Samsung Bioepis already has eight approved biosimilars. Image credit: Shutterstock/Andrii Yalanskyi.

Samsung Biopeis has initiated a Phase III trial for its proposed Keytruda (pembrolizumab) biosimilar referenced candidate SB27.

The randomised trial will compare SB27 against MSD’s Keytruda in patients with metastatic non-squamous non-small cell lung cancer (NSCLC). Efficacy, safety, pharmacokinetics, and immunogenicity will be assessed across the two treatment groups.

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Patients will either receive 200mg of SB27 or receive Keytruda intravenously every three weeks alongside chemotherapy treatment. A total of 616 NSCLC patients who have not undergone any previous anticancer therapy are estimated to enrol in the study.

After six months of treatment, Samsung Biopeis will measure the proportion of subjects who achieved a complete response (CR) or partial response (PR), the trial’s primary outcome.

MSD’s Keytruda is currently the best-selling oncology drug, it also secured the top spot as the highest-selling drug across all treatment spaces last year, generating $25bn for the big pharma. The drug’s patent expires in 2028, opening the door for biosimilars to enter the market, similar to what happened with AbbVie’s Humira (adalimumab).

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According to an analyst consensus forecast on GlobalData’s Pharma Intelligence Center, Keytruda is forecast to make $27.4bn in 2029, a decrease of 19% from $33.7bn in 2028.

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GlobalData is the parent company of Clinical Trials Arena.

Samsung Bioepis is an arm of Samsung Group and focuses on developing biosimilars. The company has eight approved biosimilars referencing drugs including Humira, Immunex’s Enbrel (etanercept) and Genentech’s Herceptin (trastuzumab), amongst others.

Samsung Bioepis product evaluation team leader vice-president Ilsun Hong said: “We are thrilled to announce the initiation of Phase III clinical trial for SB27, after our successful Phase I clinical trial initiation in February 2024.

“Based on our extensive clinical trial experience accumulated over the years, we will work closely with study investigators to ensure successful completion of the clinical trials for SB27.”