WHO provides GLP-1RAs to important medicines record
The World Well being Organisation (WHO) has up to date its mannequin record of important medicines (EML) to incorporate 4 key weight problems and sort 2 diabetes (T2D) medication.
This contains Novo Nordisk’s semaglutide, marketed as Ozempic and Wegovy for T2D and weight administration, respectively, in addition to Eli Lilly’s tirzepatide, marketed as Mounjaro and Zepbound, once more in T2D and weight administration, respectively.
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The United Nations (UN) company has added the glucagon-like peptide-1 receptor agonists (GLP-1RAs) and twin GLP-1/glucose-dependent insulinotropic polypeptide (GIP) receptor agonists to the EML following a overview from the WHO Skilled Committee, which discovered “sturdy scientific proof” to help their advantages in sufferers with T2D.
Nonetheless, WHO raised considerations concerning the prices of each semaglutide and tirzepatide, which include a hefty price ticket of between $997 and $1349 for a one-month prescription within the US, which the company warns might complicate affected person accessibility.
Each Lilly’s Trulicity (dulaglutide) and Novo Nordisk’s Saxenda (liraglutide) are additionally on the record. Saxenda is at present very comparable in worth to its extra efficacious successor, semaglutide. In the meantime, Trulicity additionally affords solely a small worth discount, being offered at $987 as a substitute of the $1079.77 cost for Mounjaro.
To advertise accessibility to those medication for all sufferers worldwide, the WHO has known as for his or her uptake in world major care programs, whereas encouraging the event of cheaper generic alternate options to drive down prices.
“This designation is prone to rework the general weight problems, diabetes and heart problems market by growing demand, driving worth reductions through generic competitors, and increasing utilization past prosperous populations,” mentioned Valentina Gburcik, senior director of cardiovascular and metabolic issues at GlobalData.
Gburcik additionally famous that the transfer might “shift market focus towards broader major care indications reasonably than area of interest or elite populations”, whereas it could additionally encourage pharmaceutical producers to speed up world regulatory approvals and distribution efforts.
Generics to enhance GLP-1RA accessibility
The August 2025 US approval of Teva Pharmaceutical’s generic Saxenda has left Novo Nordisk’s model weak to competitors.
Based on Gburcik, liraglutide’s EML itemizing will “solely speed up Saxenda’s market share erosion by stimulating generic manufacturing,” although the transfer might additionally probably “improve complete gross sales quantity at decrease costs”.
This has led analysts at GlobalData, mum or dad firm of Pharmaceutical Expertise, to forecast that Saxenda will make simply $135m in 2031 – down 91% from the $1.5bn gross sales seen at its peak in 2022.
In the meantime, semaglutide’s patent expiry is ready to be one other thorn in Novo Nordisk’s aspect, because the Danish pharma’s best-selling drug will face generic competitors in 2026 in India, China, Brazil, Canada and Turkey.
Although its patent in the important thing US market will not be resulting from expire till the early 2030s, generics will quickly be permitted in these markets. Chinese language drug producers at the moment are trying to leap on the GLP-1RA bandwagon, getting ready their semaglutide generics prepared for subsequent 12 months’s patent cliff.
Semaglutide’s world gross sales stood at DKr178.2bn ($28bn) in 2024.
Eli Lilly’s Trulicity patent is ready to run out in 2027, whereas the patent for the tirzepatide molecule will expire in 2036 within the US, however lively formulation patents could lengthen the exclusivity for Eli Lilly’s Mounjaro and Zepbound till round 2039.
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