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FDA advisory committee unanimously supports biosimilar to Avastin
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An FDA advisory committee today expressed unanimous support of ABP 215, a biosimilar candidate to bevacizumab.
The Oncology Drugs Advisory Committee voted 17-0 that the risk–benefit profile of ABP 215 (Amgen/Allergan) — the first biosimilar candidate to bevacizumab (Avastin, Genentech) considered by FDA — supports its approval for treatment of a variety of solid tumors.
“ABP 215 is the first product of our collaboration with Amgen to reach this important milestone,” David Nicholson, chief of research and development at Allergan, said in a press release. “If approved, ABP 215 has the potential to provide another high-quality treatment option for [patients with cancer] and pave the way for additional high-quality oncology biosimilars from Allergan and Amgen.”
Bevacizumab, a recombinant immunoglobulin G1 monoclonal antibody, binds to vascular endothelial growth factor and inhibits the interaction of VEGF with its receptors. An angiogenesis inhibitor, it prevents the establishment of new blood vessels that solid tumors need survive and grow.
Bevacizumab is indicated for treatment of certain patients with metastatic colorectal cancer, advanced nonsquamous non–small cell lung cancer, platinum-resistant ovarian cancer, advanced cervical cancer, metastatic renal cell carcinoma or recurrent glioblastoma.
Amgen’s presentation to the Oncologic Drugs Advisory Committee included clinical, pharmacokinetic and analytical data designed to show that ABP 215 and bevacizumab are highly similar. The data showed no clinically meaningful differences in efficacy, safety or immunogenicity between the two agents, according to the press release.
The data package included results of a phase 3 study that met its primary endpoint, showing clinical equivalence between ABP 215 and bevacizumab as treatment for patients with nonsquamous NSCLC.
The FDA is not required to follow the opinion of the Oncologic Drugs Advisory Committee when making its final decisions, but the agency often does so.