Sandoz Decides Against Marketing Rituximab Biosimilar in US

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 releaSandoz Halts Rituximab Biosimilar Filingse, 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.

FDA Hands Sandoz a Rejection on Its Rituximab Biosimilar

Sandoz announced today that the Food and Drug Administration (FDA) has decided not to approve its biosimilar version of the oncology biosimilar rituximab. The content of the complete response letter was not revealed by Sandoz.

This marks the second rituximab biosimilar rejected by the FDA. Celltrion and Teva’s Truxima™ was also rejected in early April. Both Sandoz’s biosimilar (Rixathon™) and Truxima™ are marketed in Europe and in other parts of the globe. In Europe, Rixathon was approved in June 2017, and Truxima received marketing authorization in February of that year.

Although the European approval for Rixathon was for all of Rituxan/MabThera’s oncology and autoimmune indications, Sandoz was seeking oncology indications only in the US with its rituximab biosimilar.

Sandoz registered early success with filgrastim (Zarxio®) and etanercept (Erelzi®), but was handed a set back from FDA on its biosimilar pegfilgrastim. We’ll report any updates we receive on Sandoz’s progress in resolving the issues in question with rituximab.

Next up is the Allergan/Amgen biosimilar of trastuzumab, which has an FDA PDUFA date of May 28.