EU to set new biosimilar drug rules by mid-year

(Ref: MSNBC)
  • The European Medicines Agency's (EMA) new executive director Guido Rasi said that the regulator would issue its final guidelines on biosimilar monoclonal antibodies in March or April, as reported Friday on MSNBC.
  • Draft guidelines on the approval process for biosimilar versions of other therapies will follow in May or June, which will include low molecular weight heparin, such as Sanofi's Lovenox (enoxaparin), and modern insulin analogues.
  • Rasi indicated he believed that biosimilars would play an important role in future European healthcare, as cheaper alternatives to original branded products, although he noted that many drugmakers are also developing next-generation versions of medicines which might limit the competition.
  • "I don't really have concern about the level of safety [of biosimilars]," he said, adding: "What is a question-mark is efficacy, since many biotechnology products are now being improved."
  • Some biosimilars have already been authorised in Europe, including versions of human growth hormone and the anaemia treatment EPO.