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- 2026-05-05 11:57:09
- Policy
- GOV engrossed in minimizing damage from US's Bio Initiative
- by Lee, Jeong-Hwan Sep 20, 2022 05:57am
- The Korean government is busy preparing measures to protect the Korean industry from the Executive Order signed in the US by President Biden to launch a National Biotechnology and Biomanufacturing Initiative that focuses on research and manufacturing of pharmaceuticals within the United States, As the US government has not yet finalized its direction in regulating other countries on bio-related matters, the Korean government has also not yet decided on specific measures other than to actively utilize the Korea-US dialogue channel. However, the authorities are planning to seek countermeasures by increasing the frequency of joint ministerial meetings after holding an industry inspection meeting in relevant ministries. On the 19th, the Ministry of Trade, Industry, and Energy announced plans to hold a joint meeting this week with the Ministry of Health and Welfare, Ministry of Food and Drug Safety, Ministry of Science and ITC, etc. to discuss countermeasures. The authorities that will be directly responding to the US's Initiative are MOTIE and MOHW. The MOTIE and MOHW have held individual review meetings with relevant industries and institutions upon US’s decision to launch the Executive Order to launch the Initiative (Bio Executive Order). The MOTIE had discussed countermeasures with KoreaBIO and bio companies, and the MOHW with pharmaceutical and bio companies including the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, based on which the ministries will be sharing results to establish future plans at the joint meeting. In particular, the MOTIE plans to convey the position of domestic pharmaceutical and bio companies at the scheduled ministerial-level dialogue with the US Secretary of Commerce. The Korean government is expected to first prepare measures to minimize the impact of the Bio Executive Order by utilizing all of the Korea-US dialogue channels in each ministry until the US government finalizes specific regulations. An MOTIE official said, “As only the broad framework of the biomanufacturing policy has been yet set by the US, we plan to continue holding joint ministerial and industry inspection meetings until a specific regulatory plan is announced. In order to maximize opportunities for Korean companies and minimize damage, we will discuss the issue through various dialogue channels including the ministerial-level Korea-U.S. supply chain and industry dialogue, etc.” he explained. The official added, “The executive order launched by the US this time has given more weight to promoting its own domestic industry rather than regulating industry of other companies. The MOTIE will be holding a joint meeting with the MOHW and other ministries based on the results of the review meeting it had held with KoreaBIO. As the case may be, the Executive Order may become an opportunity for domestic pharmaceutical and bio companies to advance into the US market.”
- Policy
- 37 Tenelia's generics will soon be listed
- by Lee, Tak-Sun Sep 20, 2022 05:57am
- Earlier this year, Tenelia's generics followed Galvus generics, and the generic drug market for DPP-4 diabetes treatments began in earnest. According to the industry on the 19th, the Ministry of Health and Welfare recently disclosed the registration of Tenelia's generics next month. Tenelia of material patent is expired on October 25th. A total of 37 items of next month to enter the generic market. DPP-4 inhibitor market has used a total of nine species of products had not been released, but a strong patent protection for markets are opening up generic. 18 current generic for Galvus are reimbursed. The DPP-4 generic market is expected to begin in earnest. As a result, it is analyzed that as competition among pharmaceutical companies intensifies, it will affect original drugs that maintained the existing monopoly. In particular, some analysts say that Galvus and Tenelia, which are allowed to compete generically, could weaken their competitiveness among the nine original DPP-4 types.
