GeneMedix's Big Biogeneric Gamble
Patent expiries in Europe on proteins such as EPO and interferon alpha may open up a huge market for cheaper versions of these proteins-one which GeneMedix and others are preparing to tap into. But it's a risky game, since there's still no regulatory process in Europe for approving such products.
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The biogenerics industry is experiencing a painful adolescence. After taking off on the back of the biotech boom during the late 90s, it has since come down with a thud as costs and timelines rise beyond most firms' forecasts. Unlike the rest of the biotech sector, biogenerics firms can't yet point to a successful precedent, and regulatory and clinical risks remain considerable. So while the entrepreneurship and flexibility associated with traditional biotech can favor small, standalone firms, the opposite is true in biogenerics. Most of the (likely few) winners in this game will be those quietly developing biosimilar products within divisions of traditional generics players.
The EMEA's recommended approval of Novartis' generic growth hormone Omnitrop may pave the way for further biogeneric approvals in Europe. But high entry costs and questionable demand mean straight copies of biologics may not prove the most threatening to branded players/the most valuable market. The real battle will likely be around improved biologics: longer-lasting, safer and more efficacious versions. This widens the playing field, but places branded players with the advantage-for now.
Biologics contract manufacturing is changing rapidly. To maintain its leading position, Lonza Biologics is adopting a more flexible and responsive approach in its dealmaking.