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- 2025-12-23 23:22:10
- Policy
- Can Pfizer Vaccine be vaccinated immediately after arrival?
- by Lee, Tak-Sun Feb 24, 2021 06:03am
- On the 3rd, KIM Kang-lip, head of the MFDS, announced the approval of the special import of COVAX-Pfizer 117,000 doses of Pfizer's COVID-19 vaccine supplied by the COVAX Facility will arrive in Korea on the 26th, and attention is focused on whether vaccination is possible immediately. COVAX Facility's Pfizer vaccine is highly likely to greatly simplify the assay method, as it is introduced in Korea through a special import rather than a domestic official license. The MFDS is known to be planning to discuss this with the KCDA in the near future. According to the MFDS and the KCDA on the 22nd, consultations will be held soon to test the Pfizer vaccine supplied from COVAX. The MFDS approves national lot release by conducting an inspection for quality verification on vaccines that have been approved for the product. It is a national lot release system, which is to verify the efficacy and safety of the vaccine before the government releases the lot. The previously approved AstraZeneca vaccine was also approved for lot release through this system on the 17th. The lot release of this vaccine was comlpeted in 20 days. However, there is insufficient evidence for the Pfizer vaccine supplied by COVAX to undergo a national lot release. The MFDS announced on the 3rd that it would verify the Pfizer vaccine through a separate test plan while deciding on a special import. There is currently no basis for national lot release obligations for special import drugs. It is highly likely that the MFDS will go through a minimum screening procedure in consultation with the KCDA and take measures to enable immediate vaccination. According to the verification method, vaccination on the 27th, which is proposed as a target, may be delayed. In a briefing for approval of the special import of COVAX Pfizer's vaccine on the 3rd, Kim Kang-lip, head of the MFDS, said, "If the domestic supply is confirmed and a test report for the quantity is secured through COVAX, we will discuss the quality verification method with the KCDA."
- Policy
- IMDs for Champix are being commercialized
- by Lee, Tak-Sun Feb 24, 2021 06:02am
- IMDs of domestic pharmaceutical companies that challenge Champix (Varenicline Tartrate, Pfizer) are attracting attention. This is because film-type formulations with enhanced convenience and SR formulations are promoting commercialization. Although generic products have already been released, demand for IMDs is expected to remain high. According to the industry on the 19th, CTC Bio, Boryung, etc. are challenging Champix as a new formulation of smoking cessation treatment. CTC Bio applied for permission for a film-type formulation of Varenicline, the same active ingredient as Champix, for the first time in Korea in September last year. This product has a salicylate salt that is different from the original salt (Tartrate). Champix is a tablet type that is taken twice a day, and it should be taken with a sufficient amount of water after meals. Since the film type is taken by dissolving it on the tongue, it will be useful for patients who have difficulty swallowing tablets or have a reluctance to drink water. Boryung recently got approval for phase 1 clinical trial plan for BR9003. Although BR9003 is unknown, it is SR tablet type that has been changed from existing twice a day to once a day. The industry is evaluating Champix SR as a competitive drug against the original drug. SK chemicals applied for a patent for Varenicline SR in 2018. Varenicline formulations have a high solubility in water, resulting in rapid effects, but a disadvantage in that the effect doesn’t last. It is believed that SK Chemicals has secured a patented formulation technology that extends the duration of drug effects by replacing salts that release drugs slowly. Champix's patent ended last July. Korean pharmaceutical companies previously challenged the market with a strategy to avoid patents by changing salts, but they lost a patent lawsuit and had a brake on early launch. Champix was used as a drug to support smoking cessation projects initiated by the former President Park Geun-hye's government, and once rose to a mega blockbuster drug of ₩60 billion per year. However, it is analyzed that there is a high possibility of success if IMD with enhanced convenience comes out as it still has a large share of smoking cessation drugs.
