Henlius’ Perjeta Biosimilar Under FDA Review Ahead Of Potential Entry In 2026
US Agency’s Acceptance Of Filing Follows Recent Action By China’s NMPA
Organon is one step closer to introducing US biosimilar competition to Roche’s Perjeta blockbuster after partner Shanghai Henlius Biotech saw its application accepted for review by the US FDA. Roche meanwhile has spoken about how it expects to defend its loss of exclusivity, beginning potentially in 2026.
