Phase III study success for bevacizumab biosimilar ABP 215 in NSCLC- Allergan + Amgen

Amgen and Allergan announced that a Phase III study of biosimilar candidate ABP 215 met its primary and secondary endpoints. The study evaluated the efficacy and safety of ABP 215 compared with Avastin (bevacizumab) in adult patients with advanced non-squamous non-small cell lung cancer (NSCLC). The primary endpoint, an assessment of objective response rates (ORR), was within the prespecified margin for ABP 215 compared to bevacizumab, showing clinical equivalence. Safety and immunogenicity of ABP 215 were comparable to bevacizumab. Secondary endpoint results were consistent with the primary finding and included risk difference of ORR, duration of response and progression-free survival (PFS).

Comment: The Avastin US patents expire in July 2019 and outside the US around 2022. Launch of a biosimilar before patent expiry of the originator drug creates a liability of patent infringement litigation.