EMA to Review Henlius' Trastuzumab Biosimilar, HLX02

June 24, 2019
The Center for Biosimilars Staff

China-based drug maker Henlius has announced that the European Medicines Agency (EMA) has accepted for review the company’s marketing authorization application for a trastuzumab biosimilar, HLX02, referencing Herceptin.

China-based drug maker Henlius has announced that the European Medicines Agency (EMA) has accepted for review the company’s marketing authorization application (MMA) for a trastuzumab biosimilar, HLX02, referencing Herceptin.

"We are very pleased to receive the EMA acceptance to review of our trastuzumab biosimilar HLX02 MAA submission," Scott Liu, PhD, cofounder, president, and chief executive officer at Henlius, said in a statement announcing the application. "It shows that our clinical, medical, regulatory affairs and quality system capabilities have been internationally recognized. We plan to work closely with EMA on this HLX02 MAA and hope to benefit [HER2-positive] cancer patients globally with its high quality and affordability."

Last year, during the European Society for Medical Oncology’s 2018 annual meeting, Henlius reported on the clinical program for the biosimilar.1 The drug maker indicated that it had enrolled 12 healthy male volunteers to evaluate the safety and tolerability of a single infusion of the biosimilar at 2, 4, 6, and 8 mg/kg. The different concentrations demonstrated acute and dose-dependent effects on serum concentration.

A subsequent demonstration of safety and pharmacokinetic equivalence of the biosimilar and its US- and EU-licensed reference products was conducted in 109 healthy male volunteers. No deaths, serious adverse events, or antidrug antibodies were observed in any of the groups.

Finally, a phase 3 study was conducted in 649 patients with previously untreated HER2-positive metastatic breast cancer at centers in China, Ukraine, Poland, and the Philippines.

Henlius’ biosimilar trastuzumab is also under review by authorities at the National Medical Products Administration in China, which recently approved another Henlius biosimilar, HLX01, a rituximab product.

If approved, HLX02 would join a growing number of biosimilar options referencing Herceptin: Currently approved in the European Union are Trazimera, Ogivri, Ontruzant, Herzuma, and Kanjinti.

Reference

1. Zhang Q, Xu B, Zhang Q, et al. Global clinical trials validating bioequivalence with China-manufactured trastuzumab biosimilar. Presented at: European Society for Medical Oncology Asia 2018 Congress; November 23-25, 2018; Singapore. Abstract 44P.