Securing the World's Insulin Supply: New Producers, Persistent Gaps

A century after its discovery, insulin remains concentrated in the hands of a few manufacturers, and people living with diabetes feel every disruption in that system. This quarter brought encouraging signs of diversification, alongside a reminder of how vulnerable patients remain when a product leaves the market.

In the United States, the Food and Drug Administration approved Garzulys (insulin aspart fsan) on 30 July 2026, a biosimilar to NovoLog. The product brings together several partners: Emerge Bioscience holds the licence, Meitheal Pharmaceuticals will commercialize it in the United States, and Tonghua Dongbao developed the drug substance. Legal analysts at Goodwin describe it as the third insulin biosimilar approved by the agency.

Manufacturing capacity is also spreading. On 16 July, Biocon announced that the European Medicines Agency had approved a new fill and finish unit and production line for Semglee (insulin glargine) at its site in Malaysia, with commercial supply to Europe expected from the second quarter of its 2027 financial year. In Saudi Arabia, Sudair Pharma announced plans for a SAR 280 million (US$74.6 million) plant to produce long and short acting insulin from 2027. The company intends to hold three years of active ingredient stock, while the national procurement company NUPCO is using artificial intelligence to anticipate supply disruptions.

Yet supply security is not only about new products. In the United Kingdom, Novo Nordisk's withdrawal of Levemir (insulin detemir) is forcing people across the country to change treatment. On 5 August, NHS North East London warned that national stock was expected to run out by December 2026, possibly earlier, and asked practices to switch all patients by 30 November; more than 1,000 people in that area alone were still using it. Australia's Therapeutic Goods Administration expects no insulin detemir on its market from 2027. For a person who has spent years finding the right dose, a forced switch means new uncertainty, closer monitoring and renewed contact with an already stretched health service.