On 7 August 2025, Sandoz announced that it is streamlining the clinical development programs for its nivolumab and ocrelizumab biosimilars, following “ongoing encouraging and favourable regulatory developments” and feedback from major regulatory authorities regarding the requirements for biosimilar approvals.
Sandoz has suspended its Phase 3 trial for JPB898, biosimilar to BMS’ Opdivo® (nivolumab), administered in combination with Yervoy® (ipilimumab) in patients with unresectable Stage III or metastatic Stage IV melanoma. It is modifying its Phase 1/3 trial for CYB704, biosimilar to Genentech’s Ocrevus® (ocrelizumab), so that it will become a comparative pharmacokinetic trial.
Sandoz’s decision to streamline its nivolumab and ocrelizumab clinical trials follows its April 2025 announcement that it is “minimising” its Phase 3 trial of GME751, biosimilar to MSD’s Keytruda® (pembrolizumab), in patients with untreated metastatic non-squamous NSCLC. Sandoz is continuing its Phase 1 trial of the pembrolizumab biosimilar in patients with resected advanced melanoma.
In February 2025, Formycon similarly announced the premature termination of its “Lotus” Phase 3 trial of FYB206, biosimilar to Keytruda®. According to Formycon, following “intensive scientific dialogue” with the US FDA, it concluded that the Phase 3 study was no longer necessary for the development and US approval of FYB206. Instead, Formycon will be relying on data from its ongoing Phase 1 trial (“Dahlia”), combined with “a comprehensive analytical program”.