FDA Approves Third Bevacizumab Biosimilar

The FDA has approved bevacizumab-maly (Almysys), a biosimilar of bevacizumab (Avastin). This regulatory decision represents the third bevacizumab biosimilar to receive the green light in the United States.^1,2

The biosimilar was developed by the global biotechnology company mAbxience. Bevacizumab-maly is a VEGF inhibitor that is indicated for the treatment of patients with:

• 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

"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, stated in a press release.

Important safety information for the biosimilar includes warnings and precautions regarding the following: 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.

The adverse drug reactions that have been reported with the agent include epistaxis, hemorrhage, hypertension, exfoliative dermatitis, proteinuria, back pain, headache, rhinitis, taste alteration, dry skin, and lacrimation disorder.

"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., stated in another 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."

Previously, in September 2017, the FDA gave the green light to ABP-215 (bevacizumab-awwb; Mvasi), a bevacizumab biosimilar developed by Amgen and Allergan, which was indicated for the treatment of colorectal, lung, brain, kidney, and cervical cancers in adult patients.³ This was the first biosimilar to be approved by the regulatory agency for cancer treatment.

More recently, 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.⁴ The regulatory decision was based on data from a comprehensive data package, which demonstrated biosimilarity of PF-06439535 to reference bevacizumab. This includes results from the REFLECTIONS B7391003 trial (NCT02364999), which showed clinical equivalence and found no clinically meaningful differences between PF-06439535 and bevacizumab in patients with advanced non-squamous NSCLC.

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
3. FDA approves first biosimilar for the treatment of cancer. News release. FDA; September 14, 2017. Accessed April 18, 2022. https://bit.ly/3jPH0nf
4. Pfizer receives US FDA approval for its oncology biosimilar, Zirabev (bevacizumab-bvzr). News release. Pfizer; June 28, 2019. Accessed April 18, 2022. https://bit.ly/3L7mGcQ