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- 2025-12-24 02:11:43
- Policy
- Development of generics for DPP4+SGLT2 has begun
- by Lee, Tak-Sun Oct 27, 2021 05:49am
- The development of generics that combines "DPP-4 Inhibitors" and "SGLT-2 Inhibitors," which are not covered so far, is underway. This is because there are less than two years left until the end of the PMS, which can be approved for generics. Until now, the domestic market for DPP4+SGLT2 complex has not been formed due to benefit issues, but generic companies are also paying attention as benefit issues are recently being discussed. GC Pharma received approval from the MFDS on the 25th for the biological equivalence test plan of GC2123A. The active ingredients are known as Empagliflozin+Linagliptin. Empagliflozin+Linaglipin are the active ingredients of Esglito, which was approved by Beringer Ingelheim Korea in March 2017. Four years have passed since Esglito was granted permission, but it has not yet reimbursed. There are only two years left before the PMS period, when generic license applications are blocked. The PMS period ends in March 2023. Generic development began after March 2023. Currently, the DPP4+SGLT2 complex licensed in Korea is three items, including Esglito, AstraZeneca's Qtern (Dapagliflozin+Saxagliptin) and MSD's Stegluzan (Ertugliflozin+Sitagliptin), all of which are unreimbursed. Qtern also ends PMS in March 2023, and Stegluzan ends in August 2024. They need to solve the benefit issue before the launch of generics to expect market preoccupation. Until now, insurance authorities were conservative about the prescription benefits for diabetes, so only some item combinations were recognized. However, as discussions are underway recently, it is expected that the benefit issue will be solved soon. The MFDS is also improving and applying it so that it can be used in combination between affiliates. DongKoo Bio applied for permission for the Sitagliptin+Dapagliflozin in March. LG Chem is conducting commercial clinical trials for DPP-4 inhibitors Gemigliptin and SGLT-2 inhibitors Dapagliflozin, while Aju is conducting commercialization clinical trials for Linagliptin and Dapagliflozin. Patents for originals are also expected to expire by 2023, so generic development in Korea is expected to become more active.
- Policy
- Samsung Bio’s Moderna vaccine receives GMP certification
- by Lee, Tak-Sun Oct 27, 2021 05:49am
- The Ministry of Food and Drug Safety issued a Certificate of GMP Compliance for Samsung Biologics manufacturing facility that will be producing Moderna’s COVID-19 vaccine after signing a contract manufacturing agreement with Moderna. With the GMP certification, discussions on the domestic supply of the vaccine are also expected to gain momentum. According to industry officials on the 26th, the Gyeongin Regional Office of Food and Drug Safety issued a Certificate of GMP Compliance of a Manufacturer to Samsung Biologics’ Moderna vaccine manufacturing facility on the previous day. This was in line with what Gang-lip Kim, Minister of Food and Drug Safety, said at the National Assembly audit on the 8th, that “the GMP review will be completed within the month.” However, the GMP certification does not mean that the vaccine will immediately be supplied to the domestic market. A separate marketing authorization needs to be obtained to supply to the domestic market, but Samsung Biologics has not yet applied for the authorization. Still, the vaccine can be released in Korea through the Emergency Use Authorization scheme. Therefore, authorities including the Korea Disease Control and Prevention Agency are expected to discuss granting emergency use authorization to the said vaccine. The MFDS’ GMP certificate provides an advantage in exporting drugs and medical supplies to other countries that joined the Pharmaceutical Inspection Co-operation Scheme (PIC/S), which will speed up overseas registration of the Moderna vaccines manufactured by Samsung Biologics.
