Omnitrope's US appro sets no precedents for biogenerics, says Wood Mackenzie

In a move that surprised most industry observers, at the end of May, Swiss drug major Novartis' generics subsidiary Sandoz reported that its recombinant human growth hormone (hGH) Omnitrope (somatropin) had become the first significant follow-on version of a recombinant biotechnology drug to gain approval in the USA (Marketletter June 12).

However, the decision does not set a precedent - it is the fourth recombinant biological to take this regulatory route and is unlikely to herald a flood of "biogenerics" entering the world's largest pharmaceutical market, notes a review of the situation by analysts at Wood Mackenzie. Omnitrope was approved under Section 505(b)(2) of the US Food, Drug and Cosmetics Act (FDCA). But the majority of recombinant biotechnology drugs were approved under the Public Health Services Act (PHSA) - which offers no equivalent to the Section 505(b)(2) route. Creating an abbreviated pathway for biological products approved under PHSA will require amendments to this legislation, and this is likely to take a number of years, the analysts say.

Lengthy approval process