Insulin human (rDNA origin, Novo Nordisk)

Novo Nordisk has told government and global nonprofits that it plans to significantly downsize its manufacturing of some of its insulin pens, according to one of the groups, and will transition a portion of its global supply to insulin vials and syringes that are easier to make but less convenient for patients. The company’s plans were disclosed in recent discussions with Doctors Without Borders, who described them to Endpoints News , as well as the WHO, the Australian government, and other governments and regulators. “We are not halting production of insulin in pens,” Novo said in an email to Endpoints. “In some cases, we will no longer make human insulin available in pens. It will be made available in a vial and disposable syringe.” While some countries, like Australia and South Africa, are now seeking alternatives, the full extent of Novo’s plans isn’t immediately clear. The company declined to comment further to Endpoints on exactly which markets would be affected. And it said that some — but not all — insulin pens would be affected by the shift. And it emphasized that the changes would happen slowly, over a period of years. While South Africa in June announced shortages of insulin pens due to Novo’s decision to deprioritize their manufacture and supply, Doctors Without Borders’ pharmacist coordinator Christina Cepuch told Endpoints Friday that the latest announcement would go much further, based on the company’s comments to the groups. Geneva-based Doctors Without Borders is also known as Médecins Sans Frontières, or MSF. The WHO lists Novo’s insulin pens on its essential medicines list , and will also have to find alternatives, Cepuch said. The WHO did not immediately respond to a request for comment. “What does the WHO do about this? There’s not going to be any left. I mean, Lilly makes these, but they don’t make large volumes,” Cepuch said. “And what is WHO going to tell member states? Change everyone to glargine pens or go back to vials?” Glargine is a form of long-acting insulin, and Novo is currently in the process of phasing out its own long-acting insulin, called Levemir. On Tuesday, the Therapeutic Goods Administration, Australia’s drug regulator, released a short notice saying Novo will discontinue “some of its earlier generation insulin products” over the next two years. Scant on details, the notice said Australia is looking into alternatives. Novo emphasized to Endpoints that it is expanding its overall drug manufacturing significantly with the acquisition of Catalent and other new investments. Earlier this week, the Danish company’s CEO Lars Fruergaard Jørgensen testified before the US Senate at a hearing on drug prices and was asked by Sen. Tammy Baldwin (D-WI) about its insulin manufacturing plans. Baldwin asked Jørgensen if he would commit to “continue to have a focus on providing critical insulin. You will not reduce your manufacturing capacity in that area.” “The world market for insulin is actually declining, so there’s less demand,” Jørgensen responded. “But we are committed to supply to the patient that has been using our insulin for years also into the future.” Cepuch suggested that the company might decide to use freed-up pen capacity for its GLP-1 obesity products, which are also in shortage, or other insulins. Novo said the insulin and GLP-1 pens are different.

Through a voluntary license from Lilly, Eva Pharma plans to start selling JAK inhibitor Olumiant in African countries in 2026. Two years ago, Eli Lilly linked up with Egypt-based generics maker Eva Pharma to help address insulin needs in Africa. Now, the drugmakers have partnered again, this time to expand access to Lilly’s JAK inhibitor Olumiant (baricitinib).With a “first of its kind” voluntary licensing agreement, the company will provide certain Olumiant manufacturing know-how to allow Eva Pharma to make and supply the drug to patients in 49 countries across Africa, president of Lilly International, Ilya Yuffa, said in a release."Our commitment to expanding access to affordable and innovative medicines for people living in low- to middle-income countries continues," Yuffa added.The move falls in line with Lilly’s access to healthcare initiative Lilly 30x30, which looks to widen access to its medicines for 30 million people in resource-limited settings annually by 2030.Eva Pharma, for its part, is “proud to localize the entire value chain of this critical medication on the continent, from producing high-potency baricitinib active pharmaceutical ingredient (API), to tackling complex manufacturing challenges," CEO Riad Armanious said in a statement. Eva is slated to kick off sales of the locally made Olumiant by 2026. The companies aim to reach an estimated 20,000 patients with this collaboration by 2030.JAK inhibitor Olumiant was licensed to Lilly from original maker Incyte and is approved to treat rheumatoid arthritis, atopic dermatitis, COVID-19 and most recently alopecia areata.In recent years, Lilly and Eva have been working together to ensure a “sustainable supply of life-saving medicines” across several African countries, the partners said in the release. In 2022, Lilly committed to delivering its active pharmaceutical ingredient (API) for its human and analogue insulin at a reduced cost in 56 African countries. That agreement also entailed a “pro-bono transfer” of the technology Eva needed to formulate, fill and finish vials and cartridges. Outside of that deal, Lilly also struck a similar deal with Bangladesh’s International Agencies (IABL) in 2023 to supply the API for its human insulin at a cheaper price in an effort to improve access and affordability for nearly 1 million people with diabetes in Bangladesh by the end of the decade.Eva, meanwhile, has also partnered with Gilead to supply its COVID-19 antiviral remdesivir across Africa at a major discount.