- Policy
- Dongkook started developing Dukarb's IMD
- by Lee, Tak-Sun Oct 26, 2021 05:53am
- Boryung's Dukarb (Amlodipine Besylate+Fimasartan Potassium Trihydrate), which reexamination ends in May next year, is competitively developing. While multiple pharmaceutical companies such as DongKoo Bio have already begun developing generics, DongKook has also started developing IMD. On the 22nd, the MFDS approved Dongkook's phase 1 clinical trial plan for DKF-407. The test drug names of DKF-407 are Fimasartan and S-Amlodipine, similar to Dukarb. However, Amlodipine has started to differentiate itself by using S-Amlodipine, which maximizes the efficacy of the drug through isomer separation technology. Several pharmaceutical companies have joined the development competition since the constraint was approved for a phase 1 clinical trial plan for the candidate substance DKB21001. Arlico and Navipharm were also approved for phase 1 clinical trials, all of which are known to be IMD like Dongkook. Generic development as IMD is interpreted as a strategy to avoid Dukarb's composition patent, which ends in August 2031. Pharmaceutical companies that have begun development have also raised a passive trial to confirm the scope of rights to avoid Dukarb composition patents. If composition patents are avoided, generics will be able to launch on the market after February 1, 2023, when the material patent ends. In addition, since Dukarb's re-examination will end in May next year, late-stage pharmaceutical companies are expected to hurry to develop it to review permission accordingly. The consignment production restriction law, which took effect in July, is also cited as the background of multiple pharmaceutical companies joining the development war. This is because, under the law, development and manufacturers can only produce consigned production to three companies. Analysts say that more pharmaceutical companies are likely to develop generics in the future as there are currently 30 to 40 pharmaceutical companies that have joined the Dukarb patent avoidance trial. Boryung, which owns the original Dukarb, is paying attention to diversifying the product lineup in preparation for the generics market. Dukarb is an item with a performance of 35.1 billion won last year. For this reason, competition between original and generics is expected to be fierce over market strategies.
- Policy
- Up to 500 ppl will be allowed at events from next month
- by Kim, Jung-Ju Oct 26, 2021 05:53am
- The government has set a three-phase strategy starting next month for the ‘Living with COVID-19’ era. The measure comes 1 year and 10 months since the government implemented disease control and prevention measures for COVID-19. In particular, events and gatherings of less than 100 people will be allowed starting next month, and temporary performance centers that accept more than 500 audiences will be operated at a test run in the first phase, then the limit will be lifted from the second phase, and allow large-scale events. The Central Disaster Management Headquarters and Central Disease Control Headquarters of the Ministry of Health and Welfare today (25th) held a public hearing on the ‘implementation plan for recovery to daily life from COVID-19 ' and announced the plans above. The implementation plan to return to daily life became possible with the rapidly increasing COVID-19 vaccination rate in Korea. The 2nd vaccination rate is expected to reach 70% at the end of this month, which will reduce the COVID-19 mortality rate and set the basis for returning to daily life. In addition, the prolonged COVID-19 had increased the burden on the economy and medical system, increasing the need to recover to daily life and overcome the burden. The return to daily life measures presented by the government will be implemented in 3 phases. The project will be implemented in ‘4+2 week’ intervals starting next month, then settle down to recover to daily life. The first phase of the reorganization will begin on the 1st of next month by lifting the limits on commercial facilities, followed by the second phase 6 weeks after that allows large-scale events from mid-December, then to the third phase in February next year that lifts the restrictions set on private gatherings. In particular, the number of people allowed at events and gatherings that are currently restricted to less than 50 at level 3 and a blanket ban of all events at level 4 Social Distancing measures, will be changed so that events with less than 100 people will be allowed regardless of the vaccination status from the first phase of reorganizations. At the same time, events with less than 500 people may be held if all members have completed vaccinations. Also, temporary performance centers that accept more than 500 audiences will be operated on a test run. From the second phase of reorganization, large-scale events will be allowed without limiting the number of people. From the third phase of reorganizations, the limit on the number of people for events will be completely lifted, and the events may be held while just observing the basic quarantine rules. The authorities announced that they will prepare phased measures to return to daily life based on the social consensus drawn from discussions from the “Committee to Support Recovery to Daily Life from COVID-19” and feedbacks that were continuously collected from public hearings, etc.
