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Samsung halts biosimilar rituximab trial on regulatory concerns

By Gareth Macdonald , 18-Oct-2012
Last updated on 24-Oct-2012 at 15:19 GMT2012-10-24T15:19:41Z

Reports suggest that Samsung Biologics has halted a trial of a biosimilar version of Roche and Biogen Idec's Rituxan (rituximab).

The Korea Times reported that clinical trials of Samsung's drug - SAIT101 - had stopped, quoting an unnamed company source as saying the action had been taken "due to some internal reasons."

The paper suggested that concerns over biosimilars regulations in key markets is an issue. Samsung did not respond Outsourcing-pharma.com's request for further information.

The South Korean conglomerate is a relative newcomer to the biosimilars business, setting up Samsung Biologics in collaboration with US contract research organisation Quintiles in March last year

That agreement – which gave Quintiles a 10 per cent stake in Samsung Biologics – saw the firms start work on a production site in the Free Economic Zone in Songdo, Incheon that is due to open by 2013.

More recently Samsung partnered with biologics developer Biogen Idec to establish a $300m. 

The JV formed through the deal is focused on developing biosimilar versions of marketed products which - evidently - included a version of Biogen's own product blockbuster, which is used to treat lymphomas, leukemias, transplant rejection, and some autoimmune disorders.

Samsung is not the only company to have had problems developing a biosimilar version of the product. Earlier this month Teva Pharmaceutical Industries halted trials of a rituximab biosimilar it is developing in collaboration with Lonza.

The Israeli firm took the step due - according to a report in Haaretz - to concerns about meeting regulations in the US and Europe.

Despite the setbacks suffered by Samsung and Teva, rituxmab's $7bn a year market continues to attract developers. A week ago Bloomberg reported that German drugmaker Boehringer Ingelheim is developing its own version of the drug.

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