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news.Teva Pharmaceuticals International and Polpharma Biologics have signed a global licensing agreement for a proposed biosimilar to Ocrevus (ocrelizumab) to treat multiple sclerosis (MS).
Teva will take charge of regulatory submissions and, subject to approval, subsequent commercialisation in the specified territories. Credit: JHVEPhoto / Shutterstock.com.
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Under the deal, Teva will hold exclusive rights to commercialise both intravenous and subcutaneous formulations of the biosimilar once it obtains regulatory approval.
The arrangement covers markets, including Australia, Canada, Brazil, Europe, Israel, New Zealand, Turkey, and the US.
Polpharma Biologics will retain full responsibility for developing and manufacturing the biosimilar candidate. Teva will take charge of regulatory submissions and, subject to approval, subsequent commercialisation in the specified territories.
Polpharma Biologics International CEO Anjan Selz said: “This agreement reflects our focus on pushing high-quality biologics to the finish line efficiently and at scale.
“Teva brings reach, discipline and real commercial strength to our strategic collaboration. Combining its global footprint with our technical and development capabilities creates a clear path to getting this medicine to patients who need more treatment options.”
The companies noted that the agreement is intended to support access to biologic medicines and address the sustainability of healthcare systems.
Ocrelizumab is a humanised monoclonal antibody that targets CD20-positive B cells, which are implicated in the autoimmune activity associated with MS.
In the US, Ocrevus is available as an intravenous treatment while the subcutaneous formulation is marketed as Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq).
In the EU, both versions are available under the Ocrevus name.
MS is a chronic disease of the central nervous system resulting in a range of neurological symptoms.
In March 2026, Teva Pharmaceutical secured approval from the US Food and Drug Administration for Ponlimsi (denosumab-adet) as a biosimilar to Prolia, alongside the acceptance of its biosimilar candidate applications for Xolair (omalizumab) by both the FDA and the European Medicines Agency.
