Biotech medicines: first biosimilar drug on EU marketBiotech medicines: first biosimilar drug on EU market

The first Biogenerics, – called biosimilar medicines – are about to enter the EU pharmaceutical market

Two decades after the first drugs produced by biotechnological means (as opposed to “normal” chemical pharmaceuticals) arrived on the EU market, a. number of these patents are expiring.This means that the first ‘biogenerics’ – called biosimilar medicines – are about to enter the EU pharmaceutical market.

The European Commission supports this development, given biosimilar alternatives are less costly while being safe and efficient like the “original” biotech drugs.

Omnitrope
The Commission has now granted the first marketing authorisation for such a biosimilar product. 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.
Press release from the European Commission