- Decision follows FDA request for additional information to complement submission for biosimilar rituximab
- Sandoz stands behind safety, efficacy and quality of our biosimilar rituximab, which is already approved in EU, Switzerland, Japan and Australia
- With seven biosimilars already approved globally, Sandoz will focus on progressing robust pipeline to enable early and expanded patient access and healthcare savings
Holzkirchen, Germany, November 2, 2018 - Sandoz, a Novartis division and the pioneer and global leader in biosimilars, today announced that it will not pursue its submission for biosimilar rituximab in the US at this time. The decision follows a request by the US Food and Drug Administration (FDA) for additional information to complement the submission. Sandoz will focus on progressing its biosimilar pipeline in areas of greatest unmet access needs.
"We appreciate the important conversations with the 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.
"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."
Sandoz remains committed to enabling early and expanded patient access and creating savings for healthcare systems through a robust biosimilar portfolio. 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, following a CHMP positive opinion in September 2018.