Merck, a major pharmaceutical company, is preparing for a big change in 2028, when its top cancer drug, Keytruda, will face challenges.
1. **Patent Expiration**: A key U.S. patent for Keytruda will expire at the end of 2028. This means other companies can start making similar versions, potentially cutting into Merck’s sales.
2. **Price Negotiations**: The U.S. government plans to include Keytruda in a price negotiation process under the Inflation Reduction Act (IRA) starting in 2026. The new, lower prices would be applied in January 2028.
Merck expects these factors to reduce U.S. sales of Keytruda, which currently makes a significant portion of their revenue. In 2024, Keytruda is expected to bring in $29 billion. The company is trying to offset this potential loss by making new business deals and preparing for future growth.
Other companies, like Celltrion, Samsung Bioepis, and Amgen, are already working on their own versions of Keytruda, hoping to capture part of the market once its patent protection ends in Europe in 2031.
**Related Issues**: Under the IRA, Merck’s other drugs, like Januvia, Janumet, and Janumet XR, will also face price cuts. Merck has opposed these negotiations, even suing the U.S. government, arguing that these price controls harm innovation in the pharmaceutical industry.
The IRA was enacted in 2022 during President Biden’s term. Some in the pharmaceutical industry are hoping for changes under the new administration.
Despite these challenges, Merck continues to work on minimizing the negative impacts of the IRA and is seeking changes to ensure innovation and the development of new treatments are not hindered.