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BIOSIMILARS

Celltrion Drops Late-Stage Trial of Roche Rituxan Drug Copy

Founder seeks to sell his holdings.

DANIEL S. LEVINE

The Burrill Report

South Korea-based Celltrion has stopped clinical development of its own version of the blockbuster Rituxan, the latest stumble in the fledgling area of biosimilars.

The news, based on a filling with the European Medicines Agency, was reported in a note by Bloomberg industry analyst Asthika Goonewardene and reported by the Bloomberg news service. A late-stage clinical trial in non-Hodgkin lymphoma was listed with the agency as having been terminated. It is not known why the company has terminated the trial and whether it will seek to begin it again at a later date.

News of the scrapping of the trial follows a report in The Wall Street Journal that Celltrion retained J.P. Morgan as an advisor after the company’s founder Seo Jung-jin announced plans to divest his shares in the company. Celltrion is South Korea’s largest biopharmaceutical company in terms of revenue.

The termination of the trial by Celltrion is the latest setback for the young biosimilars industry. Earlier this month, Lonza Group and Teva Pharmaceuticals said they are reevaluating their joint venture to develop, manufacture, and market biosimilars because of “significant regulatory uncertainty” and the need to take a “measured approach” before making additional long-term investments in the area. They too had been developing a Rituxan biosimilar.

Merck scrapped plans to develop a biosimilar for Amgen’s Enbrel and last year shut down its biosimilars unit with a plan to restart its efforts in the sector at a later time. And in late 2012, Samsung's biosimilar unit halted work on a biosimilar version of Rituxan.

Though there is wide belief that biosimilars continue to present an attractive market opportunity, there is a growing consensus that the market will develop at a slower pace than first anticipated, and the regulatory and technical challenges of producing these products have been underestimated by many.



April 18, 2013
http://www.burrillreport.com/article-celltrion_drops_late_stage_trial_of_roche_rituxan_drug_copy.html

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