Teva and Polpharma Biologics Announce Global Licensing Agreement for a Biosimilar Candidate to Ocrevus® (ocrelizumab) for Multiple Sclerosis
Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd, and Polpharma Biologics International AG announced a global licensing agreement granting Teva exclusive rights to commercialize both formulations of Polpharma Biologics’ proposed biosimilar to Ocrevus®1 (ocrelizumab), upon regulatory approval. This strategic agreement is expected to combine Polpharma Biologics’ proven biosimilar development expertise with Teva’s commercial footprint and capabilities.
“This agreement reflects our focus on pushing high-quality biologics to the finish line efficiently and at scale,” said Anjan Selz, Chief Executive Officer of Polpharma Biologics International AG. “Teva brings reach, discipline and real commercial strength to our strategic collaboration. Combining its global footprint with our technical and development capabilities creates a clear path to getting this medicine to patients who need more treatment options.”
Under the terms of the agreement, Polpharma Biologics retains full responsibility for the development and manufacturing of the biosimilar candidate. Teva will be responsible for regulatory submissions and, upon approval, commercialization of the intravenous and subcutaneous formulations in the United States, Europe, Brazil, Canada, Australia, New Zealand, Israel and Turkey.
“This agreement is aligned with Teva’s Pivot to Growth strategy and our focus on expanding our biosimilars pipeline. With our global commercial footprint and deep expertise in complex medicines, we are well positioned to help bring this biosimilar candidate to patients,” said Yolanda Tibbe, Vice President, Global Head of Biosimilars at Teva.
This strategic agreement reinforces both organizations’ commitment to broadening access to biologic medicines while promoting the long-term sustainability of healthcare systems.
About ocrelizumab
Ocrelizumab is a humanized monoclonal antibody designed to target CD20-positive B cells, which are believed to play a role in the autoimmune activity associated with multiple sclerosis. Ocrevus® (ocrelizumab) is indicated for the treatment of relapsing forms of multiple sclerosis and primary progressive multiple sclerosis. In the U.S., the intravenous formulation is marketed as Ocrevus®, while the subcutaneous formulation is marketed separately as Ocrevus Zunovo® (ocrelizumab and hyaluronidase-ocsq). In the EU, both formulations carry the single brand name Ocrevus®.
About Multiple Sclerosis
Multiple sclerosis is a chronic, unpredictable and progressive disease of the central nervous system, which includes the brain and spinal cord. In MS, the loss of myelin, the protective sheath surrounding nerve fibers, disrupts the transmission of electrical signals to and from the brain, leading to a wide range of symptoms.
MS affects people differently. Symptoms can fluctuate, with periods of worsening (relapses) followed by partial or full recovery (remission). Over time, some patients may also experience a gradual progression of disability.
Common symptoms include fatigue, weakness, numbness or tingling, walking difficulties, spasticity, dizziness, and vision problems, among others.
About Teva
Teva Pharmaceutical Industries Ltd. is transforming into a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment to bettering health has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health.
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