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- 2026-07-03 08:28:50
- Company
- Rising COVID-19 cases impede progress of bioequivalence test
- by Chon, Seung-Hyun Apr 08, 2022 06:08am
- Pharmaceutical companies are having trouble conducting bioequivalence tests for the development of generics due to COVID-19. The spread of COVID-19 has made it difficult for companies to recruit subjects, and even those recruited are dropping out after being confirmed with COVID-19, causing disruptions in the companies’ schedules. With delays inevitable due to the unexpected pandemic, pharmaceutical companies have been asking authorities to extend the drug pricing reevaluation deadlines that were set for February next year. According to industry sources on the 8th, several pharmaceutical companies have expressed their difficulties in progressing their ongoing bioequivalence tests due to the surge of COVID-19 cases. With hundreds of thousands of people being confirmed with COVID-19 every day, recruiting patients for the bioequivalence test itself is difficult. According to KDCA, 1,683,111 people were confirmed with COVID-19 over the past 1 week since the 6th. With over a million people in self-isolation due to COVID-19, the companies are complaining of difficulties in recruiting necessary subjects. With subject requirements are already stricter than before, difficulties in recruiting subjects for bioequivalent tests have been ongoing for some time. In accordance with the revised Pharmaceutical Affairs Act passed by the National Assembly in November 2018, people who have no experience participating in a clinical trial within 6 months prior to the trial date should be selected as subjects for clinical trials. With the restriction period extended from 3 months to 6 months. the number of participants viable for the tests has also decreased significantly. Also, even the registered subjects are frequently leaving trials to COVID-19. This renders it difficult to conduct a normal bioequivalence test due to the lack of subjects. The drug equivalence standards require 12 or more people in each group -the test group and control group for bioequivalence tests. This means the bioequivalence tests cannot be conducted unless over 24 people register for the tests. If subjects in the test group or control group are reduced to less than 12 due to COVID-19, the bioequivalence test itself may turn to waste. The companies can increase the test group or control group can by recruiting additional subjects, but this would inevitably push back the schedule. An official from a pharmaceutical company said, “We are planning to recruit more subjects than originally planned due to the rapid increase in the number of confirmed COVID-19 cases, but it isn’t easy. Even those who already registered are leaving trials after being confirmed with COVID-19, so we’re having much difficulty conducting the required bioequivalence test” Also, if the fallouts are concentrated in a specific group, such as the control or test group, the test itself may not derive significant results. For example, if 30 people were recruited for each group but 15 people from the test group leave due to COVID-19, the reliability of the test statistics may be undermined. Pharmaceutical companies have also had difficulty conducting bioequivalence tests in the early stages of the COVID-19 pandemic. In the early stages of the outbreak in 2020, the tests had been delayed with medical institutions discontinuing face-to-face work related to bioequivalence tests such as administration, screening, and monitoring. The main reason why pharmaceutical companies are expressing concern over their difficulties is because of the pressing deadline of the drug pricing re-evaluations for generic drugs. The Ministry of Health and Welfare announced a plan to re-evaluate the price ceiling of drugs, under which generics that do not meet the highest-price requirements in June 2020 are required to submit data on their ‘performance of bioequivalence tests’ and ‘use of registered APIs’ by February 28th, 2023 to maintain their previous drug price. This is a follow-up measure to apply the new drug pricing system which took effect in July 2020 to registered generic products. Under the revised drug pricing system, generic products can only be priced at the maximum price, which is 53.55% of the original drug’s price before patent expiry only when it satisfies both the requirements – directly-conducted bioequivalence tests and the use of registered raw materials. If either of the requirements is not met, the price cap is lowered by 15%. This means that a generic, which is approved by consigning the entire process to other companies without developing or producing it, will receive a drug price discount and be set at 72.25% of the previous price cap. The requirement of using a registered raw material can be met by switching the API. Due to the revised law, companies were left to decide between accepting the drug pricing discounts