EMEA COMMITTEE RECOMMENDS APPROVAL OF VALTROPIN

A European Medicines Agency (EMEA) advisory committee has recommended European pharmaceutical regulators approve Swiss biotech firm BioPartners' generic human growth hormone Valtropin.

The recommendation, from the EMEA's Committee on Medicinal Products for Human Use (CHMP), is the second for a follow-on biologic in recent weeks. Late last month, the committee recommended approval of Sandoz' generic human growth hormone Omnitrope, a version of Pfizer's Genotropin (somatropin recombinant).

It remains to be seen, however, how the CHMP decision will influence the FDA, which has balked at approving Omnitrope and other biogenerics until it establishes a regulatory approval path. Australia has already approved Omnitrope, which Sandoz launched there in September 2005.