Celltrion Drops Late-Stage Trial of Roche Rituxan Drug Copy

Celltrion Inc. (068270) dropped a late-stage trial of a biosimilar version of Roche Holding AG (ROG)’s best-selling Rituxan drug, potentially benefiting competitors such as Boehringer Ingelheim GmbH and Novartis (NOVN) AG.

Celltrion had planned to take its drug, CT-P10, into phase- III trials later this year, Asthika Goonewardene, a London-based analyst for Bloomberg Industries, wrote in a note today.

The trial in patients with non-Hodgkin lymphoma is listed as terminated, according to the European Medicine Agency’s clinical trials register. It’s not clear what prompted the change, Goonewardene said, and if the South Korea-based company will resume the trial later. Companies such as Boehringer and Novartis’ Sandoz unit are racing to bring a biosimilar version of the drug, also known as rituximab, to the market.

“In the grand scheme of things every additional entrant to the market will chip away at the pie, so this is good news to other competitors,” Goonewardene said in a telephone interview.

The original compound, sold by Roche and Biogen Idec Inc. (BIIB), had about $7 billion in sales last year.

Because Rituxan is a biological drug, made out of living cells, putting out a copy isn’t as simple as making a generic of a chemically based pill like Pfizer Inc. (PFE)’s Lipitor or Viagra. Under European Union regulations and draft U.S. guidelines, companies that want to sell a copy of a biotechnology drug, a so-called biosimilar, will need to show that their version of Rituxan does the same thing as Roche’s.

Roche’s patents on the medicine expire in 2018 in the U.S. and earlier in Europe. Biogen helps market the drug in the U.S.

To contact the reporter on this story: Eva von Schaper in Munich at evonschaper@bloomberg.net

To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net

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