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- 2025-12-23 05:26:11
- Policy
- ‘Lowest-ever’ number of drugs approved in 4 years
- by Lee, Tak-Sun Jan 05, 2022 05:59am
- The year 2021 is likely to be remembered as the year of reduced marketing authorizations for drugs. This was greatly influenced by the changes in the market and the new regulations that were introduced last year. In particular, the pricing penalty imposed on indirect bioequivalence tested drugs and the restrictions set on consigned bioequivalence tests had greatly contracted the development of consigned generic drugs, significantly decreasing the number of approved items compared to the previous year. ◆ In 2021 = a total of 2,057 items were approved, recording the lowest-ever number of approvals during the past 4 years. 2,112 items were approved in 2018, 4,893 items in 2019, and 3,350 items were approved in 2020. In the case of prescription drugs, the number of approvals is on a decline for 2 consecutive years since 2019. After reaching the peak of 4,193 in 2019, the number of approved prescription drugs decreased to 2,614 in 2020 and to 1,596 in 2021. The situation had worsened significantly due to the introduction of the penalty system that additionally discounts the price of drugs that did not directly conduct bioequivalence tests. Moreover, the so-called "1+3 restriction” system that was introduced in July regulates the number of pharmaceutical companies that can share a company’s bioequivalence test to three other pharma companies, greatly reducing the foothold of CMO generics. Therefore, the number of incrementally modified new drugs and generics that conduct their own bioequivalence tests is expected to increase greatly. OTC drugs are at greater peril. Compared to the past when OTC development increased when stricter drug pricing regulations were imposed on the industry, the number of approved items decreased to an unusual extent this year. By month, approvals peaked in February with 441 with a flood of generics of the hyperlipidemia combo ‘Atozet Tab’ being approved. Since then, the average number of approvals remained in the 100 range, dipping to 88 in September. ◆OTC = Among the 461 OTC drugs that were approved in 2021,6 were data submission drugs, 63 were herbal medicines, and 211 were drugs subject to the Standard Manufacturing Criteria for Drugs, and others including generics accounted for 181. The drugs ‘subject to the Standard Manufacturing Criteria for Drugs’ that accounted for 46% of the OTC drugs approved this year were allowed sale after simply reporting to the Ministry of Food and Drug Safety. The MFDS designates the type, standard, and limit of the ingredients, formulation, dosage·regimen, efficacy·effect, and precautions for such drugs so that they may be easily sold. It is the most preferred type of drug for pharmaceutical companies as it saves development costs. The reality is that companies cannot invest so much into R&Ds of OTCs that have a small market size and require immense marketing costs. ◆Prescription drugs = Although generic drugs account for a substantial amount of the 1,596 prescription drugs that were approved in 2021, the number of new drugs and data submission drugs are also on the rise. Among the 45 new drugs that were approved last year, 3 were advanced biological drugs that were newly approved other than reregistered drugs, and 304 were data submission drugs. These accounted for 22% of all prescription drugs approved in 2021. The trend was also evident in new drugs approvals. A record-high number of new active ingredients in 4 years was approved last year. Many new drugs and vaccines were introduced due to the DOVID-19 pandemic, and 4 homegrown new drugs were also approved last year. Starting with Yuhan Corp’s anticancer drug ‘Leclaza’ in January, Celltrion’s COVID-19 treatment ‘Regkirona’ in February, Hanmi Pharmaceutical’s neutropenia treatment ‘Rolontis’ in March, and Daewoong Pharmaceutical's ‘Fexclu’ was approved in December. Also, under the ‘Safety and Support Act for Advanced Regenerative Medicine and Advanced Biopharmaceuticals’ that was implemented in 2020, 3 new advanced biopharmaceutical drugs have entered the market. These cell therapy and gene therapy products would have been categorized as new drugs in the past. All three advanced biopharmaceuticals that were newly approved this year are Novartis’ products. The first advanced biopharmaceuticals ‘Kymriah’ was approved in March, followed by ‘Zolgensma’ in May and ‘Luxturna’ in September. Novartis’ advanced biopharmaceuticals are all ‘one-shot’ treatments that are leading the pharmaceutical revolution. However, the drugs have a long way to go before receiving health insurance benefits in Korea as these one-shot treatments for rare diseases are very expensive.
