Teva Pharmaceuticals and Polpharma Biologics have entered into a global licensing agreement under which Teva will receive exclusive rights to commercialise both intravenous and subcutaneous formulations of Polpharma Biologics' proposed biosimilar to ocrelizumab, subject to regulatory approval.

The proposed biosimilar is based on ocrelizumab, a humanised monoclonal antibody that targets CD20-positive B cells involved in the autoimmune processes associated with multiple sclerosis (MS). The reference medicine is indicated for the treatment of relapsing forms of MS and primary progressive MS. In the United States, the intravenous formulation is marketed as Ocrevus®, while the subcutaneous formulation is marketed as Ocrevus Zunovo®. In the European Union, both formulations are marketed under the Ocrevus® brand.

Multiple sclerosis is a chronic, progressive disease of the central nervous system that affects the brain and spinal cord. The disease damages myelin, the protective covering around nerve fibres, disrupting communication between the brain and the rest of the body. Symptoms vary between individuals and may include fatigue, muscle weakness, numbness, tingling, walking difficulties, spasticity, dizziness and vision problems. Patients may experience periods of relapse and remission, while some develop a gradual worsening of disability over time.

Under the agreement, Polpharma Biologics will remain responsible for the development and manufacturing of the biosimilar candidate. Teva will oversee regulatory submissions and, following approval, commercialisation across the United States, Europe, Brazil, Canada, Australia, New Zealand, Israel and Turkey.

The collaboration combines Polpharma Biologics' biosimilar development expertise with Teva's commercial capabilities. 

The agreement also supports the expansion of biosimilar availability in global markets and aims to improve patient access to biologic medicines.

 

Source: tevapharm.com

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