EMA to revise biosimilar interferon alfa guidance

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EMA to revise biosimilar interferon alfa guidance

Home/Guidelines | Posted 08/01/2016 0 Post your comment

On 4 January 2016, the European Medicines Agency (EMA) released a draft concept paper on the revision of the reflection paper on non-clinical and clinical development of interferon alfa biosimilars. The draft will be released for a three-month consultation period by the pharmaceutical industry and competent authorities of the Member States, as well as by the Committee for Medicinal Products for Human Use (CHMP) and its working parties.

The draft concept paper discusses the revision of the reflection paper ‘Non-clinical and clinical development of similar medicinal products containing recombinant interferon alfa (EMEA/CHMP/BMWP/102046/2006), which came into effect in April 2009 [1]. Since then, no products containing biosimilar interferon alfa have been licensed in the European Union (EU). However, EMA is proposing to update the guidance based on the experience gained with marketing authorization applications of reference products and scientific advice on biosimilar interferon alfa.

Draft concept paper on the revision of the reflection paper on non-clinical and clinical development of similar biological medicinal products containing recombinant interferon alpha or pegylated recombinant interferon alpha
Date: 4 January 2016
End of consultation: 31 March 2016
www.ema.europa.eu/ema/doc_index.jsp?curl=pages/includes/document/document_detail.jsp?webContentId=WC500199346&murl=menus/document_library/document_library.jsp&mid=0b01ac058009a3dc

EMA wants the following aspects to be discussed and covered as appropriate by the revised guideline:

Considerations whether specific aspects with regard to the development of biosimilar pegylated interferon alfa need to be included in the guideline.
Inclusion of the acceptance of a risk-based approach for the non-clinical comparability exercise.
Regulatory expectations to support biosimilar recombinant interferon alfa development without a confirmatory clinical trial.

EMA expects the draft revised guideline to be released for consultation in the second quarter of 2016.

Reference
1. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jan 8]. Available from: www.gabionline.net/Guidelines/EU-guidelines-for-biosimilars

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Source: EMA