♦ Eight major biologicals are facing combined losses of $15 billion when their patents expire, but the short-term prospects for biosimilars is mixed.
♦ The first biosimilar medicines have been approved in the EU, yet there are still some barriers on the way to market.
♦ Unlike the EMEA, the FDA has not applied comparability guidance to bisoimilars leaving no clear US regulatory pathway for approval of "follow-on" biologics; some observers claim that the agency is waiting for politicians to drive the process.
♦ The technical requirements for innovative product approvals have been harmonized by the ICH and the same now needs to be done for biosimilars.
♦ Eventually biosimilars will become as accepted as chemical generics are today.