Teva Pharmaceutical Industries (NYSE and TASE: TEVA) has entered a global licensing agreement with Switzerland-based Polpharma Biologics International AG, securing exclusive rights to commercialize Polpharma's proposed biosimilar to ocrelizumab (Ocrevus; Roche/Genentech) across the US, EU, Brazil, Canada, Australia, New Zealand, Israel, and Turkey. The deal covers both the intravenous and subcutaneous formulations of the candidate, internally designated PB018. Polpharma retains full responsibility for development and manufacturing; Teva will handle regulatory submissions and commercialization in the licensed markets. Financial terms were not disclosed.
Why it matters
Ocrelizumab generated approximately USD 7.9 billion in annual global sales for Roche in 2025, making it one of the largest remaining biosimilar opportunities not yet secured by a major commercial partner across Western markets. The deal's dual-formulation scope is structurally notable: Roche's subcutaneous version, Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq), received US FDA approval in September 2024 and is actively shifting prescriber preference away from the four-hour IV infusion. By securing rights to both formulations upfront, Teva avoids being stranded on a legacy IV product in a market migrating toward subcutaneous administration by the time PB018 could launch.
Deal context
This agreement represents the most commercially significant entry in Teva's biosimilar in-licensing program, which has followed a consistent capital-light template: the developer retains manufacturing and clinical risk, while Teva contributes regulatory infrastructure and commercial reach. The same structure governed Teva's January 2025 agreement with Samsung Bioepis for an eculizumab biosimilar (US-only scope) and its April 2024 and October 2024 agreements with mAbxience for oncology biosimilars — the latter involving USD 15 million in combined upfront and milestone payments, providing a rough benchmark for Teva's biosimilar deal economics.
For Polpharma, the Teva agreement functions as the anchor transaction in a deliberate geographic carve-out strategy for PB018. The MENA region was licensed to MS Pharma in September 2025, and Latin America excluding Brazil was licensed to Tuteur in May 2026. Polpharma has previously demonstrated the commercial viability of this model: its natalizumab biosimilar Tyruko launched in the US in November 2025 under a Sandoz commercialization partnership, establishing precedent for licensing MS biosimilars while retaining manufacturing.