According to executive director Guido Rasi, the European Medicines Agency will issue final guideline on biosimilar monoclonal antibodies in March or April with draft guidelines on the approval process for copies of other drugs to follow in May or June. (These will include low molecular weight heparin and modern analogues of insulin.)
Rasi said he believed biosimilars would play an important role in future European healthcare and also noted that many pharmaceutical companies are developing next-generation versions of medicines.
Rasi, "I don't really have concern about the level of safety. What is a question-mark is efficacy, since many biotechnology products are now being improved."
“Biobetters” anyone?