Brussels, 20 April 2006
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. 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.
Commission Vice President Günter Verheugen stated: “Biosimilar medicines offer new opportunities, both for the growth of our generic industry and for the control of national healthcare expenditure. 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 patients.”
Innovative substances enjoy a standard period of market exclusivity under patent law of up to twenty five years. Besides, trials and tests leading to the authorizations as medicines are covered by a period of data protection following pharmaceutical legislation of up to eleven years after authorizations of a medicine. After expiry of these periods, other companies have the chance to access the market with generics, or, from now on, as biosimilars.
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.
They therefore cannot be regarded and regulated as generics. Besides, biosimilars are, like other biotech medicines, not easy to produce and sensitive to manufacturing changes. A specific framework had to be put in place to regulate these products.
Since the adoption of the revised EU pharmaceutical legislation in 2004, the Commission has been working proactively to establish a comprehensive regulatory framework for the evaluation, authorisation and monitoring of biosimilar products. In addition, scientific guidelines on the various quality, pre-clinical and clinical aspects that are specific to biosimilars are being developed by the European Medicines Agency (EMEA).
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. 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.
Additional information on the marketing authorisation for Omnitrope can be found at:
http://pharmacos.eudra.org/F2/register/register.htm
Additional information on the EMEA scientific guidelines regarding biosimilars can be found at:
http://www.emea.eu.int/htms/human/biosimilar/biosimilarfin.htm
Item source: IP/06/511 Date: 20/04/2006