Merck Gains FDA Approval for Subcutaneous Keytruda Amid Patent Expiry Concerns

What's Happening?

Merck has received approval from the FDA for a subcutaneous version of its leading cancer therapy, Keytruda, branded as Keytruda Qlex. This new formulation is approved for most solid tumor indications that the intravenous version covers, totaling 38 cancer types. The subcutaneous injection is expected to be available in the U.S. later this month and will be priced similarly to the intravenous version, which costs approximately $11,800 for a three-week course. This development comes as Merck faces the expiration of key patent protections for Keytruda in 2028, which could lead to increased competition from biosimilars. The subcutaneous version offers a convenience advantage, as it can be administered in various healthcare settings, including doctors' offices and community clinics, and allows for dosing every three or six weeks, requiring less time than the intravenous infusion.

Why It's Important?

The approval of Keytruda Qlex is a strategic move by Merck to maintain its market position as it approaches a significant patent cliff. Keytruda has been the world's top-selling pharmaceutical product, generating $25 billion in 2023 and $29.5 billion in 2024. However, the looming expiration of its patent protections poses a threat to its market dominance. By introducing a more convenient subcutaneous option, Merck aims to retain its customer base and mitigate the impact of potential biosimilar competition. This innovation could help sustain Merck's revenue stream and market share, even if it faces challenges from generic alternatives.

What's Next?

Merck is likely to focus on marketing the convenience and flexibility of Keytruda Qlex to healthcare providers and patients. The company may also continue to explore additional lifecycle management strategies to extend the commercial viability of Keytruda. As the 2028 patent expiration approaches, Merck will need to navigate the competitive landscape carefully, potentially seeking further innovations or partnerships to bolster its oncology portfolio. The pharmaceutical industry will be watching closely to see how Merck's strategies unfold and whether they can effectively counteract the anticipated biosimilar competition.