On 9 July 2026, Teva and Polpharma Biologics announced that they entered into an exclusive licensing agreement for the commercialisation of intravenous and subcutaneous formulations of Polpharma Biologics’ PB018, biosimilar to Roche’s Ocrevus® (ocrelizumab).
PB018 is currently in early development and has not yet entered clinical trials. According to the US clinical trials database, Polpharma is planning to commence a Phase 1 study in October 2026 comparing PB018 with Ocrevus® in patients with multiple sclerosis.
Under the agreement, Swiss-based Polpharma Biologics will be responsible for the development, manufacture and supply of the ocrelizumab biosimilar, while Israeli-based Teva, will be responsible for regulatory submissions and commercialisation in the US, Europe, Brazil, Canada, Australia, New Zealand, Israel and Turkey.
Polpharma has previously entered into a licensing agreement with MS Pharma in relation to the commercialisation of PB018 (and other biosimilars) in the MENA region (September 2025).
Ocrelizumab biosimilars are in clinical trials sponsored by Amgen (Phase 3 underway, estimated primary completion in 2027), Biocad (Phase 3, enrolment commenced November 2025), Sandoz (Phase 3 trial underway, estimated primary completion in November 2026), Celltrion (Phase 3 IND for CT-P53 partially approved by the EMA in August 2023, currently recruiting, estimated primary completion dated in 2027) and R-Pharm (Phase 1 study commenced April 2025, estimated primary completion in January 2026). In January 2026, Samsung Bioepis announced that it had added an ocrelizumab biosimilar to its pipeline.