Sandoz, the generics arm of Novartis, is making no secret of its plans to grab the lead position in the race to develop a new generation of biosimilars. Unit chief Jeff George tells the German newspaper Handelsblatt that Sandoz has eight to 10 biosimilars in development, which he hopes to add to the three already on the market.
George also knows that he'll be competing with a small group of players. The entry-level cost for one of these programs, he says, is $50 million. On the high end, Sandoz will spend $200 million or more on a biosimilar program. Those costs can only be covered by developers with very deep pockets.
The news from Sandoz won't be any surprise to Thomson Reuters pharmaceuticals analyst Andrew Bourgoin, who recently completed a white paper on the biosimilar market. In an interview with FierceBiotech yesterday, Bourgoin underscored that it will be the "major generic companies that have already established themselves in the EU" which will emerge as the initial leaders.
"Companies like Merck will also be in the market," says Bourgoin, adding that the high cost of development that will limit the number of players in the game. Longtime recombinant protein products (like Epogen) represent the low hanging fruit, while follow-on versions of monoclonal antibodies like Rituximab, Avastin and Humira will be in the second wave.
Europe, which has mapped out a regulatory process for biosimilars, will be the initial playground for developers. But Merck and others clearly have their eyes on the U.S. market, where regulators are still hammering out a set of rules.
- check out the story from Reuters on Sandoz
- see the Thomson Reuters release on the new research paper