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- 2026-05-20 13:53:26
- Policy
- Truth behind COVID-19 and using antihypertensives
- by Lee, in-bok May 06, 2020 06:33am
- Although a hypertension treatment angiotensin-converting enzyme (ACE) inhibitor has aroused controversy while seeking for COVID-19 treatment, the drug’s safety issues is getting resolved by a series of related clinical investigations. Multiple clinical trials of using ACE inhibitors on COVID-19 patients have confirmed the safety of the drug and actually discovered it helps patients fighting against COVID-19. The safety concerns of using the antihypertensive and COVID-19 soon to be concluded According to medical scholars on May 5, safety concerns regarding the use of antihypertnesives amid COVID-19 pandemic has been raised early. A series of clinical studies have been published confirming the correlations between COVID-19 and antihypertensive ACE inhibitors Because the novel coronavirus uses ACE, especially ACE2, as a receptor to spread, some medical experts argued angiotensin II receptor blockers (ARBs) and ACE inhibitors could possibly worsened the disease condition. And an animal study result supported the theory as it found ARBs and ACE inhibitors upregulating the expression of ACE2, and hence, allow the virus to more actively invade lungs and heart, where ACE2 is expressed. Although internationally renowned medical organizations like World Congress of Cardiology (WCC), American College of Cardiology (ACC) and European Society of Cardiology (ESC) have urged the prescribers to maintain the prescription of the medications as suspending the treatment would cause more damage than benefit, the medical experts are still arguing over the issue. This is the background behind why so many COVID-19 related clinical trials around the world are testing the safety of using the hypertension treatments. In conclusion, however, the concerning theory was proven groundless. Three studies have already concluded in same findings—the hypertension treatments ‘do not affect COVID-19 patients at all.’ Safety test results on ACE inhibitors report “suspending prescription is more dangerous” A multiregional multicenter study led by Professor Yun Feng of Jiao Tong University at Shanghai found that halting the prescription of the hypertension drugs could threatened the patients with hypertension even worse (doi.org/10.1164/rccm.202002-0445OC). Clinical trials reported so far have refuted the claim that ARBs and ACE inhibitors affect prevalence and severity of COVID-19 Running a head-to-head comparison trial on 476 COVID-19 patients, the researchers confirmed the patient group that halted the antihypertensive prescription showed higher possibility of worsening their condition. In fact, only four out of 33 patients (12 percent) with hypertension who took ARB and ACE inhibitor have become severely ill, whereas 36 out of 80 patients (45 percent) who stopped taking the medications have become severely ill. As a result, the study has proven that stopping the medication out of the concern could actually worsen the COVID-19 condition. Another study also claims the concern over safety is baseless. Comparing groups of patients either taking or not taking the antihypertensive and without comorbidity has shown no significant difference. An investigation led by Professor Guang Yang of Hubei Provincial Academy of Traditional Chinese Medicine analyzed 126 patients with hypertension and 125 patients without the underlying condition, and also compared them to 1,942 patients who visited hospital prior to the spread of COVID-19 (doi.org/10.1101/2020.03.31.20038935). Moreover, the researchers subdivided the patient group with hypertension either administered with ARB and ACE inhibitor or not, and compared the effect of using the drugs. The study found 35.4 percent of hospitalized patients with hypertension before the spread of COVID-19 used ARB and ACE inhibitor and 34.1 percent of the patients after the spread of COVID-19 used the medications, which demonstrated no significant difference. It also meant the concern of administering ARB and ACE inhibitor raised from the animal study is not meaningful in clinical terms (P=0.756). In some cases, hospitalized patients with COVID-19 who were administered with ARB and ACE inhibitor showed lower severity level and mortality rate than the ones that did not take the medications. But the figure did not have statistical meaning, and the researchers recommended interpreting the result to understand that the medications do not worsen the disease severity. A study led by Professor Yingxia Liu at Southern University of Science and Technology of China also resulted in similar outcomes. The investigators analyzed 78 COVID-19 patients with the hypertension comorbidity, and discovered the administration of ARB or ACE inhibitor did not affect prevalence or severity of the disease (doi.org/10.1101/2020.03.20.20039586). 