You know the patent-cliff drill: Companies can count down the days until their biggest drugs lose exclusivity--and they do. Not so for biologic treatments, even now that FDA has a pathway for biosimilar equivalents. A big drug's patent might expire without any competition ready to launch.
That's exactly the scenario Roche ($RHHBY) is predicting for its megablockbuster Rituxan, among others. The company says that its would-be rivals aren't likely to have biosimilars waiting in the wings when Rituxan's exclusivity expires at the end of next year. Despite the fact that some major players are developing their own versions--including Teva Pharmaceutical Industries ($TEVA)--Roche expects no head-to-head competition till 2015.
Why? Roche's marketing chief, David Loew, told investors yesterday that its rival developers may be scrambling to add more patients to their clinical trials, to satisfy European gatekeepers, Reuters reports.
- read the Reuters news
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