- Policy
- Combination drugs of PPI+ antacid have also been released
- by Lee, Tak-Sun Jan 05, 2022 05:57am
- In the anti- ulcer drug market, combination drugs of PPI+ antacids have been released. This time, it is a drug that combines Rabeprazole and sodium bicarbonate. The PPI+ antacids, which started with Chong Kun Dang's Eso Duo (Esomeprazole Magnesium Trihydrate+Sodium Bicarbonate), continues to develop new products. The MFDS approved Youngjin Pharmaceutical's Rabenew, Ildong Pharmaceutical's Rabietduo, Dongwha's Rabeduet, Samjin's Rabeol Duo, Whanin's Rabemore, and Dong-A ST Rabiduo on the 31st. These products are combination drugs that combine the PPI formulation Rabeprazole Sodium and the antacids Sodium Bicarbonate. Youngjin is in charge of all production. The new combination drugs are used fir ▲ gastric ulcer/duodenal ulcer, ▲ erosive or ulcerative GERD, ▲ relieving symptoms of GERD, and ▲ for long-term maintenance therapy for GERD, and can be taken once a day. The usage is similar to the existing Rabeprazole only indication. However, the use of PPI+ antacids in the prescription market is expected to change as they complement the side effects of night acid secretion and late drug effects, which are disadvantages of PPI single drugs that are weak against stomach acid. It is already the third time this year that combination of PPI+ antacid has been used. Yuhan Corporation, GC Pharma, and Kyung Dong were approved in February, and Hanmi Pharmaceutical in October. This is the first drug that combines Rabeprazole and antacids. Analysts say that the successive development of new PPI+ antacid products is due to the popularity of Chong Kun Dang's "Eso Duo," which was launched in 2018. As soon as Eso Duo was released, it grew into a blockbuster worth 10 billion won a year, recording 7.8 billion won in outpatient prescriptions based on UBIST in the first half of this year. The new product is expected to further strengthen Ildong Pharmaceutical's market competitiveness. Ildong has the number one generic called Rabiet in the single Rabeprazole market. This is because it recently decided to start selling co-promotion of Nexium, the original PPI sales top. Competition in the anti- ulcer drug market is expected to heat up next year as Daewoong Pharmaceutical is releasing new products such as Fexuclue (Fexuprazan HCl), a new P-CAB drug, on the 30th.
- Policy
- Recovery Action held by the Legislation/Judiciary Committee
- by Lee, Jeong-Hwan Jan 04, 2022 05:56am
- The recovery system of drug prices bill, which drew attention from the government and domestic and foreign pharmaceutical companies, has been held by the National Assembly's Legislation and Judiciary Committee and is in trouble to deal with it. As it was excluded from the Legislation and Judiciary Committee agenda again during the extraordinary National Assembly in December last year, even the screening committee failed to rise, and there are concerns that it will not be passed even if it is barely introduced this year. The second subcommittee of the Legislation and Judiciary Committee, which is in charge of reviewing other standing committees' resolutions, tends to be rarely reviewed once handed over, so it is often called the "black hole in the bill" and the "tomb of the bill." On the 3rd, the National Assembly's Legislation and Judiciary Committee did not review the alternative of the chairman of the National Health Insurance Act on the resolution at a plenary session held within last year's extraordinary session. Some pharmaceutical and legal circles are strongly opposed to the review and processing of bills on the redemption and refund of drug prices, which reportedly affected the unknown agenda of the Legislation and Judiciary Committee. Some say that it will not be easy to deal with even if a plenary session of the Legislation and Judiciary Committee is held at the extraordinary National Assembly to be held in the new year and a revision to the Health Insurance Act, which includes a bill to return and refund drug prices, is on the agenda. It could be held by the Legislation and Judiciary Committee if some members of the Legislation and Judiciary Committee hold the bill at the plenary session or hand it over to a second subcommittee that examines other standing committee bills.If it is handed over to the second subcommittee on bills, it is not clear whether it will be able to obtain a proper opportunity for examination until the end of its 21st term in the National Assembly. The government and the ruling party plan to continue to urge the opposition party and the judiciary committee to review the agenda ahead of the need for a bill to recover and refund drug prices. The MOHW is expected to push ahead with the introduction of a refund system as planned through the revision of the health insurance care benefit rules and related notices reported to the Health Insurance Policy Deliberation Committee late last year. An official from the ruling party of the National Assembly's Health and Welfare Committee said, "The Pharmaceutical Affairs Committee and the opposition party are boycotting the agenda, even though the Restitution and Refund Act is a bill that settles and compensates for unnecessary damage to both pharmaceutical companies and the NHIS. Because of this, bills such as regulations on office managers' illegal hospitals, illegal pharmacies lending licenses, and mandatory identification of patient health insurance are also delayed." The official said, "The ruling party plans to select the revision of the health insurance law as an intensive promotion bill and continue to urge it to be processed. I understand that the MOHW is also repeatedly appealing to the Legislation and Judiciary Committee to pass the bill."
