EC praises advent of biosimilars

Two decades after the first drugs produced by biotechnological means arrived on the EU market, a number of these patents are expiring. This means that the first 'biogenerics' – called biosimilars – are about to enter the European market. The European Commission said that it supports this development, given that biosimilar alternatives are less costly while being safe and efficient, like the 'original' biotech drugs.

The Commission has now granted the first marketing authorization for a biosimilar product, namely Novartis' Omnitrope, which is intended for the treatment of growth disturbance and growth hormone deficiency in children and adults.

“Biosimilar medicines offer new opportunities, both for the growth of our generic industry and for the control of national healthcare expenditure,” said Commission vice president Gunter 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 patients.”

Unlike standard generics, which are 'copy' versions of existing chemical drugs that have run out of patent protection, biosimilar products are usually complex biological molecules claimed to be similar – but not identical – to already authorized biotech medicines.

They therefore cannot be regarded and regulated as generics. In addition, 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 to establish a comprehensive regulatory framework for the evaluation, authorization and monitoring of biosimilars. Scientific guidelines on the various quality, preclinical and clinical aspects that are specific to biosimilars are also being developed by the European Medicines Agency (EMEA).

These specific provisions 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.