Biosimilars, FDA

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.

Roche has also been fighting off Pfizer’s biosimilar of Herceptin, suing them for patent infringement. The FDA knocked back Pfizer’s pitch for their knockoff just days ago, which the pharma giant says was due to a request for “additional technical information.”

European regulators signaled well ahead of the FDA that they were open to biosimilars of these older, first-gen biologics, looking to benefit from lower-cost replacements. The US, though, has presented a dramatically different landscape, finding a late regulatory pathway to an approval. And big players like J&J have been successful in stalling the competition through a framework of deals with the companies managing pharma benefits in the US.

That’s expected to be the focus of an upcoming speech from the president, who has vowed to “slash” drug prices. In the meantime, the delays in North America have been worth billions to the franchise owners like Roche.


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Biotech Primer Toronto 2018

Head of DMPK, Director
Magenta Therapeutics Cambridge, MA
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Recursion Pharmaceuticals Salt Lake City
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A Rare Disease Biotech New Brunswick, NJ
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