Last reviewed 2026-04-20 · How we verify

ALYMSYS (BEVACIZUMAB-MALY)

ALYMSYS (generic name: BEVACIZUMAB-MALY) is a drug developed by AMNEAL PHARMS LLC. It is currently FDA-approved for Metastatic Colorectal Cancer - First/Second Line, Metastatic Colorectal Cancer - Second Line Post Bevacizumab, Non-Squamous Non-Small Cell Lung Cancer - First Line.

Bevacizumab-maly (Alymsys), marketed by Amneal Pharms LLC, is a biosimilar approved for the treatment of metastatic colorectal cancer in first and second lines. The drug leverages its key composition patent, which expires in 2028, providing a strong competitive barrier. However, the lack of revenue data and key trial results poses a significant risk in assessing its market performance and clinical efficacy.

At a glance

Approved indications

• Metastatic Colorectal Cancer - First/Second Line
• Metastatic Colorectal Cancer - Second Line Post Bevacizumab
• Non-Squamous Non-Small Cell Lung Cancer - First Line
• Recurrent Glioblastoma
• Metastatic Renal Cell Carcinoma
• Persistent, Recurrent, or Metastatic Cervical Cancer
• Platinum-Resistant Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Common side effects

• Leukopenia
• Diarrhea
• Neutropenia
• Fatigue
• Sensory neuropathy
• Hypertension
• Nausea
• Asthenia
• Dehydration
• Vomiting
• Abdominal pain
• Pain

Serious adverse events

• Intra-abdominal thrombosis
• Syncope
• Constipation

Key clinical trials

• Endocrine Therapy With or Without Anti-VEGF Therapy: A Randomized, Phase III Trial of Endocrine Therapy Alone or Endocrine Therapy Plus Bevacizumab (NSC 704865) for Women With Hormone Receptor-Positiv (Phase 3)
• Phase III Prospective Randomized Comparison of Depot Octreotide Plus Interferon Alpha Versus Depot Octreotide Plus Bevacizumab (NSC #704865) in Advanced, Poor Prognosis Carcinoid Patients (Phase 3)
• A Pilot Trial of Cisplatin/Etoposide/Radiotherapy Followed by Consolidation Docetaxel and the Addition of Bevacizumab (NSC-704865) in Three Cohorts of Patients With Inoperable Locally Advanced Stage I (Phase 2)
• A Randomized Phase II Trial of Ipilimumab With or Without Bevacizumab in Patients With Unresectable Stage III or Stage IV Melanoma (Phase 2)
• A Prospective Cohort Study of Integrating Radiotherapy Into Chemotherapy With Pembrolizumab and Bevacizumab in Newly Diagnosed Stage IVB Cervical Cancer (Phase 1)
• A Phase III Randomized Controlled Clinical Trial of Carboplatin and Paclitaxel (or Gemcitabine) Alone or in Combination With Bevacizumab (NSC #704865) Followed by Bevacizumab and Secondary Cytoreducti (Phase 3)
• A Phase 2 Study of Bevacizumab, Erlotinib and Atezolizumab in Subjects With Advanced Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC) Associated or Sporadic Papillary Renal Cell Cancer (Phase 2)
• A Phase 1 Study of MLN0128 and Bevacizumab in Patients With Recurrent Glioblastoma and Other Solid Tumors (Phase 1)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• ALYMSYS CI brief — competitive landscape report
• ALYMSYS updates RSS · CI watch RSS
• AMNEAL PHARMS LLC portfolio CI

Frequently asked questions about ALYMSYS

Related

• Manufacturer: AMNEAL PHARMS LLC — full pipeline
• Therapeutic area: All drugs in Other
• Indication: Drugs for Metastatic Colorectal Cancer - First/Second Line
• Indication: Drugs for Metastatic Colorectal Cancer - Second Line Post Bevacizumab
• Indication: Drugs for Non-Squamous Non-Small Cell Lung Cancer - First Line

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing