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2025-01-26 10:21
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Policy
Boryung¡¯s Pomalyst generic first to be reimbursed in Korea
by
Lee, Tak-Sun
Jan 20, 2025 05:54am
Boryung will be the first in Korea to receive reimbursement for its generic version of Pomalyst (pomalidomide, BMS), a multiple myeloma treatment. As a product from an innovative pharmaceutical company, the drug also receives premium pricing. According to industry sources on the 17th, four dosage forms (1, 2, 3, and 4 mg) of Boryung's ¡®P
Policy
Drug expenditures surge due to the use of high-priced drugs
by
Lee, Tak-Sun
Jan 17, 2025 05:53am
Drug expenditures have risen significantly in 2023 due to the rising cost of high-priced anticancer drugs and rare disease treatments. Due to the aging population increasing the expenditures spent on treating chronic diseases, an urgent need has arisen to come up with a measure to reduce drug expenditures. According to the National Health Ins
Policy
Pulmonary fibrosis drug 'Ofev' under consideration for reimb
by
Lee, Tak-Sun
Jan 17, 2025 05:53am
As 'Ofev Soft cap (nintedanib),' a treatment for pulmonary fibrosis, has been approved for reimbursement appropriateness, latecomer drugs are projected to enter the market quickly. Following the expiration of Ofev's usage patent, latecomer companies are anticipated to prepare for launching their drugs. According to industry sources on J
Policy
Innovative Pharmaceutical Company certification to change
by
Lee, Jeong-Hwan
Jan 17, 2025 05:53am
The Ministry of Health and Welfare will improve the certification system for innovative pharmaceutical companies to a 'certification evaluation score system' that will increase the proportion of new drug research and development (R&D) and change the disqualification criteria to a point-based score system. The MOHW plans to issue an admin
Policy
Boryung¡¯s Pomalyst generic soon to be released
by
Lee, Tak-Sun
Jan 14, 2025 05:57am
Boryung's multiple myeloma drug Pomalikin Cap may soon be released in Korea¡¯s market. The drug is the first generic version of Pomalyst Cap (pomalidomide, BMS). The risk-sharing agreement (RSA) applied to the original drug, Pomalyst Cap, ended this month, and the insurance price cap of the drug had been adjusted following the reimburseme
Policy
Will 'Lorviqua' secure a deal on drug price negotiations?
by
Lee, Tak-Sun
Jan 13, 2025 05:53am
The reimbursement expansion case for Lorviqua (lorlatinib, Pfizer), which was stalled during the drug price negotiation last year, has passed the Drug Reimbursement Evaluation Committee (DREC) of the Health Insurance Review and Assessment Service (HIRA) under a conditional term. It draws attention to whether it will succeed this round. Pfi
Policy
New criteria set for unstable supply and demand drugs
by
Lee, Tak-Sun
Jan 13, 2025 05:53am
The Health Insurance Review and Assessment Service has decided to clarify the criteria for evaluating adjustment applications for drugs with unstable supply and demand and strengthen preliminary management of high-priced anticancer drugs. HIRA announced so on the 9th while issuing a prenotification of the ¡°Partial Amendments to the Eva
Policy
Chinese pharma targeting KOR, BeiGene gets greenlight
by
Lee, Hye-Kyung
Jan 10, 2025 05:52am
BeiGene Korea expands market dominance by conducting clinical trials to achieve competitiveness in the Korean market. Based on this year's Ministry of Food and Drug Safety (MFDS)'s clinical trial approval report, two out of ten approved clinical trial applications were BeiGene Korea's Phase 1 clinical trials. BeiGene has been strengthen
Policy
AML treatment Mylotarg stalled at the DREC review
by
Lee, Tak-Sun
Jan 9, 2025 05:56am
The high price was found to be the reason Pfizer Korea's new drug Mylotarg (gemtuzumab ozogamicin), a treatment for acute myeloid leukemia (AML), did not pass the Health Insurance Review and Assessment Service (HIRA) stage. HIRA acknowledged the drug's improvement in clinical utility but did not approve its cost-effectiveness. According
Policy
Dong-A ST first to pay the raised new drug approval fee?
by
Lee, Hye-Kyung
Jan 7, 2025 06:05am
With the new drug approval fee raised to KRW 410 million on Jan. 1 this year, the industry is eyeing whether Dong-A ST will become the first to apply for marketing authorization and pay the raised new drug approval fee. According to industry sources on the 7th, Dong-A ST applied for a prior consultation before applying for marketing authoriza
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