FDA Approves Third Bevacizumab Biosimilar

Alymsys from Amneal Pharmaceuticals and mAbxience is the third biosimilar referencing Avastin approved in the United States and the second of 3 biosimilar approvals Amneal expects in 2022.

The FDA has approved bevacizumab-maly (Alymsys) developed by Amneal Pharmaceuticals and mAbxience. This marks the third bevacizumab, referencing Avastin, approved in the United States.

The first bevacizumab biosimilar was Mvasi and it was approved September 2017 and launched July 2019. IQVIA has reported that the annual US sales for bevacizumab for the 12 months ending February 2022 were $2.6 billion. Of the total sales, $1.6 billion (61.5%) represented biosimilar sales.

Bevacizumab-maly is a vascular endothelial growth factor inhibitor, and it is approved to treat:

  • Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment
  • Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan– or fluoropyrimidine-oxaliplatin–based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen
  • First-line non-squamous non–small cell lung cancer, in combination with carboplatin and paclitaxel
  • Recurrent glioblastoma in adults
  • Metastatic renal cell carcinoma in combination with interferon alfa
  • Persistent, recurrent, or metastatic cervical cancer, in combination with paclitaxel and cisplatin or paclitaxel and topotecan
  • Epithelial ovarian, fallopian tube, or primary peritoneal cancer, in combination with paclitaxel

When it submitted bevacizumab-maly to the FDA, Amneal noted that it intends to seek approval for the remaining indications of the reference product label as soon as possible, subject to patent and regulatory exclusivities.

The biosimilar was already approved by the European Medicines Agency in February 2021.

“Biosimilars represent the next wave of affordable medicines in the US and are closely aligned with our strategy to provide high quality, affordable medicines to as many patients as possible,” Chirag and Chintu Patel, co-CEOs, said in a statement.

In March, FDA approved Amneal’s first biosimilar, Releuko (filgrastim-ayow), which references Neupogen. Releuko was the third filgrastim biosimilar approved and was approved to treat and prevent febrile neutropenia. Releuko is expected to launch in the third quarter of 2022.

There are 3 other filgrastim biosimilars already on the market in the United States: Granix from Teva, which was approved August 2012 and launched November 2013; Zarxio from Sandoz, which was approved March 2015 and launched September 2015; and Nivestym from Pfizer/Hospira, which was approved July 2018 and launched October 2018.

Amneal also has a pegfilgrastim biosimilar referencing Neulasta under review at the FDA. Pegfilgrastim is also used to treat febrile neutropenia, as well as acute myelosuppressive radiation exposure.

There are 4 pegfilgrastim biosimilars on the market in the United States: Fulphila from Viatris/Biocon approved June 2018 and launched July 2018; Udenyca from Coherus Biosciences approved November 2018 and launched January 2019; Ziextenzo from Sandoz approved November 2019 and launched the same month; and Nyvepria from Pfizer approved June 2020 and launched December 2020.