24.3 percent of the study participants had taken ARB and 3.8 percent had been prescribed with ACE inhibitor. But each group only had 15.8 percent and 2.6 percent of severe cases, respectively. The study also saw the group that was prescribed with ARB and ACE inhibitor had lower severity in the disease than the group with hypertension but had not taken the drugs. Compared to the control group, only 54 percent of the ARB-prescribed patient group had severe cases of COVID-19 and ACE inhibitor-prescribed group showed the similar result with 57 percent. Large-scale clinical trials in preparation to “seek evidences for continuing prescription” Based on the study results refuting the claim of ACE inhibitors affecting the prevalence and severity of COVID-19, the international scholars’ clinical reasoning and recommendation to continue the antihypertensive medications would likely to be accepted more widely. Medical experts anticipate these investigations would provide evidences supporting the medical scholars’ recommendations to continue prescribing the hypertension treatments WCC, ACC, ESC and Korean Society of Hypertension (KSH) have urged on maintaining the prescription, but it was rather a clinical reasoning than from concrete evidence. However, their recommendation is gaining more support as more and more clinical evidences are generated in continuous investigations on the matter. Besides the published study results, there are large-scale randomized, double-blinded, head-to-head clinical trials in progress globally, and they would provide more concrete evidences in May. A KSH official stated, “The already available study outcomes are sufficient enough to say ARB and ACE inhibitor prescription should be maintained,” but “the findings are only based on observational studies with limitation. Regardless, the soon-to-be-published randomized double-blinded placebo-controlled studies would provide more clear direction.”
- Company
- Toujeo passed DC of big 5 general hospitals
- by Eo, Yun-Ho May 06, 2020 06:32am
- Next-generation insulin Toujeo can be prescribed at the Big 5 General Hospitals. According to the related industry, 'Toujeo inj Solostar (gene recombination insulin Glargine)' recently passed DC of Seoul National University Hospital, Seoul St. Mary's Hospital, Samsung Medical Center, and AMC including Severance Hospital. In addition, it has been approved for indications for type I and type II diabetes in children and adolescents over 6 years of age in the US and Europe. Toujeo's expansion of pediatric indications was based on the results of the EDITION JUNIOR clinical trial. The EDITION JUNIOR study compared Toujeo to Gla-100 in 463 children and adolescents (aged 6 to 17 years) treated for type I diabetes for at least one year and with HbA1c between 7.5% and 11.0% at screening. Participants continued to use their existing mealtime insulin. The study met its primary endpoint, confirming non-inferior reduction of HbA1c with Toujeo vs Gla-100 after 26 weeks. An official from the KDA said that next-generation insulins that solved existing adverse effects such as hypoglycemia would be a useful treatment option for children and adolescents with diabetes, as they have excellent drug effects. Meanwhile, Toujeo was listed on the insurance benefits list in November after domestic approval in August 2015. Toujeo's insurance premium per insulin unit is about ₩153 (₩15,306 per 100 units).
- Product
- The KPA, criticized the MFDS/the Regulatory Reform Committee
- by Kang, Shin-Kook May 06, 2020 06:32am
- The Korean Pharmaceutical Association (KPA) strongly objected to the withdrawal of step-by-step abolition policy for generic co-biological equivalence testing. On the 28th, the Korean Pharmaceutical Association (Chairman Dae-up Kim) announced that the Regulatory Reform Committee recommended the withdrawal of the amendment to the 'Regulation for Pharmaceutical Approvals, Notifications and Reviews', which contains the phased abolition of the generic bioequivalence test, and the MFDS, which accepted this without policy alternatives, is pursuing lush policy. The KPA said, "Even if there are three or four alternative generics available in the pharmacy, the patients will have to experience the inconvenience of searching for drugs, and the cost of illegal rebate due to excessive competition is being passed on to the public." In addition, there is a high social cost for the retrieval of excess medicines and the retrieval of hazardous drugs, and the proportion of pharmaceutical expenses in health insurance finances is increasing day by day. In the current situation, due to the drug price system that guarantees the high price for most of the licensed drugs, there is no limit to the extent to which the number of generic items will increase. The MFDS and the Regulatory Reform Committee are playing into each other's hands. The KPA asked that the Regulatory Reform Committee should play a role in recognizing the problems more seriously and painfully in the pharmaceutical industry as well as in the fields, and it should play a role of deliberating and coordinating policies in the direction of restoring to the pharmaceutical industry and health care in addition to reviewing regulations. The necessity of improving drug management efficiency by improving the difficulty of generic drugs due to the NDMA impurities has been strongly raised, but the situation is further exacerbated by governments that have to implement policies that must prevent the indiscriminate approval of generic drugs. This is due to the MFDS' irresponsible policy promotion and recommendation by the Regulatory Reform Committee. The KPA said that it should reorganize the abnormal generic license system, which can even drop generic drugs that are in good quality and safety management at a low price. The KPA aurged the immediate enforcement of a policy that prohibits the use of different brand names of generic drugs and only permits the same ingredient names (generic names).
