On October 30, Novartis announced that it was culling its investigational drug pipeline and dropping 20% of its development programs. Just three days later, its subsidiary Sandoz announced that it would halt its efforts to obtain approval for its biosimilar version of rituximab from the US Food and Drug Administration (FDA). The decision by Sandoz to halt its rituximab biosimilar filing efforts seems to have culminated from Novartis’ announcement and FDA actions.
Sandoz had received a complete response letter on May 2, 2018 in its attempt to obtain approval for use for Rituxan®’s oncologic (but not autoimmune) indications. According to Sandoz’s press release, the FDA had asked them for additional information before providing a new decision. Sandoz did not specify the type of data sought in the request, although the company’s Global Head of Biopharmaceuticals, Stefan Hedriks, hinted that additional studies were involved. He stated, “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.” Generally, that means more than a re-analysis of existing data. This seems to be the principal reason for its decision to development and the rituximab biosimilar filing.
However, Rituxan is already available in several major markets, including Australia and New Zealand, the European Union, Japan, and Switzerland. Sandoz received US approval for three biosimilars, but only Zarxio® is currently marketed. Next up for Sandoz will be a refiling for FDA approval of its pegfilgrastim biosimilar. The company announced the original FDA rejection of this product in July 2016.