- Policy
- Antidiabetic drug GLP-1 RA to be recommended for NASH
- by Lee, in-bok Feb 23, 2021 06:11am
- The use of antidiabetic drug is to be expanded in treating non-alcoholic steatohepatitis (NASH) as the Korean Association for the Study of the Liver (KASL) gave a priority recommendation on prescription of pioglitazone. The prospective prescription strategy is likely to see a significant change as a glucagon-like peptide 1 receptor agonist (GLP-1 RA) semaglutide, becoming a star obesity drug with exceptional weight-loss effect, has emerged as a new key treatment option. # On Feb. 17, KASL convened an online hearing session to revise the NASH treatment guideline and unveiled the first draft of the revision scheduled to be published on Mar. 5. The guideline would vastly revise the year 2013 edition of NASH treatment guideline for the first time in nine years. The association formed a revision committee last year and held eight sessions of meeting focusing on seeking an evidence-based guideline. The amended version of the guideline would specify the pharmaceutical therapy in detail, when in 2013 the guideline was published with a simple description. Many of the drugs that accumulated evidences through clinical trial and meta-analysis so far were addressed in the new version. Most of the pharmaceutical therapies recommended by the new guideline were antidiabetic treatments—pioglitazone, metformin and semaglutide. First, the guideline recommends administering pioglitazone for treating patients with biopsy-confirmed NASH regardless of underlying diabetes, based on four large-scale studies, including the randomized study published in the New England Journal of Medicine (NEJM) in 2015, proving efficacy of the substance. The evidence level is B1. However, the guideline also noted a condition to the prescription that the prescriber should be aware of the benefit and risk of the drug as the large-scale randomized study warned of safety issues regarding adverse reaction reported during a long-term prescription. And for the same reason, metformin was also recommended by the latest guideline with the efficacy in NASH treatment confirmed by a randomized controlled trial that found a six years or more long-term prescription of the drug lower mortality, liver transplant and hepatocellular carcinoma expression rate in patients diagnosed with NASH and liver fibrosis. Moreover, the newest version of the guideline approved of a GLP-1 RA semaglutide as a priority recommendation. A 72-week Phase II trial with NASH patients observed the drug stopped the fibrosis worsening by 40 percent with 0.1mg dose. Professor Kim Won of Seoul National University School of Medicine specializing in Internal Medicine evaluated, “Semaglutide seems to show efficacy in treating NASH based on its outstanding weight-loss rate.” However, other drug like Saxenda (liragultide), also known for the notable weight-loss effect, was not included in the guideline. The association concluded, liraglutide showed efficacy of improving insulin resistance (IR) and lowering the cardiovascular risk factors, but they were limited in treating diabetes and obesity, and medical evidence relevant to NASH is insufficient. In the revised draft of the guideline, KASL also added a statin prescription strategy considering the high mortality rate by cardiovascular disease in NASH patients. In fact, in the GREACE study, statin significantly improved the reduction of the expression of cardiovascular disease in NASH patients, who have increasing liver enzyme concentration. And another clinical trial conducted in South Korea also confirmed the same efficacy. The head of the treatment guideline revision committee, Professor Cho Yong Kyun (Sungkyunkwan University School of Medicine) noted, “We also reviewed SGLT-2 inhibitor lowering body weight and carnitine combination therapy improving the antioxidant activity, but we could not find enough clinical data regarding the treatment of NASH to be included in the guideline.”
