FDA Approves First Biosimilar Cancer Treatment

Regulatory NewsRegulatory News
| 14 September 2017 | By Zachary Brennan 

The US Food and Drug Administration (FDA) on Thursday approved Amgen’s biosimilar to Roche’s cancer treatment Avastin (bevacizumab). Amgen’s biosimilar was approved under the brand name Mvasi (bevacizumab-awwb).

FDA’s approval of Mvasi follows an advisory committee’s unanimous backing of the treatment and is based on review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates

Mvasi is biosimilar to Avastin, though not an interchangeable product. FDA has now approved seven biosimilars. 

Mvasi has been approved 13 years after the blockbuster Avastin first won FDA approval, though it's unclear how soon Mvasi will be marketed in the US as patents could protect Avastin until 2019. Last March, Roche's complaint against Amgen in regards to the biosimilar was dismissed. Amgen said it would not comment on the launch date or price of Mvasi.

Last December, Amgen and partner Allergan also submitted what they said is the first Avastin biosimilar application with the European Medicines Agency (EMA). And in India, generics company Hetero launched its Avastin biosimilar in June 2016, known there as Cizumab. Last month, FDA sent a warning letter to one of Hetero's manufacturing sites.


The approval in the US is for the treatment of adult patients with certain colorectal, lung, brain, kidney and cervical cancers. Specifically, the approved indications include:

  • “Metastatic colorectal cancer, in combination with intravenous 5-fluorouracil-based chemotherapy for first- or second-line treatment. Mvasi is not indicated for the adjuvant treatment of surgically resected colorectal cancer.
  • Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrmidine-oxaliplatin-based chemotherapy for the second-line treatment of patients who have progressed on a first-line bevacizumab product-containing regimen. Mvasi is not indicated for the adjuvant treatment of surgically resected colorectal cancer.
  • Non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first line treatment of unresectable, locally advanced, recurrent or metastatic disease.
  • Glioblastoma with progressive disease following prior therapy, based on improvement in objective response rate. No data is available demonstrating improvement in disease-related symptoms or survival with bevacizumab products.
  • Metastatic renal cell carcinoma, in combination with interferon alfa.
  • Cervical cancer that is persistent, recurrent, or metastatic, in combination with paclitaxel and cisplatin or paclitaxel and topotecan.”



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