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FDA Approves Amneal Pharmaceuticals’ Avastin Biosimilar, Bevacizumab-maly
Amneal said the product, to be sold under the name Alymsys, is the second of 3 US biosimilars the company expects to see approved this year.
Amneal Pharmaceuticals Wednesday said the FDA approved the company’s Biologics License Application (BLA) for bevacizumab-maly, a biosimilar referencing the originator product (Avastin).
Amneal said the product will be sold under the name Alymsys. It is the third bevacizumab biosimilar approved in the United States, and the second of 3 US biosimilars the company expects to see approved this year.
Earlier this year, Amneal received approval of filgrastim-ayow (Releuko) which references Neupogen. The firm’s pegfilgrastim biosimilar referencing Neulasta is currently under FDA review.
Bevacizumab-maly was developed by mAbxience. The vascular endothelial growth factor inhibitor is indicated for the treatment of:
- 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
Avastin, made by Roche, brought in $7 billion for the company in 2018, according to Forbes.
Switching From Avastin to Bevacizumab-bvzr in CRC, NSCLC Can Reduce Medicare Costs
May 10th 2025Monthly savings from fully converting Medicare patients with metastatic colorectal cancer (CRC) and non-squamous metastatic non-small cell lung cancer (NSCLC) from reference bevacizumab to bevacizumab-bvzr could fund 13,887 and 8,959 additional patient-months of treatment, respectively, according to a cost-effectiveness study.
Escaping the Void: All Things Biosimilars With Craig & G
May 4th 2025To close out the Festival of Biologics, Craig Burton and Giuseppe Randazzo from the Association for Accessible Medicines and the Biosimilars Council tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."
Targeted Reimbursement Encourages Oncology Biosimilar Use
May 7th 2025Incentivizing physicians with modest financial bonuses may seem like a small step, but in Japan’s outpatient oncology setting, it helped push trastuzumab biosimilars toward broader adoption, demonstrating how even limited reimbursement reforms can reshape prescribing behavior under the right conditions.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
Biosimilar Market Development Requires Strategic Flexibility and Global Partnerships
April 29th 2025Thriving in the evolving biosimilar market demands bold collaboration, early global partnerships, and a fresh approach to development strategies to overcome uncertainty and drive future success.
Eye on Pharma: Sandoz Files Antitrust Suit; Yuflyma Interchangeability; Costco’s Ustekinumab Pick
April 22nd 2025Sandoz's antitrust suit against Amgen, the FDA’s interchangeability designation for Celltrion’s adalimumab biosimilar, and the inclusion of an ustekinumab biosimilar in Costco’s prescription program highlight growing momentum to expand biosimilar access and affordability for patients with chronic inflammatory diseases.
