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Published on 24 January 2012

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EMA releases biosimilar interferon-beta guide

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The European Medicines Agency has released a guideline on how pharmaceutical companies should test biosimilar medicines containing interferon beta for public consultation.

The guideline covers the non-clinical and clinical requirements for interferon beta-containing medicines that claim to be similar to another interferon beta already on the market.

Interferon beta-containing medicines are currently used to treat patients with multiple sclerosis.

The guideline was adopted by the Agency’s Committee for Medicinal Products for Human Use (CHMP) in December 2011. It is open for consultation until the end of May 2012.



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