Poherdy, first biosimilar to Roche’s Perjeta, scores FDA nod
The FDA has approved Poherdy, developed by Henlius Biotech and licensed to Organon, as an interchangeable biosimilar to Roche's Perjeta for HER2-positive breast cancer. This approval allows pharmacists to substitute Poherdy for Perjeta without another prescription. Roche's Perjeta sales have declined due to a shift to its fixed-dose combination, Phesgo. Roche faces patent challenges from Henlius and Organon, and more biosimilars may enter the market as the FDA aims to reduce development costs.
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 subscription, 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.
It’s not clear if Organon can immediately launch Poherdy. In its second-quarter earnings report (PDF) in July, Roche said it expects to face the first U.S. Perjeta biosimilars in 2026 as primary patents of the drug had expired in the second quarter earlier this year. The Roche drug won its original FDA approval in 2012.
Roche and its U.S. subsidiary Genentech brought a patent infringement lawsuit against Henlius and Organon in August, asserting arguments around a laundry list of patents on Perjeta. Organon did not immediately respond to Fierce Pharma’s inquiry.
Even before Perjeta’s eventual loss of exclusivity, sales of the drug have been in decline thanks to Roche’s efforts to switch patients to its Perjeta-Herceptin fixed-dose combination called Phesgo.
In the first nine months of 2025, Perjeta sales were down 13% year over year to 2.3 billion Swiss francs ($2.9 billion), whereas Phesgo sales jumped 54% to 1.8 billion Swiss francs.
More Perjeta biosimilars could be on their way. Sandoz just announced a deal licensing global commercial rights to EirGenix’s proposed pertuzumab product, excluding certain countries in Asia.
Meanwhile, the biosimilar market may be poised for a renaissance. In recent draft guidance, the FDA said it’s taking steps to reduce clinical testing burdens for biosimilars and to categorize all approved biosimilars as “interchangeable” without requirements for switching studies. The new measures, according to FDA Commissioner Martin Makary, M.D., would cut the average development cost for biosimilars in half.