- Policy
- President Moon "will make all efforts to return to normalcy"
- by Lee, Jeong-Hwan Jan 04, 2022 05:56am
- During his 2022 New Year’s address, President Moon Jae-in expressed his gratitude and respect to the medical professionals and personnel working to contain and prevent COVID-19 and restressed the excellence of Korea’s disease control and prevention system. The president also expressed his ambition to achieve complete recovery of the peoples’ lives by strengthening epidemic prevention and control in the new year. While delivering his New Year’s address at Cheong Wa Dae on the 3rd, President Moon Jae-In said,” Korea’s response to the virus has risen to prominence on its merit amid the global fight against COVID-19." “During the past two years of the COVID-19 pandemic, the Government and the people have come together as one to surmount crises. We have turned those crises into opportunities while demonstrating once again the potential of the crisis-resilient Republic of Korea. This achievement has been made possible by combining the efforts of the Government, the dedication of medical professionals, and our people’s strong sense of solidarity.” President Moon said, "We stand again on the starting line of a New Year. I wish everyone a happy New Year and a year to make yet another leap forward, inspired by the tiger’s vigorous energy. Even at this moment, our anti-epidemic workers and medical professionals are struggling in freezing temperatures. Once more, I extend my profound respect and gratitude to them.” President Moon emphasized that moving toward normal daily routines while strengthening epidemic prevention and control is the starting point for a full recovery and that the country's anti-epidemic measures have begun to take effect. He expected that as the number of confirmed cases will continue to decrease, the number of severely or critically ill patients will also decline soon. However still, the president expressed concerns over the rise of COVID-19 cases due to the spread of the Omicron variant. The president is determined to make all-out efforts to overcome the COVID-19 crisis that arose from the variant and achieve complete recovery in the people's lives. President Moon said, “The administering of booster shots and the inoculation of adolescents are also picking up speed, and a great number of hospital beds and medical professionals are being secured. Starting this month, pills for oral COVID-19 treatment will be dispensed. However, it is too early to let our guard down as the number of newly confirmed cases is breaking records around the world due to the Omicron variant." “We will work intensively to overcome this crisis. With a long-term perspective, the government will nourish hope for a return to normal life by riding out the difficulties along with the people in a steady manner. It is truly regrettable that our people are facing growing hardships in their livelihoods with tightened anti-epidemic measures being extended and a return to normalcy being delayed. I’d like to give special words of comfort to the microbusiness owners.” While mentioning the upcoming presidential election in March, the president expressed wishes for the election to become an election of unity that embodies the hope of the people, instead of hostility, hatred, and division. President Moon said, “With the presidential election up ahead, I hope that the election will become a celebration of democracy in which a candidate is chosen by the people through fierce competition, for the sake of people’s lives and the country’s future. Our people are the master of politics, and their participation is what advances democracy and raises the level of politics.” He added, “As an administration devoted to overcoming the crises and pioneering the future, my administration will work at full capacity for the remaining four months.”
