Novartis will stop working toward FDA approval for its biosimilar of rituximab, a medication used to treat certain cancers and rheumatoid arthritis, according to Reuters.
Here are five things to know:
1. Novartis' Sandoz unit is retreating from an effort to get regulatory clearance in the U.S. after the FDA sought more information to support the drugmaker's application for approval. Sandoz's biosimilar is already approved in Switzerland, Japan, Australia and the EU.
2. Sandoz received a full response letter from the FDA. A full response letter means the FDA can't approve the drug in its current form.
3. "We are disappointed to have to make this decision and stand behind the safety, efficacy and quality of our medicine," Stefan Hendriks, global head of biopharmaceuticals at Sandoz, told Reuters.
4. Rituximab is a biosimilar of Roche Holding's Rituxan. The drug is used to treat non-Hodgkin lymphoma and rheumatoid arthritis. Roche's drug had more than $4 billion in U.S. sales in 2016.
5. The FDA has recommended approval for other rituximab biosimilars, including Teva Pharmaceuticals and Celltrion. Full clearance is expected in late November.
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