Swiss biopharmaceuticals company BioPartners has filed its first application in Europe for a generic version of interferon alpha, a biological drug. If approved, the 'biosimilar' could be on the market as early as next year.
This development comes shortly after the US government turned down an application to market Omnitrop/Omnitrope (somatropin), a generic version of recombinant human growth hormone developed by Sandoz, citing problems in establishing an appropriate regulatory route for 'biogeneric' products.
Last year, the European Parliament approved new pharmaceutical legislation that, among other things, set out a legal framework for the registration of so-called 'biosimilars', biological therapies that are therapeutically the same as existing, approved biological products.
Sandoz had also filed for approval with the European Medicines Evaluation Agency for Omnitrop, but was unable to progress the application. BioPartner's filing represents the first occasion that the EMEA has accepted an application for a biosimilar drug for review, said a spokesperson for the company.
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.
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 - are set to lose patent protection in the US in 2005 and beyond. 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.
And a new study, also reported on In-Pharmatechnologist.com today, predicts that the market for generic and biogeneric drugs in Europe alone will reach more than $20 billion by 2010.
Commenting on the submission, Professor Christian Trepo, chief of the hepatogastroenterology unit at Hotel-Dieu Hospital in Lyon, France, said: "The incidence of hepatitis C is growing on a worldwide basis and is increasingly becoming a burden on healthcare systems.
"The introduction of a cost-effective interferon alpha in the Western world may enable us to treat more patients and thereby reduce the potential deleterious outcomes of this disease."
Hepatitis C is a blood-borne infectious disease of the liver and is transmitted through body fluids, primarily blood or blood products, and by sharing needles. In many patients, the mode of transmission is unknown. Unfortunately, most people infected with hepatitis C are unaware of it because it may take years for symptoms to develop and it is therefore sometimes referred to as the 'hidden epidemic'.
The virus chronically infects an estimated 170 million people worldwide (three percent of the world's population), with as many as 180,000 new cases occurring each year. It is the leading cause of cirrhosis and liver cancer and one of the most common reasons for liver transplants in Europe. If left untreated, hepatitis C can be fatal for some patients.
The standard treatment for hepatitis C is recombinant interferon alpha - currently represented in Europe by Roche's Roferon (interferon alpha 2a) and Schering-Plough's Intron A (interferon alpha 2b), in combination with ribavirin.
More recently, two extended release versions of these two branded drugs - Roche's Pegasys and Schering-Plough's Pegintron - have been introduced. These have the benefit of reducing the frequency of injections that need to be delivered to patients, and will also help defend the branded companies' franchises from generic attack.
BioPartners has partnered with LG Life Sciences, the leading South Korean manufacturer of biopharmaceuticals and German manufacturer Rentschler Biotechnologie, for the development and manufacture of its entire portfolio of drugs, including interferon alpha.
To date, the development of the market for biosimilar drugs outside regions with less stringent intellectual property protection such as Asia has been patchy, to say the least. Last year, SICOR (now part of Teva) gained approval in Lithuania for a generic version of granulocyte colony stimulating factor (G-CSF), the active principle in Genentech's Neupogen (filgrastim) drug for treating neutropenia in patients undergoing cytotoxic cancer chemotherapy.
Meanwhile, other companies, for example Wockhardt (with erythropoietin) and GeneMedix (with granulocyte macrophage colony stimulating factor or GM-CSF), have concentrated on Asian markets until such time as a route to market for these drugs in the US and Europe opens up.