| ■ EU guidelines clear way for biosimilar antibodies | 2010.11.26 |
| European regulators on Friday set out broad guidelines for the approval of biosimilar antibody drugs, including lower hurdles than for new medicines and allowing the possibility of different diseases being addressed by the same copy antibody. The long-awaited guidelines pave the way for cheaper copies of multi-billion-dollar medicines used to treat cancer and other serious diseases, although analysts said the requirements would still limit competition to a few well-funded companies. The European Medicines Agency said drugmakers would have to establish that a generic was not inferior to the reference antibody -- a lesser requirement than for a new non-generic drug, with deviations from guidelines warranted as long as they could be scientifically justified. |