- Policy
- Weighted average price of α-GPC, ₩512
- by Lee, Hye-Kyung Feb 22, 2021 06:18am
- The weighted average price of Choline alfoscerate 0.4g, which was the subject of reevaluation of the adequacy of benefits last year, decreased 0.2% from the previous year to ₩512. The weighted average price of Vitis vinifera 50mg. and Avocado-Soya unsaponifiables 0.3g, which are undergoing re-evaluation this year, decreased by 1.7% and 5.3%, respectively, compared to the previous year. Dailypharm recently revealed this trend as a result of calculating the low-dose weighted average price of major ingredients over the last three years based on the '2020 yearly weighted average price of drug per year' that the HIRA recently released. The data released this time was calculated as a weighted average price of 3, 554 ingredients for health insurance review in the previous year for items listed on the drug benefit list as of February 1 of this year. The weighted average price of each major ingredient was reduced by 2.9% for Donepezil 10mg, a dementia treatment drug, from ₩1,971 in 2019 to ₩1,941 in 2020. The weighted average price of Amlopidine besylate 5 mg, a hypertension drug, was calculated last year at ₩358 (-0.3%), and the average price of the combination drug Amlodipine besylate 10 mg/ Telmisartan 80 mg was calculated at ₩845 (-0.7%), and The average price of Amlodipine besylate/Valsartan 80mg was calculated as ₩982 (no change). The price of Ezetemib 10mg/Rosuvastatin 5mg, a combination treatment for hyperlipidemia, was cut last year to ₩883 (-0.3%), and the price of Clopidogrel was reduced to ₩1,118 (-0.9%). The weighted average price of Ginkgo leaf dried extract 0.12g last year was ₩110, the weighted average price of Bilberry dried extract 0.17g was ₩238, and the weighted average price of Silymarin 0.35g was ₩401, the same as the previous year. The weighted average price by active ingredient is used as a reference price when preparing drug economic evaluation data or negotiating drug prices. The weighted average price released this time was excluded from calculation when there was no billing performance last year, when the upper limit price could not be calculated or Amino acid preparation. The same ingredient, same formulation, and same dosage were calculated by weighted average value with the same main ingredient. The formulation code was TB·CH·CS as TB, CE·TE as TE, CR·TR as TR, and GN·PD is calculated as GN, CM·OM·PA as OM, PC·PL·PO as PL, and SY·SS as SY. In the case of product code changes due to transfer, the amount of claim for the item before the change is incorporated into the item after the change. For patent-related items, the upper limit of the item is calculated as a weighted average price.
- Policy
- Central Committee conflicted over Rekirona limits use
- by Lee, Tak-Sun Feb 22, 2021 06:17am
- Apparently, the Central Pharmaceutical Affairs Deliberation Committee has reached a conclusion after an intense discussion in approving of Celltrion’s COVID-19 monoclonal antibody treatment Rekirona, conditionally authorized for use on Feb. 5. The Central Pharmaceutical Affairs Deliberation Committee was convened for a meeting on Jan. 27 and advised Rekirona to be conditionally used on high-risk patients with mild COVID-19 symptoms and patients with moderate symptoms. The indication was actually narrowed from the COVID-19 Treatment Advisory Panel’s previously opinion that the treatment can be used without a limitation in patients with mild to moderate symptoms. In the Central Committee meeting minute disclosed on Feb. 18, many have raised concerns of using the drug for patients with mild symptoms and the opinions were vastly split. Total 18 of experts and five Ministry of Food and Drug Safety (MFDS) officials participated in the meeting held on the day. A committee member proposed a conditional approval, as “the clinical recovery as of Feb. 14 confirmed the meaningful efficacy. The applicant targets patients with mild to moderate symptom, but the submitted evidence showed statistical improvement of the symptoms only in patients with moderate symptoms (40 mg/ kg) among overall patients with mild and moderate symptoms and age 50 and over patients with moderate level of symptoms.” Another committee member recommended, “As an advisor, I can see the data confirming the improvement in patients with mild symptoms, but considering it would be an expensive drug, shortening the time to recover by a few days in the mild condition patient would not be meaningful, clinically speaking.” However, Celltrion refuted shortening the time to recover in mild condition patient is a meaningful outcome. The company official was connected via video conference call during the meeting and said, “As far as the symptom improvement goes, the efficacy in patients with mild symptoms is comparatively lower than in patients with moderate symptoms, but still the time to recover was reduced. It would be beneficial to