FDA’s back-to-back punches against biosims from Celltrion, Novartis leave Roche’s big Rituxan franchise untouched
A month after the FDA kicked backed Celltrion’s application to market a biosimilar for Roche’s big blockbuster Rituxan, the agency made it a clean sweep Thursday by doing the same for Novartis’ copycat.
Novartis didn’t say why Sandoz’s application got the boot, remarking only that it “stands behind the robust body of evidence.” The FDA never remarks on its rejections.
Roche, meanwhile, will do some quiet celebrating. The pharma giant has been hustling up new meds like Hemlibra to fill the gap that will be created as cheaper generic versions of their biologics eat into their franchise revenue for Rituxan, Herceptin and Avastin. It’s been feeling the heat in Europe, where biosimilars are far more advanced in competing with the branded originals.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.