Sandoz, the generics arm of Novartis, has decided to not pursue its submission for a biosimilar to Roche’s Rituxan (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 has a rituximab biosimilar approved in the European Union (EU). Rituxan is one of Roche’s top-selling drugs with 2017 global sales of CHF 7.3 billion ($7.8 billion).

“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 in a November 2, 2018 company statement. Sandoz says it will now focus on progressing its biosimilar pipeline in areas of greatest unmet access needs.

Sandoz received EU approval of its Rituxan biosimilar in June 2017 from the European Commission (EC), making it second EU biosimilar approval for Rituxan at the time. In February 2017, Teva Pharmaceutical Industries and Celltrion Healthcare, the marketing, sales, and distribution arm of Celltrion, an Incheon, South Korea-based pharmaceutical company, received approval from the EC for Truxima (rituximab), another biosimilar to Roche’s Rituxan. Teva and Celltrion resubmitted a biologics license application (BLA) to the FDA for approval of its biosimilar candidate that references Roche’s Rituxan in June 2018.

Sandoz has multiple approved biosimilars worldwide (Erelzi [etanercept], Rixathon [rituximab], Binocrit [epoetin alfa], Omnitrope [somatropin], Zarzio/Zarxio [filgrastim-sndz], and Zessly [infliximab]), three of which (Binocrit, Omnitrope, Zarxio) are approved in the US.

Source: Novartis