- Company
- 902 trials around the world seeking for COVID-19 treatment
- by Kim, Jin-Gu May 06, 2020 06:32am
- 100 days have passed since the first confirmed case of COVID-19 was reported in Korea. While Korea seems to have flattened the curve, other countries like the U.S. and European countries are still enforcing strict emergency orders. Meanwhile, the global community is unprecedentedly speeding up the treatment and vaccine development. As of Apr. 27, total 902 cases of COVID-19 related clinical trials are reportedly in process. Compared to 66 cases reported in early March, the number has multiplied by 13.6 times. The world’s largest clinical trial registry by the U.S. National Institutes of Health (NIH), ClinicalTrials.gov has been keeping up with the number. Among those trials, 404 cases are testing pharmaceuticals. 190 drugs or candidate medicine are undergoing clinical trial to be labeled as a COVID-19 treatment. Most of the ongoing studies around the world are for drug repurposing. Instead of testing new candidate medicine, the studies aim to reevaluate existing drugs as a COVID-19 treatment. COVID-19 related clinical trials conducted around the world as of Apr. 27 (Source: ClinicalTrials.gov) Currently, hydroxychloroquine has been the most popular medicine to be tested. Total 114 cases are confirming hydroxychloroquine’s efficacy and safety profile (including redundant cases). And axithromycin is the second most popular medicine with 28 cases. Industry sources see that the U.S. President Donald Trump’s comments have heavily affected the number of studies in hydroxychloroquine and axithromycin. At the White House press conference, President Trump has expressed his optimism for those two drugs to be the game changer amid pandemic. Unlike his words, however, the outcome seems to have been rather disappointing. An interim report of a U.S. study found the treatment did not demonstrate significant effect, but almost doubled the mortality rate. Following those two drugs, AbbVie’s HIV treatment Kaletra (lopinavir plus ritonavir) is running 21 clinical trials. But Kaletra also had a number of studies reporting no significant effect on COVID-19 treatment. The sources say the drug would unlikely to be labeled as a COVID-19 treatment, unless it reports otherwise in other studies. Tocilizumab (Brand name: Actemra) used for treating multiple myeloma has ranked itself on the fourth spot with 20 ongoing trials. The interleukin-6 inhibitor is expected to prevent the cytokine storm. As a majority of the COVID-19 patients experience cytokine storm, a form of systemic inflammatory response syndrome, pharmaceutical experts have high hopes for the treatment. Interestingly, a number of hypertension treatments were included in the COVID-19 treatment related studies. 12 studies are testing losartan and other angiotensin II receptor blockers (ARBs), eight studies are testing angiotensin-converting enzyme (ACE) inhibitors, and calcium-channel blockers (CCB) and diuretic each have one study in progress. In total, there are 22 antihypertensives in testing. Among ARBs, losartan (6), telmisartan (2), candesartan (1) and valsartan (1) have the most number of ongoing tests, in the order. Two other studies have undisclosed substances in trial. Other drugs like myelofibrosis treatment ruxolitinib (Brand name: Kakavi) and a corticosteroid methylprednisolone have 11 and 10 clinical trials in progress, respectively. Remdesivir, a highly anticipated potential COVID-19 treatment, has total of nine trials in progress at the moment, which the three of them are conducted in Korea. The results of remdesivir clinical trials would be unveiled next month at earliest. Also, Japanese-made favipiravir (Brand name: Avigan), a rheumatoid arthritis treatment sarilumab co-developed by Sanofi and Regeneron, and an antiprotozoal medicine nitaxosanide respectively have eight trials in process. While a gout treatment colchicine and a rheumatoid arthritis treatment anakinra have seven and six ongoing trials, a Soviet-developed flu drug Arbidol and a corticosteroid medication dexamethasone each have five ongoing clinical trials.
