- Opinion
- [Reporter’s View] Concerns over US drug tariffs
- by Kim, Jin-Gu Feb 13, 2025 05:58am
- The US President Donald Trump has hinted at the possibility of imposing tariffs on drugs imported into the country. Although he says he is still “reviewing” the matter, it would not be surprising if he signs a tariff declaration at any time. The United States has played a major role in the recent development of the Korean pharmaceutical
- Opinion
- [Reporter's View] KRW 400m drug approval fee
- by Lee, Hye-Kyung Feb 12, 2025 06:13am
- Now, the new drug approval fee in South Korea costs KRW 410 million. On September 9th, 2024, the Ministry of Food and Drug Safety (MFDS) issued an administrative notice of 'Revision to the Regulation of Fees for Pharmaceutical Approval.' The revision specifies details of increasing the new drug approval fee to KRW 410 million and reducing th
- Opinion
- [Reporter’s View] Trodelvy makes way to reimb in KOR
- by Eo, Yun-Ho Feb 10, 2025 05:51am
- The wait was worth it. The triple-negative breast cancer (TNBC) treatment Trodelvy (sacituzumab govitecan-hziy) has passed the Drug Reimbursement Evaluation Committee review, nearly 15 months after passing the Health Insurance Review and Assessment Service’s Cancer Disease Review Committee review. The most promising aspect of the news
- Opinion
- [Reporter's View] Slow but steady wins the race
- by Whang, byung-woo Feb 4, 2025 05:55am
- The Korean government has finally launched the National Bio Commission. The launch of this proper control tower has come several years after the government declared the bio-health industry as a national strategic industry. The news of its launch is encouraging, considering how the launch of the committee itself was almost stranded due to
- Opinion
- [Reporter's View] Improving rare disease care environment
- by Eo, Yun-Ho Jan 17, 2025 05:54am
- A few patients can only make a small noise. Despite the need for the improvement of the rare disease treatment environment, which has risen year after year, the voice of its patients that implore difficulties has never ceased to exist. In particular, there are cases where a drug is available, but due to the small number of eligible patien
- Opinion
- [Reporter's View] K-Bio's development and human resource
- by Whang, byung-woo Jan 14, 2025 05:56am
- The Korean pharmaceutical and biotech industry (known as 'K-Bio') has grown robustly over the past few years. K-Bio has successfully out-licensed new drug developments, including the In Vitro Diagnostic (IVD), biosimilar, and CDMO, since the Covid-19 pandemic. However, the industry is concerned about sustainability. The key issue is hu
- Opinion
- [Reporter’s View] Korean drugs go international this year
- by Son, Hyung Min Jan 14, 2025 05:56am
- Last year, new drugs developed by domestic pharmaceutical companies recorded remarkable achievements overseas. Hanmi Pharmaceutical's Rolontis (U.S. brand name Rolvedon) has continued to grow in the U.S. market. Rolontis is a neutropenia treatment developed by Hanmi Pharmaceutical and became the 33rd new domestic drug to be approved in Ko
- Opinion
- [Reporter's View] Pharma bio stocks shunned for good reason
- by Kim, Jin-Gu Jan 8, 2025 05:53am
- The sarcastic comment that “escaping from the KOSPI (Korean stock market) is a matter of intelligence” has become a trend for some time. Although the so-called “Korea discount” is not new, the distrust of the Korean stock market among individual investors has been rising recently. Pharmaceutical, biotech, and healthcare stocks are no
- Opinion
- [Reporter's View] Switching of drugs reimbursable
- by Eo, Yun-Ho Jan 6, 2025 05:57am
- When a patient chooses one medication and switches to another, reimbursement does not cover the latter. Non-reimbursable drug switching has been a long-standing issue in South Korea. At the end of last year, a long-standing issue in one field was resolved. The Ministry of Health and Welfare (MOHW) granted approval for drug switching for p
- Opinion
- [Reporter’s View] The dilemma of companion diagnostics
- by Whang, byung-woo Dec 31, 2024 05:56am
- A drug is available but unusable. This is the story of the Claudin 18.2 targeted gastric cancer drug Vyloy (zolbetuximab). This is not the typical situation where a breakthrough drug is approved but is inaccessible due to its high price. The problem is companion diagnostics (CDx). In order to use a Vyloy, which targets Claudin 18.2, i
