EMA: Few pharmas expected to tackle biosimilar antibodies

A group of European experts are pondering a new set of rules to govern the development of biosimilar monoclonal antibodies, paving the way for a lower-cost version of some of the world's priciest therapeutics. But despite the big market that waits for these biosimilars, regulators say this field will be so tough to crack that they expect to see only a handful of applications each year.

"This is much more complicated than the normal generic business, so it will be a lot of work for these companies," European Medicines Agency Executive Director Thomas Lonngren tells Reuters. The agency has fielded only six applications for biosimilar antibodies and expects them to come in at the anemic rate of only two or three a year.

Like the FDA, the EMA is not handing out recommendations on drug substitutions. Companies interested in developing these new products will be expected to turn in extensive clinical trial data and will be forced to spend heavily to market their new products. That means developers will be faced with steep costs from the moment they step into the game.

First up for biosimilar competition: Rituxan, which has a European patent that expires in 2014 and earns more than $6 billion a year in sales.

- here's the story from Reuters