- Policy
- NHIS negotiations complete for Erbitux·Zerbaxa·Eylea
- by Lee, Tak-Sun Sep 20, 2022 05:56am
- The National Health Insurance Service’s pricing negotiations for Merck’s anticancer drug Erbitux and MSD’s next-generation antibiotic Zerbaxa among others have been completed. In the case of Erbitux, Merck has been conducting drug pricing negotiations with the NHIS upon the expiry of its risk-sharing agreement (RSA) contract. For Zerbaxa, its company, MSD, had been conducting pricing negotiations for its new reimbursement. As both agendas were not listed for deliberation at the MOHW’s Health Insurance Policy Deliberative Committee (HIPDC) meeting last month, industry analysis is that the agendas may likely receive reimbursement approvals at the HIPDC meeting this month. Merck’s Erbitux and Zerbaxa were included in the drug pricing negotiation completion list that NHIS disclosed on its webpage on August 31st. Erbitux (cetuximab) is an anticancer drug indicated for metastatic colorectal cancer and head and neck squamous cell cancer that was approved for reimbursement in March 2014 under the Refund-type RSA in Korea. The company had already succeeded in renewing the agreement once in 2018. Upon its expiry in June this year, Merck has been in negotiations with the NHIS to renew its agreement for the third time. Industry’s prospects on the possibility of RSA renewal have been increasing as Erbitux was included in the negotiation completion list of the NHIS, In the case of Zerbaxa, news of its negotiation completion had already been announced last month. As a result, it is expected that the drug will be added to the reimbursement list after going through the HIPDC review this month. The drug had attempted reimbursement since it was approved in April 2017 in Korea, but had difficulty being listed, being unable to demonstrate adequacy of its reimbursement. However, the government’s coverage expansion plan allowed antibiotics like Zerbaxa to also be included and be eligible to waive pharmacoeconomic evaluations, based on which Zerbaxa was recognized adequate for reimbursement at HIRA’s Drug Reimbursement Evaluation Committee meeting in June. Since then, MSD had been conducting drug pricing negotiations with the NHIS, which were successfully concluded at the end of last month. The NHIS’s disclosure of such has made the negotiation completion official. Zerbaxa is a next-generation antibiotic indicated for use in combination with metronidazole for complicated intra-abdominal infections (cIAI) and complicated urinary tract infections. The antibiotic is receiving particular attention as a ‘super antibiotic’ that can be used against multidrug-resistant bacteria. In addition, the NHIS also announced the completion of drug price negotiations for Takeda's anticancer drug 'Adcetris (brentuximab vedotin)' and Bayer's age-related macular degeneration drug ‘Eylea.’ The drugs have been in negotiations with the NHIS since June under category ‘Type B’ of the Price-Volume Agreement. PVA negotiations under Type B are applied every year when the claims amount increases by over 60% from the previous year, or the rate of increase is over 10% and exceeds KRW 5 billion for drugs in the same therapeutic class for which the maximum amount had already been adjusted according to type A or exceeded 4 years since its initial listing but had not undergone type A negotiations. The price of subject drugs are discounted within the 10% range after pricing negotiations with the NHIS.
- Policy
- Empagliflozin's permission changes
- by Lee, Hye-Kyung Sep 19, 2022 05:56am
- Epilepsy neurosurgery is added to the abnormal reaction of a formulation containing Empagliflozin, an SGLT-2 inhibitor used to treat type 2 diabetes. The Ministry of Food and Drug Safety announced a change in permits based on the results of a review of safety information on Empagliflozin-containing drugs by EC and EMA. The drugs that announce the change of permits are 104 items such as Jardiance, an Empagliflozin-based drug of Beringer Ingelheim Korea, 106 items such as Jardiance Duo, an Empagliflozin and Metformin complex, and SGLT-2, an Empagliflozin and Linaglipin complex. As a result of a review by the Ministry of Food and Drug Safety, "interstitial neurosurgery" is added to the abnormal response term for both Empagliflozin and complex drugs. Serum Li concentrations should be observed more frequently after administration and dose change of Empagliflozin, and patient care should be referred to the doctor who prescribed Li for observation of serum lithium concentrations. The review opinion inquiry on the change of permission (proposal) will be held until the 30th. Meanwhile, SGLT-2 inhibitors, which started as type 2 diabetes treatment, are expanding their scope to heart failure. Last year, SGLT-2 inhibitors were recommended as a major drug for chronic heart failure treatment in domestic heart failure treatment guidelines.