- Policy
- Calculation criteria for COVID-19 are being considered
- by Kim, Jung-Ju May 06, 2020 06:32am
- The government said it was in the process of evaluating the calculation standards for medical institutions that participated in Corona 19 response. It means that various types of compensation appear due to treatment segmentation and environment different from that of MERS in the past. Yoon Tae-ho, a senior health ministry official of the Central Disaster Management Headquarters, answered this through a question and answer at the regular briefing at the COVID-19 Central Disaster and Safety Countermeasure Headquarters today (28th). The government had previously set up a committee for deliberation on compensation for loss and paid some of the losses from the hospitals participating in COVID-19 outbreak in the form of advance payment by rough estimate on the 9th. However, there are opinions that compensation is insufficient due to the fact that the official standards such as targets and items for compensation for loss have not been finalized. Regarding this, Yoon Tae-ho, a senior health ministry official of the Disaster Management Headquarters explained that it has the basic principle that appropriate compensation should be given to hospitals that actively participate in treatment and participate in government policies in relation to COVID-19. According to him, the 3rd Professional committee for deliberation on compensation for loss is held today. It is expected that some details will be made regarding loss compensation. Yoon Tae-ho, a senior health ministry official said that the advance payment by rough estimate on the 9th was only partially paid in consideration of the urgency, and further compensation measures will be made in the future. Also he added that new types of compensation are emerging, such as community treatment centers, screening clinics, and hospitalizations for severely ill patients, and appropriate calculation standards are prepared for each institution type and are being considered.
- What's the reason for the rapid increase for Dantrolene?
- by Lee, in-bok Apr 29, 2020 06:20am
- Dantrolene, a muscle relaxant that was supplied in a very small quantity to be designated as an orphan drug, has recently attracted attention in the background as demand has increased in Korea. In the past, it was required to hold only in emergency medical centers in each region, but demand was low. However, there are increasing cases of using this as part of safety marketing for the recent increase in anesthesia. #According to the KSA (Korean Society of Anesthesiologists) on the 28th, demand for an orphan drug, Dantrolene has been increasing recently. Dantrolene is a drug that is mainly used as a muscle relaxant as a muscle vesicle inhibitor. There are two types, oral and injectable. Among these, oral drugs are used for stiffness symptoms of chronic diseases with high severity, such as cerebral palsy, according to the original purpose, but injections are used for malignant hyperthermia, one of the fatal anesthesia side effects. Malignant hyperthermia is a disease in which the body temperature rises rapidly every 5 minutes, and muscle spasticity, respiratory acidosis, and hyperkalemia appear, and the fatality rate reaches 70%. However, in reality, demand was extremely rare because malignant hyperthermia itself was a very rare anesthesia side effect with 4 to 5 cases per 10,000 patients. For this reason, Dantrolene is designated as an orphan drug and can only be supplied through the KOEDC. In particular, it is true that there was only a small amount of inventory in that the expiration date was only one or two years. An official from the KSA said, "It is true that the distribution of Dantrolene injections is complicated and the expiration date is short, so it is true that there was almost no inventory other than the regional center." In fact, as of April, the inventory of Dantrolene injections reported to the KOEDC is only 21 ampules in 8 regional centers nationwide, including Seoul National University Hospital and Kyungpook National University Hospital. There was virtually no more demand for the fact that when the stock was used, it was operated in a form that only the inventory was adjusted through the KOEDC. However, it has been recently reported that the demand for Dantrolene has doubled compared to the previous year. Then, why is there a sudden increase in demand for rare drugs that are consumed only a small number each year? Experts are analyzing this as the demand for primary and secondary medical institutions that have large-scale non-reimbursed procedures such as skin and beauty has increased. In recent years, an anesthesia accident occurs during a surgery or procedure in a medical institution, and negative public opinion is being formed, and thus, there is a case of having Dantrolene as part of marketing. #An official at the KSA said that he knew that some clinics were equipped with Dantrolens to conduct marketing, and that the local clinics may have more than the regional centers. In fact, hospital-grade plastic surgery, dentistry, and dermatology in Gangnam, Seoul are widely promoting the provision of Dantrolene and stressing the safety of anesthesia. It is used as a publicity that a kind of safety device has been created for patients concerned with anesthesia. An official from the KSA said that there are often no problems with anesthesiologists in hospital-level medical institutions. However, some organizations are looking carefully at the fact that some institutions do not have anesthesiologists. He said that most of them are for publicity purposes, and the probability of actually using them is extremely rare, and it would be dangerous to make a fatal heart and liver side effect if they were injected incorrectly.
