EMA guidance points up challenges to biosimilar interferon beta developers

Jan 20 2012

• By Ian Schofield

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The European Medicines Agency has issued a draft guideline for companies wanting to develop biosimilar versions of interferon beta for the treatment of multiple sclerosis. As with all biosimilars, there will be a number of challenges for developers of interferon beta, not least the complexity of the disease and the substance, safety issues, and differences among the available reference products.

The European Medicines Agency has issued a draft guideline for companies wanting to develop biosimilar versions of interferon beta for the treatment of multiple sclerosis. As with all biosimilars, there will be a number of challenges for developers of interferon beta, not least the complexity of the disease and the substance, safety issues, and differences among the available reference products.

Recombinant interferon beta is currently the mainstay of disease-modifying therapies in MS, which is one of the most common causes...

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