- Policy
- Drug price negotiation completed 307 drugs in 2022
- by Lee, Tak-Sun Sep 16, 2022 05:53am
- The number of drugs that completed drug price negotiations between the NHIS and pharmaceutical companies increased significantly from 15 years ago. As drug price negotiations began in earnest in 2007, the expansion of PVA negotiations is believed to be the cause. According to the NHIS' recent list of drugs that completed drug negotiations, the number of drugs that completed drug negotiations exploded from only 10 in 2007 to 307 in 2020. Drug price negotiations began in May 2006 with the introduction of a "plan to optimize drug costs" to stabilize health insurance finances. At the end of that year, guidelines for drug price negotiations were enacted, PVA negotiations as well as new drug drug negotiations, and later RSA were introduced. Looking at the number of drugs that have completed annual drug price negotiations, the number exceeded 100 for the first time in 2009 and surpassed 200 in 2011. 2020 is the only drug that has completed more than 300 negotiations. Last year, 238 drugs completed drug price negotiations, and 273 drugs have already completed drug price negotiations by August this year. As 172 items completed negotiations in the PVA multi-type negotiations in August, the number of drugs that completed drug negotiations has already exceeded last year. This year, Lutathera, Vitrakvi , Rozlytrek, Lorviqua, Zolgensma, Fexuclue, Donerion patch, Zerbaxa also successfully completed drug price negotiations. However, the number of drug price negotiations completed is increasing, but there are also disappointing opinions in the pharmaceutical industry. In particular, there are many calls for quick registration of salaries by shortening the duration of drug price negotiations. The corporation recently revised the guidelines for drug price negotiations, predicting that drug price negotiations will be shortened from 60 days to 30 days for treatments for severe and rare diseases without alternative drugs.
- Policy
- “GOV to prove causal relationship of vaccine side effects"
- by Lee, Jeong-Hwan Sep 16, 2022 05:53am
- The ruling party has set out to enact a Special Act to obligate the nation to compensate for damages caused by COVID-19 vaccinations. The Special Act was proposed because the compensation for damages caused by COVID-19 vaccinations currently implemented by the government is too passive in recognizing the causal relationship between vaccination and its side effects. To address this, the new law strengthened the government’s duty of post-vaccination management by obliging the Commissioner of the Korea Disease Control and Prevention Agency to bear the burden of proof when a dispute related to side effects, such as diseases caused by vaccination, arises. On the 14th, People Power Party member Gi-yun Kang submitted a bill to enact a ‘Special Act on Compensation for Damages from COVID-19 Vaccinations’ as a representative. Currently, vaccinations are being conducted and the damage compensated by the state under the “Infectious Disease Control and Prevention Act” to prevent the spread of infectious diseases and to promote public health. NA Rep. Kang pointed out that the current national compensation system is very passive in recognizing the causality between adverse reactions from vaccinations and vaccine’s side effects. To address this, Kang proposed a bill that can provide compensation to victims by including the adverse events and side effects from vaccinations as damages caused by vaccinations. If passed, the bill will prioritize compensation for damages arising from vaccinations above other laws. Also, for damages caused by vaccination, the state will pay national compensation after deliberation and resolution by the Vaccination Committee. In particular, in resolving disputes about damage caused by vaccination, the burden of proof will be borne by the Commissioner of the Korea Disease Control and Prevention Agency. Also, the Special Act included a provision to establish a Vaccination Committee that can check the causal relationship between vaccination and arising diseases to raise the public’s credibility.
- Policy
- The introduction of Moderna COVID-19 vaccine has begun
- by Kim, Jung-Ju Sep 16, 2022 05:53am
- Moderna's omicron mutation (BA.1) bivalent vaccine of 1.611 million doses will be introduced in Korea sequentially from today (15th). According to the Korea Centers for Disease Control and Prevention, 805,000 doses will arrive at Incheon International Airport on the 15th and 806,000 doses on the 17th, respectively, and will be used for winter vaccinations in October after the Ministry of Food and Drug Safety approves the lot release. The vaccine to be introduced this time is a divalent vaccine containing two antigens (the virus and omicron mutation BA.1), and was approved by the Ministry of Food and Drug Safety on the 8th. The detailed implementation plan for winter vaccinations using divalent vaccines will be announced at the end of September when divalent vaccines are prepared. The government will continue to closely consult with pharmaceutical companies for a stable supply of vaccines, and will promptly guide the additional supply schedule as soon as it is set. The authorities have contributed to the international community through overseas donations along with related ministries such as the Ministry of Foreign Affairs, and have donated a total of 4.86 million doses to nine countries since last year. In addition, 4.83 million doses of the AZ vaccine, which was distributed through COVAX, were also provided to COVAX without introduction in Korea.
