Novo Nordisk and Sanofi are under investigation in South Africa for anti-competitive practices concerning insulin pens. The inquiry examines their patent policies amid recent global pressures to reduce insulin prices. Competition Commission scrutiny follows increased legislative action aimed at making insulin more affordable, and involves potential implications for market entry by new suppliers. Despite price cuts, companies have announced product discontinuations, resulting in a rapidly evolving insulin market.
The South African government is investigating Novo Nordisk and Sanofi for alleged anti-competitive practices related to human insulin pens. This inquiry, conducted by the Competition Commission of South Africa, aims to scrutinize the companies’ device patents and proprietary designs to see if they hinder competition and block other suppliers from entering the market. Coordination with the local entities of both companies is currently underway.
The insulin market has faced significant changes recently, driven by global policy reforms such as the Inflation Reduction Act and the Affordable Insulin Now Act, aimed at reducing out-of-pocket insulin costs for Americans. Legislative pressure has encouraged a decrease in insulin prices throughout the U.S., which may have implications for international markets as well.
The investigation into Novo and Sanofi follows substantial fines imposed on tech giants, including Google, for practices damaging to South African media. Recently, Eli Lilly announced a drastic 70% price reduction for its insulins while capping monthly out-of-pocket costs at $35. Following this, both Novo and Sanofi implemented their own price cuts shortly thereafter.
However, as these price cuts took effect, Novo announced it would discontinue its long-acting insulin product, Levemir, by the end of 2024. Furthermore, Eli Lilly indicated limitations on the availability of its products due to marketing constraints. Sanofi also stopped offering its pre-mixed insulin product, Insuman, primarily affecting the U.K. market. These discontinuations raise concerns over the sustainability of insulin pricing amid rising costs for manufacturers.
Despite these challenges, companies continue to innovate within the insulin sector. Eli Lilly is developing a once-weekly insulin injection, showing effective A1C reduction in Phase III trials. Meanwhile, Novo is also working on a once-weekly product named insulin icodec, but faced regulatory challenges when the FDA rejected its application, citing concerns regarding its use in type 1 diabetes.
The investigation into Novo Nordisk and Sanofi underscores the complexities of the insulin market amid external pressures for price reductions. As companies navigate regulatory scrutiny and innovate to meet patient needs, the implications for competition and market access remain significant. The ongoing shifts in pricing strategies, alongside the introduction of new products, highlight the dynamic landscape of insulin development in response to policy reforms.
Original Source: www.biospace.com
