# Samsung Bioepis: pembrolizumab biosimilar SB27 met phase 3 equivalence endpoint in 555 patients

- Published: 2026-11-09 00:25 UTC
- Section: Life & Health › Medicine
- Tags: Samsung Bioepis, SB27 biosimilar, pembrolizumab biosimilar, Keytruda biosimilar, phase 3 equivalence, non-small cell lung cancer, objective response rate, SITC 2026, neutralizing antibodies, FDA application
- URL: https://realtech.media/news/rt-8a635487dfe63b244b2ab6e0_samsung_bioepis_pembrolizumab/

**Samsung Bioepis presented phase 3 results for SB27, a Keytruda biosimilar candidate: the primary endpoint was met and no neutralizing antibodies were reported.**

![Samsung Bioepis: pembrolizumab biosimilar SB27 met phase 3 equivalence endpoint in 555 patients](https://realtech.media/media/2026/11/a930928a64bce288.jpg)
*biz.heraldcorp.com*

Samsung Bioepis announced on the 9th that it had presented global phase 3 results for SB27 (pembrolizumab), a biosimilar candidate to the cancer immunotherapy Keytruda. The data were shown at the SITC 2026 annual meeting of the Society for Immunotherapy of Cancer, held from the 4th to the 8th in Phoenix, Arizona, according to biz.heraldcorp.com. [1]

Keytruda was developed by the US company MSD. It binds to the immune checkpoint receptor PD-1 and helps the immune system attack cancer cells. Its global sales last year were about 46 trillion won, which makes it the largest-selling drug of its kind. [1]

## Trial design and efficacy

Since 2024 the company has run a phase 3 trial in 14 countries. It enrolled 555 patients with metastatic non-squamous non-small cell lung cancer. SB27 and the original drug were each given in combination with standard chemotherapy, and the two were compared. [1]

The primary efficacy endpoint was the objective response rate (ORR) at week 24. SB27 met the equivalence margin predefined by regulators on this endpoint. [1]

Secondary efficacy endpoints, including progression-free survival (PFS), duration of response (DOR) and overall survival (OS), showed data similar to the original drug. [1]

## Safety and regulatory filings

The share of treatment-emergent adverse events and of serious adverse events was similar to that of the original. No neutralizing antibodies (NAb), which can neutralize a drug's effect in the body, were reported: zero cases. [1]

In August the company filed a marketing application for SB27 with the Ministry of Food and Drug Safety of Korea, the first such filing in the country. In October it completed an application to the US Food and Drug Administration (FDA). The company said it plans to finish the approval procedures with regulators in each country quickly and launch on the global market on schedule. [1]

Shin Dong-hoon, vice president and head of the clinical medicine division at Samsung Bioepis, said the large global phase 3 trial confirmed the clinical equivalence and consistent safety of SB27 by meeting the primary endpoint. He added that the company will concentrate its development capabilities on improving patient access to high-quality oncology biologics. [1]

## Sources

1. [biz.heraldcorp.com](https://biz.heraldcorp.com/article/10930017)

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Source: RealTech, realtech.media — https://realtech.media/news/rt-8a635487dfe63b244b2ab6e0_samsung_bioepis_pembrolizumab/