On the five-year anniversary of the Global Diabetes Compact, WHO has issued a call to manufacturers to submit requests for “prequalification” of generic versions of the GLP-1 weight-control drug semaglutide and newer, fast-acting insulin analogues. The call is part of a broader initiative to accelerate access to life-saving diagnosis and treatment which remains out of reach for most people living with diabetes in developing countries.  

It was only when Silasi Hormenoo was hospitalized in Accra Ghana’s Regional Hospital in a coma in 2021 that doctors finally diagnosed her Type 1 diabetes – just in time to save her life. 

The university student had been in and out of clinics and smaller hospitals for a variety of infectious diseases as well as chronic conditions. Following a mistaken diagnosis with Type 2 diabetes, she was put on insulin for a while. But when the medication ran out, she didn’t try to get it refilled. No one had even explained to her that diabetes was a lifelong condition. 

“The diagnosis, in a way, was a blessing,” says the young woman, now 25 and a peer mentor for others living with the condition.  “I no longer have to be consistently in the hospital for any minor issue. I graduated university in 2024 and I can confidently work and go out into the corporate space.” 

But until last year, when Ghana included injectable insulin into the National Health Insurance Scheme basket of free medicines, she was spending about $200 a month for insulin drugs. And she can only access newer, rapid-acting insulin analogue products, which she finds more convenient to use, through donations – when they are available. 

Milestone moves to expand access to diabetes treatment   

This week, in milestone moves, WHO published a call to generic manufacturers of both rapid-acting analogue insulin and the now famous GLP-1 weight loss drug, semaglutide, to submit their products for “WHO Prequalification” approval – a global label of quality control. 

WHO “Prequalification” of products by manufacturers aims to help expedite mass procurement of generic versions of the treatments in low- and middle countries, signaling quality assurance of the manufactured product to global and national procurement agencies.    

And those moves aim to help dramatically expand access to improved diabetes treatment across low- and middle-income countries. 

“The burden of diabetes falls disproportionately on people with the least access to diagnosis and treatment. Increasing the number of quality-assured manufacturers can help reduce barriers to access and support more equitable diabetes care globally,” said WHO’s Alarcos Cieza, who heads up the WHO unit on Management of Noncommunicable Diseases (NCDs).  

The moves coincide with the five year anniversary of the Global Diabetes Compact agreed upon by the World Health Assembly in 2021.

The Compact’s targets, subsequently endorsed by WHA in 2022, aim to achieve by 2030 an 80% rate of diabetes diagnosis, glycaemic and blood pressure control – along with 60% use of statins to reduce the risks of cardiovascular disease from high cholesterol.  And 100% of people with type 1 diabetes, the most threatening, should have access to affordable insulin and self-monitoring tools. 

World far from reaching diabetes diagnosis and treatment goals

The world remains far from those goals. As of 2024, roughly 43% of adults living with diabetes were undiagnosed with 90% of the undiagnosed living in low and middle income countries. Around 830 million people worldwide are living with diabetes, up from 200 million in 1990. That includes about 589 million adults in 2025, according to the International Diabetes Federation. 

And while diabetes prevalence was once higher in wealthier nations, it is now rising most rapidly in low- and middle-income countries, a 2025 Lancet study found. Obesity, a leading risk factor for diabetes, also is accelerating in developing countries, even while it has plateaued in high-income countries, according to another study published this week in Nature. 

Yet in those same countries, insulin products remain unaffordable if available at all. And the even newer GLP-1s like semaglutide, which helps reduce obesity and other health risks for people living with type 2 diabetes, is even harder to come by in Ghana, notes Hormenoo, who works as a peer mentor with Diabetes Youth Care, a Ghana-based non-profit.

While use  of GLP-1s are not usually recommended for type 1 diabetics – people she knows with type 2 diabetes find the products “extremely inaccessible,” Hormenoo says.

Just one semaglutide pen costs around $500 in Accra, meaning that monthly costs for the weekly injections can amount to $2000 or more. 

“GLP-1s are almost unknown – the knowledge that people do have is more around celebrities using it for weight loss,” she concludes.