- Policy
- Hanmi Pharmaceutical's Esomezole Plus has been approved
- by Lee, Tak-Sun Oct 26, 2021 05:53am
- Competition is fierce with the emergence of Hanmi Pharmaceutical, which topped the PPI single-drug market. Hanmi Pharmaceutical's Esomezole Plus will launch in the highly competitive PPI+ antacids complex market. As Hanmi has a high market share with Esomezole, a single PPI drug, it is expected to cause significant changes in the current market composition if the complex is released. The MFDS approved Hanmi Pharmaceutical's Esomezole Plus 40/350mg on the 22nd. This product is a combination drug that combines "Esomeprazole magnesium trihydrate," a PPI-based gastroesophageal reflux disease treatment, and "Magnesium Hydroxide," a antacid. This is the first time that the ingredient has been combined. The side effects of secreting acid at night and the late expression of medicinal effects, which are disadvantages of PPI single drugs, are supplemented through antacids of PPI+ antacids complex drugs. In particular, the market size of Chong Kun Dang's Eso Duo (Esomeprazole Magnesium Trihydrate+Sodium Bicarbonate) has increased significantly every year since its launch in 2018. With the success of Eso Duo, new PPI+ antacids complex drugs are also appearing one after another. Yuhan, GC Pharma, and Chong Kun Dang were licensed in February for a composite that combines Esomeprazole Magnesium Trihydrate+Sodium Bicarbonate. All 24 generics for Eso Duo were also listed in September. They succeeded in challenging patents and succeeded in launching them early. The emergence of Hanmi Pharmaceutical is expected to have another impact on the market. Hanmi Pharmaceutical's PPI single-drug Esomezol topped the related market with 23.2 billion won based on UBIST in the first half of last year. As Hanmi steadily increased their customers, they beat original drugs such as Nexium. During the same period, Chong Kun Dang's Eso Duo, a PPI+ antacid reading item, recorded 7.8 billion won in offshore prescription performance. Although it is smaller than a single system, it is steadily rising. Against this backdrop, competition is expected to intensify as Hanmi Pharmaceutical enters the market. Hanmi's Esomezole Plus 40/350mg is used to treat erosive reflux esophagitis and should be taken on an empty stomach 1 hour before meals. It proved its efficacy by comparing the drug with a single drug in clinical trials in healthy adults.
- Policy
- HIRA “Will improve RSA and prior authorization system”
- by Lee, Hye-Kyung Oct 25, 2021 05:50am
- The increasing number of applications filed for reimbursement decisions on the use of ultra-high-priced new drugs, such as ‘Zolgensma’ and ‘Keytruda’ that cost 2.5 billion won and 500 million won per shot, respectively, has upped the National Assembly’s demand for the improvement of the Risk-sharing Agreement system (RSA) and prior authorization system. The Health Insurance Review and Assessment Service, which is in charge of the first step to reimbursement, has expressed its position that it will continue to work to determine a reasonable price for drugs and improve the patients’ accessibility to such drugs. At the written responses provided by HIRA after the NA Health and Welfare Committee’s audit that was conducted on the 15th, HIRA expressed its will to improve the RSA and prior authorization system. In-soon Nam the Democratic Party of Korea inquired on the RSA evaluation system and on the direction for mid-to-long-term policy improvement that the authorities will take to address the issue. HIRA explained that comparing the period 2008-2013 (before implementing the RSA system) to 2014-2020 (after implementing the RSA system), the reimbursement rate of anticancer drugs had risen from 58% to 76%, rare disease drugs from 79% to 86%, making a positive influence in improving the listing rate of pharmaceuticals in general. In other words, the authorities explained that the RSA system had helped improve new drug accessibility and reinforce NHI coverage. Also, in the process of operations, subjects for RSA were expanded in July 2019 to drugs subject to special exemption of calculation as rare and severe incurable disease treatments that exceed 2 years of life expectancy, and even to latecomer drugs in October last year. HIRA assured, “To overcome the uncertainties in the long-term effect of the increasing ultra-high-priced drugs, we will prepare a separate RSA scheme to meet the characteristic of each drug, such as a performance-based RSA system." NA member Yeong Suk Seo of the Democratic Party of Korea proposed improving the prior approval system to minimize the fiscal burden of ultra-high-priced new drugs. Seo pointed to the need to regulate prescriptions to ensure the quality of medicines that are ultra-high-priced, require high-level technology, or have high patient risk by systemizing the prior authorization program. Currently 4 products including Strensiq inj., Immune Tolerance Induction (ITI) therapy, Soliris inj. Ultomiris, inj., have received prior authorization. HIRA said, “We agree with the need to secure justification for the administration and prescription of new drugs. We will review the necessity of prior authorization when listing ultra-high-priced drugs." Also, HIRA added that the need to manage patients by unit, the efficiency of the management method, and the need for prompt prescription of such drugs should be considered for medicines that require high-level technology or have high patient risk. HIRA said, “We will discuss with the government and review the reimbursement standards for prescriptions of such medications and procedures.”