- Policy
- Minister Kwon said he would develop vaccines and txs
- by Kim, Jung-Ju Jan 04, 2022 05:55am
- Minister of Health and Welfare said he will foster the biohealth industry by investing in building a global bio-human resource training hub, developing vaccines and treatments, creating a "K-Global" vaccine fund and revitalizing the use of domestic medical devices in 2022. Minister Kwon issued a New Year's address today (31st) and explained tasks and directions such as responding to the current COVID-19 crisis, developing and fostering the health industry, establishing a medical system, and strengthening health insurance coverage. First of all, the government's budget for next year has been confirmed to be 607.7 trillion won, of which the budget is set at 97.4767 trillion won. It accounts for the largest portion of the government's budget at 16%. Minister Kwon said, "Next year, we will do our best to overcome the COVID-19 crisis by actively investing our budget in preemptive securing of COVID-19 vaccines and treatments, securing treatment beds for severely ill patients, and supporting COVID-19 depression." Regarding the pharmaceutical bio-industry, he also explained that he plans to foster the bio-health industry by investing in building a global bio-human resource training hub, developing vaccines and treatments, creating a K-global vaccine fund, and activating the use of domestic medical devices. Minister Kwon said, "The MOHW will always think about whether even a single policy can change the lives of the people and contribute to the happiness of the people, and work while finding answers and communicating on the spot." He said, "As it is Year of the Black Tiger, I look forward to starting the year vigorously with the spirit of Black Tiger and overcoming the COVID-19 crisis."
- Policy
- Additional contracts for COVID-19 PO tx are under discussion
- by Kim, Jung-Ju Jan 04, 2022 05:55am
- The government is pushing for additional purchases of oral COVID-19 treatments separately from existing contracts.The KDCA announced its 2022 work plan today (30th) under the theme of "COVID-19 Disease Control and Prevention Response and National Health Support." Authorities plan to strengthen severe prevention by introducing oral treatments next year. It plans to expand the target institutions for domestic antibody treatment and operate a rapid supply system to reduce the transition of mild patients to severe diseases. It will also actively introduce oral treatments to supply them to home treatment patients and hospitalized patients dedicated to infectious diseases, reduce hospitalization or death of patients, and maintain a medical and quarantine system. Currently, authorities are pushing for a pre-purchase contract for 1 million and have signed a contract for 604,000 people so far. Authorities said they are discussing additional purchase contracts separately from the existing contract volume for the spread of Omicron and a soft landing of daily recovery, and will sign the contract in early January next year and disclose it to the public. ◆ By strengthening daily disease prevention and management= the KDCA operates a visiting tuberculosis screening and regular screening center, and strengthens support for tuberculosis patients in vulnerable groups through integrated health and welfare services. In addition, genital infections caused by HPV, the main cause of cervical cancer, can be prevented by vaccinating more than 90%, but it will be actively supported by expanding the free support for HPV vaccinations due to expensive vaccination costs. The target, which was limited to 12-year-old girls this year, will be expanded from next year to girls aged 13 to 17, basic livelihood recipients aged 18 to 26 from 2018 to 2026, and women in the second-highest class.The government will continue to promote the prevention and management of non-infectious diseases by expanding the scope of registration management of hypertension and diabetes and medical expenses to rare diseases. The results of the first climate health impact assessment will be announced in the first half of next year after evaluating the impact of climate change on people's health, and based on this, a disease management policy will be established to prepare for climate change. In preparation for future public health threats, the government will provide all-out support to advance the national quarantine system = commercialization of COVID-19 vaccine in Korea, and strengthen its full-cycle investment in R&D to secure various technologies such as new technology platform vaccines (mRNA). The KDCA expands core technology development, non-clinical research, and establishes a regular cooperative system for clinical research to strengthen its capability to develop new strain virus treatments such as COVID-19. International cooperation will be strengthened through cooperation in sharing information and substances on infectious diseases through participation in WHO new hubs and expansion of ASEAN infectious diseases and technological cooperation. In order to respond quickly and effectively to new infectious diseases such as COVID-19, related systems such as infectious disease systems and quarantine systems will be efficiently integrated to establish an integrated quarantine information system. It plans to systematically collect and manage information related to COVID-19 (confirmed patients, vaccinations, adverse reactions, etc.) and promote policies to respond to infectious diseases based on scientific evidence.
