Week-in-Review editorial: US biotech buyout bonanza

Two major acquisitions of biotech companies occurred this week, as pharmaceutical companies scurry to add biologic drugs to their existing R&D programmes and pad out their flagging pipelines.

Japan-based Astellas revealed it would buy US biotech Agensys for USD 387m to augment its current antibody R&D programme for cancer drugs. Then sanofi-aventis expanded its original 2003 collaboration with US-based biotech Regeneron by increasing its equity stake from four per cent to 19 per cent. The company said it would invest USD 872m to augment research into humanised therapeutic antibodies, which do not cause rejection in patients.

In the US, the FDA has been slow to permit the faster approval process for generic biologics, while in contrast the EMEA has had a regulatory pathway in place for almost three years. As a result, despite there being more biotechs in the US, it makes some sense to acquire one in order to profit from the agency's current indecision and the lack of development of biogenerics in the region.

The FDA claims it is difficult to assess the similarity or otherwise of biogeneric drugs because they are based on complex biological organisms, rather than the simple molecules of more traditional drugs. But supporters of biogeneric drugs in the US claim that the agency is slowing progress and that manufacturers in other countries are already producing them.

Even in Europe, biogenerics are not as big a threat to biotech as the normal generic industry is to ethical pharmaceuticals, as they are unlikely to be direct copies of their original biotech counterparts. Unlike conventional generic manufacturers, biogeneric companies will have to run expensive and time-consuming clinical trials, and even then the eventual product could not be exactly the same as the original.

However, despite the expense and the risk, biogeneric companies are getting on with the job. For example, Teva has bought plants in Mexico and Lithuania to make biogenerics, and that production could move into Western Europe and Canada, even before US companies get the chance.

Usually generic competition would be evident by now, but no regulatory system exists in the US to approve generic versions of biotech drugs. As a result, despite the fact that there are more biotechs in the US, the regulatory environment is friendlier so acquiring a biotech there is a wise move. In the long-term, however, the biogeneric industry in the US may find itself out in the cold, as the EU and other more decisive regions take advantage of this.