or maintaining the previous price by conducting bioequivalence tests. This is why companies have been actively conducting bioequivalence tests on their registered generics. According to the Ministry of Food and Drug Safety, a total of 768 plans for bioequivalence tests were approved in 1.8 years from July 2020 to February this year, which averages at 38 plans per month. Compared to 445 (22 per month on average) that were approved during the 1.8 years prior to July 2020 (November 2018 to June 2020), this is a 72.6% increase. Over half of the bioequivalence test plans approved recently are for registered generics. Of the 51 bioequivalence test plans approved in February, 39 were already on sale as registered generic products. Most of the bioequivalence tests are being conducted for ‘'in-house conversion' of the generics to manufacture in their own companies. If the companies make generics through formulation research and conduct bioequivalence tests that demonstrate bioequivalence, the companies can avoid the price cuts by obtaining change approvals. If companies convert consigned manufacturing to in-house manufacturing while applying for license changes, the companies can satisfy the ‘conducting bioequivalence test’ condition. Whichever way, it is said that it takes up to six months or more for bioequivalence tests to be imitated and render results. However, if the bioequivalence test data cannot be submitted by February next year due to a delay in the test schedules caused by the surge in confirmed COVID-19 cases, generic drugs will have no choice but to bear the drug price cuts. This means that the price of generic drugs may be reduced by 15%, even after the companies spent a lot of money and effort to avoid such discounts.
- Policy
- The benefit adequacy of Lorviqua was recognized
- by Lee, Tak-Sun Apr 08, 2022 06:08am
- Pfizer Pharmaceutical's Lorviqua has taken a step closer to insurance benefits in recognition of benefit adequacy as a treatment for non-small cell lung cancer. If negotiations with the NHIS are smoothly concluded in the future, the final benefit will be successful. The HIRA announced on the 7th that it held the 4th Drug Reimbursement Evaluation Committee in 2022 and recognized the benefit adequacy of Pfizer Pharmaceutical. The target products were Lorviqua 25 mg and Lorviqua 100 mg, and the Drug Reimbursment Evaluation Committee judged that there was benefit adequacy as a treatment for adult patients with ALK positive progressive non-small cell lung cancer (NSCLC). Results of deliberation by the 4th Drug Reimbursement Evaluation Committee in 2022 Lorviqua was approved in Korea in July last year to use Alecensa Cap or Zykadia Cap as a sole therapy for adult patients with ALK-positive progressive non-small cell lung cancer or as treated with Xalkori and at least one other ALK inhibitor. The Drug Reimbursement Evaluation Committee judged that Sonazoid and Duchembio's Dopa check at GE Healthcare's Korean branch had benefits when accepting less than the evaluation amount. It is subject to acceptance conditions below the evaluation amount. Sonazoid applied for benefits when used for liver gastric tumor lesion ultrasonography in adult patients, and Dopa check applied for use in positron emission tomography (PET).
- Company
- GC Pharma’s Hunterase ICV approved for P1T in Korea
- by Kim, Jin-Gu Apr 08, 2022 06:08am
- On the 7th, GC Pharma announced that it had received approval for a Phase I trial of its severe Hunter syndrome treatment ‘Hunterase ICV’ in Korea from the Ministry of Food and Drug Safety. Hunterase ICV comes in a new formulation that is inserted as a device in the head, through which a drug is directly administered into a patient’s cerebral ventricle. It overcomes the limitations of existing IV-type formulations that were unable to penetrate the blood brain barrier (BBB) and reach the cerebral parenchyma. The clinical trial will be conducted in 3 institutions in Korea - the Samsun Medical Center, Seoul National University Hospital, and Pusan National University Yangsan Hospital – on 12 patients with a severe type of Hunter syndrome to evaluate the safety and efficacy of the drug. GC Pharma said that the unmet medical need is high in the area as 70% of the patients have the severe, neuropathic form of Hunter syndrome. An official from GC Pharma said, “We will continue our efforts to improve the quality of life of our rare disease patients. As the product has already been successfully commercialized abroad, we will make the best effort so that the drug could be supplied to our patients in Korea as soon as possible.” GC Pharma received marketing authorization for ‘Hunterase ICV,’ the world’s first treatment for sever-type Hunter syndrome in Japan in January last year. In a clinical trial conducted in Japan, "Hunterase ICV" significantly reduced ‘heparan sulfate (HS),’ a key substance that causes central nerve damage, and demonstrated an effect in maintaining and improving the developmental age.
