Complex clinical trial designs and manufacturing steps required for biosimilars treating multiple sclerosis (MS) in Europe will likely stave off market entry for at least several years, drug consultants told Biopharm Insight.
The European Medicines Agency (EMA) recently issued draft non-clinical and clinical requirements for the development of biosimilar interferon-beta products.
The three, first-line, interferon-beta treatments approved in the EU for MS are Biogen Idec’s Avonex, Merck Serono’s Rebif and Bayer’s Betaseron; they differ with respect to their molecular structures, injection routes, dose recommendations and MS indications.
EMA requires a single, one-year trial with an MRI primary endpoint in relapsing-remitting MS (RRMS) patients as the basis for biosimilar approval. The agency further allows the results to be extrapolated to similar conditions such as clinically isolated syndrome.... Read More - http://www.msrc.co.uk/index.cfm/fuseact ... ageid/2479