Sandoz Strengthens Oncology Portfolio with Global License for Pertuzumab Biosimilar

Sandoz, the global leader in affordable medicines, has announced a significant expansion of its oncology pipeline by signing a global license agreement with EirGenix Inc. (6589.TW) to commercialize a proposed biosimilar of the key oncology medicine, pertuzumab.

This strategic move will allow Sandoz to capitalize on the estimated USD 4.1 billion global market for the reference medicine and contribute to the projected ~USD 300 billion biosimilar market opportunity over the next decade.

Deal Structure and Commercial Rights

The agreement is structured on a milestone-based consideration of up to USD 152 million, which includes an upfront payment and further potential incentives tied to market performance.

Sandoz Responsibility: Sandoz obtains exclusive worldwide commercial rights to the pertuzumab biosimilar, with the exception of certain countries in Asia (including Taiwan, China, Japan, Korea, and others).
EirGenix Inc. Responsibility: EirGenix will retain responsibility for the development, manufacturing, and supply of the proposed biosimilar.
Development Status: The medicine has already successfully completed a human pharmacokinetic similarity clinical study.

Addressing HER2-Positive Breast Cancer

The reference medicine, Perjeta® (pertuzumab), is a humanized IgG1 monoclonal antibody used in combination with other therapies, notably trastuzumab, to treat HER2-positive early breast cancer and HER2-positive metastatic or locally recurrent unresectable breast cancer.

Richard Saynor, CEO of Sandoz, highlighted the impact of the agreement: “According to the latest estimates, up to 2.3 million patients worldwide are diagnosed with breast cancer each year and, of these cases, approximately 15% to 20% are HER2-positive breast cancer.”

He added that this agreement “enhances our biosimilar oncology portfolio and complements our pipeline, given that the combination of pertuzumab and trastuzumab represents the standard of care in this field.”

Deepening Collaboration and Pipeline Synergy

This licensing deal strengthens the existing partnership between Sandoz and EirGenix, which already have an agreement in place for the worldwide commercialization of a proposed trastuzumab biosimilar (in both 150 mg and 420 mg forms).

The collaboration is strategically focused on the evolving breast cancer treatment landscape, where studies suggest that a combination of pertuzumab and trastuzumab deruxtecan could become a new first-line standard for HER2-positive metastatic breast cancer. Sandoz already has a biosimilar of trastuzumab deruxtecan in its pipeline.

Sandoz is committed to patient access, currently holding a leading global portfolio of 11 marketed biosimilars and 27 assets in development. Its marketed biosimilar oncology portfolio includes Rixathon®, Zarzio®, Ziextenzo®, and Binocrit®.