BioPartners files for 'biosimilar' hGH
Authorisation Application in Europe for a generic copy of a
biologic drug under the recently agreed European Union framework
for so-called 'biosimilar' drugs.
The company has filed a dossier with the European Medicines Agency for Valtropin (somatropin), a recombinant human growth hormone developed in conjunction with Korea's LG Life Sciences.
Last year, the European Parliament approved new pharmaceutical legislation that, among other things, set out a route for the registration of biosimilars, defined as biological therapies that are therapeutically the same as existing, approved biological products. But to date no biosimilar drugs has been approved for marketing in Europe.
BioPartners is seeking approval of Valtropin for the treatment of paediatric and adult growth hormone deficiency and other growth disorders. It would compete with other somatropin products on the European market sold by Novo Nordisk, Eli Lilly, Genentech and Serono.
Recently, the firm filed its biosimilar recombinant interferon alpha for the treatment of hepatitis C with the EMEA.
This development comes shortly after the US Food and Drug Administration turned down an application to market Omnitrop/Omnitrope (somatropin), a generic version of recombinant hGH developed by Novartis' generics subsidiary Sandoz, citing problems in establishing an appropriate regulatory route for what are also known as biogeneric' products.
Sandoz had also filed for approval with the European Medicines Evaluation Agency for Omnitrop, but was unable to progress the application on procedural grounds.
Companies specialising in the contract manufacture of conventional and biological active pharmaceutical ingredients (APIs) are watching the progress of the deliberations on biogenerics in Europe and the US with keen interest, given yesterday's report by Frost & Sullivan suggested that biopharmaceuticals will be a strong growth area for a sector hit by overcapacity in chemical synthesis.
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 - but only if a regulatory route to market can be teased out.
API and generic companies are hoping that biologicals can provide additional impetus to the strong growth being seen in the market for chemical-based generics worldwide. Biogenerics could quickly address a $10 billion market in which many treatments cost upwards of $10,000 per patient per year.