Teva Signs Global Licensing Deal with Polpharma Biologics for Ocrelizumab Biosimilar Candidate

A structural split between CMC ownership and regulatory accountability is now formalized in Teva's global licensing agreement with Polpharma Biologics, covering a biosimilar candidate to Ocrevus® (ocrelizumab) in both intravenous and subcutaneous formulations. For QA directors and regulatory leads managing multi-market biologics programs, the arrangement sets a clear precedent for how development-stage and commercial-stage responsibilities can be partitioned across organizations.

Under the agreement, Polpharma Biologics retains full responsibility for development and manufacturing of the biosimilar candidate, while Teva assumes accountability for regulatory submissions and, upon approval, commercialization across the United States, Europe, Brazil, Canada, Australia, New Zealand, Israel, and Turkey. That division places the quality agreement and tech transfer framework at the center of execution risk: Polpharma holds process knowledge and manufacturing controls; Teva carries the submission dossier and post-approval obligations across at least eight regulatory jurisdictions with distinct requirements under 21 CFR Part 211, EMA biosimilar guidelines, and their regional equivalents.

Ocrelizumab is a humanized anti-CD20 monoclonal antibody indicated for relapsing and primary progressive multiple sclerosis. The reference product's dual-formulation commercial footprint adds analytical complexity to the biosimilar program: in the U.S., the IV formulation is marketed as Ocrevus® and the subcutaneous formulation as Ocrevus Zunovo® (ocrelizumab and hyaluronidase-ocsq), while the EU carries both under a single brand. Demonstrating biosimilarity across two distinct formulations, each with its own device and delivery considerations, will require parallel comparability packages and device-specific human factors data in several markets.

The 'develop-and-hand-off' model embedded in this deal reflects a broader industry pattern in which specialized biologics developers retain CMC ownership through to approval while large commercial operators absorb the regulatory submission burden and market access infrastructure. For plant heads, the operational read is direct: robust quality agreements and clearly scoped technology transfer protocols will determine whether Polpharma's process validation data translates cleanly into Teva's submission packages without gaps that invite agency queries.

Teva has framed the agreement within its Pivot to Growth strategy, which targets pipeline expansion through external collaborations rather than internal biologics buildout. Polpharma Biologics, headquartered in Zug, Switzerland, brings an established biosimilar development track record to the partnership.

Regulatory filing timelines have not been disclosed; the pace of submissions across eight markets will serve as the first measurable indicator of how effectively the two organizations have aligned their quality and regulatory functions.

Source: GlobeNewswire via Teva Pharmaceutical Industries Ltd. and Polpharma Biologics International AG, 9 July 2026.