The current reflection paper on similar medicinal products containing recombinant interferon alpha provides recommendations for the non-clinical and clinical development of recombinant interferon alpha claimed to be similar to a reference product already authorised in the European Union (EU). This reflection paper was published in April 2009. Since then, no products containing biosimilar interferon alpha have been licensed in the EU. It is proposed to update the guidance based on the experience gained with marketing authorisation applications of reference products and scientific advice on biosimilar interferon alpha.

 

 

Posted on the EMA website on 4 January 2016