June 03, 2026 – Polpharma Biologics, a leading biopharmaceutical company specializing in the development of biosimilars, announced a collaboration with PSI CRO for the execution of a Phase 1 clinical study evaluating PB018, a proposed biosimilar to Ocrevus® (ocrelizumab), in patients with Multiple Sclerosis (MS).
The randomized, double-blind, parallel-group study is designed to compare the pharmacokinetics (PK), pharmacodynamics (PD), safety, and immunogenicity of PB018 with both US-licensed and EU-approved Ocrevus®. The trial is expected to enroll approximately 222 participants across multiple clinical sites.
PB018 is being developed as a proposed biosimilar monoclonal antibody referencing Ocrevus®, an anti-CD20 therapy widely used in the treatment of relapsing and primary progressive forms of Multiple Sclerosis.
The study will assess PK similarity as the primary endpoint, alongside additional evaluations including B-cell depletion, MRI lesion activity, immunogenicity, and safety parameters over a 24-week treatment period.
The study is anticipated to begin in October 2026.
About Polpharma Biologics
Polpharma Biologics is a group of biopharmaceutical companies focused on the development and manufacturing of biopharmaceuticals and biosimilars for global markets. Its Switzerland-based biosimilars platform manages the entire value chain—from product selection and investment allocation through development and commercialization—ensuring efficient progression from concept to launch in close collaboration with global partners. The company’s biosimilar portfolio spans multiple programs at various stages of development, from early-stage research to commercialization. Its international team brings deep expertise across program leadership, regulatory strategy, CMC integration, device development, clinical oversight, and quality assurance. Through Polpharma Biologics partnerships with trusted CDMOs, Polpharma Biologics delivers end-to-end biosimilar solutions, from cell line development to finished products, across key therapeutic areas. Polpharma Biologics is committed to accelerating access to biologic therapies worldwide by maintaining a robust and expanding pipeline of biosimilars.
More information: https://polpharmabiologics.com/
About PSI CRO
PSI CRO is a global full-service contract research organization (CRO) supporting pharmaceutical and biotechnology companies in the conduct of clinical trials across a wide range of therapeutic areas. PSI CRO provides comprehensive clinical development services, combining operational excellence, scientific expertise, and global trial management capabilities to support the successful delivery of complex international studies.
More information: https://psi-cro.com/
