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2025-07-12 16:42
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Policy
P3T for Sanofi¡¯s Itepekimab in rhinosinusitis approved
by
Lee, Hye-Kyung
Feb 12, 2025 06:13am
Sanofi Aventis' biological drug 'Itepekimab' is entering Phase III trial in Korea to secure an indication for chronic rhinosinusitis following chronic obstructive pulmonary disease (COPD). On the 10th, the Ministry of Food and Drug Safety approved Sanofi¡¯s 52-week Phase III randomized, double-blind, placebo-controlled, parallel-group cli
Policy
Boryung¡¯s Lenvima generic approved in Korea
by
Lee, Hye-Kyung
Feb 11, 2025 06:03am
Boryung has received approval for a generic version of the liver cancer treatment 'Lenvima Cap (lenvatinib).' It received approval as an incrementally modified drug (new salt version) and added a 12 mg dose, which is not available with the original drug. The Ministry of Food and Drug Safety (MFDS) approved three items on the 6th, includin
Policy
KAPO ¡®CDDC should pass Keytruda¡¯s reimb extension agenda¡¯
by
Lee, Tak-Sun
Feb 11, 2025 06:02am
A patient group has called for the immediate expansion of the coverage of the immuno-oncology drug 'Keytruda'. With the National Health Insurance Service's Cancer Disease Deliberation Committee scheduled to meet on the 12th, the group is asking for the establishment of reimbursement standards to strengthen patient access to treatment. In
Policy
Pricing negotiations complete for Pfizer¡¯s Vyndamax
by
Lee, Tak-Sun
Feb 10, 2025 05:50am
Pfizer has completed pricing negotiations with the National Health Insurance Service for its cardiomyopathy drug, Vyndamax Cap (tafamidis). As a result, the drug is soon expected to be listed for reimbursement benefits in Korea. Four and a half years after its approval in August 2020, the drug is finally being included in Korea¡¯s health
Policy
HIRA to develop RWE guidelines for post-listing drug evals
by
Lee, Tak-Sun
Feb 7, 2025 05:51am
The Health Insurance Review and Assessment Service (HIRA) has begun developing real-world evidence (RWE) guidelines for the evaluation of drugs listed under the post-listing drug control condition, with the goal of resolving uncertainties in the reimbursement decision-making process On the 5th, HIRA announced a request for proposals for r
Policy
Daewon to sell AZ¡¯s Symbicort in Korea
by
Lee, Tak-Sun
Feb 6, 2025 05:56am
Daewon Pharmaceutical will start selling AstraZeneca's asthma inhaler Symbicort (budesonide + formoterol fumarate hydrate) in Korea. The move is expected to expand the company's asthma inhaler lineup in addition to its existing Compona and expand the company¡¯s market share. According to industry sources, Daewon Pharmaceutical will start
Policy
Imlunestrant becomes first reviewed after new drug approval
by
Lee, Hye-Kyung
Feb 6, 2025 05:56am
The first application for a new drug license has been submitted since the fee for drug approval was raised to KRW 410 million. According to industry sources on the 6th, the multinational pharmaceutical company Eli Lilly applied for an marketing authorization for its breast cancer drug 'Inrulio (imlunestrant)' to the Ministry of Food and D
Policy
Reimb imminent for switching between atopic dermatitis drugs
by
Lee, Tak-Sun
Feb 5, 2025 05:53am
Switching between atopic dermatitis drugs may be reimbursed soon. This is because the National Health Insurance Service has completed its review through the preliminary drug price reduction system, and all that remains is the National Health Insurance Service's negotiations. As the expected claim amount is not large, the negotiations are e
Policy
Low-dose nicergoline continues to be popular
by
Lee, Hye-Kyung
Feb 5, 2025 05:52am
Although it does not indicate the primary treatment of dementia, companies continue to receive approval for their low-dose nicergoline products. . The Ministry of Food and Drug Safety (MFDS) approved Reyon Pharm¡¯s ¡®Nicechol Tab. 10mg¡¯ on the 3rd. This is the second approval this year, following the approval of the ¡®Neurogoline Tab. 10mg¡¯
Policy
3-way race starts in faslodex mkt with new generic entry
by
Lee, Tak-Sun
Feb 3, 2025 05:52am
A new generic company entered the fulvestrant drug market that has been a battle between the original¡¯s owner AstraZeneca and the first generic developer Boryung. The new entrant, Korus Pharm, will spark three-way competition in the market with its product being reimbursed this month. According to industry sources on the 31st, Korus
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