EMA draft guidance points out challenges to biosimilar interferon beta developers
This article was originally published in SRA
Executive Summary
The European Medicines Agency has issued a draft guideline for companies wanting to develop biosimilar versions of interferon beta for the treatment of multiple sclerosis1,2. 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.