FDA
2nd November 2017

Amgen Gains Unanimous Approval for ABP 215: A Proposed Biosimilar to Genentech/Roche’s AVASTIN (bevacizumab)

The FDA’s Oncologic Drugs Advisory Committee (ODAC) met on the morning of July 13th to discuss Biologics License Application (BLA) 761028.

Amgen Gains Unanimous Approval for ABP 215: A Proposed Biosimilar to Genentech/Roche’s AVASTIN (bevacizumab)

The FDA’s Oncologic Drugs Advisory Committee (ODAC) met on the morning of July 13th to discuss Biologics License Application (BLA) 761028 for Amgen’s biosimilar to Genentech/Roche’s AVASTIN (bevacizumab), ABP 215. ABP 215’s proposed indications include: non-squamous non-small cell lung cancer, metastatic colorectal cancer, metastatic renal cell carcinoma, glioblastoma, and cervical cancer.

ABP 215 is a monoclonal antibody (MAB), which inhibits vascular endothelial growth factor (VEGF), thus blocking tumor angiogenesis. The sponsor presented results from their analytical similarity assessment, which included the establishment of primary structure, higher order structure and aggregate, impurities, and functional activity similarities between ABP 215 and the reference product, bevacizumab. The sponsor concluded that the results from the analytical similarity assessment demonstrated that ABP 215 was highly similar to bevacizumab. The sponsor then proceeded to present their findings on the non-clinical and clinical similarity assessments, which also resulted in ABP 215 demonstrating high pharmacological, pharmacokinetic (PK), as well as safety/efficacy profile similarity to bevacizumab. The sponsor concluded that ABP 215 will serve as a high-quality biosimilar, which will increase access to an important therapy for cancer patients.

The FDA presentation was largely supportive of the ABP 215 product and supported the sponsor’s claim that ABP 215 is an appropriate biosimilar to US-licensed bevacizumab. Additionally, the FDA supported that ABP 215 is scientifically justified to be extrapolated to all bevacizumab indications, due to analytical, non-clinical, and clinical similarity, which led to the conclusion of no meaningful differences between the two products. The FDA then posed several discussion questions and a voting question to the committee, regarding the similarity of ABP 215 to the reference product and extrapolation of ABP 215 to all proposed indications, currently held by the reference product. The committee was largely in agreement with the FDA and the vote resulted in a 17-0 positive outcome, supporting licensure of ABP 215 for all indications of US-licensed bevacizumab.

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