the patients with mild condition to lessen the number of recovery days, too.” The official also told the company aims to complete registering 1,172 participating COVID-19 patients in April through May for the Phase III clinical trial. Some also urged the agenda should be revisited when more data is collected from the Phase III trial. A committee member advised, “Rather, it would be more appropriate to grant a limited approval for patients with underlying condition of pneumonia, who could develop the symptoms worse. The definite decision should be made after re-discussing about the drug, when it comes back with sufficient Phase III trial data.” Rekirona injection, in fact, has caused a conflict already, when the company presented the Phase II trial outcome. Among the primary efficacy endpoints, the drug demonstrated statistically meaningful improvement in clinical recovery only, while the drug did not achieve another satisfactory endpoint, the virus shedding time. A MFDS official participating at the meeting commented, “Some Phase III trials designed with multiple primary endpoints confirm the efficacy when two endpoints are achieved. But this Phase II trial was not designed as a multiple testing.” “Comparing the two endpoints, the clinical recovery seems to be more valuable endpoint, which was met. The virus shedding endpoint was not met as expected, but the drug could have shown the mechanism of shedding the virus as patients’ level of virus demonstrated the descending tendency with the drug administration,” the official added. However, some even urged they can hardly support the idea of conditional approval as the secondary endpoints, such as hospitalization, oxygen therapy, and decrease in death rate, were not able to verify properly, let alone the primary endpoints. One of the members also noted, “The current data is only sufficient for an emergency use authorization than a conditional approval,” and some others agreed. Rekirona injection earned the authorization on Feb. 5 with a condition to provide Phase III clinical trial data. In accordance to the Central Committee’s recommendation, the drug is indicated to be used on high-risk COVID-19 patients with mild symptoms, or patients with moderate symptoms (age over 18) to improve their clinical symptoms. The high-risk patients with mild symptoms are limited to patients aged over 60 or having one of underlying conditions (cardiovascular disease, chronic respiratory disease, diabetes or hypertension). On Feb. 17, Rekirona injection started supplying to healthcare institutes in South Korea.
- Policy
- Ninlaro for multiple myeloma & Lutathera are listed
- by Lee, Hye-Kyung Feb 22, 2021 06:17am
- The standard of benefit of Ninlaro (Ixazomib Citrate), combination therapy for multiple myeloma and Lutathera (Lutetium Oxodotreotide) for neuroendocrine cancer will be established. The HIRA announced that it is proceeding with the amendment of the announcement according to drugs prescribed and administered to cancer patients and will receive comments by the 23rd. It will be applied from the 1st of next month. Ninlaro is a drug approved for combination therapy with Lenalidomide and Dexamethasone in the treatment of patients with multiple myeloma who have previously received more than one treatment. According to the textbook review, Ninlaro is mentioned as an oral drug in the PI (proteasome inhibitor) family. In the NCCN guidelines, combination therapy of Ninlaro, Lenalidomide & Dexamethasone is recommended as Category 1 for the treatment of multiple myeloma that has been previously treated, and as 'I, A' in the ESMO guidelines. As a result of comparing Ninlaro/Lenalidomide/Dexamethasone with Lenalidomide/ Dexamethasone in a randomized phase 3 clinical trial (TOURMALINE-MM) in multiple myeloma patients with previous treatment experience, the median progression-free survival was 20.6. months vs. 14.7 months, and the overall response rate was 78.3% vs. 71.5%. As both Lenalidomide and Dexamethasone are taken orally, the effect was improved compared to the control group, so the supplement standard was newly established. On November 17, 2019, Lutathera was recognized as an emergency drug by the MFDS for the treatment of adult patients with advanced and metastatic somatostatin receptor-positive gastrointestinal tract and pancreatic neuroendocrine tumors that are not resectable and highly differentiated. As a result of reviewing textbooks, guidelines, and clinical papers by the HIRA, Lutathera is a clinically useful and medically necessary drug and has been listed as a monotherapy for neuroendocrine cancer 3rd, 4th or higher. However, IV infusion is possible up to 4 times in consideration of the evidence of related clinical literature. It was set to 3rd-4th steps, reflecting the opinions of experts and the society that it is quite expensive compared to alternative drugs and that realistic standards appropriate to the Korean situation are needed.