- Policy
- Changes in Benefit standards such as diabetes drugs
- by Kim, Jung-Ju Dec 31, 2021 05:50am
- The general principles of diabetes solvents and psychotropic drugs and some of Soliris (Eculizumab)'s detailed recognition criteria and methods for benefits change. Testosterone undecanoate, such as Andriol Testocaps Soft Cap, a male hormone drug, is classified by item, and detailed recognition criteria and methods are deleted. The MOHW announced on the 28th a partial amendment to the details (drugs) on the application standards and methods of medical care benefits. As Vildagliptin PO is newly registered next month, it will be added to the general principles of diabetes solvents, single and complex sectors. This standard will take effect and apply on the 9th of next month. Some specified doses are deleted to reflect the MFDS permits (treatment period) of Zolpidem CR 6.25 mg and Zolpidem CR 12.5 mg. Specifically, from the 1st of next month, the doses previously defined as Zolpidem 5mg and Zolpidem 10mg will be deleted. After discontinuation of Soliris administration to Atypical Hemolytic Uremic Syndrome, benefits related to recurrence are expanded. Specifically, it is the case where the improvement of symptoms is stopped according to the recommendations and decisions of the committee and the judgment of the medical staff. The part requiring medical judgment was subject to the committee's decision. Meanwhile, Testosterone undecanoate is deleted from the drug benefit list and the standard notice is also deleted, and the date of other central neuropharmaceuticals, such as Wakix Film Coated Tab 5mg, is changed from January 1 to February 1 next year.
- Policy
- Will Boryung succeed in tackling Sprycel’s patent
- by Lee, Tak-Sun Dec 30, 2021 05:51am
- Whether a generic for the second-generation chronic myeloid leukemia treatment ‘Sprycel (dasatinib, BMS)’ will be introduced following generics for the first-generation ‘Gleevec (imatinib mesylate, Novartis)' is gaining attention. If introduced, Sprycel’s generic is expected to greatly improve patient accessibility. According to the industry on the 28th, Boryung Pharmaceutical is starting to develop a generic for Sprycel. Since 2013 when the first generic Gleevec was introduced to the market, domestic pharmaceutical companies have attempted the development of a generic version of Sprycel. However, the companies were not able to progress due to patents, etc. No approvals nor bioequivalence tests were made for generic Sprycel since its PMS expiry on August 19th, 2016. Some domestic pharmaceutical companies had attempted patent challenges in 2015 but dropped their suits the same year. Sprycel’s substance patent expired last year on April 12th. Attempts at generic Sprycel started again in December last year with Boryung Pharmaceutical filing an invalidation trial and a Passive trial to confirm the scope of the patent on Sprycel’s use patent (expires on March 23rd, 2024) and crystalline form patent (expires on February 4th, 2025). Daewoong also joined in the invalidation trial on Sprycel’s use patent. Boryung Pharmaceutical then applied and received approval for a bioequivalence test protocol on 'BR2009' from the Ministry of Food and Drug Safety. The BR2009 targets chronic myeloid leukemia like Sprycel. Given this, analysts are assuming that the bioequivalence test is for the development of a generic for Sprycel. Boryung Pharmaceutical currently owns a generic version of Gleevec, ‘Glima Tab.’ The company had opened the doors for generic entry by winning the patent invalidation suit for Gleevec’s composition patent. If Boryung Pharmaceutical succeeds in releasing a generic version of the second-generation Sprycel following its success in releasing a generic for the first-generation Gleevec, the company’s status and competitivity in the relevant market is expected to further increase. However, it is difficult to predict the success as the company is in the early stages of the patent challenge. Therefore, attention is focused on whether Boryung Pharmaceutical will be able to open the tightly closed latch for generic versions in Sprycel as in Gleevec.
