Samsung joins biosimilar race for Merck & Co.'s Keytruda blockbuster

2024-02-21

上市批准临床1期免疫疗法抗体药物偶联物

Merck & Co. was buoyed by record sales for Keytruda (pembrolizumab) last year, raking in $25 billion from the cancer immunotherapy alone, half of the company's total pharma revenue. But the party will wind down in a few years when the mega blockbuster loses exclusivity in 2028, with biosimilar contenders waiting in the wings.

On Wednesday, Samsung Bioepis announced that a randomised Phase I trial of its proposed biosimilar referencing Keytruda has gotten under way. The study will evaluate its candidate, dubbed SB27, in about 135 patients with stage II-IIIA non-small-cell lung cancer (NSCLC) following complete resection and adjuvant platinum-based chemotherapy.

Participants will receive either SB27, EU-sourced Keytruda or US-sourced Keytruda, every three weeks for a maximum 18 cycles to compare for pharmacokinetics, efficacy, safety, and immunogenicity.

Other proposed Keytruda biosimilars in development include a candidate from Formycon, which has said it aimed to adjust its manufacturing process for large-scale production by the end of 2022. NeuClone also has a late preclinical candidate in the process scale-up stage, according to its website.