- Policy
- Bavencio by Merck passed the Cancer Drugs Benefit Committee
- by Lee, Tak-Sun Apr 08, 2022 06:08am
- Bavencio by Merck Immuno-cancer drug Merck Bavencio passed the Cancer Drugs Benefit Appraisal Committee as an indication for urinary tract epithelial cell cancer. The HIRA's Cancer Drugs Benefit Appraisal Committee held the 4th meeting in 2022 on the 6th and announced that Bavencio's standards for urinary epithelial cell cancer have been set. Cancer Drugs Benefit Appraisal Committee also set standards only for WM in the case of BeiGene's Brukinsa, which applied for benefits on the same day. It is expected to be used as a monotherapy in adult WM patients who have previously received more than one treatment. However, Brukinsa failed to set the standard for "single therapy in adult patients with osmotic cell lymphoma (MCL) who have previously received more than one treatment." Lynparza of AstraZeneca, Korea, known as an ovarian cancer treatment, also started to expand the standard, but it was bittersweet. The standards were set for the treatment of adult patients with BRCA mutagenic castration resistant prostate cancer, who had previously experienced disease progression after treatment with new hormone treatments, but the remaining three indications were not set. Combination maintenance therapy in adult patients with highly epithelial ovarian cancer, ovarian cancer, or primary peritoneal cancer, which is HRD-positive (defined as BRCA mutation or dielectric instability) in response to primary platinum-based chemotherapy and Bevacizumab combination therapy, did not pass the Cancer Drugs Benefit Application Committee. The treatment of gBRCA mutant HER2-negative metastatic breast cancer adult patients with previous chemotherapy experience and maintenance therapy of gBRCA mutant metastatic pancreatic cancer adult patients who did not undergo primary platinum-based chemotherapy for at least 16 weeks were not recognized.
- Company
- Yuhan's gastric atony tx has completed the registration
- by Nho, Byung Chul Apr 08, 2022 06:08am
- Yuhan Corporation (CEO Cho Wook-je) announced on the 6th that it has completed the first patient registration in phase 2A of clinical trial for patients with gastric atony of the new drug candidate "YH12852 (PCS12852)" exported by Technology to Processa Pharmaceuticals. Gastric atony is a chronic gastric motor disorder that causes severe heartburn, nausea, vomiting, and bloating due to delayed gastric emptying. In the United States, millions of patients suffer from dysentery, and there is a high demand for more effective treatment development. Currently, the only FDA-approved gastric atony treatment is Metoclopramide, a dopamine D2 receptor antagonist. However, the drug has been approved only for diabatic gastric atony and has a limited duration of up to 12 weeks due to serious potential side effects. Although past 5-HT4 agonists are effective, they bind non-selectively to other 5-HT receptors, resulting in serious side effects. YH12852 developed by Yuhan shows more than 200 times higher binding power to 5-HT4 receptors than other 5-HT receptors and has excellent selectivity and efficacy. Preclinical and clinical studies using YH12852 also showed minimal side effects in effective doses, so more clinical results are expected. Dr. Sian Bigora, head of development at Processa Pharmaceuticals, said, "We expect that this clinical 2A will have a similar effect on the gastric emptying rate of patients with gastric atony, as we confirmed that the gastrostomy rate was significantly improved while using YH12852 for constipation patients." He said, "The results of this study will provide important data to confirm the effect of YH12852 on the symptoms of patients with idiopathic and diabatic gastric atony, and will be useful for further designing clinical phase 2B." This clinical trial is a phase 2A clinical trial aimed at evaluating safety, pharmacokinetic properties, and efficacy of 13C-Spirulina Gastric Emptying Breath Test (GEBT) according to the dose of YH12852 in moderate or severe gastric atony patients, and will be conducted in a total of 24 patients in the U.S.
