AstraZeneca, Samsung quit race to develop Rituxan copycat as rivals crowd out the market

Six years after AstraZeneca teamed up with Samsung Biologics to develop a biosimilar for Roche’s rituximab, they are throwing in the towel.

The partners have decided to stop all R&D work on the program known as SAIT101, Korea Biomedical Review reported, citing a quarterly report from Samsung. Archigen, a 50-50 joint venture set up around the program, is set to be liquidated.

AstraZeneca had wagered $70 million in cash back in 2014 to get it all started, and topped up with an extra $30 million two years later. For Samsung, Korea Biomed calculations suggest a total investment of $126 million.

Archigen was set up before any biosimilar for Rituxan (MabThera in certain countries) — a megablockbuster prescribed for both cancer and inflammation that brought Roche $6.54 billion in revenue last year — existed. Samsung had hoped that combining its contract manufacturing skills and capacity with AstraZeneca’s marketing prowess would make a successful copycat in the US.

But the space has filled up in recent years.

Just in the past year Teva/Celltrion and Pfizer both scored FDA OKs for their knockoffs. Amgen and Allergan are close on their heels, and while Novartis’ Sandoz has pulled out of the US race, it remains a player in Europe.

All that may explain why, despite completing a Phase III study for lymphoma this August suggesting similar effects to Rituxan, a Samsung spokesperson told Korea Biomed “we concluded that the product lacks commercial viability after discussing with AstraZeneca.”

The Korean conglomerate has had better luck with Samsung Bioepis, a biosimilars-focused joint venture it established with Biogen, getting five drugs cleared in Europe and recently filing for a copycat of Lucentis in the US.

But don’t look for Bioepis to take over the development of SAIT101. As the original developer of Rituxan, Biogen is still on the receiving end of a royalty stream from Roche. In fact, as execs explained last year in a trial relating to accounting fraud, the decision to set up Samsung Bioepis in 2012 was exactly why they had abruptly halted the biosimilar program — which had a Phase III already underway — until AstraZeneca came along. The studies began anew in June 2016.

Execs had apparently made up their mind in that trial, noting: “Rituxan business failed because the product development was too late.”