- Policy
- Domestic approval for Pfizer's Cibinqo (PO) is imminent
- by Lee, Tak-Sun Oct 22, 2021 05:45am
- It was found that the domestic approval for oral atopic dermatitis treatment developed by Pfizer is imminent. This product is a JAK inhibitor in the same family as Xeljanz, which is used as a treatment for rheumatoid arthritis. As JAK inhibitors have recently obtained permission with atopy treatment indications one after another, it remains to be seen what Dupixent's sales will be like. According to the industry on the 21st, the MFDS recently completed safety and effectiveness screening for Pfizer's Cibinqo 50mg (Abrocitinib), an oral atopic treatment. When the review is completed, The approval is expected to be granted soon. This product was first approved in the UK in August as a moderate to severe atopic dermatitis treatment for adolescents and adults aged 12 or older who are suitable for systemic therapy as a one-time use per day. In September, it was also approved by the Ministry of Health, Labor and Self-care of Japan. Cibinqo is known to regulate (IL)-4, IL-13, IL-31, IL-22 and TSLP, which are known to be involved in atopic dermatitis. In a phase 3 JADE Mono-1 study, 62.7% of patients improved by more than 75% at 12 weeks after administration of Cibinqo, compared with 11.8% of the placebo group. The percentage of patients with more than 90% improvement in symptoms was also 38.6% in the Cibinqo group and 5.3% in the placebo group. JAK inhibitors such as Cibinqo have been approved with atopic dermatitis indications in Korea, and treatment benefits are expected to return to patients. Lilly's Oluminant, which was previously used to treat rheumatoid arthritis, obtained an additional indication for treatment of secondary or severe atopic dermatitis in patients subject to systemic therapy in May. AbbVie's Rinvoq was also approved this month for use in adults suffering from severe atopic dermatitis and patients over the age of 12. Rinvoq has also been used as a treatment for rheumatoid arthritis. Analysts say that if Pfizer JAK inhibitory oral treatments are approved, they may lead the atopic dermatitis treatment market. This is because PO formulations are convenient to use. Sanofi's Dupixent, which was launched in 2018, dominates the atopic dermatitis treatment market. Dupixent is the first targeted biological therapy developed for atopic dermatitis, and is gaining high popularity as soon as it is released in Korea. Last year, it recorded annual sales of 23.6 billion won based on IQVIA.
- Policy
- "Annual unused drug returns record ₩2.7 trillion”
- by Lee, Jeong-Hwan Oct 22, 2021 05:45am
- NA member Jung-sook Suh (Pic provided by NA Press Corp) NA member and pharmacist Jung-sook Suh of the People Power Party urged the Ministry of Health and Welfare and the Ministry of Food and Drug Safety to present a specific solution to resolve the long-standing issue of ‘unused surplus inventory of drugs' in pharmacies. Currently, the burden of the unused surplus drugs is solely borne by the community pharmacists that owns or operates pharmacies, and Suh’s request is that the ministries should operate a consultative group with pharmacists’ associations, pharmaceutical industry, and the distribution industry to come up with a practical and direct solution. On the 21st, Suh criticized that “Medicines are public goods, therefore, the issue of surplus inventory of drugs should be resolved by the government with policies. However, the authorities have been passing on the responsibility to the private sector.” Surplus inventory of unused pharmaceuticals had remained a long-standing issue in the pharmacy community since the separation of prescribing and dispensing drugs. However, no clear solution has been found yet. In particular, a considerable amount of normal drugs are being disposed of without being used, which is increasing the socioeconomic cost and even causing environmental pollution. According to Suh, the total amount of surplus inventory of unused drugs that were returned to wholesalers and manufacturers amounted to ₩13 trillion during the past five years, which roughly translates to an average of ₩2.7 trillion per year. Suh pointed out that returns of opened drugs are a major nuisance in pharmacies, and 100 billion's worth of returns and losses occur every year due to such returns. Suh said that the cause and responsibility for this surplus inventory of unused pharmaceuticals are due to the government’s policy failure. As the government has been transferring the burden and responsibility of surplus inventory of drugs to the private sector, it now needs to establish a system for returning unused drugs and standardize the return process at the government’s level. Suh also pointed out that a private consultative body consisting of members of the MOHW, MFDS, Korean Pharmaceutical Association, Korea Pharmaceutical and Bio-Pharma Manufacturers Association, and Korean Pharmaceutical Distribution Association that had been established in August to seek solutions on the issues of unused inventory drugs and out-of-stock drugs should come up with a solution. Suh emphasized, “Various government agencies, KPA, the pharmaceutical industry, and distributors have recognized the issue of unused inventory drugs and established a consultative group. The group should discuss pending issues in depth including the mushrooming generics, generic substitutions, and small packaging unit supply of drugs. She added, “The responsibility should be shared by relevant associations and not be borne solely by the pharmacies. With a strong will to resolve the issues, the relevant bodies should promptly prepare a practical solution.”
