Sandoz 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.
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"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."