Merck Receives Japan Approval for Keytruda SC
- has secured marketing approval in Japan for its subcutaneous formulation of the blockbuster PD-1 inhibitor Keytruda, according to reports from industry sources including Biospectator.
- The subcutaneous (SC) version of Keytruda provides an alternative delivery method to the traditional intravenous infusion that patients have relied on for years.
- Regulatory submissions across multiple international jurisdictions have marked a coordinated effort by Merck to transition patients to the newer formulation before the core patents lapse.
Merck & Co. has secured marketing approval in Japan for its subcutaneous formulation of the blockbuster PD-1 inhibitor Keytruda, according to reports from industry sources including Biospectator. The Japanese authorization follows similar regulatory milestones achieved by the pharmaceutical giant in the United States, Europe, and Canada as the company works to expand delivery options for the cancer immunotherapy.
Keytruda SC Regulatory Timeline and Approvals
The subcutaneous (SC) version of Keytruda provides an alternative delivery method to the traditional intravenous infusion that patients have relied on for years. According to international biopharmaceutical reporting, the Japanese approval comes as Merck prepares for the upcoming patent expiration for the intravenous Keytruda product, which is slated for 2028. By introducing a subcutaneous option, the company aims to offer patients faster administration times while securing its market position ahead of anticipated biosimilar competition.
Global Strategy Ahead of 2028 Patent Expiration
Regulatory submissions across multiple international jurisdictions have marked a coordinated effort by Merck to transition patients to the newer formulation before the core patents lapse. The subcutaneous delivery mechanism is designed to reduce clinic chair time for patients receiving cancer treatments. Regulatory agencies in the United States, Europe, and Canada previously reviewed and cleared the formulation based on clinical data demonstrating pharmacokinetics and efficacy comparable to the intravenous standard.