Three years after Teva and Switzerland's Lonza joined forces to create a new joint venture to develop a few blockbuster biosimilars, one of their lead programs has hit an unexpected roadblock. The Israeli newspaper Haaretz reports that Teva has suspended its Phase III study of a biosimilar of Rituxan, one of the world's top-selling drugs from Roche ($RHHBY).
According to the report, Teva ($TEVA) wants to pause to consider the best path to a regulatory approval in Europe--where patent protection lapses next year--and the U.S., off bounds until 2018. The move puts Teva/Lonza a step behind Sandoz and Celltrion, which are on path to deliver late-stage results for oncology early next year with a potential approval arriving in 2014, according to Haaretz. Samsung and Quintiles--another of the world's big biosimilar joint ventures--are teamed on a program to develop a biosimilar of Rituxan for use against rheumatoid arthritis.
Rituxan has always represented one of the biggest targets in the biosimilars world, where top players are investing heavily in late-stage programs that can win regulatory nods for lower-cost knockoffs that can grab market share away from the aging biologic blockbusters. Unlike traditional generics, biosimilars will have to be put through extensive advanced tests to prove that they have the same therapeutic punch as the original. And at least initially, most will have to be marketed as a new product, looking to angle in on payers around the globe looking for ways to shave costs.
As a result of the pricey business model, the biosimilars business is being dominated by major global corporations with the kind of deep pockets and expertise that can coordinate this level of development work. And it's proved an attractive proposition for multinationals like Samsung.
- here's the story from Haaretz
Special Report: Rituxan - Top 10 Best-selling Cancer Drugs in 2011