Teva and Polpharma Biologics sign an exclusive global licensing deal for a proposed biosimilar to Ocrevus (ocrelizumab), covering IV and SC formulations.
Written By: Fariha Sameen, PharmD
Reviewed By: Pharmacally Editorial Team
Teva has entered an exclusive global licensing agreement with Polpharma Biologics to commercialize the company’s proposed biosimilar to Ocrevus (ocrelizumab), pending regulatory approval. The agreement covers both the intravenous (IV) and subcutaneous (SC) formulations of the anti-CD20 monoclonal antibody and expands Teva’s biosimilars pipeline under its Pivot to Growth strategy.
Under the agreement, Polpharma Biologics will retain responsibility for developing and manufacturing the biosimilar candidate. Teva will manage regulatory submissions and commercialization in the United States, Europe, Brazil, Canada, Australia, New Zealand, Israel, and Turkey.
Ocrelizumab Targets CD20-Positive B Cells in Multiple Sclerosis
Ocrelizumab is a humanized monoclonal antibody that selectively targets CD20-positive B cells, which contribute to the autoimmune inflammation underlying multiple sclerosis (MS). By depleting these B cells, the therapy helps reduce disease activity and slow disability progression in patients with relapsing forms of MS and primary progressive MS.
The reference product, marketed by Roche as Ocrevus, is available as an intravenous infusion in the United States, while the subcutaneous formulation is marketed separately as Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq). In Europe, both formulations are marketed under the Ocrevus brand. Through this agreement, Teva gains exclusive commercialization rights for biosimilar versions of both administration routes across multiple global markets.
Development Responsibilities and Commercial Scope
Polpharma Biologics will continue to lead the development and manufacturing of the proposed biosimilar, leveraging its experience in biosimilar research and production. Teva will assume responsibility for regulatory filings and commercial launch activities once the product receives marketing approvals.
The companies did not disclose the clinical development stage of the biosimilar candidate, financial terms of the agreement, or expected timelines for regulatory submissions.
Executives Highlight Strategic Value of the Collaboration
Anjan Selz, Chief Executive Officer of Polpharma Biologics International AG, said the partnership combines the company’s biosimilar development expertise with Teva’s global commercial infrastructure, creating a pathway to expand patient access to additional treatment options while supporting efficient global commercialization.
Yolanda Tibbe, Vice President and Global Head of Biosimilars at Teva, said the agreement aligns with the company’s Pivot to Growth strategy and strengthens its expanding biosimilars pipeline. She added that Teva’s experience in complex medicines and established commercial network position the company to bring the proposed biosimilar to patients following regulatory approval.
Multiple Sclerosis Remains a Major Global Health Burden
Multiple sclerosis is a chronic autoimmune disease affecting the brain and spinal cord. Damage to the protective myelin sheath surrounding nerve fibers disrupts communication between the brain and the rest of the body, leading to symptoms including fatigue, muscle weakness, numbness, impaired mobility, spasticity, dizziness, and vision problems.
Disease progression varies among patients. Many experience periods of relapse and remission, while others develop gradual worsening of neurological disability over time. Ocrelizumab remains one of the leading biologic therapies approved for both relapsing and primary progressive forms of MS.
Partnership Expands Future Biosimilar Opportunities
The licensing agreement reflects continued investment in biosimilars targeting high-value biologic medicines. By combining Polpharma Biologics’ development and manufacturing capabilities with Teva’s global regulatory and commercial infrastructure, the companies aim to broaden access to ocrelizumab therapy following regulatory approval.
If approved, the proposed biosimilar could expand treatment options for patients with multiple sclerosis while increasing competition in the growing global market for anti-CD20 biologic therapies.
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About the Writer
Fariha Sameen, PharmD (LinkedIn), is a clinical pharmacy professional with hands-on experience in patient counselling, medication review, therapeutic monitoring, and clinical documentation across multiple departments. She has experience identifying and assessing drug-related problems and supporting medication safety practices. Her interests include pharmacovigilance, ADR reporting, clinical research, and medical writing focused on clear, evidence-based communication.