2nd quarter 2006

First biotech generic approved

The US Food and Drug Administration (FDA) has approved the first generic biotech medicine (biopharmaceutical). The Swiss company Novartis can now market the growth hormone Omnitrope, produced by its subsidiary Sandoz, in the USA. Omnitrope is similar to human growth hormone (hGH) and has been developed for the treatment of growth disorders and growth hormone deficiencies in children.

Approval has been given for Omnitrope as a "follow-on protein product" — the official designation for these generic biopharmaceuticals, which are also referred to as "biosimilars". The Swiss Group submitted their application for marketing authorisation to the FDA in 2003, in order to bring the product on to the market as soon as the patent of the original product expired. The US government agency, however, took its time over the approval. One reason for this was that the demonstration of sameness with the originator product was not a priori assured for Omnitrope. This sameness is easy to establish for conventional, chemically-synthesised drugs but in the case of biologically-produced substances, such as Omnitrope, very slight changes in manufacture can lead to significant differences in the medicine. This argument has been used by some manufacturers and holders of original product patents to support the view that biosimilars have to be treated as completely new products as far as the application for marketing authorisation is concerned. The FDA considered this problem for a long time and has now apparently come to the conclusion that the dangers of weaker action and/or additional adverse effects can be regarded as negligible. The present decision brings clarity into the marketing authorisation processes of generic biopharmaceuticals in the USA.

In the next few years, the patents will expire on a number of high-revenue biopharmaceuticals. Sandoz and other companies are working on a variety of biosimilars. The drop in price due to biosimilars may, however, be less than seen with conventional, chemical drugs. This is for two reasons: the complexity of production and more complicated licensing procedures, both of which will limit the competition. While some generics are now offered by a couple of dozen manufacturers, there will be only a few competitors for biosimilars.