Organon and Henlius’ Poherdy, first biosimilar to Roche’s Perjeta, scores FDA nod
As Roche works to switch certain patients with breast cancer over to a fixed-dose combination of two medicines, its 13-year-old drug Perjeta is inching toward the end of its exclusive run in the U.S.
The FDA said Thursday that it has approved Poherdy as an interchangeable biosimilar to Perjeta. The agency’s endorsement covers the Roche drug’s existing HER2-positive breast cancer indications.
Perjeta’s label currently includes its use in combination with trastuzumab and chemo for first-line HER2-positive metastatic breast cancer and as a neoadjuvant or adjuvant treatment for early-stage disease.
Poherdy was originally developed by Henlius Biotech, which out-licensed ex-China rights of the drug—along with a copycat to Amgen’s Prolia-Xgeva duo—to Organon in 2022.
The FDA said the approval, which allows pharmacists to substitute Poherdy for Perjeta without another prescription, was based on a “comprehensive review” of evidence showing the copy product is highly similar to Perjeta. The evidence includes comparisons across various quality attributes demonstrating similarity in the structural and functional features of the two products as well as results in humans confirming similar body exposure to the products following a single infusion.
A parallel-controlled phase 3 showed Poherdy, also known as HLX11, matched up to Perjeta on efficacy and safety as a neoadjuvant therapy in HER2-positive early breast cancer, earning the biosimilar its “interchangeable” tag, according to the agency.
