Samsung Bioepis announced on August 10 that it has applied for domestic approval of its biosimilar candidate SB27 (active ingredient: pembrolizumab), which is based on the world’s top-selling immuno-oncology drug, Keytruda. This marks the first instance of a domestic pharmaceutical company seeking approval for a Keytruda biosimilar in South Korea.
Keytruda, developed by Merck (MSD) in the United States, is a PD-1 inhibitor-based immuno-oncology drug. It generated approximately $31.7 billion in global sales last year. The drug works by blocking PD-1, which helps cancer cells evade the immune system, thereby restoring the cancer-fighting action of immune cells. It is used for 16 indications, including melanoma, non-small cell lung cancer, and head and neck cancer.
Starting in 2024, Samsung Bioepis will conduct global Phase 1 and Phase 3 clinical trials targeting non-small cell lung cancer patients to confirm the equivalence of SB27 to the original drug.
In the Phase 1 trial, conducted in four countries including South Korea with 163 participants, the pharmacokinetic evaluation metric, area under the concentration-time curve (AUC), met pre-established criteria, demonstrating equivalence to the original drug.
The Phase 3 trial involved 555 participants across 14 countries, analyzing the objective response rate (ORR) at 24 weeks as the primary endpoint. The results indicated that SB27 showed equivalent efficacy to the original drug without statistically significant differences. No meaningful differences in safety and immunogenicity were observed between the two groups.
Shin Dong-hoon, head of clinical medicine at Samsung Bioepis, stated, "We will thoroughly explain the research and development results of SB27 during the approval review process and ensure that related procedures are carried out smoothly to provide immuno-oncology treatment options to domestic patients as soon as possible."
Meanwhile, the U.S. Food and Drug Administration (FDA) has decided to lower the application review fees for specialty drugs (PDUFA) and biosimilars starting in October. This is expected to reduce the financial burden on domestic companies like Samsung Bioepis that are developing biosimilars for the U.S. market.
The application review fee for new drug applications (NDA) and biologics license applications (BLA) has been set at $4,600,753 (approximately 6.6 billion won), a 1.7% decrease from last year when clinical data is included. The biosimilar (BsUFA) fee has also been reduced by 6.3% to $1,124,936 (approximately 1.6 billion won).
Keytruda, developed by Merck (MSD) in the United States, is a PD-1 inhibitor-based immuno-oncology drug. It generated approximately $31.7 billion in global sales last year. The drug works by blocking PD-1, which helps cancer cells evade the immune system, thereby restoring the cancer-fighting action of immune cells. It is used for 16 indications, including melanoma, non-small cell lung cancer, and head and neck cancer.
Starting in 2024, Samsung Bioepis will conduct global Phase 1 and Phase 3 clinical trials targeting non-small cell lung cancer patients to confirm the equivalence of SB27 to the original drug.
In the Phase 1 trial, conducted in four countries including South Korea with 163 participants, the pharmacokinetic evaluation metric, area under the concentration-time curve (AUC), met pre-established criteria, demonstrating equivalence to the original drug.
The Phase 3 trial involved 555 participants across 14 countries, analyzing the objective response rate (ORR) at 24 weeks as the primary endpoint. The results indicated that SB27 showed equivalent efficacy to the original drug without statistically significant differences. No meaningful differences in safety and immunogenicity were observed between the two groups.
Shin Dong-hoon, head of clinical medicine at Samsung Bioepis, stated, "We will thoroughly explain the research and development results of SB27 during the approval review process and ensure that related procedures are carried out smoothly to provide immuno-oncology treatment options to domestic patients as soon as possible."
Meanwhile, the U.S. Food and Drug Administration (FDA) has decided to lower the application review fees for specialty drugs (PDUFA) and biosimilars starting in October. This is expected to reduce the financial burden on domestic companies like Samsung Bioepis that are developing biosimilars for the U.S. market.
The application review fee for new drug applications (NDA) and biologics license applications (BLA) has been set at $4,600,753 (approximately 6.6 billion won), a 1.7% decrease from last year when clinical data is included. The biosimilar (BsUFA) fee has also been reduced by 6.3% to $1,124,936 (approximately 1.6 billion won).
* This article has been translated by AI.
Copyright ⓒ Aju Press All rights reserved.