Sandoz, the global leader in affordable medicines, has signed a global license agreement with Taiwanese biotech company EirGenix to commercialise a proposed biosimilar of the oncology medicine pertuzumab. The milestone-based deal, valued at up to USD 152 million, includes an upfront payment and potential market-based incentives.  

Under the agreement, Sandoz gains exclusive worldwide commercial rights to EirGenix’s breast cancer biosimilar EG1206A—a proposed biosimilar to Roche’s Perjeta (pertuzumab) - excluding Asia markets. The agreement covers all territories except Taiwan, Mainland China, Macau, South Korea, Mongolia, Brunei, Cambodia, Indonesia, Laos, Myanmar, the Philippines and Japan.

EirGenix will be responsible for product development, manufacturing and supply, while receiving up to USD 152 million in upfront and milestone payments, as well as a profit share and potential sales-based incentives following product launch in licensed territories.

EG1206A has completed its pharmacokinetic (PK) clinical study and recently received positive feedback from both the US FDA and the European Medicines Agency (EMA), confirming its eligibility for an abbreviated development pathway—potentially allowing for a waiver of Phase III comparative efficacy trials.

Richard Saynor, CEO of Sandoz, said, “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 percent to 20 percent are HER2-positive breast cancer.”

“This agreement underscores our commitment to expand patient access, as well as support healthcare systems by offering high-quality and more affordable treatment options. It also 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,” he added.

The deal builds on the existing collaboration between Sandoz and EirGenix, following their previous global commercialisation agreement for EG12014 (trastuzumab biosimilar, 150 mg and 420 mg formulations). EG12014 has already been approved by the European Commission and is under BLA review by the US FDA.

Globally, HER2-positive breast cancer accounts for around 20 percent of the 2.3 million breast cancer cases diagnosed annually. Combination therapy with trastuzumab and pertuzumab remains the current standard of care, while emerging studies indicate that pertuzumab combined with trastuzumab deruxtecan (Enhertu) could become a new first-line treatment for HER2-positive metastatic disease—highlighting strong market potential for EG1206A.

With EG12014 already available and EG1206A in development, EirGenix aims to broaden treatment options for HER2-positive breast cancer patients. Sandoz also continues to advance its pipeline, which includes a biosimilar of trastuzumab deruxtecan currently under development.