Explosion in generic manufacture may lead to chain

But the recent expiration of the core patent for the weight-loss drug Semaglutide in India, China and Brazil in March may signal a big change for Africa as well. Domestically, the patent expiration has already led to expanded generic production in countries that are drug manufacturing as well as export powerhouses.  And therein lies the role of the WHO prequalification of that and other products, to ensure that the products purchased and sold are quality-controlled. 

“WHO Prequalification does not re-evaluate whether semaglutide works or is safe –  that has already been established through clinical trials, subsequent approvals by stringent national regulatory authorities and confirmed by its inclusion on the WHO Essential Medicines List,” said WHO’s Bianca Hemmingsen, technical lead for diabetes.

“What WHO Prequalification assesses is whether a specific [generic] manufacturer can produce semaglutide at the required quality standard. The WHO invitation to manufacturers opens a pathway to apply for prequalification of GLP-1 receptor agonists, specifically semaglutide, for the first time.”

Semaglutide was added to the WHO Essential Medicines List in 2025 

While the drug first gained fame for its effects on weight loss, semaglutide,  originally developed by Novo Nordisk and marketed under the brand names of Wegovy®, Ozempic® and Rybelsus®, was added to WHO’s essential medicines list last year. That was in recognition of the drug’s beneficial effects on diabetes control. 

The medication, part of a family of new glucagon-like peptide-1 receptor agonists (GLP-1 RA) drugs, mimics the natural incretin hormone GLP-1, lowering blood sugar, slowing stomach emptying to increase satiety, and reducing appetite.  While used first for weight loss and glucose control, the medication also improves cardiovascular health, reduces blood pressure, and is being studied for neuroprotective effects.

“It’s a very welcome step, we believe it will allow more access to more markets than the generic manufacturers had until now, presuming they meet the technical qualifications and standards,” said Dr Nikhil Tandon, professor and head of the Department of Endocrinology and Metabolism at the All India Institute of Medical Sciences in New Delhi, of the WHO moves.  

“Generic manufacture of GLP-1 has already dramatically brought down the price in India,”  by as much as 80%, said Tandon. Indian manufacturers were “ready to launch” generic versions of the drug in late March, the day after the patent expired. 

Now, the WHO prequalification process should provide a gateway for manufacturers to export more easily to other low- and middle-income countries –  where national regulatory processes may be weaker and slower to take up new products.  Recent research has meanwhile projected a worldwide price drop as a result of the shift to generics. 

Although generic sales in developing countries may soon begin to boom, secondary patents for the drugs will continue to protect the brand-name drugs from generic competition in the United States and Europe until around 2031-2032.

WHO process may also expand access to rapid-acting insulin analogues 

While semaglutide may be headline-grabbing, Tandon is also hopeful that the global manufacture of insulin will also increase through the expanded WHO Prequalification insulin track, which now includes rapid-acting analogues in both vial and cartridge forms. 

Just three large pharma firms, Novo Nordisk, Eli Lilly and Sanofi still produce more than 90% of the world’s insulin. 

Smaller manufacturers based in China, India and elsewhere are gradually scaling up activities, particularly in emerging markets, including production of popular “biosimilar” analogues of human insulin products – which have also been off patent for some time. But breaking into new markets remains difficult. 

That makes the WHO prequalification call particularly timely with respect to insulin analogues particularly, as well, observes Tandon, who sits on a WHO Technical Advisory Committee for Insulin products.  

“In India, a drug price control order already makes insulin much cheaper than products sold in many other parts of the world,” he noted.  But in many low-income countries, conventional human insulin remains difficult to access – while analogues can be almost impossible.  

“If the products of manufacturers are based in lower income countries are prequalified by the WHO, this will allow many countries to access insulin at much cheaper rates than those sold by other manufacturers,” Tandon said. “With WHO prequalification, it helps cut through some of the steps of the [country’s] regulatory process.” 

While Tandon still regards human insulin as largely equivalent in terms of clinical benefits for the type 1 diabetes patients who need it the most, newer analogues also offer some “nuanced” benefits in the case of risks of night-time  or severe hypoglycemia, he said.  

