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The EMA released a draft guidline on biosimilar interferon beta for public consultation

2012.01.28

This guideline lays down the non-clinical and clinical requirements for interferon beta (IFN-β)
26 containing medicinal products claiming to be similar to another interferon beta already marketed. The
27 non-clinical section addresses the pharmaco-toxicological requirements and the clinical section the
28 requirements for pharmacokinetic, pharmacodynamic, efficacy and safety studies as well as
29 pharmacovigilance aspects.

http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/01/WC500120652.pdf

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