Teva Pharmaceuticals and Polpharma Biologics have entered into a global licensing agreement covering a proposed biosimilar to Ocrevus (ocrelizumab), a biologic therapy used to treat multiple sclerosis (MS).
Under the agreement, Teva Pharmaceutical Industries subsidiary Teva Pharmaceuticals International will receive exclusive rights to commercialise Polpharma Biologics’ biosimilar candidate, including both intravenous (IV) and subcutaneous (SC) formulations, subject to regulatory approval.
The collaboration will bring together Polpharma Biologics' expertise in biosimilar development and manufacturing with Teva’s global commercial infrastructure and regulatory capabilities.
Polpharma Biologics will retain responsibility for the development and manufacturing of the candidate, while Teva will lead regulatory submissions and commercialisation activities across the US, Europe, Brazil, Canada, Australia, New Zealand, Israel and Turkey.
The deal forms part of Teva's wider Pivot to Growth strategy, which includes expanding its biologics and biosimilars portfolio through strategic partnerships.
“This agreement is aligned with Teva's Pivot to Growth strategy and our focus on expanding our biosimilars pipeline,” said Yolanda Tibbe, Vice President and Global Head of Biosimilars at Teva.
With our global commercial footprint and deep expertise in complex medicines, we are well positioned to help bring this biosimilar candidate to patients.
Ocrelizumab is a humanised monoclonal antibody targeting CD20-positive B cells, which are involved in the autoimmune processes associated with multiple sclerosis.
The reference product, developed by Roche, is approved for the treatment of relapsing forms of MS and primary progressive MS.
In the US, intravenous ocrelizumab is marketed as Ocrevus, while a subcutaneous formulation is marketed as Ocrevus Zunovo; in the European Union, both formulations are available under the Ocrevus brand.
As healthcare systems continue to face pressure to improve affordability while maintaining access to advanced therapies, biosimilars are becoming an increasingly important part of pharmaceutical supply strategies.
The global biosimilars market is expanding as more complex biologics approach patent expiry, creating opportunities for manufacturers with expertise in developing and scaling highly similar biological medicines.
Anjan Selz, CEO of Polpharma Biologics International AG, added that the partnership would combine Teva’s commercial reach with Polpharma’s technical capabilities to support broader patient access to biologic medicines.
The agreement adds another potential large-molecule asset to the competitive biosimilars landscape, while highlighting continued investment from pharmaceutical companies in partnerships that can accelerate the development, approval and commercial delivery of complex biologic therapies.
