Brussels, 20/04/2006 (Agence Europe) - On 20 April the European Commission granted the first marketing authorisation for a biosimilar product since the adoption of the revised EU pharmaceutical legislation in 2004. The medicament, Omnitrope, is intended for the treatment of growth disturbance and growth hormone deficiency in children and adults. It had been evaluated and given a positive scientific opinion by the European Medicines Agency in January 2006. Omnitrope has been shown by studies demonstrating comparable quality, safety and efficacy to be similar to a reference medicinal product already authorised in the EU, named Genotropin. Unlike standard generics, which are 'copy' versions of existing chemical drugs which have run out of protection, biosimilar products are usually complex biological molecules claimed to be similar - but not identical - to already authorised biotechnology medicines. Unlike generics, where chemical identity has to be proven, biological similarity is assessed following the performance of additional trials, set up on case by case bases. Scientific guidelines on the various quality, pre-clinical and clinical aspects that are specific to biosimilars are being developed by the European Medicines Agency. These specific provisions being part of the pharmaceutical regulatory framework lay down how the biological similarity of the substance to an innovative medicine can be scientifically established, as a precondition for the authorization to market the product in the EU.
The European Generic Medicines Association (EGA) gave a positive welcome to the arrival on this first biosimilar drug onto the market. It is organising its fourth annual conference on this kind of medicine on 18-19 May in London.