- Policy
- AstraZeneca's vaccine, lot release for 780,000 people
- by Lee, Tak-Sun Feb 22, 2021 06:17am
- All administrative procedures for AstraZeneca's COVID-19 vaccine, scheduled for vaccination on the 26th, have been completed. The final step was approved by the MFDS. The MFDS announced that it had national lot release of 787,000 people (1,574,000 doses) of AstraZeneca's COVID-19 vaccine applied on the 29th of last month on Wednesday. This approval was carried out quickly in 20 days, the national lot release usually takes 2-3 months and it is expected to be used for the first domestic COVID-19 vaccine vaccination from February. National lot release is a system in which the country checks the quality of vaccines once more before distribution to the market by comprehensively evaluating the results of the qualification test for each manufacturing unit (lot) of the vaccine and the data review that produced and tested the results as permitted by the manufacturer. AstraZeneca's COVID-19 vaccine is a quantity manufactured by consigning all processes from SK Bioscience. In preparation for the concentration of applications for national lot release of COVID-19 vaccine, the sample storage room was expanded and additional storage freezers were secured. For national lot release, the MFDS confirmed the safety and effectiveness of each manufacturing unit through a verification test of 1,574,000 batches and a review of data on manufacturing and testing. As for the assay, AstraZeneca's COVID-19 vaccine was a viral vector vaccine and conducted a sterility test and a bacterial endotoxins test for safety, and confirmed that there was no contamination of microorganisms such as bacteria during the manufacturing process of the vaccine. Regarding the effectiveness, a potency test and a viral vector content test were conducted to measure the amount of protein expression effect, the maintenance of the desired genetic material, and the amount of the vector as a genetic material delivery. In addition, properties tests, pH measurement tests, and actual dose tests of syringe injections were conducted as general vaccine quality test items. The MFDS explained that as a result of reviewing detailed information and manufacturing and quality control records related to vaccine raw materials, undiluted solutions, and finished drugs, it was in compliance with the drug manufacturing and quality control standards (GMP) and approved matters. In addition, manufacturing and storage information, test methods, test standards, and results were confirmed by each stage of the manufacturing process, including information on the history of cell lines and virus lines used as vaccine materials. The MFDS emphasized that it will do its best to ensure that the Korean people can receive the vaccine by thoroughly verifying COVId-19 vaccine introduced in Korea by making full use of the professional manpower and equipment-related infrastructure required for national lot release.
- Policy
- Atozet’s generics are approved
- by Lee, Tak-Sun Feb 19, 2021 06:17am
- AtozetGenerics for Atozet (Ezetimibe/Atorvastatin, MSD Korea) were approved on the 18th. Dongkoo Bio, which had joined the Chong Kun Dang group, was also approved. It is reported that Dongkoo Bio transferred and acquired the existing licensed items and newly licensed generic for Atozet according to the license regulations. On the 18th, the MFDS approved a number of generic drugs of Ezetimibe/Atorvastatin. All of them are products that have been tested for bioequivalence using the original drug Atozet as a reference drug, and are products that were applied for approval on January 23, after re-examination. Pharmaceutical companies such as Yuhan, Daewoong, and Ildong are included. It also included Dongkoo Bio, Jinyang, and Dasan, which conduct bioequivalence tests and commission production to other companies. In particular, Dongkoo Bio attracted attention. Dongkoo Bio has been preparing generic drugs and recruiting consignment companies, but was detested from consignment companies as they suddenly entered the data submission drug group preoccupied by Chong Kun Dang. In January, Dongkoo Bio’s Atoeve was approved, the same ingredient, through data sharing with Chong Kun Dang. However, Dongkoo Bio transferred Atoeve to Hwail, and Dongkoo Bio’s Jetstan, generic for Atozet, was approved. Kuhnil, Young Poong, and TDS pharm have succeeded in obtaining approval for generics manufactured by Dongkoo Bio. It is known that the approval regulations of the MFDS were affected by Dongkoo Bio's transfer of the existing licensed items to other companies and the approval of generic products. This is because in order for the consignment bioequivalence item to be proved bioequivalence, the consignment item must also obtain permission. Dongkoo Bio had a plan to obtain approval for its own products early through Chong Kun Dang Group, and to produce only consigned items for direct development generics. This is because if Dongkoo Bio joins Chong Kun Dang Group, it will be possible to receive preferential treatment at drug prices over generics by entering within 20 of the same ingredients under the stepped drug price system. However, it is said that it was impossible due to the regulations of the MFDS. Under the current stepped drug price regulation, if more than 20 identical drugs are listed, the upper limit of newly listed items is reduced to 85% of the existing lowest price. Generics for Atozet already have more than 20. Therefore, the drug price is also determined according to the lowest price item that applied for the drug price in January. Generic companies are worried about whether there will be a data-submitted pharmaceutical company that has intentionally listed the drug price at a low price so that competitors have applied for a lower drug price. Regardless of this, the market is concerned about overheating competition as dozens of Atozet’s generics are pouring out. Usually, when the competition for generics is severe, illegal rebates have also been on the rise.