- Opinion
- [Reporter’s View] What COVID-19 revealed in drug industry
- by Kim, Jin-Gu Apr 29, 2020 06:20am
- The humanity will ultimately overcome the COVID-19 pandemic. But the problem is what follows next. Scholars around the world talk about the Post-COVID-19. Each of them theorizes their own seemingly realistic ideas of “New Normal.” Among all of their hypotheses, ‘giving science back to the public’ speaks to the heart. At an online forum convened on Apr. 28 regarding the Post-COVID-19 and the new normal, Professor Park Sangook of Earth and Environmental Sciences Department at Seoul National University stated, “The science and technology should find their way back to the public in the future.” In fact, it was on the 100th day since the first reported case of COVID-19 in Korea. His diagnosis was unyieldingly honest. He said the science and technology in pharmaceutical and bio sector have advanced remarkably, but they are skewed to specific areas. It is as it is. Quoting his words, regardless of developed countries, global pharmaceutical giants or Korean pharmaceutical and bio industry, no one can deny the fact their R&D was fixated on “profitable sector.” Every one of them was into developing chronic disease treatment and “happy drugs.” The result is what we see today. According to Professor Park Sangook, the humanity is “in a dire situation, where we helplessly face a simple virus generated from the nature.” In their defense, the companies could claim their concentration on profitable business is obviously justifiable with their corporate nature. However, considering the pharmaceutical and bio industry put down their roots in public healthcare, they need to take a look back at themselves even shunning the ‘bare minimum.’ The government’s role is essential in turning the corporations around. To let the companies open their eyes on the public healthcare, the government should pay more attention and provide further support. Motivated by the pandemic, the Korean government seems to be making various promises to provide support for the pharmaceutical companies responding against the threat of the infectious disease. The government means to properly compensate the companies developing treatment and vaccines for the virus. These should not be empty promises for temporary purposes. Not just to spike their stock prices, but the government should show pharmaceutical companies that taking up a challenge for the public interest, despite the risk in failure and loss, would be compensated appropriately. Only when the government takes the right action, science and technology would find their way back to the public.
