BioPartners, currently leading the line amongst companies trying to bring copies of off-patent biologic drugs to the European market, has licensed a needle-free delivery technology for its human growth hormone (hGH) product.
The Swiss company has signed a 10-year license agreement with privately-owned UK company The Medical House for the use of its GH1 reusable, spring-powered, needle-free delivery system as the platform for Valtropin (saltropin), filed under new EU legislation that provides a route to market for so-called 'biosimilar' versions of biologics.
BioPartners filed a dossier seeking marketing approval for Valtropin with the European Medicines Agency (EMEA) for Valtropin last year. This was its second EMEA application for a biosimilar product, as it filed for the approval of its interferon-alpha product as a treatment for hepatitis C in October 2004.
The exclusive global license follows from the development of an agreement between the two companies which was signed in June 2002. Biopartners and TMH are currently exploring the use of the latter's disposable AutoSafety Injector with BioPartner's sustained-release compound formulations.
Some of the biggest-selling biological drugs developed during the first phase of the biotechnology revolution in the 1980s - including hGH, interferon alpha and insulin - have already lost or will lose patent protection in the next few years. This opens up a market currently worth $30 billion (€23.4bn) and growing at 10 per cent a year.
Other companies developing biosimilar drugs include the top two generics houses, Sandoz and Teva, as well as Aceto and Pliva/Mayne Pharma.