- Policy
- The MFDS plans to approve Daewoong's Fexuprazan
- by Lee, Tak-Sun Dec 30, 2021 05:51am
- Fexuprazan, a new drug for GERD that Daewoong Pharmaceutical has researched and developed for 14 years, is expected to obtain domestic approval soon. When Fexuprazan is released, Daewoong is expected to fill the gap in the PPI-based treatment Nexium. According to the industry on the 28th, the MFDS completed the safety and effectiveness examination of Fexuprazan and left only the final approval procedure. Fexuprazan applied for an item license to the MFDS in November 2019. Fexuprazan is P-CAB drug such as K-Cab (Tegoprazan, HK inno.N) licensed in July 2018. The advantage of P-CAB-based drugs is that they have a longer gastric acid secretion inhibition effect than conventional PPI-based drugs. Therefore, it is possible to administer regardless of meals. With the launch of K-Cab, the existing PPI-oriented GERD market structure is also changing. K-Cab is expected to achieve 100 billion won in sales this year and has risen to the No. 1 item in the market. Prior to the launch of K-Cab, the No. 1 item in the market was Nexium. Nexium is an imported drug developed by AstraZeneca and has long been sold by Daewoong Pharmaceutical in Korea. AstraZeneca recently terminated its Nexium co-promotion contract with Daewoong Pharmaceutical and chose Ildong Pharmaceutical as a new sales partner. Analysts say that Daewoo's termination of the contract for Nexium, which generates annual sales of 50 billion won, is due to the imminent approval of Fexuprazan. With K-Cab has become the next-generation leader in GERD, so it is predicted that Fexuprazan's launch will quickly resolve the gap in Nexium. If Fexuprazan is approved, it is likely to become the 34th new domestic drug. The MFDS approved two new domestic drugs this year, with No. 32 Leclaza and No. 33 Rolontis (Hanmi Pharmaceutical). If Fexuprazan is approved by the end of this year, three new domestic drugs will be released a year.
- Policy
- Paxlovid is a new weapon added to our fight against COVID-19
- by Lee, Jeong-Hwan Dec 29, 2021 05:58am
- Minister Gang-lip Kim “An oral-type treatment will be prescribed to patients with severe or critical COVID-19 that are unsuitable to be treated with an injection-type (antiviral). In other words, we have secured another option in our armory to use against COVID-19.” Ministry of Food and Drug Safety Minister Gang-lip Kim This is what Minister Gang-lip Kim of the Ministry of Food and Drug Safety said, explaining that a new viable strategy for the control and management of COVID-19 will be added with the early use authorization of the oral COVID-19 treatment ‘Paxlovid.’ Although it is too early to jump to a conclusion on whether the oral pill has a better effect than the injectable drug, Minister Kim sees that the added option for severe or critical COVID-19 patients can bring a synergetic effect with the national vaccination scheme and social measures and diversify the methods against COVID-19. Kim said the decisive difference between the oral and injectable drugs is in their convenience in storage, distribution, and intake, and that the oral option may be a more appropriate option for patients treated from home. Minister Kim explained so on CBS radio’s ‘Kim Hyun-Jung’s News Show’ on the 28th after the MFDS had granted emergency use authorization for Pfizer’s oral COVID-19 treatment Paxlovid on the 27th. Kim said although Paxlovid cannot be directly compared with the injection-type form of treatment, it is a reassuring ‘weapon’ added to the fight against COVID-19. Therefore, he said it is too soon to call it a game-changer. The oral COVID-19 pill Paxlovid is taken as three tablets at once. More specifically, a set of drugs (two pink pills, one white pill) is taken together orally every 12 hours for five days. Kim said even if Paxlovid is distributed, it would be difficult to purchase Paxlovid other general prescription drugs. The government handles all of the purchased Paxlovid and will coordinate its provision to the patients. “The government plans to first purchase all of the pills then provide them to those in need. The authorities with the Korea Disease Control and Prevention Agency (KDCA) are discussing the best way to distribute and administer the drug in the field.” In addition, Kim said that the oral pill is significantly different in terms of storage, distribution, and administration compared to the injected-type drug that is being used in severe patients. “Subjects eligible for the oral pill are virtually the same as those for injections. The biggest difference is that the injection needs to be administered by another person for an hour. The oral pill may be self-administered with prescription every 12 hours for 5 days, and therefore is appropriate for patients treated at home.” “Also, in terms of storage, the drug can be stored at room temperature. Therefore, the decisive difference between the oral and injectable drug is in its convenience in storage, distribution, and intake.” On the question of whether the injection and oral pill has the same effect, Kim said that the two options cannot be compared horizontally. Rather, the use of oral drugs should be considered as an additional option to the injection already in use, and one more option in the fight against COVID-19. Kim said, “The most difficult question to answer is whether the treatments have the same effect. The treatments had different subjects in clinical trials and we cannot tell whether the drugs have the same effect or which is superior. Paxlovid and the existing injection-type treatment both showed a significant effect on severe and critical COVID-19 patients at analysis. We will be able to provide treatments appropriate for every patient -injection for hospitalized patients and oral pills for those that cannot receive the injections - with the added option. In other words, we have secured another weapon against COVID-19.”
