Samsung Bioepis, a biosimilar developer under Samsung Group, will embark on the development of a biosimilar candidate referencing MSD’s Keytruda (pembrolizumab), one of the best-selling drugs in the world.

According to the Ministry of Food and Drug Safety on Wednesday, Samsung Bioepis has received approval for its phase 1 clinical trial of SB27, a biosimilar candidate referencing Keytruda.

Samsung Bioepis is now the first Korean biosimilar company to receive approval from the government to develop a biosimilar of Keytruda.

“Samsung Bioepis is preparing for a phase 1 clinical trial in South Korea. But, the company cannot comment on when it will begin the clinical study yet,” an official from the company said.

Keytruda is used to treat solid tumors, metastatic melanomas and non-small cell lung cancer.

It is one of the world's best-selling drugs, with its sales reaching nearly $20.9 billion in 2022, according to data from Statista. This year, revenue from Keytruda is expected to increase further and become the top-ranked drug, followed by Pfizer’s Comirnaty and Abbvie’s Humira, according to industry sources.

Samsung Bioepis said the company will conduct its clinical study at nine different clinical institutions, including Samsung Medical Center, Severance Hospital and Cha Bundang Medical Center.

Samsung Bioepis is expected to reveal more detailed plans for its clinical studies soon, according to industry sources. In South Korea, drug developers have to begin phase 1 clinical trials within a year of gaining regulatory approval.

Currently, Samsung Bioepis is likely to aim to launch its Keytruda biosimilar in 2028, when MSD’s key patents on Keytruda will begin to expire.

Aside from Samsung Bioepis, Celltrion and Chong Kun Dang are preparing for the development of biosimilar candidates referencing Keytruda.

In September last year, Chong Kun Dang signed a license agreement with a Singaporean company Favorex to acquire sales rights of biosimilar candidate Keytruda in South Korea. The biosimilar candidate is under preclinical research.

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