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Samsung Epis Seeks Korean Approval for a Cancer Immunotherapy Biosimilar

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Samsung Epis (KRX:0126Z0) filed a marketing application in South Korea for a biosimilar to cancer immunotherapy Keytruda, according to a bourse filing on Monday.

The Aug. 7 filing is backed by a phase 3 trial of 555 patients with metastatic non-squamous non-small cell lung cancer, which showed SB27 matched Keytruda in the key measure of 24-week response rate within the set equivalence range. Safety profiles, including treatment-emergent adverse events and serious adverse events, were also similar.

The application covers a broad range of indications including melanoma, non-small cell lung cancer, gastric cancer and breast cancer. Additional regulatory approvals in other countries are also being planned.

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