How interferon beta maxed: a tale of holey data, wannabes and biodifferents
This article was originally published in Scrip
If regulator’s documents guide a market that doesn’t exist, is it guidance? Or is it a tree falling in a silent forest? Case in point: The European Medicines Agency has put out guidelines to help developers of biosimilar interferon beta products, the main market for which is in multiple sclerosis. Virtually none of that market is open for biosimilar products.