Brussels, 21 Apr 2006
The first ever biosimilar drug - developed with complex biological molecules that are similar, but not identical, to biotechnology medicines already authorised - has been approved for marketing within the EU.
Two decades after the first biotechnology drugs arrived on the EU market, a number of their patents are expiring. This leaves a door open for the development of biogenerics, or biosimilar medicines. The European Commission supports the development of biosimilar alternatives, as they are less costly than the original biotech drugs, but just as safe.
'Biosimilar medicines offer new opportunities, both for the growth of our generic industry and for the control of national healthcare expenditure,' said Enterprise and Industry Commissioner Günter Verheugen. 'Nevertheless, these complex products must comply with the same rigorous standards for quality, safety and efficacy as for any other medicine, for the benefit of European patents.'
The first drug to be authorised is Omnitrope, which can be used for the treatment of growth disturbance and growth hormone deficiency in children and adults. The drug was evaluated and awarded a positive opinion by the European Medicines Agency in January 2006.
Innovative substances enjoy a period of market exclusivity under patent law of up to 25 years. After the expiry of these patents, other companies have the chance to access the market with generics, or biosimilars.