The last few years have been tough for the insulin market, with recent policies and high-level pressure forcing companies to lower drug prices.
The South African government is investigating alleged anti-competitive practices by Novo Nordisk and Sanofi in connection with human insulin pens, Bloomberg reported on Monday evening.
The Competition Commission of South Africa, the government’s anti-trust agency, is scrutinizing the companies’ device patents and proprietary designs to determine if these are being exploited to limit competition and block the entry of other developers and suppliers, as per Bloomberg. The watchdog is currently in the process of coordinating with Novo Nordisk’s and Sanofi’s local entities.
BioSpace has reached out to Sanofi and Novo Nordisk for their statements and will update this article accordingly.
The insulin market has seen some heavy upheaval over the last few years, driven by key policy changes around the world. Chief among these is the Inflation Reduction Act, signed into law in August 2022, and the Affordable Insulin Now Act, both of which seek to dramatically minimize Americans’ out-of-pocket spending for insulins. Pressure from lawmakers have also helped lower insulin prices in the U.S.
The Competition Commission’s investigation comes shortly after it fined Google about $30 million per year for the next five years, while also investigating Meta and the social media network X (formerly Twitter), all for business practices that harmed South African media.
Eli Lilly in March 2023 announced that it would lower insulin prices by 70% and cap out-of-pocket costs at $35 per month. Novo and Sanofi followed suit soon after, enacting their respective price cuts in the subsequent weeks.
Months later, however, Novo announced that it would discontinue its long-acting insulin product Levemir, removing both the vials and pen from the market by the end of 2024. Lilly in Mach 2024 announced that due to marketing constraints, availability of two of its inulin products—Humalog an Lispro—would be limited.
Sanofi also discontinued its pre-mixed insulin product Insuman, though this move mostly affected the U.K. and came in February 2023, a month before it announced the insulin price cuts.
In a May 2024 interview with BioSpace, BMO Capital Markets analyst Evan Seigerman said that Novo “can’t make a product they’re losing money on, which may be the case with some insulins, and at some point they need to be smart with capital.”
Still, the drugmakers continue to innovate on insulins. Lilly, for instance, is advancing a once-weekly insulin injection, Phase III readouts for which showed it could lower A1C by 1.34%, as compared with the 1.26% reduction for once-daily insulin degludec. Novo is also working on its own once-weekly product, dubbed insulin icodec. In July 2024, however, the program hit a regulatory road bump when the FDA rejected its drug application, flagging issues with the use of the product in type 1 diabetes.