- Policy
- MFDS reviews enacting a separate and special law for drugs
- by Lee, Hye-Kyung Mar 26, 2024 06:30am
- The Ministry of Food and Drug Safety (MFDS) is considering enacting a 'special law' to separately manage drug safety management. For this, the MFDS recently launched a call for researchers for the ‘Study for the Analysis of the Legal System of the Pharmaceutical Affairs Act and Review of the Special Act on Drug Safety Management'. The
- Policy
- Daewoong joins in competition in the Forxiga generic market
- by Lee, Tak-Sun Mar 26, 2024 06:30am
- Daewoong Pharmaceutical, which had been in charge of the domestic sales and marketing of the original SGLT-2 diabetes drug ‘Forxiga (propanediol hydrate),’ is belatedly entering the generic market through a transfer and acquisition deal. Daewoong had sold Forxiga until January this year. It is analyzed that Daewoong also entered the gen
- Policy
- Pfizer tops global mkt…Samsung Biologics tops Korean mkt
- by Lee, Hye-Kyung Mar 26, 2024 06:30am
- In 2022, global pharmaceutical giant Pfizer and Korean pharmaceutical giant Samsung Biologics took the top spots in terms of sales, earning KRW 91 billion and KRW 2.437 trillion, respectively. in 2022, according to a new report released by the Korea Health Industry Development Institute, According to the '2023 Health Industry Statistics' rec
- Policy
- Sotyktu, Livtencity to be reimb from April
- by Lee, Jeong-Hwan Mar 25, 2024 05:59am
- Sotyktu for plaque psoriasis and Livtencity 200 mg for cytomegalovirus (CMV) infection will be newly listed for reimbursement from the 1st of next month. GLP-1 receptor agonists (GLP-1 RAs, single-agent therapy, and combination therapy) will be reimbursed for use in combination with basal insulin therapy when a patient’s HbA1c level is 7
- Policy
- Expanded ‘pre-notification for change approval’
- by Lee, Hye-Kyung Mar 25, 2024 05:59am
- The pilot system for ‘pre-notification for pharmaceutical change approval,’ which allows companies to predict the schedule of post-approval changes, will now applied to pharmaceuticals required for reporting production, imports, and supply disruptions. Since December 18th of last year, the Ministry of Food and Drug Safety (MFDS) has been i
- Policy
- Samsung Bioepis’s Soliris biosimilar is introduced
- by Lee, Tak-Sun Mar 25, 2024 05:59am
- The cost of Soliris (eculizumab), a drug known for its high price, is expected to drop significantly with the introduction of its biosimilar. The original Soliris will also cut its price by 30% in line with the expansion of its reimbursement benefit to cover neuromyelitis optica, to compete with its biosimilars. According to industry s
- Policy
- Economic benefits paid to doctors to be publicly disclosed
- by Lee, Jeong-Hwan Mar 22, 2024 06:08am
- On the 21st, the government announced the guidelines for the public disclosure of expenditure reports on the legitimate financial benefits paid by pharmaceutical and medical device companies to doctors and pharmacists that will be disclosed in December. The guidelines stipulate the detailed schedule, content, and method for disclosure of
- Policy
- Enhertu’s price falls to KRW 70 mil range with reimb
- by Lee, Tak-Sun Mar 22, 2024 06:06am
- The list price of the petitioned anti-cancer drug Enhertu was reportedly set at KRW 1.4 million per vial. This is significantly cheaper than the non-reimbursed price of KRW 2.3 million. In addition, the National Health Insurance Service (NHIS) will apply a risk-sharing agreement (RSA) system for the reimbursement of the drug, so the actua
- Policy
- National Essential Medicines to be categorized into 4 groups
- by Lee, Hye-Kyung Mar 21, 2024 05:53am
- The Ministry of Food and Drug Safety (MFDS) plans to categorize national essential drugs into 4 groups and conduct regular level assessments to better manage the drugs. According to the 'Research Service to Prepare a Measure to Classify and Manage the National Essential Medicine ‘ that was recently announced by MFDS, the authorities will dis
- Policy
- Gov’t raises price of Harmonilan due to unstable supply
- by Lee, Tak-Sun Mar 21, 2024 05:52am
- The insurance ceiling price of the enteral nutrition formula Harmonilan (B Braun Korea), which the company has been experiencing difficulties in ensuring supply and demand recently, is expected to rise from April. The company had continuously been applying to register the drug as a ‘drug shortage prevention drug' and preserve productio
