After repeated run-ins with the FDA in the past few months regarding site inspections and biosimilar filings, Celltrion might finally be turning things around with an unanimous thumbs up for its Rituxan copycat from the FDA advisory committee.
All 16 oncologic drug experts on the panel endorsed CT-P10 for three of the eight indications on Rituxan’s label — as either standalone or maintenance therapy for B-cell non-Hodgkin lymphoma.
“We are encouraged by the outcome of today’s meeting,” said Brendan O’Grady, head of North America Commercial at Teva, which has partnered with Celltrion to commercialize the drug in the US.
While CP-010 is already approved in 40 countries — including EU member states and Korea — it would be the first biosimilar competition for Roche’s big blockbuster in the US, where regulators are notoriously slow in pushing cheaper replacements of first-gen biologics. In May, the FDA kicked back a BLA from Novartis’ Sandoz just a month after rejecting Celltrion’s.
The agency cited “clinical, product quality, and facility deficiencies” in their complete response letter to Celltron, in light of a warning letter issued to their manufacturing site in Incheon, South Korea, a few months prior.
In recent years Roche has been feeling the heat — and quite actively fending off — biosimilar rivals eating into revenues for its big Rituxan, Herceptin and Avastin franchises. In Europe, where rituximab is known as MabThera, sales declined by 11% in 2017 after Celltrion and Sandoz’s rivals emerged.
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