Notably, users tend to find them “more convenient” because they can be taken just a few minutes before meals, as compared to human insulin, which requires more advance planning. 

In the updated WHO call, it is these rapid-acting insulin analogues that are a new addition; the rest of the analogues were already listed for WHO prequalification. 

But Tandon is hopeful that this new addition of these very popular, rapid-acting formulations could make a difference, stimulating more manufacturing interest and leveling the playing field “with good and sound technical targets. With the number of players available, I think access to markets will perhaps increase and it will bring prices down.”

Marketing surveys show growth of manufacturing capacity 

Indeed, the number of companies manufacturing both GLP-1 and insulin analogue products seems to be slowly increasing. 

Earllier this year, WHO conducted a marketing survey of manufacturers of semaglutide in collaboration with the University of Geneva. The results were striking.  

Preliminary findings indicate that more than 80 companies are currently marketing or registering the new generic GLP-1 formulations across 11 countries including Argentina, Bangladesh, Brazil, Canada, China, India, Indonesia, Laos, Pakistan, Paraguay, and Russia. The bulk of production, particularly for injectable formulations (such as prefilled pens and syringes) as well as oral forms, is concentrated in India and China.

In February, WHO convened an insulin manufacturers’ dialogue.  Some  28 insulin manufacturers joined the meeting – more than even the WHO team had heard about previously.  

Collaborative Registration Procedure another gateway to increasing access

As production and export of new diabetes products expands to more low- and middle-income countries national regulatory authorities still face challenges in reviewing and approving the drugs and devices – even if their producers have been approved by the WHO prequalification channel.

“This is due to the often limited capacity to assess complex biological medicines. And there are additional complexities for those delivered in delivery systems like injection pens, which require evaluation of both the product and the device,” Hemmingsen notes. 

So along with the prequalification process, which can single out quality-approved manufacturers, WHO is also encouraging low- and middle-income countries to take advantage of another tool, called the Collaborative Registration Procedure (CRP), which can support more rapid national regulatory evaluation and approval. 

“The goal is to avoid duplication of effort,” stresses Hemmingsen.  “If a product has already been rigorously assessed, countries should not need to start from scratch. This is particularly important for LMICs where regulatory capacity often is limited.  

This process can work through two complementary pathways, she explains: 

• If the product of a particular manufacturer has been “prequalified” by WHO, countries can reliably use that assessment as the basis for expedited national registration via the CRP. 
• If a product has been approved by another stringent national regulatory authority – that  recognized as such as a “WHO Listed Authority”, other countries can rely upon that country’s regulatory approval to fast-track their own.   

Current WHO-listed Authorities that participate in the WHO CRP process include the European Medicines Agency, SwissMedic, the United Kingdom’s MHRA, TGA Australia and, most recently, Health Canada. 

“Both pathways reduce the regulatory burden on under-resourced national authorities and accelerate the journey from manufacturer approval to patient access,” observed Hemningsen. 

Together, the combined processes should help expedite access of quality-controlled products to more markets than generic manufacturers have had until now, leading to eventual price reductions and more access – along the lines of the 2030 goals. 

For Hormenoo, the young woman living with diabetes in Ghana, her diagnosis and regular access to insulin has been nothing short of transformational. From being chronically ill, and in and out of hospitals, she has completed university, national service, and is now hunting for a job.  

“It’s still hellish walking in the sun and I can’t go to the beach at all,” Hormenoo notes, referring to the nerve damage she suffered before she began regular insulin treatment.  “But the diagnosis has really helped with my quality of life – having uninterrupted education and being able to work, has been a major upgrade for me. I can confidentaly go out into the corporate space.”

And as Tandon puts it: “Every single person with type 1 diabetes should have access to insulin and monitoring equipment. It’s critical, because there is no other way of putting it politely, people who have Type 1 diabetes and who don’t have access to insulin will die.”

Image Credits: isensusa/Unsplash, Nature , Chemist4u, WHO, MSF, WHO Special Access Programme, Regulation and Safety Unit.