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Celltrion Changes Late-Stage Trial Plans on Drug Copy

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

Celltrion will pursue phase III tests after it completes phase I this month, and not at the same time, on the advice of some state regulators, the Inchon, South Korea-based company said in a statement on its website. Celltrion wasn’t available for further comment after business hours today.

The trial in non-Hodgkin lymphoma patients is listed as terminated in three of four trial sites, according to the European Medicine Agency’s clinical trials register. It’s not clear what prompted the change, said Asthika Goonewardene, a London-based analyst with Bloomberg Industries. Companies such as Boehringer and Novartis’s 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.

Celltrion’s late-stage trial of the CT-P10 drug was authorized to commence in December 2011, but had not yet started in January of this year. The company told Bloomberg Industries at the time it would start into phase III trials later this year.

Latvian Site

The trials were slated to enroll 740 patients, with 18 of them in Latvia, the site that is still listed as active, according to the EMA register.

The original compound, sold by Roche and Biogen Idec Inc., had about $7 billion in revenue 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.’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.

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