- Policy
- The flu-coronavirus outbreak has been predicted
- by Kim, Jung-Ju Sep 15, 2022 05:55am
- Amid the prevailing pessimistic outlook that flu and COVID-19 will be all the rage at the same time this fall, quarantine authorities stressed that flu and COVID-19 vaccines should be vaccinated respectively. This is due to similar symptoms such as headaches and fever, which can be mistaken, and people are confused by rumors that "if getting the flu vaccine, pts don't have to get the COVID-19 vaccine." Jung Ki-seok, head of the COVID-19 Special Response Team at the Central Disaster and Safety Countermeasures Headquarters, explained this in a Q&A session at a regular COVID-19 briefing this morning (14th). According to Jeong, the flu and COVID-19 are not often distinguishable from symptoms, but the expected flu is not much different from the influenza A types H1N1 and H3N2 that they have experienced before, so the symptoms are not expected to be significantly different. "The flu has a very typical symptom that only the flu has," Jeong said. "It starts with a sudden fever, aching body, and a headache, and it is effective to take medicine within 48 hours, when the virus is relatively less proliferation," he explained. "Not all flu symptoms follow typical symptoms," Jeong said. COVID-19 Some patients may suddenly have a fever and get sick, but doctors may know a lot from experience because the symptoms of the typical flu and the typical COVID-19 are very different. However, in order to ensure accuracy and not to rely on experience, the test must be performed," he stressed. Jeong dismissed the false information such as "the COVID-19 vaccine helps prevent the flu," as "a groundless rumor." "Children should receive both vaccines at the same time as they do every season," he said. "On the day they visit the hospital, they can get both vaccines to arms at the same time." Jeong then recommended simultaneous vaccination, saying, "The Korea Centers for Disease Control and Prevention will soon announce the national vaccination project, and if the second flu vaccine comes out in early October, it can be received along with the COVID-19 vaccine."
- Policy
- Lowest price falls to PVA
- by Lee, Tak-Sun Sep 14, 2022 05:50am
- Despite the increase from 1.5 billion won to 2 billion won based on claims, the industry "needs small and medium-sized pharmaceutical remedies." Some products fell to the lowest price under PVA this year. Most of the products of small and medium-sized pharmaceutical companies lost money. According to industries on the 12th, some products such as Dongkoo's Glyforce fell to the lowest price in the same formulation due to this PVA. Glyforce fell 7.7% from 482 won to 445 won under the PVA. As a result, it has become the lowest price among 51 capsules of Choline alfoscerate 0.4g, a brain function improvement. Richwood Trading Company's single-use Hyalon Eye Drops also saw two products fall to their lowest prices. Hyalon Eye Drops (single use 0.35 mg/0.35 mL) fell 9.6% from 198 won to 179 won. Hyalon Eye Drops (0.45mg/0.45mL for a single use), which has been equally reduced, is also the lowest price among 26 identical products. Arlico's hyperlipidemia drug Pitavastatin 2mg also became the lowest-priced product. This product fell 9.6% from 561 won to 507 won. The lowest price due to PVA cuts is mainly from small and medium-sized pharmaceutical companies. The NHIS raised the standard for product claims from 1.5 billion won to 2 billion won while improving the exclusion target of PVA. The move was aimed at relieving small and medium-sized pharmaceutical products with low sales. However, there are still opinions that want to improve as a number of small and medium-sized products are included in the PVA cut. The NHIS is also conducting research services to improve PVA by the end of the year.
