Novartis pulls US rituximab program citing FDA data demands

Novartis subsidiary Sandoz has decided not to pursue a biosimilar of Roche’s Rituxan in the US after receiving a complete response letter from the FDA.

In June 2017, biosimilar developer Sandoz received approval in Europe for Rixathon, a version of Rituxan (rituximab), which Roche markets as Mabthera in the region.

But across the Atlantic, the Swiss biopharma has failed to replicate such regulatory success, and received a US Food and Drug Administration (FDA) complete response letter (CRL) in June this year asking for additional data to complement the submission.

Sandoz pulls plug on US rituximab program Image: iStock/d3images

Five months on and the firm has chosen to drop the program, with Stefan Hendriks – global head of biopharmaceuticals at Sandoz – saying the needs of the US marketplace “will be satisfied before we can generate the data required.”

Chris Lewis, a spokesperson from the firm, added that “each market has specific and stringent requirements for approvability, which can evolve over time.”

He told BioProcess Insider that “each agency applies its own interpretation and experience to complex submissions, which can total tens of thousands of pages of data. This can lead to differences in the types and amount of question that each file receives.”

Therefore, he continued: “In light of the FDA request, we believe the US patient and market need for rituximab biosimilars would be met before we could bring our medicine forward.”

In 2017, Rituxan clocked in sales of CHF 7.4 billion ($7.4 billion) for Roche.

Pipped to the post?

The news comes weeks after the FDA’s Oncologic Drugs Advisory Committee voted unanimously 16-0 to recommend approval of CT-P10, a rituximab biosimilar developed by Korean drugmaker Celltrion.

The recommendation came on the second attempt after the FDA issued a CRL for the product earlier this year, citing a warning letter​ sent to Celltrion in January highlighting “multiple poor aseptic practices” at its production site in Songdo, Incheon.

If approved CT-P10 will be the first rituximab biosimilar in the US and will be marketed by Israeli drugmaker Teva Pharmaceutical Industries.

Lewis said being first to the market is not decisive in Sandoz’s biosimilar marketing strategy and did not directly influence the decision to drop the rituximab program.

“We aim to bring our biosimilars to patients at the earliest possible opportunity, but exact strategy will vary by product and market. Thanks to our decade-plus of commercial experience, we are confident we can win in markets even where we do not enter first,” he told us.

“A good example is Zarzio [filgrastim] in the EU, where we are the market leader (ahead of the reference medicine) despite not being first to market.”