Both the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) and the FDA have recently recommended and approved a new subcutaneous (subQ) formulation of Merck's Keytruda (pembrolizumab), respectively. This formulation simplifies administration compared to intravenous infusions and is expected to help extend Keytruda's competitive lifecycle against biosimilars. Additionally, positive opinions have been issued for subcutaneous delivery of other biologics, indicating a broader regulatory trend toward more convenient dosing modalities in oncology and other therapeutic areas.