FDA Approves Amneal's Lanreotide Injection as Generic Rival to Somatuline Depot
核心洞察
Amneal Pharmaceuticals received FDA approval for lanreotide injection 120 mg/0.5 mL in a single-dose prefilled syringe, referencing Ipsen's Somatuline Depot (搜索).
The product launched immediately and carries Competitive Generic Therapy designation, supported by Amneal's in-house manufacturing capacity for complex injectables.
Lanreotide is indicated for acromegaly (搜索), advanced gastro-enteropancreatic neuroendocrine tumors (搜索) and carcinoid syndrome (搜索), controlling hormone levels and improving progression-free survival in eligible patients.
Amneal Pharmaceuticals has received U.S. Food and Drug Administration approval for its lanreotide injection, 120 mg/0.5 mL, supplied in a sterile, single-dose prefilled syringe. The company announced the approval on Sept. 18, 2026, and said the product launched immediately. The injection references SOMATULINE Depot (搜索) and was granted Competitive Generic Therapy designation by the FDA.
The approval adds a long-acting oncology and endocrinology product to Amneal's complex injectables portfolio. U.S. annual sales for SOMATULINE Depot (搜索) for the 12 months ended July 2026 were $983 million, according to IQVIA data cited by the company. SOMATULINE Depot is a registered trademark of Ipsen Pharma S.A.S.
Indications and Clinical Role
Lanreotide injection is indicated for the treatment of acromegaly (搜索), advanced gastro-enteropancreatic neuroendocrine tumors (搜索) (GEP-NETs), and carcinoid syndrome (搜索). According to the company, the drug helps control hormone levels in acromegaly, improves progression-free survival in eligible GEP-NET patients, and reduces the need for rescue therapy in patients with carcinoid syndrome, a condition caused by tumors releasing high amounts of hormones.
Manufacturing and Commercial Positioning
Amneal said the launch is supported by dedicated, large-scale in-house manufacturing capacity, which the company expects to allow reliable market supply.
"The approval and launch of lanreotide adds another material growth driver to our Affordable Medicines business," said Srinivas Kone, Ph.D., Senior Vice President and Chief Scientific Officer, Affordable Medicines. "Lanreotide is a significant addition to our expanding complex injectables portfolio and reflects the strength of our integrated development and manufacturing capabilities."
Amneal, headquartered in Bridgewater, New Jersey, describes itself as a diversified global biopharmaceutical company with a portfolio of approximately 300 complex generic, specialty and biosimilar medicines, delivering more than 160 million prescriptions annually, primarily in the United States. Its Affordable Medicines segment covers retail generics, injectables and biosimilars, while its Specialty segment provides branded treatments in neurology and endocrinology.