- Policy
- GOV·Pharma starts work to localize 57 essential medicines
- by Lee, Jeong-Hwan Sep 13, 2022 05:52am
- The government and the pharmaceutical industry have entered the final stages of localizing the finished drug products and active pharmaceutical ingredients that are essential for national disease control and prevention as well as the treatment of emergency patients. The supply of such products and ingredients has been mainly dependent on imports despite the evident need to be manufactured and produced in Korea due to low profitability. Among drugs that are imported from 3 or fewer countries and therefore are vulnerable supply-wise, those from highly export-dependent countries of China, Japan, and India will be finally confirmed, upon which the government and the pharmaceutical industry plan to cooperate in securing domestic production technologies. The movement bears significance as it is the first time the government and the pharmaceutical industry joined forces to fundamentally increase the self-sufficiency rate of rare or essential drugs that are subject to stable supply measures in Korea. On the 12th, the Korea Orphan & Essential Drug Center (KODC) announced that it has tentatively finalized the list of 21 finished drugs and 35 APIs that are deemed to be in need of domestic technology development after discussion with the Ministry of Food and Drug Safety (MFDS) and Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA), and will be collecting opinions from the industry as its last step. After collecting and reviewing opinions submitted by pharmaceutical companies, the KODC will hold an expert advisory meeting and finalize the list. Indications for the 21 tentatively confirmed finished drugs that were chosen due to the diseases’ difficulty in treatment or rarity of their patient group were treatments for emergency hypertension, ulcerative colitis, multiple myeloma, phosphorus excretion, acute heart failure or bradycardia, iron deficiency in patients unable to take oral medications, parasitic infection, adrenogenital syndrome, malignant hyperthermia, iron intoxication, methanol intoxication, Dravet syndrome, etc. Subject products were: Nitroprusside injection, mesalamine suppository·powder, melphalan tablet, bromocriptine oral tablet, sevelamer powder, etomidate injection, amiodarone injection, imiquimod cream, isoproterenol injection, ferric carboxymaltose hydroxide Injections, clarithromycin injections, pentamidine injections, fludrocortisone tablets, nisoldipine tablets, amiodarone hydrochloride tablets, dantrolene sodium injections, deferoxamine injections, dehydrated ethanol injections, stiripentol capsules, anakinra injections, etc. The 36 active pharmaceutical ingredients that were imported from countries with high import-dependency such as China, India, and Japan, are used for Brucellosis tularemia plague, Wilms' tumor, anthrax·plague·tularemia, drug-induced dystonia, Parkinson's disease, acute and chronic diarrhea, hypothyroidism, invasive fungal infection, supraventricular tachycardia, sepsis, tuberculosis, patent ductus arteriosus in preterm infants, Cushing's syndrome, atrophic vaginitis kraurosis vulvae, etc., that pose a fatal threat due to terrorism risk or in disease control and prevention in the nation, or have a rare patient group. The subject ingredients are Levodopa/benserazide tablet, loperamide capsule, liothyronine tablet, lincomycin hydrochloride capsule, voriconazole injection, bisoprolol tablet, salbutamol inhalent, adenosine injection, amiodarone tablet, amikacin injection, Amphotericin B injection, edaravone injection, ethambutol tablet, captopril tablet, clindamycin injection·capsule, pyridoxine injection, albendazole tablet, ketoconazole tablet, etc. The KODC plans to finalize the selection of drugs in need of stable supply after holding an expert advisory meeting on their selection criteria and considering their individual need for development, etc. In addition, in consideration of the potential for domestic development, industry interest, and the international supply network status of drugs that are not on the candidate list, the KODC will be collecting opinions on finished drugs and APIS that the industry believes are in need of domestic manufacturing technologies. A KODC official said, “We ask pharmaceutical companies that have separate opinions on our drug list selection, such as addition or deletion of items or the need for priority development, to submit their reviewed opinions and reasons. We will also be identifying pharmaceutical companies that are willing to produce products that are not yet approved for the manufacture of finished pharmaceuticals on paper, such as APIs in the Drug Master File system that are only being imported in Korea.”. Meanwhile, KODC is in charge of the MFDS’s research project on establishing a stable supply system for products with concerns over unstable supply and demand, focusing on National essential medicines that are used in public health crises.
