Biosimilars

Tripped up by the FDA, Novartis says it is dropping out of the US race to win an OK for a blockbuster Rituxan rival

Novartis may have had little trouble getting an EU approval for their knockoff of Roche’s Rituxan last year, but they’ve reached a dead end in the US.

The pharma giant announced Friday that it is throwing in the towel on its campaign to win an OK at the FDA after regulators demanded additional information — throwing a monkey wrench into its timeline as a host of rivals pressed for a green light.

Just a few weeks ago Celltrion persevered and won an influential recommendation for approval for its own blockbuster killer from an expert panel at the FDA. With a likely FDA OK looming, Novartis wasn’t willing to keep fighting for a runner-up position in what will likely be a heated competition for Roche’s $4 billion US franchise.

Teva will take the lead on marketing the Celltrion drug, with much to prove as it looks to mount a turnaround after a wrenching fall from grace.

Novartis’ decision follows several notable setbacks at the Basel-based group. The FDA iced their application for canakinumab for heart disease — a move that leaves its late-stage pipeline looking wobbly as new CEO Vas Narasimhan looks to position the company as a winner on the global stage. Novartis has been executing a series of cutbacks, dropping out of antibiotics and cutting 20% of its programs at NIBR. Novartis has also fallen well behind Gilead/Kite on marketing CAR-T, where it gained the first approval.

But the company has made progress on the radiopharmaceuticals niche.

Novartis’ execs “believe the patient and marketplace needs in the US will be satisfied before we can generate the data required,” said Stefan Hendriks, global head of biopharmaceuticals at Sandoz. “We are disappointed to have to make this decision and stand behind the safety, efficacy and quality of our medicine, which met the stringent criteria for approval in the European Union, Switzerland, Japan, New Zealand and Australia. Given the breadth of our biosimilar pipeline, we believe we should now focus on opportunities in the US and around the world where we can best meet rapidly evolving patient and healthcare system needs.”

Images: Vas Narasimhan (Novartis), Novartis (Shutterstock)


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