- Policy
- Phase 3 of Voclosporin has been approved in Korea
- by Lee, Hye-Kyung Apr 07, 2022 06:10am
- Phase 3 clinical trials of Voclosporin, the first oral treatment for lupus nephritis, will be conducted in Korea. On the 6th, the MFDS approved a clinical trial of Voclosporin, an LN treatment of Aurinia Pharmaceuticals, a subsidiary of Iljin SNT. Phase 3 clinical trials will be conducted at Seoul National University Hospital and Kyungpook National University Hospital as a double blindfold, placebo-controlled, and dose-increasing test to evaluate the efficacy, safety, and pharmacokinetics of Voclosporin for adolescents with lupus nephritis. Voclosporin was approved by the FDA in January last year for the treatment of adult patients with active lupus nephritis. Voclosporin, a calcineurin inhibitor, blocks interleukin (IL)-2 expression and T cell-mediated immune response and stabilizes podocytes in the kidney. According to the results of a study released by Aurinia Pharmaceuticals in November last year, Voclosporin showed continuous safety and weakness compared to placebo in the interim analysis of phase 3 clinical continuous research. Patients in the Voclosporin group maintained a significant decrease in proteinuria. From the baseline prior to treatment of AURORA 1 to 30 months of AURORA 2, UPCR was found to be -3.32 mg/mg for the Voclosporin group and –2.55 mg/mg for the control group (n=90). The eGFR, an important measure of renal function, remained stable until 30 months, and there were no unexpected new side effects reported in the Voclosporin group compared to the control group. Treatments for lupus nephritis include Cyclophosphamide, Cellcept, and Prednisone.
- Opinion
- [Reporter’s View] Deleting exemptions for industry dev.
- by Lee, Jeong-Hwan Apr 07, 2022 06:10am
- Until now, the pharmaceutical authorities had partially exempted the safety and efficacy review for ETCs and OTCs listed on drug formularies of 8 advanced countries – the US, Japan, UK, Germany, France, Italy, Switzerland, and Canada - for the prompt introduction of drugs to Korea. This special exemption system for drugs listed in foreign drug formularies was introduced and operated to promote domestic drug approval and production in 1970 in consideration of Korea’s relatively low drug development capabilities then. For the past several years, the system has been repeatedly criticized for impeding the development of the pharmaceutical industry and increasing unnecessary waste of health insurance finances, and there is little need to maintain the system. The Ministry of Food and Drug Safety accepted the National Assembly’s request for discontinuation of such special administrative measures and the regulation that exempts part of the data required for ETC and OTC drug approvals will be deleted from November this year. As a result, the safety and efficacy hurdle for OTC and ETC drugs listed on foreign drug formularies will be raised somewhat compared to now. The domestic industry and MFDS should use the amendment as a turning point to increase the quality and safety level of drugs in Korea. Breaking away from the past when the drugs were more leniently approved just because they were used in advanced countries, the regulatory environment should be restructured in which pharmaceutical companies directly generate and submit safety and efficacy clinical data, and the MFDS reinforces its review expertise in granting marketing authorizations. The Korean pharmaceutical industry today has secured competitivity by improving its own capabilities and even some global competitivity. In addition, the domestic pharmaceutical industry now bears the fate of needing to continuously evolve and develop as the new growth engine and national key industry. Based on the competitivity acquired in the pharmaceutical industry, experts believe that the government should generalize the verification process without exempting approval and review data for drugs taken by the people in Korea to further foster basic growth of the pharmaceutical industry and increase the possibility of development. In addition, more meticulous verification of the efficacy and safety of ETCs that are granted marketing authorization should be made for the more efficient management of health insurance finances. Some have raised the concern that non-essential regulations may be added due to the deletion of the special regulations for drugs listed on the foreign drug formulary, but it is predicted that the domestic pharmaceutical industry and approval and review authorities will be able to discover and approve effective and safe drugs based on the capabilities it had built until now. In 2020, in response to the NA’s criticism regarding the special exemption system for drugs listed in foreign drug formularies, the MFDS Minister at the time, Eui-Kyung Lee, had answered that “The domestic industry has enough expertise to conduct review and assessments..” With the revised regulations this time, it is the reporter’s hope that the pharmaceutical companies prepare data for pharmaceutical approvals based on scientific evidence, and that the MFDS strengthen the drug review environment through self-reviews to strengthen quality-based drug approvals and public trust.
