UPDATED: Roche sees another Rituxan biosimilar trial bite the dust

Roche ($RHHBY) might face a reduced threat from one copycat competitor to its blockbuster Rituxan franchise. The South Korea-based biotech Celltrion has nixed late-stage development of a biosimilar version of Rituxan, which is expected to face knockoff rivals first in Europe and then in the U.S. in the coming years, Bloomberg reported.

As Bloomberg reported, Celltrion aimed to advance its biosimilar candidate CT-P10 into Phase III development this year, yet the European Medicines Agency's clinical trials registry lists the planned study for patients with non-Hodgkin lymphoma as terminated. However, Celltrion and its partner Hospira might only be delayed in their pursuit of a Rituxan biosimilar, as Celltrion has issued a statement saying that it plans to push ahead with late-stage development later in 2013, RBC Capital Markets wrote to investors this morning.

"The biosimilar opportunity for Hospira has been a tenet of the bull thesis, as management has touted that Hospira has 11 biosimilar molecules under development that target $40 billion of branded value," RBC analysts wrote this morning. "If the trial was terminated due to complications, it would validate our view that developing biosimilars is very difficult and complex, and may not lead to scientific, regulatory, or commercial success."

Samsung Electronics and Teva Pharmaceutical ($TEVA) both bailed out on biosimilar versions of rituximab (MabThera/Rituxan) last year amid uncertainty in regulation of copycat biologics in the U.S. and expensive development requirements that reduce the financial rewards of the drugs. Yet the $7 billion seller could find competition from others, as both Novartis's ($NVS) Sandoz unit and Boehringer Ingelheim have had Rituxan in their biosimilar plans.

It's no wonder why biosimilars players are eyeing Rituxan: On top of huge sales, the antibody drug loses patent exclusivity in Europe later this year, Reuters reported, and exclusivity vanishes in 2018 in the U.S., where Biogen Idec ($BIIB) helps sell the therapy. To get a biosimilar to market, however, generics players must clear a gauntlet of regulatory, development, manufacturing and marketing obstacles. And the upfront investment in the programs can easily dwarf the expense of a small molecule generic before it hits the market.

"This is not for the faint of heart," Jeff George, head of Sandoz, told Reuters earlier this year.

Right now, it's starting to look like the major providers of original biologics such as Amgen ($AMGN) and Biogen could have an upper hand in the market. Both those biotech giants have biosimilars partnerships and have all the requisite expertise to compete with and even beat rivals in this game.

The news about Celltrion's dropped trial comes amid reports about the company's chairman and CEO, Seo Jung-jin, seeking a major pharma company to buy his controlling stake in the company, The South Korea Times reported. Now that the company's Rituxan biosimilar is at least on the ice, I'm even more interested to find out which "multinational" pharma group is in the market for the controlling stake.

- see Bloomberg's article

Editor's note: Updated with analyst comments.

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