EMEA opens the doors for "biosimilars" with Omnitrope

As reported last week in the Monitor section of the Marketletter, Datamonitor has predicted that the first bio-engineered generic drugs, or "biosimilars," would possibly hit the European market this year, but this looks set to happen sooner rather than later, with the European Medicines Agency (EMEA) recommendation for approval of Sandoz' human growth hormone Omnitrope, the generic equivalent of drug giant Pfizer's Genotropin, which generated revenues of $808.0 million for the firm in 2005 (see page 23).

Although final approval is still required from the European Commission, this is seen as a major step forward for generic drugmakers to get clearance of their copies of biotechnology drugs, which regulators in the USA and Europe have been reluctant to do because of fears over safety, as well as pressure from the research-driven biotechnology industry.

The European Union put out guidelines for biosimilar drugs in 2004, setting out the regulatory approval system, which made it easier to file than had been the case previously, as Sandoz found out when the Commission rejected Omnitrope in 2003.