- Company
- Organon Korea "No NDPA detected in Singulair”
- by Apr 07, 2022 06:10am
- Organon Korea announced on the 6th that no impurities were detected in ‘montelukast,’ the active ingredient of the allergic rhinitis and asthma treatment ‘Singulair.’ Organon Korea had conducted an impurity investigation for N- nitrosodipropylamine (NDPA) in January after the Ministry of Food and Drug Safety ordered companies to investigate the possibility of impurities. The company had brought in the active pharmaceutical ingredient used for the manufacture of Singulair for investigations in Korea. The company used a liquid chromatography-mass spectrometry device (LC-MS/MS) that could detect minimal amounts of the impurity. The results of the investigation and assessment data will be submitted to the MFDS soon. NDPA is a type of nitrosamine impurity that can be formed in the presence of amines or amine sources together with nitrite or nitrite equivalent reagents. The company explained, "The process was not included in the montelukast synthesis process, and it was found that there is no possibility of cross-contamination in the final manufacturing process." The company had also reached the same conclusion in an impurity investigation conducted at the request of the European Medicines Agency (EMA) in 2019. Keon-Young Jung, Managing Director of Marketing at Organon, said, “Organon Korea has confirmed the safety of its products from impurities through evaluation of the manufacturing process and quantitative analysis on the API of all its formulations. We hope that the tests will help HCPs and patients to resolve concerns about impurities in the original Singulair.”
- Company
- Competition for Pelubi's generics worth ₩30 billion
- by Kim, Jin-Gu Apr 07, 2022 06:10am
- Pelubi It is expected that generic competition will take place in earnest in the Pelubi market, a osteoarthritis treatment worth 30 billion won per year. Following Youngjin Pharmaceutical, which launched generic alone, Huons and Chong Kun Dang are predicting their entry into the market. Daewon Pharmaceutical, which faces the challenge of generic, is in a situation where it is confronting each other by releasing follow-up drugs such as original formulation change and salt change products. ◆Generic for exclusivity of first generics ends According to the pharmaceutical industry on the 6th, the period of Youngjin's Pelubi will end on the 25th of this month. Phelps is the first generic of Daewon Pharmaceutical. Youngjin Pharmaceutical received generic for exclusivity. Accordingly, except for Youngjin Pharmaceutical, the other generic companies were not able to release the same-active ingredients within the generic for exclusivity period. Huons and Chong Kun Dang are expected to release Generics in earnest when Phelps' priority sales period expires on the 25th of this month. Like Youngjin Pharmaceutical, the two companies have surpassed patent of Pelubi. In April and May last year, generics for Pelubi received product approval, respectively. Huons has already received insurance benefits. When generic for exclusivity expires, generic can be released immediately within this month. Daewon Pharmaceutical, the original company, is developing strategies such as developing follow-up drugs and adding indications. Daewon Pharmaceutical plans to release Pelubi S, which was approved as a salt-changing product last year, soon. Daewon Pharmaceutical explained that it improved drug solubility and side effects of GI disorders through salt changes. In the case of Pelubi SR, which was released earlier, it already has more performance than Pelubi. According to UBIST, a pharmaceutical market research firm, Pelubi and Pelubi SR's outpatient prescriptions amounted to 32.5 billion won last year. Among them, Pelubi SR's prescription performance is said to account for about 70% of the total. It is analyzed that the addition of indications