The EMA has adopted a new policy guideline for biosimilars that it expects to announce within a couple of weeks. EMA watchers expect the agency to be conservative in its approach - for example requiring separate clinical trials for different diseases addressed by the same antibody. The guideline is entitled, "Similar Biological Medicinal Products Containing Monoclonal Antibodies". It will be relased for a 5-month consultation period.
The EMA's press release states the guideline lays down the nonclinical and clinical requirementsfor MAb-containing medicines claiming to be similar to one on the market. The expected clinical testing provision to establish safety and efficacy of new biosimilars is expected to drive up costs and make biosimilar applications the province of only the larger competitors for now - like Teva, Sandoz or Hospira. See Fierce Biotech.
Posted by Bruce Lehr November 21st 2010.