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Teva and mAbxience Expand Partnership with New PD-1 Biosimilar Candidate

• Teva and mAbxience have broadened their strategic alliance to include a novel anti-PD-1 oncology biosimilar, enhancing their commitment to accessible biosimilars. • mAbxience will spearhead the biosimilar's development and production, utilizing its advanced facilities in Spain and Argentina for cGMP-compliant manufacturing. • Teva will manage regulatory submissions and commercialization across key markets, including Europe and the U.S., leveraging its commercial infrastructure. • This collaboration aligns with Teva's 'Pivot to Growth' strategy, adding a crucial biosimilar to its portfolio and optimizing development costs through strategic partnerships.

Teva Pharmaceuticals and mAbxience, a Fresenius Kabi majority-owned group, have announced a global licensing agreement to develop an anti-PD-1 oncology biosimilar. This agreement builds upon their initial alliance from April, reinforcing their dedication to providing high-quality, accessible biosimilars. The collaboration aims to improve healthcare outcomes on a global scale.

Development and Production

Under the terms of the agreement, mAbxience will lead the development and production of the PD-1 biosimilar, utilizing its state-of-the-art, cGMP-compliant facilities in Spain and Argentina. This ensures adherence to stringent manufacturing standards and facilitates efficient production.

Regulatory and Commercial Strategy

Teva will manage regulatory approvals and oversee commercialization in key markets, including Europe and the United States. This leverages Teva's regulatory expertise and extensive commercial capabilities to bring new treatment options to patients. Dr. Angus Grant, Executive Vice President of Business Development at Teva, emphasized that this partnership model optimizes development costs and enhances the company's ability to deliver innovative treatments.

Strategic Alignment

The licensing agreement grants exclusive rights for multiple markets, aligning with mAbxience’s global expansion strategy. For Teva, this collaboration supports its 'Pivot to Growth' strategy by incorporating a new biosimilar into its portfolio through focused partnerships and business development efforts. Jurgen van Broeck, CEO of mAbxience, noted that this second collaboration underscores the strength of their partnership with Teva and reinforces their commitment to making high-quality biosimilars accessible worldwide.
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Reference News

[1]
Teva and mAbxience Add Additional Oncology Biosimilar Candidate, Expanding Strategic ...
goodwinlaw.com · Oct 17, 2024

Teva Pharmaceuticals and mAbxience expand strategic partnership with a new global licensing agreement for an anti PD-1 o...

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