EU regulators in April gave the green light to Europe's first "biosimilar" drug, the human growth hormone Omnitrope produced by Novartis subsidiary Sandoz. The drug is a generic for Pfizer's Genotropin and is expected to hit European markets shortly. Around the same time that Sandoz got its EU approval, a US federal judge ordered the Food & Drug Administration to rule on Sandoz's new drug application for Omnitrope, which the company had submitted in 2003.
A new US process for regulating the marketing of biogenerics isn't expected until at least 2007. Though, the European decision might put pressure on the FDA to formulate a policy on the marketing of biosimilars, says Suzette Kox, senior director of scientific affairs at the European Generic Medicines Association.
European health authorities hope biosimilars will offer cost savings for healthcare expenditures. But the ability of companies to turn a profit from small-selling biogenerics is going to be a key to their continued production, says Joanna Chertkow, a pharmaceutical analyst at DataMonitor, a market analysis firm based in London. Several factors remain unanswered, she says, including manufacturing costs, pricing, and the effort companies need to encourage switching from existing brands. How Sandoz does with Omnitrope will be closely watched, says Chertokow, who forecasts that sales of biogenerics will reach $2.2 billion by 2010. Other key product categories likely for a first-wave of biosimilars include erythropoietin and insulin, says Chertkow.