had a significant impact on the expansion of Pelubi SR's prescription performance. Daewon Pharmaceutical added "post-traumatic pain" as an indication of Pelubi SR in May 2020. It is an indication that Pelubi does not have. ◆ Unfinished patent dispute, Pelubi SR's New Patent Challenge Variables There are two main variables of generic competition in Pelubiprofen market in the future. One is the Pelubi patent dispute. Youngjin Pharmaceutical, Huons, and Chong Kun Dang won in the first trial, but Daewon Pharmaceutical objected to the decision. If Daewon Pharmaceutical wins, sales of Pelubi generic will be discontinued. Generics companies are also forced to compensate for damages caused by patent infringement is inevitable. There is a possibility that Daewon Pharmaceutical's delayed drug price reduction may be executed according to the subsequent ruling. Daewon Pharmaceutical filed a lawsuit with the Seoul Administrative Court to cancel the drug price reduction, dragging the patent dispute against Pelubi to the second trial. If Daewon Pharmaceutical loses in the second trial, the drug price of Pelubi will be reduced by 30%. Another variable is the new patent challenge for Pelubi SR. With Pelubi SR performing more than Pelubi, Huons, Chong Kun Dang, and Mothers are reportedly preparing to challenge composition patent of Pelubi SR . Mothers Pharmaceutical has already begun BA test of generics for Pelubi SR. Mothers Pharmaceutical was approved by the MFDS in July 2020 for a clinical trial for BA evaluation of Pelubi SR and Pelum SR.
- Policy
- The negotiation period for patent expired drugs ,shortened
- by Lee, Jeong-Hwan Apr 07, 2022 06:10am
- The Regulatory Reform Committee passed a regulation that would shorten the negotiation period for lowering the drug price of the original patented drug from 60 days to 20 days, effectively confirming its implementation. According to the results of the drug price reduction dispute, the revision of the law, in which the government refunds damages to pharmaceutical companies, was judged unregulated and was not reviewed by the Regulatory Reform Committee. The MOHW announced on the 4th that it received the results of a preliminary review of the Rules Amendment to the Standards of National Health Insurance Care Benefits" from the Regulatory Reform Committee. According to the MOHW, the Regulatory Reform Committee judged that among the contents of the regulations, a regulation strengthening plan to shorten the negotiation period for the reduction of drug prices from the current 60 days to 20 days is a "non-important regulation." The Regulatory Reform Committee also agreed with the MOHW's decision that the deadline for negotiations on ex officio adjustment is not needed until 60 days if the original drug price is lowered due to the registration of first generics. Regulations, which have been judged as non-critical in the preliminary review of the Regulatory Reform Committee, can be introduced immediately after going through the procedures of the Ministry of Legislation in the future. The system to shorten the original price reduction negotiation period to 20 days is expected to be implemented as scheduled, and the refund system for the price reduction lawsuit will be implemented based on the results of internal discussions by the MOHW. The timing of implementation is still difficult to estimate. This is because the MOHW must finalize the revision of the medical care benefit rule and set the effective date through all remaining administrative procedures. An official from the MOHW said, "The regulation to reduce the negotiation period for the original ex officio adjustment to 20 days has passed the Regulatory Reform Committee. The system was not reviewed by the Regulatory Reform Committee because it was judged unregulated. "We are discussing internally the revision of the rules for medical care benefits, including the two systems."
