Report: Samsung stung with delay on Rituxan biosimilar

Samsung Electronics has stumbled in its sprint into the biotechnology field. The South Korea-based conglomerate has halted development of a biosimilar version of the blockbuster biologic Rituxan/MabThera, with the path to develop the knockoff version of the protein drug appearing thornier than some people thought, The Korea Times reported. 

The article doesn't explain exactly why Samsung hit the brakes, saying that the company stopped clinical development of SAIT101--the biosimilar version of the MabThera or Rituxan--because of "some internal reasons," an unnamed company source told the Korean newspaper, which appears to speculate that recent regulatory guidelines from U.S. regulators could be partly to blame for the delay. For now, Samsung is speaking with FDA officials about clinical development requirements and a way forward for the SAIT101 program.

Those who have been following biosimilars news won't be surprised to learn of Samsung's setback, as earlier this month a report out of Israel said that Teva Pharmaceutical ($TEVA) hit the pause button on late-stage development of its own Rituxan biosimilar. Rituxan, a huge seller from Roche ($RHHBY) and Biogen Idec ($BIIB), has been one of the most pursued assets among developers of biosimilars because of its blockbuster profile and loss of patent protection in Europe next year.

The market for biosimilars is expected to grow in the U.S. and abroad as big-selling biologics such as Rituxan lose patent protection. Yet the molecular complexity of monoclonal antibodies and other biologics relative to small-molecule drugs such as Lipitor has prompted regulators to treat the review of biosimilars differently, and developers of the knockoffs are unlikely to be able to offer them at as steep a discount as small-molecule generics.

Samsung, known for its mobile devices and flat-screen TVs, has touted plans to invest more than $2 billion in biopharmaceuticals and life sciences, dedicating part of its investment in biopharma to biologics manufacturing in partnership with the giant CRO group Quintiles. Biogen and Samsung also have an agreement to pool resources to advance biosimilars, but the agreement between the two companies excludes Rituxan and other therapeutics from the Weston, MA-based biotech giant.

Clearly, Samsung has found the biotech game, at least as it concerns its MabThera knockoff, trickier than expected.

"We had vowed to get quicker approval in Europe, so this will definitely put us behind our original schedule," the unnamed Samsung source told The Korea Times. "There was also a need to better prepare for testing in the U.S. which is even a larger market. We will eventually be fine."

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