Samsung Biologics recently gave up developing SAIT101, a biosimilar of follicular lymphoma treatment Rituxan (ingredient: rituximab), which it had promoted as its first product since entering the bio business.

According to the Samsung Biologics’ quarterly report released on Monday, the company and AstraZeneca, a U.K. pharmaceutical company, decided in September to suspend research and development activities by their joint venture, Archigen Biotech, and liquidate the latter.

Samsung Biologics and AstraZeneca have decided to liquidate their joint-venture company and halt developing follicular lymphoma therapy SAIT101, a biosimilar of Biogen’s Rituxan (ingredient: rituximab).
Samsung Biologics and AstraZeneca have decided to liquidate their joint-venture company and halt developing follicular lymphoma therapy SAIT101, a biosimilar of Biogen’s Rituxan (ingredient: rituximab).

The two companies had set up the tie-up firm to focus on developing only the anticancer drug.

It is also difficult for Samsung Bioepis, another biosimilar developer of the Samsung Group, to keep developing SAIT101 by itself because the company was established in collaboration with the U.S. Biogen, the original developer of Rituxan.

Samsung Biologics has invested about 140 billion won ($126 million) in Archigen Biotech -- 71.4 billion won at the time of its founding, 34.7 billion won in 2016, 16.4 billion won in 2018, and 18.1 billion won in 2019.

Samsung halted the SAIT101 global phase 3 clinical trials in October 2012 and resumed it in 2014 through Archigen Biotech. The latter completed the study of SAIT101 for lymphoma in August 2020. As a result of a global phase 3 trial, SAIT101 showed similar therapeutic effects to Rituxan, supplied under the name of MabThera in the Korean market.

In the study comparing the effects of MabThera and SAIT101 in 315 follicular lymphoma patients, the objective response rate (ORR) of the MabThera group was 70.6 percent, and the SAIT101 group was 66.3 percent.

In February, Archigen Biotech also presented phase 1 trials' results comparing the effects of MabThera and SAIT101 on rheumatoid arthritis. The study results were successful, as the company did not see much difference in therapeutic effects between the two drugs.

The global market for Rituximab is big worth about 9 trillion won. However, the market is already crowded with other products, including Celltrion’s biosimilar Truxima, in addition to Biogen’s original drug Rituxan.

Truxima showed a 37 percent market share in the European Rituximab market in the second quarter of 2020, even surpassing Rituxan’s 36 percent. The Celltrion biosimilar also occupies more than 20 percent of the Rituximab market in the U.S.

“Samsung Biologics and AstraZeneca decided to stop commercializing SAIT101 and take steps for the liquidation of Archigen Biotech as we concluded that the product lacks commercial viability after discussing with AstraZeneca,” a Samsung Biologics official said. “The details of the plan, such as asset distribution, have not yet been finalized.”

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