Third Biosimilar to Bevacizumab Granted FDA Approval

The FDA has approved bevacizumab-maly (Almysys; mAbxience), the third biosimilar of bevacizumab (Avastin) approved in the United States.^1,2

Bevacizumab, a vascular endothelial growth factor (VEGF) inhibitor, binds VEGF and prevents the interaction of VEGF to its receptors (Flt-1 and KDR) on the surface of endothelial cells. The interaction of VEGF with its receptors leads to endothelial cell proliferation and new blood vessel formation in in vitro models of angiogenesis.

"The entire Brand Institute and Drug Safety Institute Team congratulates Amneal Pharmaceuticals and mAbxience on the FDA approval of Alymsys," James L. Dettore, chairman and chief executive officer of Brand Institute, said in a press release.

Bevacizumab-maly is indicated for the following:

• metastatic colorectal cancer (mCRC) in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment.
• mCRC, in combination with fluoropyrimidine/irinotecan– or fluoropyrimidine/oxaliplatin–based chemotherapy for second-line treatment of those who have progressed on a frontline bevacizumab product–containing regimen.
• frontline nonsquamous non–small cell lung cancer (NSCLC), in combination with carboplatin and paclitaxel.
• recurrent glioblastoma.
• metastatic renal cell carcinoma (RCC), 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.

However, bevacizumab-maly is not approved as an adjuvant treatment for patients with colon cancer.

The biosimilar has warnings and precautions for severe and fatal hemorrhage; arterial and venous thromboembolic events; hypertension, hypertensive crisis, and hypertensive encephalopathy; renal injury, proteinuria, and nephrotic syndrome; posterior reversible encephalopathy syndrome; embryo-fetal toxicity; ovarian failure; congestive heart failure; gastrointestinal perforations and fistula; surgery and wound healing complications, and infusion-related reactions.

Adverse events reported with bevacizumab-maly include epistaxis, hemorrhage, hypertension, exfoliative dermatitis, proteinuria, back pain, headache, rhinitis, taste alteration, dry skin, and lacrimation disorder.

In September 2017, the FDA approved ABP-215 (bevacizumab-awwb; Mvasi), a bevacizumab biosimilar developed by Amgen and Allergan indicated for the treatment of colorectal, lung, brain, kidney, and cervical cancers in adult patients.

In June 2019, the FDA approved PF-06439535 (bevacizumab-bvzr; Zirabev) as a bevacizumab biosimilar for the treatment of patients with metastatic carcinoma of the colon or rectum; unresectable advanced, metastatic, or recurrent NSCLC; advanced and/or metastatic RCC, and persistent recurrent or metastatic carcinoma of the cervix.

"With the US approval of our second biosimilar, Alymsys, we are continuing our momentum and establishing our presence in the $28 billion US biosimilars market," Chirag and Chintu Patel, co-chief executive officers at Amneal Pharmaceuticals, Inc., said in a press release. "By combining partner assets with our own key capabilities, we are on a clear path to becoming a meaningful player in this high growth category. Biosimilars represent the next wave of affordable medicines in the United States and are closely aligned with our strategy to provide high quality, affordable medicines to as many patients as possible."

References

1. FDA approves Alymsys (bevacizumab-maly), a biosimilar of bevacizumab by Amneal Pharmaceuticals, Inc., developed by mAbxience. News release. Brand Institute, Inc.; April 18, 2022. Accessed April 18, 2022. https://prn.to/3k7MGt7
2. Amneal achieves second US biosimilars approval with ALYMSYS (bevacizumab-maly). News release. Amneal Pharmaceuticals, Inc.; April 13, 2022. Accessed April 18, 2022. https://bit.ly/37xqFkq