EMA announced on 31 May 2012 that it had released a revised guideline for public consultation describing how pharmaceutical companies should address the quality aspects of biosimilar medicines.
EMA revised guideline on quality of biosimilar medicines open for comments
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Posted 08/06/2012
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The guideline is intended to update the previous guidance from 2006 and explains the requirements for the manufacture and comparability testing for biological medicines claiming to be similar to another medicine already on the market, i.e. biosimilars.
The revised guideline was adopted by the Agency’s Committee for Medicinal Products for Human Use in May 2012 and is open for consultation until the end of November 2012.
Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1)
Effective date: 31 May 2011
End of consultation: 30 Nov 2012
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/05/WC500127960.pdf
Comments on the revised guideline can be sent to bwp.biosimilar.revision@ema.europa.eu using the form for submission of comments at the EMA website.
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