- Policy
- Issues to remain as restricting bioequivalence test scrapped
- by Lee, Tak-Sun Apr 29, 2020 06:19am
- The issues regarding highly saturated first generic market would likely to remain as the Regulatory Reform Committee has axed the Korea Ministry of Food and Drug Safety’s (MFDS) plan to restrict joint and cosigned bioequivalence test. Even if the government grants favorable pricing on generics with individual test data from July, the industry experts expect that many of pharmaceutical companies would still choose to run joint bioequivalence tests to not miss out on their market release timing. Accordingly, pharmaceutical companies can now save much on their R&D and production costs like on pharmaceutical research and bioequivalence test. But the issues of pharmacy and primary consumer’s difficulty in product dispensing and illegal rebate provision within the heated competition would remain the same in the saturated generic market. Moreover, the issue of multiple generic receiving preferential sales approvals, initially expected to be eliminated with the joint bioequivalence test restriction, would likely to continue causing inefficiency in the market. Nothing to cripple first generic market saturation On April 24, the Regulatory Reform Committee has disclosed its meeting minutes deliberating the MFDS’ revision on the Regulation on Pharmaceuticals Approval, Notification and Review that restricts joint and cosigned bioequivalence test, and recommended to abolish the plan. Sources report MFDS is reviewing on accepting the recommendation and issuing the regulation revision notice without the restriction on bioequivalence test. The Regulatory Reform Committee has recommended the ministry to abolish its plan to limit the number of generics with joint or cosigned bioequivalence test data as one (main tester) plus three (number of cosigned testers), which the restriction was supposed to be reevaluated after five years. The restriction on the joint bioequivalence test was temporarily imposed (one-plus-one) due to the 2006 joint test manipulation incident, but it was lifted in 2010 by the Regulatory Reform Committee’s demand. Currently, an unlimited number of cosigned testers can share the bioequivalence test results and use CMOs to manufacture generic product. Since the discovery of impurity in valsartan products, MFDS pointed out the quality control as a reason for the restriction on the joint bioequivalence test, but it actually targeted prevention of further saturation in the generic market. Moreover, the Ministry of Health and Welfare (MOHW) has also started restraining the generics market by pricing the products depending on the submission of individual bioequivalence test results and the use of DMF registered substances. The differentiated drug pricing by MOHW would be enforced from coming July, starting from newly approved items. For instance, a product using pharmaceutical ingredients registered on DMF but submitted data from a cosigned bioequivalence test would be priced at 45.52 percent of the original’s price. Whereas the ones with individual test data are priced at 53.55 percent of the original’s price as stipulated by the existing drug pricing formula. But many of the pharmaceutical industry claim the differentiated pricing would inevitably change the cosigned manufactured generic policy, regardless of the joint bioequivalence test policy. As a result, the industry also projects the effect of abolishing the joint bioequivalence test policy would be insignificant. As for the effort to prevent saturation of generics market, however, the number of generic products in the first generic market would unlikely to be affected, because the joint bioequivalence test policy is scrapped. There are several reasons as to why the industry experts expect the demand on cosigned manufactured generic would not be crippled any time soon. Many of the pharmaceutical companies without individual bioequivalence test result would highly likely to resort to CMOs to not miss out on timely market release. And the CMOs without strong sales power would call for clients to generate as much profit as possible. On Apr. 17, 16 of benign prostatic hyperplasia (BPH) treating generics, tamsulosin 0.4 mg, were approved by the Korean government. All of them are manufactured by a same CMO, Dongkoo Bio&Phama. And other various items manufactured by CMOs like Kolmar Korea, Dasan Pharmaceutical and others are seeking for approvals. If the joint bioequivalence test was limited to one-plus-three, Dongkoo Bio&Pharma would only get to manufacture four items, which would then reduce the number by 12. Despite the policy that prices CMO generics 8 percent less, the industry experts see that the small and medium companies’ demand on CMO generics in the first generic market would remain the same, as they can still save on R&D cost and make profit from early release in the market. Questionable benefit of preferential sales approval on multiple items As long as the preferential sales approval grants exclusivity in the generic market for nine months, the generic market would never seize to get even more saturated. A number of pharmaceutical companies competing against each other for the patent-challenged first generic market would turn to the CMOs once they lose out in the game, and share its bioequivalence test data to join the generic market early. And generic makers with an option to opt out on investing on drug development would eventually sign the CMO deals. CMOs that have developed generics for client deals would have nothing to fear with the abolishment of the joint bioequivalence test restriction. The pharmaceutical industry has been constantly reprimanding the existing preferential sales approval system distributing the benefit to multiple companies. Some expected the restriction on the joint bioequivalence test would also eliminate the preferential sales approval issues, but now it seems it would remain the same as the plan has been shut off. Due to the government’s action, now the industry may demand for the change more than before.
