FDA Approves Subcutaneous Keytruda Amid Looming Patent Expiry

What's Happening?

The FDA has approved a subcutaneous version of Merck's Keytruda, known as Keytruda Qlex, for most solid tumor indications. This approval comes as Merck prepares for the loss of exclusivity of Keytruda in 2028, which could lead to challenges from biosimilars. The subcutaneous version is expected to help Merck maintain sales as it offers a similar efficacy to the intravenous version, with a 45% overall response rate in non-small cell lung cancer patients compared to 42% for the original formulation. The approval is part of Merck's strategy to mitigate the impact of the patent cliff.

Why It's Important?

The approval of Keytruda Qlex is significant for Merck as it faces the impending expiration of Keytruda's patent protections in 2028. Keytruda has been a top-selling pharmaceutical product, generating substantial revenue for Merck. The introduction of a subcutaneous version could help sustain sales by offering a more convenient administration method, potentially appealing to patients and healthcare providers. This move is crucial for Merck to maintain its market position and revenue stream in the face of potential competition from biosimilars.

What's Next?

Merck plans to make Keytruda Qlex available by late September, with pricing set at parity with the intravenous version. The company will continue to monitor the market response and adjust its strategies to address the challenges posed by the upcoming patent expiration. Additionally, Merck may explore further innovations or partnerships to strengthen its oncology portfolio and maintain its competitive edge.

Beyond the Headlines

The approval of Keytruda Qlex highlights the importance of innovation in pharmaceutical formulations to extend the lifecycle of blockbuster drugs. It also underscores the challenges faced by pharmaceutical companies in navigating patent expirations and the competitive landscape. Merck's approach may serve as a case study for other companies facing similar patent cliffs.