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ODAC Unanimously Supports Bevacizumab Biosimilar ABP-215

Jason Harris
Published: Thursday, Jul 13, 2017

The FDA’s Oncologic Drugs Advisory Committee voted 17-0 to recommend approval for ABP-215, a biosimilar for bevacizumab (Avastin) manufactured by Amgen and Allergan, to treat a range of solid tumors.

The committee determined that ABP-215 is highly similar to bevacizumab and there is no clinically meaningful difference between the two drugs. Amgen and Allergan filed a biologics license application (BLA) for 6 indications:
  • Metastatic colorectal cancer, with intravenous 5-fluorouracil–based chemotherapy for first- or second-line treatment
  • Metastatic colorectal cancer, with fluoropyrimidine/irinotecan- or fluoropyrimidine/oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab-containing regimen
  • Non-squamous non–small cell lung cancer (NSCLC), with carboplatin and paclitaxel for first-line treatment of unresectable, locally advanced, recurrent or metastatic disease
  • Glioblastoma, as a single agent for adult patients with progressive disease following prior therapy
  • Metastatic renal cell carcinoma with interferon alfa
  • Cervical cancer, in combination with paclitaxel and cisplatin or paclitaxel and topotecan in persistent, recurrent, or metastatic disease
ABP-215 was developed as 100 mg per 4 mL and 400 mg per 16 mL single-use vials, the same strength and presentations approved for bevacizumab in the United States. Proposed dosing and administration labeling instructions are also the same.
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