Sandoz, a leading global player in generic and biosimilar medications, has received a noteworthy endorsement from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The CHMP has issued a favorable opinion, recommending the granting of marketing authorization for Sandoz’s biosimilar trastuzumab (150 mg, for intravenous use), which was developed in collaboration with EirGenix, Inc.
This positive opinion encompasses the utilization of Sandoz trastuzumab, a monoclonal antibody, for the treatment of human epidermal growth factor receptor 2 positive (HER2-positive) breast cancer and metastatic gastric cancers. These indications align with the approvals granted by the EMA for the reference biologic.
The foundation for this significant milestone was laid back in April 2019 when Sandoz and EirGenix entered into a strategic license agreement. Under the terms of this agreement, EirGenix retained responsibility for the development and manufacturing of trastuzumab, while Sandoz secured the rights to market the medication upon receiving regulatory approval in their respective markets.
The impact of both breast and gastric cancers across Europe cannot be overstated. Annually, over 355,000 women grapple with a breast cancer diagnosis, and sadly, it remains the leading cause of cancer-related mortality among women, claiming 92,000 lives each year. Gastric cancer, though less prevalent, still exerts significant influence as the sixth most common cancer type in the region, with approximately 107,000 deaths annually, ranking it as the fourth leading cause of cancer-related death in Europe. It’s noteworthy that up to 20% of breast cancer cases and up to 30% of gastric cancer cases exhibit HER2 protein overexpression or HER2 gene amplification, resulting in uncontrolled cell growth and division. These HER2-positive cancers are particularly aggressive but respond well to targeted therapies.
The regulatory submission package was robust and thorough, encompassing a comprehensive array of analytical, preclinical, and clinical data. This included extensive analytical characterization, findings from a Phase I pharmacokinetics/pharmacodynamics (PK/PD) study, and the outcomes of a confirmatory Phase III study conducted in breast cancer patients (EGC002). Importantly, both studies successfully achieved their primary endpoints, affirming that the biosimilar is pharmacokinetically equivalent to the reference biologic while maintaining comparable levels of efficacy, safety, and immunogenicity.
“Breast and gastric cancers are among the most frequently occurring in Europe and, combined, are responsible for nearly 200,000 deaths annually. Biosimilars have enormous potential to improve cancer care by substantially increasing access to these critical medicines.”
– Pierre Bourdage, Chief Commercial Officer, Sandoz
This positive development marks a significant stride forward in the availability of biosimilar trastuzumab, which holds immense promise in improving the lives of patients battling HER2-positive breast and gastric cancers in Europe. The imminent approval and commercialization of this biosimilar underscore Sandoz’s commitment to advancing accessible and effective treatments for these challenging conditions, offering renewed hope to patients and healthcare providers alike.
