Teva licenses Polpharma ocrelizumab biosimilar for global markets
Teva Pharmaceutical Industries has signed a global licensing agreement granting it exclusive rights to commercialise Polpharma Biologics' proposed biosimilar to ocrelizumab, the anti-CD20 monoclonal antibody marketed by Roche as Ocrevus for multiple sclerosis. The deal, announced on 9 July 2026, covers both the intravenous and subcutaneous formulations of the biosimilar candidate and spans markets including the United States, Europe, Brazil, Canada, Australia, New Zealand, Israel and Turkey.
Under the terms of the agreement, Polpharma Biologics retains full responsibility for development and manufacturing, while Teva will handle regulatory submissions and, on approval, commercialisation across the named territories. No financial terms were disclosed, and neither party gave a timeline for anticipated regulatory filings.
The deal
Teva is framing the agreement as consistent with its "Pivot to Growth" strategy, which centres on expanding both its innovative and biosimilar pipelines through external partnerships rather than solely internal development. Yolanda Tibbe, Teva's vice president and global head of biosimilars, said the company's commercial infrastructure and expertise in complex medicines positioned it to bring the candidate to patients. Polpharma Biologics chief executive Anjan Selz said the partnership creates "a clear path to getting this medicine to patients who need more treatment options."
Ocrelizumab is a humanised monoclonal antibody that targets CD20-positive B cells, which are implicated in the autoimmune processes underlying multiple sclerosis. Ocrevus holds approvals for both relapsing and primary progressive MS, a particularly hard-to-treat form of the disease that historically had no approved disease-modifying therapy. In the United States, Roche also markets a subcutaneous formulation under the separate brand name Ocrevus Zunovo.
Market context
Ocrevus has been one of the most commercially significant neurology launches of the past decade, generating multi-billion dollar annual revenues for Roche. Its composition-of-matter patents have begun to expire in some jurisdictions, opening the door to biosimilar competition, and several developers have been building towards filings in both the US and European markets. Sandoz, Mylan and a number of specialist biosimilar manufacturers have active ocrelizumab biosimilar programmes at various stages, meaning Teva and Polpharma will enter a contested field.
For Teva, which carries a substantial debt burden from prior acquisitions, the biosimilar partnership route is a capital-efficient way to fill its pipeline without the full cost of clinical development. The company already markets a broad generics and biosimilars portfolio, and ocrelizumab would add a high-value neurology asset. Polpharma Biologics, headquartered in Zug, Switzerland, operates as a dedicated biosimilar development and manufacturing organisation and has previously partnered assets with larger commercial players, making this deal consistent with its established monetisation model.
Multiple sclerosis affects an estimated 2.8 million people globally, and the availability of biosimilar alternatives to high-cost reference biologics remains a significant policy priority in most developed markets. Payers and health technology assessment bodies in Europe have been active in encouraging uptake of approved biosimilars through tendering and formulary decisions, which could support rapid market penetration if Polpharma's candidate clears regulatory review.
The next material milestone for investors and analysts to watch will be the submission of marketing authorisation applications, likely to the EMA and the US FDA, and whether the candidate generates interchangeability data sufficient to support automatic substitution in US pharmacy settings. Neither party indicated when those filings are expected.