EMA to Review Samsung Bioepis' Bevacizumab Biosimilar, SB8

Samsung Bioepis has announced that the European Medicines Agency (EMA) has accepted for review its market authorization application for SB8, a proposed bevacizumab biosimilar referencing Avastin.

The biosimilar was studied in a phase 3 clinical trial in 763 patients with metastatic or recurrent nonsquamous, non—small cell lung cancer (NSCLC). The study, which was completed in October 2018, comprised 2 arms: In each, patients were treated with either the reference Avastin or SB8 in combination with carboplatin and paclitaxel. The primary outcome measure was best objective response rate by week 24. Pharmacokinetics and immunogenicity were also compared between the proposed biosimilar and its reference.

Samsung Bioepis has not yet published the results of the trial.

If the biosimilar is approved, it will join Amgen’s Mvasi and Pfizer’s Zirabev among the ranks of EMA-authorized biosimilar bevacizumab products, and it will be commercialized in Europe by Samsung Bioepis’ partner, MSD (known as Merck in the US and Canadian markets).

The drug is also part of an agreement with 3SBio to commercialize several biosimilars in mainland China; if the drug is approved in the Chinese market, the companies will focus on sales of the biosimilar in the indications of NSCLC and metastatic colon cancer, which have high incidence rates in China.

Among Samsung Bioepis’ other biosimilar assets under development are SB11, a biosimilar ranibizumab referencing Lucentis, which is currently in a phase 3 trial in 705 patients with neovascular age-related macular degeneration, and SB12, a biosimilar eculizumab referencing Soliris, which recently completed a phase 1 clinical trial in 240 healthy volunteers.

The company is also branching out in the development of novel biologics; SB26, a novel ulinastatin-Fc fusion protein that is intended to treat gastrointestinal diseases, is currently in a phase 1 clinical trial in 58 healthy volunteers to explore the safety, tolerability, and pharmacokinetics of the product.