EMA organizes workshop on biosimilars guidelines

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EMA organizes workshop on biosimilars guidelines

Home/Guidelines | Posted 27/09/2013 0 Post your comment

The European Medicines Agency (EMA) announced on 25 September 2013 that the agency would be organizing a workshop on biosimilars.

The workshop, which will be held on 31 October 2013 in London, UK, is being organized as part of EMA’s public-consultation exercise on its three draft revised overarching guidelines on biosimilars [1, 2].

Draft guideline on similar biological medicinal products
Date: 22 May 2013
End of consultation (deadline for comments): 31 October 2013
http://www.ema.europa.eu/docs/en_GB/document_library/
Scientific_guideline/2013/05/WC500142978.pdf

Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1)
Date: 24 May 2012
End of consultation (deadline for comments): 30 November 2012
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/05/WC500127960.pdf

Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues
Date: 3 June 2013
End of consultation (deadline for comments): 30 November 2013
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/06/WC500144124.pdf

The workshop will bring together regulators and stakeholders to discuss the three draft revised guidelines, including comments received so far during the public consultation.

Presentations and discussions will focus on the main topics identified through the comments received, including:

the choice of the reference product
the concept of quality target product profile
the stepwise approach to non-clinical programme
biosimilar specific clinical model and endpoints.

Stakeholders interested in participating in the workshop can send their request to bmwp.secretariat@ema.europa.eu by 10 October 2013 using the registration form available on the EMA website: (http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/09/WC500150502.doc). There are limited places available and places will be offered on a first come, first served basis.

Related article

EU guidelines for biosimilars

References

1. GaBI Online - Generics and Biosimilars Initiative. Revision of guideline on clinical and non-clinical issues for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Sep 27]. Available from: www.gabionline.net/Guidelines/Revision-of-guideline-on-clinical-and-non-clinical-issues-for-biosimilars

2. GaBI Online - Generics and Biosimilars Initiative. EMA issues draft revision of overarching biosimilar guidelines [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Sep 27]. Available from: www.gabionline.net/Guidelines/EMA-issues-draft-revision-of-overarching-biosimilar-guidelines

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Source: EMA