Teva secures global rights to Polpharma’s Ocrelizumab biosimilar candidate

USA—Teva Pharmaceuticals has signed a global licensing agreement with Polpharma Biologics to commercialize a proposed biosimilar to Ocrevus (ocrelizumab), enhancing its biosimilars portfolio through strategic partnerships.

The agreement, announced on July 9, grants Teva exclusive rights to commercialise both the intravenous and subcutaneous formulations of the biosimilar once it secures regulatory approval.

The partnership covers key markets, including the United States, Europe, Canada, Brazil, Australia, New Zealand, Israel and Turkey.

Under the agreement, Polpharma Biologics will remain responsible for the development and manufacturing of the biosimilar candidate, while Teva will oversee regulatory submissions and lead commercialisation following regulatory clearance.

The latest agreement aligns with Teva’s broader “Pivot to Growth” strategy, which focuses on strengthening its innovative medicines and biosimilars businesses through collaborations that expand its global pipeline.

According to the company, the partnership combines Polpharma Biologics’ expertise in biosimilar development with Teva’s established commercial infrastructure across major pharmaceutical markets.

Expanding access to multiple sclerosis treatments

Polpharma Biologics International Chief Executive Officer Anjan Selz said the agreement reflects the company’s commitment to advancing high-quality biologic medicines efficiently and at scale.

He noted that Teva’s global commercial reach, regulatory expertise and market presence complement Polpharma’s scientific and development capabilities, creating a clearer pathway to make the proposed therapy available to patients who need additional treatment options.

Both companies said the collaboration aims to improve patient access to biologic medicines while supporting the long-term sustainability of healthcare systems through increased competition in the biologics market.

The proposed biosimilar targets Ocrevus (ocrelizumab), a humanised monoclonal antibody that selectively binds to CD20-positive B cells.

These immune cells play a central role in the autoimmune processes that damage the protective covering of nerve fibres in people living with multiple sclerosis.

Ocrevus is approved for treating relapsing forms of multiple sclerosis and primary progressive multiple sclerosis.

In the United States, the intravenous formulation is marketed as Ocrevus, while the subcutaneous version is sold under the brand name Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq).

In the European Union, both formulations are marketed under the Ocrevus brand.

Multiple sclerosis is a chronic neurological disorder that affects the brain and spinal cord.

The disease disrupts communication between the brain and the rest of the body, leading to symptoms such as muscle weakness, impaired coordination, vision problems, numbness and difficulties with balance and mobility.

Recent progress in Teva’s biosimilars business

The licensing agreement builds on a series of recent milestones for Teva’s biosimilars portfolio.

Earlier this year, the US Food and Drug Administration approved Ponlimsi (denosumab-adet), Teva’s biosimilar to Prolia.

The company also secured regulatory approval of its proposed Xolair (omalizumab) biosimilar from both the FDA and the European Medicines Agency.

Meanwhile, Polpharma Biologics has continued advancing the development of its ocrelizumab biosimilar programme.

In June, the company announced a collaboration with PSI CRO to conduct a Phase I clinical study evaluating PB018, its proposed Ocrevus biosimilar, in patients with multiple sclerosis.

The trial is designed to compare the candidate’s pharmacokinetics, pharmacodynamics, safety and immunogenicity with both US-licensed and EU-approved Ocrevus.