Trastuzumab biosimilar ABP 980 provides an additional treatment option for patients with breast and gastric cancer
The testing and approval pathway for ABP 980 provides a model of accelerated development programs for novel, safe, and efficacious biosimilars.
There is increasing interest in biosimilars as alternatives to their originator reference product (RP), given their potential to improve patient access to important biological treatments. ABP 980 is a biosimilar of trastuzumab (Herceptin). Like trastuzumab, ABP 980 exerts its therapeutic effects by targeting cancer cells that overexpress the HER2 receptor, including those of the breast and stomach. ABP 980 is approved in the EU, USA, and Japan for the same indications, dosages, and route of administration as trastuzumab RP.
During development, ABP 980 underwent comprehensive analytical characterisation using state-of-the-art techniques. These assessments demonstrated ABP 980 has highly similar structural and functional attributes to trastuzumab RP, with only minor differences that are not expected to alter its biological activity or clinical performance. Phase I pharmacology studies conducted in healthy subjects confirmed ABP 980 has equivalent pharmacokinetics properties relative to trastuzumab RP.
Clinical similarity was evaluated in the LILAC study in women with HER2+ early breast cancer – who were deemed a sensitive patient population. The primary endpoint, pathologic complete response, was noted in 48% of patients treated with ABP 980 and 41% of those receiving trastuzumab RP – demonstrating noninferiority between the two groups. The trial confirmed clinical similarity between ABP 980 and trastuzumab RP. Safety and immunogenicity of the two test products were also similar. On the basis that the drug’s mechanism of action – inhibition of HER2-mediated proliferation – is the same for different cancer cells, the totality of evidence for ABP 980 supported scientific justification for extrapolation across all approved indications for trastuzumab RP. ABP 980 provides an additional treatment option for patients with breast and gastric cancers.
The biosimilar, ABP 980, shows similar structural and functional attributes, as well as demonstrating clinical non-inferiority in a clinical trial, when compared to its trastuzumab RP. This provides an additional treatment for breast and gastric cancer therapy, and therefore improving patient access.