- Policy
- The MOHW, support for pharmaceuticals entering overseas
- by Lee, Jeong-Hwan Apr 29, 2020 06:19am
- The government will create a ₩100 billion fund to support domestic biohealth companies that have excellent technology but are having difficulty attracting external investment. The final goal of the fund is to enhance the international competitiveness of Korean bio-health companies and to expand into the global market due to the COVID-19 crisis. The government's plan is to recruit fund managers by June and form a fund within the year. The policy is to focus on investment in the domestic pharmaceutical, bio, and medical device industries and overseas support areas for medical institutions. On the 27th, the MOHW (Minister Park Neung-hoo) said, "We will create a new fund worth ₩100 billion to support overseas expansion of K-BIO." Since 2013, the MOHW has raised and invested ₩80 billion in funds to foster the domestic bio-health industry and support overseas expansion. The MOHW said that it has created a number of successful cases by actively investing by discovering companies that have technological skills but are having difficulties in attracting investment. The MOHW added that there is no bio-health fund that has yet to be liquidated by investing for 4 years and operating for 8 years, but it has been recovering investments of ₩51 billion. The fund to be newly raised is about ₩100 billion by recruiting private investors with initial investment of ₩15 billion of investment funds and ₩25 billion of the Export and Import Bank of Korea contributions. In addition, the MOHW plans to unify the five funds that have been created and operated as K-BIO new growth funds. The new fund will be named 'K-BIO New Growth Fund No. 6'. The MOHW will announce the selection of managers to manage the fund through Korea Venture Investment and Korea Export-Import Bank from 28th to 20th next month. It will plan to select fund managers in June and close the fund formation in September at the earliest and this year at the latest. The MOHW's Eul-ki Lim, . the Health Industry Development Division Officer, said that COVID-19 is a concern for the global economic downturn, but it will be an opportunity for the domestic bio-health industry, which is attracting attention all over the world.
- Policy
- Amendment to cascading drug price revision proceeds as it is
- by Kim, Jung-Ju Apr 29, 2020 06:19am
- If the co-biological equivalence test 1 + 3 system is discarded by the Regulatory Reform Committee among the 'Regulation on Pharmaceuticals Approval, Notification and Review', what will happen to the 'cascading drug price revision' of ‘a partial revision of the Criteria for Decision or Adjustment on Drugs’? The MOHW plans to carry out the so-called 'the cascading drug price system' to be implemented in July. According to the government, the Regulatory Reform Committee previously recommended to withdraw the 1+3 system, that is, the MFDS' amendment, which restricts the number of items that are exempt from bioequivalence test submissions when drug approval is granted. The reason for this is that it is difficult to achieve the goal of improving the generic quality even if the exemption of co-biological equivalence test is limited based on this system. However, it was because the effectiveness of the regulation introduction was difficult, and there were large negative opinions within the regulatory framework, such as the problem of restrictions on market entry, lack of direct effect on quality and safety, and lack of effect on promoting R & D. The issue is insurance price. When the generic price revision was originally announced, the government said that it would grant the drug price by calculating the 'drug approval and price linkage system' based on the content of differentiating the generic insurance price depending on whether or not it has its own bioequivalence test. However, the MOHW plans to carry out the cascading drug price system, in July, in a scheduled order without change. According to the government, the core of the standard of drug price addition is ▲ self-biological equivalence test and ▲the use of DMF registration, the method of granting the drug price (53.55% of the original) by preferentially treating its own biological equivalence product is separate from the withdrawal of this 1+3 system. In addition, the reorganization of drug prices is a major source of stabilization for health insurance finance, and self-biological equivalence testing and the preferential treatment of DMF registration in cascading reorganization is different from the effectiveness of the system that the Regulatory Reform Committee made as a justification. However, even if the government pursues drug price revision, there is a concern that the reorganization of the 'drug approval and price linkage system' will be changed to a regulation pattern in a direction different from the original goal, even if the drug price lawsuits surrounding generics are still being pursued. This means that it could spread to another lawsuit issue between the government and the industry. For this reason, the company's position is expected to be divided according to the revision of the MFDS’ amendment (deletion of the new provision of the 1 + 3 system for co-biological equivalence test) and the realization of the MOHW's generic cascading drug price revision.
