Positive Equivalency Data for a Trio of Biosimilars Are Reported

At the European Society for Medical Oncology (ESMO) Virtual Congress 2020 this week, detailed presentations will be offered on biosimilar studies for agents from Mylan, Samsung Bioepis, and Shanghai Henlius Biotech.

Investigators plan to report phase 3 efficacy and safety data for Mylan’s proposed bevacizumab biosimilar MYL-14020 versus the reference product, Avastin, in the first-line treatment of patients with stage IV nonsquamous non–small cell lung cancer.

Investigators randomized 671 patients to the biosimilar candidate (n = 337) and Avastin (n = 334). In the preconference abstract, they reported that the confidence intervals for objective response rate (ORR) were within the predefined equivalence margins, demonstrating equivalence for MYL-14020.

In March 2020, Mylan reported that the FDA had accepted its 351(k) filing application for MYL-14020. An application decision date was scheduled for December 27, 2020.

A poster on a randomized equivalence study for the Shanghai Henlius Biotech trastuzumab biosimilar (HLX02) also will be presented at ESMO. The multicenter study randomized women (N = 649) 1:1 to receive intravenous HLX02 or a European Union–marketed version of reference trastuzumab combined with docetaxel, with the primary end point being ORR at week 24.

In their preconference abstract, the investigators reported a 71.3% ORR for HLX02 vs 71.4% for the reference product. The group difference of –0.1% (95% CI, –7.0% to 6.9%) was “completely within the predefined equivalence margins of ±13.5%.”

In June, Henlius and Accord received a positive recommendation for marketing approval for HLX02 from the European Medicines Agency.

Samsung Bioepis reported phase 3 exploratory results for its bevacizumab biosimilar (Aybintio) ahead of the scheduled ESMO poster presentation.