The race to ready copies of Roche's ($RHHBY) super-selling rheumatoid arthritis drug Rituxan in advance of its patent loss has just gotten more interesting.
Even as Teva Pharmaceutical Industries ($TEVA) said it and partner Lonza were seeking some guidance from regulators before moving forward with their clinical trials for a biosimilar, it turns out that Germany's Boehringer Ingelheim is looking to do a combined clinical trial that might satisfy both U.S. and European regulators. Bloomberg said Boehringer will try to do that by using medicine made in both places in an effort to shorten the time to approval.
A copy of Rituxan is considered a real prize. Roche earned 6 billion Swiss francs ($6.45 billion) on the drug last year. Novartis ($NVS), Celltrion, and partners Samsung Electronics and Quintiles Transnational, are all in the quest for a copy, in addition to Teva and Lonza. Roche's marketing chief, David Loew, last month told investors that Roche does not expect any competition before 2015. It loses its patent in the U.S. in 2015 but earlier in Europe, Bloomberg says.
Teva and Lonza this week discontinued their planned 544-patient, final-stage trial of a Rituxan copy, saying they wanted to get input from regulators on how to design the trial program, Bloomberg reports. In a statement Thursday, the world's biggest generics maker said, "Teva is firmly committed to the development of biosimilars. However, given the changes in the regulatory and competitive environment, Teva (through its joint venture with Lonza) is evaluating the path forward for rituximab."
This comes even as Teva said it was pulling its version of Wellbutrin XL from the market after the FDA determined that Teva's generic really isn't equivalent to the branded drug. The agency is requiring other generics companies to test whether their own versions of Wellbutrin XL are acceptable. There had been lots of complaints by patients that Teva's drug gave them side effects after the FDA approved the drug. A follow-up study by the FDA found that the generic really didn't release the active ingredient at the same rate and extent.
- read the Bloomberg story
Teva calls halt to late-stage test of Rituxan biosimilar
Roche expects to keep Rituxan monopoly until 2015
Teva yanks Wellbutrin copy after FDA says it's not equivalent to brand