Merck"s experimental under-the-skin injection of Keytruda demonstrated comparable characteristics to the intravenous version in a Phase 3 trial, prompting plans for discussions with regulators. With the IV formulation"s U.S. patent set to expire in 2028, Merck aims to sustain revenue from its leading cancer drug, which generated nearly $22 billion in sales in 2024. The subcutaneous version could offer greater convenience and is protected by new patents, but timely approval is crucial to fend off emerging biosimilar competition.
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