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EMA issues revised version of biosimilars quality guideline Posted 04/07/2014

On 26 June 2014, the European Medicines Agency (EMA) published the new version of its biosimilars quality guideline, which will revise the agency’s 2005 overarching guideline on the quality of similar biological medicinal products. The guideline will come into effect by the end of the year.

The guideline addresses the requirements regarding manufacturing processes, the biosimilar comparability exercise for quality, considering the choice of reference biological, analytical methods, physicochemical characterization, biological activity, purity and quality attributes for relevant specifications of the biosimilar.

The guideline replaces EMA’s ‘Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (EMEA/CHMP/BWP/49348/2005)’.

Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1)
Effective date: 1 December 2014
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/06/WC500167838.pdf

The final guideline, which will replace EMEA/CHMP/BWP/49348/2005, comes into effect on 1 December 2014.

EMA is also revising two other overarching guidelines for biosimilars:

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

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

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EMA issues draft revision of overarching biosimilar guidelines

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Source: EMA

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