Meitheal Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for its liraglutide injection (18mg/3mL), a generic equivalent of Victoza, and has commenced its distribution in the US.
The company, which specialises in the development and commercialisation of generic injectables, fertility, biologic, and branded products, has expanded its portfolio with this launch.
Meitheal CEO Tom Shea said: “We are pleased to be launching and bringing liraglutide injection to market – an important option for patients with type 2 diabetes at a time when there is increased demand and limited availability for these medications.
“This generic provides patients with a more accessible GLP-1 treatment option, and we look forward to delivering it to our customers as quickly as possible and ensuring a sustainable, high-quality supply.”
The liraglutide injection, a glucagon-like peptide-1 (GLP-1) receptor agonist, is administered via an injector pen. It is intended to aid glycemic control in adults and children aged 10 and above with type 2 diabetes mellitus, in conjunction with diet and exercise.
As of 24 March 2025, both the FDA and the American Society of Health-System Pharmacists (ASHP) have reported an active shortage of the branded Victoza.
Meitheal has introduced the liraglutide injection in a three-pack format and plans to release additional pack sizes later in the year. The product, including both its generic and branded versions, generated approximately $1bn in US sales as of November 2024.
The launch marks Meitheal’s first foray into commercial injector pen products and diabetes medications.
The FDA’s approval of the liraglutide injection increases Meitheal’s offering of on-market generic injectables to 61 products. In 2023, the company acquired an exclusive commercial license for three insulin biosimilars in the US, which are in the clinical development phase.
Following a successful year in 2024 with the approval and launch of 12 new products, Meitheal plans to introduce 22 new products in 2025, focusing on therapeutic areas such as anti-infectives, anaesthetics, critical care, fertility, and oncology.
