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The decision follows an FDA request for additional information to complement the company’s submission for biosimilar rituximab.
Sandoz, a Novartis division, announced on Nov. 2, 2018 that it will not pursue its submission for biosimilar rituximab in the United States at this time. The decision follows a request by the FDA for additional information to complement the submission. The company will instead focus on progressing other candidates in its biosimilar pipeline.
The company’s biosimilar references Roche’s Rituxan/MabThera (rituximab), a top-selling product for Roche with CHF 7.4 billion (US$7.4 billion) in 2017 sales.
"We appreciate the important conversations with [FDA], which have provided specific requirements for our potential US biosimilar rituximab, but 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, Sandoz, in a company press release.
"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 (EU), 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," Hendriks added.
Sandoz has seven approved biosimilars worldwide, three of which are approved in the US, and is currently awaiting marketing authorization in the EU for pegfilgrastim, a generic version of Amgen’s Neulasta (pegfilgrastim), following a positive opinion from the European Medicine Agency’s Committee for Medicinal Products for Human Use in September 2018.