Samsung Biologics, AstraZeneca to dissolve biosimilar JV, scrap Rituxan copy program: report

Samsung Biologics May 2019
Samsung Biologics and joint venture partner AstraZeneca have decided to stop developing their biosimilar to Roche's Rituxan. (Samsung Biologics)(Samsung Biologics May 2019)

Back in 2014, Samsung Biologics and AstraZeneca set up a joint venture to develop a biosimilar to Roche’s blockbuster cancer drug Rituxan. Fast-forward to 2020, and the pair has admitted defeat.

Archigen Biotech, a 50-50 JV between Samsung and AstraZeneca, will stop development of a Rituxan copycat dubbed SAIT101, Korea Biomedical Review reported, citing Samsung Biologics’ third-quarter report.

Given that Archigen was built around that single asset, the two companies have decided to liquidate the JV, ending Samsung Biologics’ history of a 140 billion won ($125 million) investment in the small shop.

The South Korean CMO also has Samsung Bioepis, a separate biosimilar-focused JV with Biogen. But because Rituxan was originally developed by Biogen, it would have been difficult for Bioepis to take the copycat on.

Archigen launched a phase 3 trial of SAIT101 in follicular lymphoma in June 2016. The trial was progressing slowly, with its target completion date getting pushed back by more than a year. Results unveiled last month showed the copycat triggered a response in 66.3% of patients, on par with the 70.6% posted by the originator.

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However, the market is already crowded. Teva and Korea compatriot Celltrion have launched their version, called Truxima; Pfizer started marketing Ruxience early this year at a 24% discount to Rituxan; Amgen and Allergan (now part of AbbVie) also have a knockoff, and so does Mylan through a collaboration with Mabion; and Novartis' Sandoz has been selling Rixathon in the EU.

As such, Samsung and AZ have “concluded that the product lacks commercial viability,” a Samsung Biologics official said, as quoted by Korea Biomedical Review.

At least that means one less competitor for Roche to worry about, and biosimilars have not exactly been kind to the Swiss drugmaker’s business.

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During a conference call in October, Roche’s pharma chief Bill Anderson admitted that the company is experiencing biosimilar attacks to its big cancer trio—Avastin, Rituxan and Herceptin—at the high end of the company’s already dialed-up expectations. For Rituxan, the drug’s sales were down 33% at constant currencies to CHF 1.0 billion ($1.1 billion) in the third quarter.

Meanwhile, the Bioepis side of Samsung's biosim business has been progressing well. The Biogen-partnered JV grew sales by 13% year over year to $208 million in the third quarter. An application for a copy of Roche and Novartis’ eye drug Lucentis was also just accepted by the FDA.

Though Archigen is slated to bow out, Samsung Biologics and AstraZeneca recently penned a long-term supply deal. For $331 million, the Korean CMO will help produce drug substance and drug product to support the British pharma’s biologics portfolio. The pact can be increased to $545.6 million.