European Medicines Agency releases guideline on biosimilar interferon beta for public consultation
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The European Medicines Agency has released a Draft guideline on similar biological medicinal products containing interferon beta 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.
Comments should be provided to bmwp.secretariat@ema.europa.eu using the .