Teva Secures Global Rights to Polpharma's Ocrevus Biosimilar Candidate for Multiple Sclerosis

Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries, and Polpharma Biologics International AG have entered a global licensing agreement granting Teva exclusive rights to commercialize both intravenous and subcutaneous formulations of Polpharma's proposed biosimilar to ocrelizumab (Ocrevus), pending regulatory approval.¹ Under the terms, Polpharma retains responsibility for development and manufacturing of the biosimilar candidate, while Teva will handle regulatory submissions and, upon approval, commercialization across the US, Europe, Brazil, Canada, Australia, New Zealand, Israel, and Turkey.¹

Ocrelizumab is a humanized monoclonal antibody that targets CD20-positive B cells, believed to play a central role in the autoimmune activity underlying multiple sclerosis (MS). The reference product, marketed by Genentech and Roche, was approved by the FDA on March 28, 2017, for relapsing forms of MS and became the first therapy ever approved for primary progressive MS.² In the US, the intravenous formulation is sold as Ocrevus, while a subcutaneous version launched more recently as Ocrevus Zunovo.

Why does the timing of this deal matter?

Ocrevus remains Roche's best-selling US product, with the company reporting CHF 4.9 billion in US sales for the drug in 2025, a 7% increase driven by both new and existing patients on the newer subcutaneous formulation.³ Globally, Ocrevus generated 7.6 billion Swiss francs in sales the prior year, making it the dominant revenue driver in the MS drug category.⁴ That commercial scale is precisely what makes the drug an attractive biosimilar target, and Ocrevus's US primary patent is expected to expire after October 2028, with market exclusivity running through March 2029.⁴ “You start at 10% of the originator price," Rhonda Duffy, chief operating officer of Biocon Biologics, told delegates at the Sartorius PI Forum in India, as reported by BioPharm International. That price continues to decline roughly 10% year over year after launch, a commercial reality that shapes how deals like this one get structured, prioritizing manufacturing efficiency and speed to market as much as clinical similarity.Companies positioning biosimilar candidates now are effectively racing to be ready for launch as soon as that exclusivity window closes.

Teva and Polpharma are not the only ones pursuing this asset Polpharma has also used this same development-and-commercialization split structure before, having licensed a proposed biosimilar to Takeda's Entyvio to Fresenius Kabi in August 2025, suggesting this partnership model is becoming Polpharma's standard approach to biosimilar commercialization.

In addition, an Iranian company, CinnaGen, has reported phase 3 results for its own ocrelizumab biosimilar candidate, though its plans for the US market remain unclear.⁴ That makes the Teva-Polpharma agreement one entry in what is shaping up to be a multi-company race toward the first approved ocrelizumab biosimilar.

What would a biosimilar mean for MS patients and payers?

MS is a chronic, unpredictable disease of the central nervous system in which loss of myelin disrupts nerve signal transmission, producing symptoms ranging from fatigue and numbness to walking difficulty and vision problems. Ocrelizumab depletes CD20-positive B cells while preserving the capacity for B-cell reconstitution and pre-existing humoral immunity, a mechanism that helped it become, according to the FDA, the first approved treatment specifically for primary progressive MS, a subtype that previously had no FDA-sanctioned disease-modifying therapy.² A successful biosimilar would introduce price competition to a therapy that has posted sustained annual sales growth even a decade after its original approval, potentially reshaping access economics in MS care as more patients would gain a lower-cost alternative once exclusivity lapses.

What happens next?

The agreement does not include a stated timeline for regulatory submission or expected launch, and the biosimilar candidate's current development stage was not disclosed. Both companies said the deal reflects a shared commitment to broadening access to biologic medicines while supporting the long-term sustainability of healthcare systems.¹ With Ocrevus's US exclusivity period running into 2029, the practical impact of this agreement will depend heavily on how quickly Polpharma can complete development and how the regulatory review process unfolds in the years ahead.

References

1. Teva and Polpharma Biologics Announce Global Licensing Agreement for a Biosimilar Candidate to Ocrevus (ocrelizumab) for Multiple Sclerosis. (2026 Jul 9). GlobeNewswire. https://www.globenewswire.com/news-release/2026/07/09/3324800/0/en/teva-and-polpharma-biologics-announce-global-licensing-agreement-for-a-biosimilar-candidate-to-ocrevus-ocrelizumab-for-multiple-sclerosis.html
2. FDA Approves New Drug to Treat Multiple Sclerosis. (2017 Mar 28). The New York Times. https://www.nytimes.com/2017/03/28/health/fda-drug-approved-multiple-sclerosis-ocrevus.html
3. F. Hoffmann-La Roche Ltd. Finance Report 2025. Roche. https://www.roche.com/investors/annualreport25
4. The Early Outlook for Ocrelizumab Biosimilars. (2025 Oct 21). Biosimilars Review & Report. https://biosimilarsrr.com/2025/10/21/the-early-outlook-for-ocrelizumab-biosimilars/