SB3 (Ontruzant^®): A Trastuzumab Biosimilar

Area of Science:

• Oncology
• Immunology
• Pharmacology

Background:

• Trastuzumab is a critical anti-HER2 antibody for treating HER2-positive cancers.
• The development of biosimilars offers potential for increased patient access and cost savings.

Purpose of the Study:

• To evaluate SB3 (Ontruzant®) as the first approved biosimilar to trastuzumab in the European Union.
• To confirm the biosimilarity of SB3 to reference trastuzumab across various parameters.

Main Methods:

• Comparative assessment of physicochemical and pharmacodynamic properties.
• Pharmacokinetic studies in healthy volunteers and HER2-positive breast cancer patients.
• Clinical efficacy, safety, tolerability, and immunogenicity evaluations.

Main Results:

• SB3 demonstrated similar physicochemical and pharmacodynamic profiles to reference trastuzumab.
• Pharmacokinetic and clinical efficacy were found to be equivalent between SB3 and trastuzumab.
• Comparable safety, tolerability, and immunogenicity profiles were observed.

Conclusions:

• SB3 is a highly similar biosimilar to trastuzumab, approved for all indications of the reference product.
• SB3 provides a clinically effective and safe alternative for patients with HER2-positive breast and gastric cancers.