Drug news
Sandoz will not pursue its submission for biosimilar rituximab in the US.
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 FDA for additional information to complement the submission. Sandoz will focus on progressing its biosimilar pipeline in areas of greatest unmet access 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.