Samsung halts biosimilar rituximab trial on regulatory concerns

By Gareth Macdonald

- Last updated on GMT

Samsung biologics halts Rituxan trial
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.

Related topics: Regulatory & Safety, Regulations

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