Biosimilars Initiative Journal (GaBI Journal). 2015;4(2):90-2. doi:10.5639/gabij.2015.0402.018
3. Pen A, Klein AV, Wang J. Health Canada’s perspective on the clinical development of biosimilars and related scientific and regulatory challenges. Generics and Biosimilars Initiative Journal (GaBI Journal). 2015;4(1):36-41. doi:10.5639/gabij.2015.0401.009
4. GaBI Online - Generics and Biosimilars Initiative. Subsequent entry biologics approved in Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Sep 24]. Available from: www.gabionline.net/Biosimilars/General/Subsequent-entry-biologics-approved-in-Canada

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