- Policy
- Korean-made COVID-19 treatment Rekirona distributed
- by Kim, Jung-Ju Feb 19, 2021 06:17am
- Celltrion has started supplying the first South Korean-made COVID-19 monoclonal antibody treatment Rekirona to healthcare institutes from Feb. 17. Rekirona is a first COVID-19 antibody treatment developed and manufactured in South Korea and it was approved by the Ministry of Food and Drug Safety (MFDS) with condition to further submit clinical data. The company stated it completed manufacturing doses for 100,000 people to treat patients in the country, and it plans to annually manufacture doses for 1.5 million to 3 million people, depending on the demand. MFDS indicated the drug to treat patients confirmed to have COVID-19, within seven days of the diagnosis, who are aged over 60 without the need of oxygen therapy, or have underlying diseases like cardiovascular disease, chronic respiratory disease, diabetes, hypertension, or pneumonia. The details of the treatment supply would be informed to each healthcare institute by related city and province office. Celltrion’s subsidiary Celltrion Pharm owns the sales rights in the country, and it would be in charge of supplying the treatment nationwide.
- Policy
- The first generic of birth control pills Yaz is released
- by Lee, Tak-Sun Feb 19, 2021 06:17am
- YazThe first generic for Yaz, a pre-contraceptive drug that has established itself in the market, and Duowell’s generic, a combination drug for hypertension and hyperlipidemia, was released. Generic for Yaz is the first with the same ingredients as the original, but in the case of Duowell’s generics, the same ingredient formulations are already available as drug for data-based re-evaluation. The MFDS approved Hyundai’s Yarose and Kolmarpharma's Telovatin on the 16th. Yaroz is the first generic in Bayer's pre-contraceptive drug Yaz (Drospirenone/Ethinyl estradiol). Hyundai proved equivalence in a bioequivalence test using Yaz as a reference drug. Yaz is the drug with the highest sales value in the domestic pre-contraceptive market. In 2019, IQVIA sales amounted to ₩14.4 billion, which outpaced the rival drug Mercilon (₩9.1 billion) by a big gap. However, Yaz is a Rx drug, so its distribution channel is different from that of the OTC drug Mercilon. Therefore, pharmaceutical companies are commercializing Mercilon as a competitive drug rather than Yaz. Hyundai is the No. 1 pharmaceutical company in the market for post-mortem contraceptives that require a doctor's prescription, such as Ellaone and Norebwon. Although it is releasing pre-contraceptive pills in the OTC market, it is far from the leading market. It is analyzed that Hyundai, which has a distribution channel for hospitals and clinics as a post-contraceptive drug, will have a competitive edge in the pre-contraceptive drug market with the generic of Yaz, an Rx drug. Hyundai has been working on Yaz's patent challenge for about 4 years. However, the patent challenge was not successful. Then, when Yaz's patent expired in August last year, it became possible to develop and release generic drugs. DuowellKolmarpharma's Telovatin is also the first generic to conduct a bioequivalence test using Duowell as a reference drug. This drug is a combination of Rosuvastatin and Telmisartan. Generics for Rosuvastatin-Telmisartan have already been approved by more than 20 companies and has been released on the market. Ildong, which was licensed for drug for data-based re-evaluation, shared the data, and multiple pharmaceutical companies received permission before PMS (re-examination). Duowell's PMS expired on October 30th. Kolmarpharma’s Telovatin, which was approved this time, is the first generic drug that has been applied for approval after the end of PMS. Generics are expected to be much cheaper than existing generics due to the stepped drug price system. If the drug price is low, sales are detrimental, but it is expected that generics that appeal to low drug prices will continue to emerge in a situation where market competition is severe.