- Policy
- There are expectations & concerns about ordering research
- by Lee, Jeong-Hwan Oct 22, 2021 05:44am
- While the government has ordered a study on preferential treatment for domestic new drugs developed by innovative pharmaceutical companies, domestic pharmaceutical companies with new drug technology are expressing both expectations and concerns at the same time. As the government accepts demands from the pharmaceutical industry and criticism from the National Assembly, many pharmaceutical companies think positively about the possibility of enacting a sub-law on innovative new drugs in the Special Act on the Pharmaceutical Industry within next year. International trade friction is not a problem that can be solved by the MOHW alone, but trade pressure-related ministries such as the Ministry of Commerce, Industry and Energy can also make opinions, and if there is a difference in positions between the MOHW. On the 20th, the domestic pharmaceutical industry is paying keen attention to the direction of promoting the "Study on Pharmaceutical Price Support Policy of Innovative Pharmaceutical Companies in Conformity with the International Trade Order" announced by the KHIDI to Korea Online E-Procurement System on the 19th. Pharmaceutical companies said that in order to enact a subordinate law on the preferential treatment of innovative new drugs without problems, the key is to create a "policy and fast policy" by regularizing cooperation between government ministries and government-pharmaceutical companies. First of all, members of the National Assembly's Health and Welfare Committee criticized the absence of Article 17-2 of the Special Act on the Pharmaceutical Industry in this year's parliamentary audit. Pharmaceutical companies are welcoming the Ministry of Health and Welfare's order for research services through the KHIDI. Analysts say that the government has officially promised to enact subordinate laws that have been empty for more than two years after the law was created due to the order of research services. In particular, pharmaceutical companies are positively evaluating the fact that the research service, which was originally scheduled to be ordered next year, has been drastically advanced by nearly half a year due to the announcement of the results in October this year and May next year. Pharmaceutical companies are raising expectations, saying, "More effective domestic drug price preferential measures could be created," when the study included incentives such as suspension and restriction of drug prices after listing for the first time since the development of innovative drugs. Pharmaceutical companies suggested that domestic pharmaceutical companies' willingness to develop new drugs should be specified in the subordinate laws to enjoy the effect of promoting and encouraging domestic pharmaceutical companies' willingness to develop new drugs. Pharmaceutical experts say that the first listed drug price preferential treatment helps domestic new drugs acquire good drug prices in overseas markets when entering the global market, and that the post incentive gives them an advantage over other competitive drugs in the domestic market. An official from A Pharmaceutical, which owns a new domestic drug, explained, "It is positive that the government took the pharmaceutical industry's appeal and the National Assembly's criticism heavily and ordered research sooner than expected. We can expect the government to introduce a specific domestic drug preferential policy in the second half of next year." An official from Company A said, "The fact that we will conduct drug price preferential research, including incentives to lower drug prices, is also in favor of substantially increasing the effectiveness of drug preferential treatment," adding, "However, the upper limit preferential clause should also be prepared at a level without friction." "Only when the government sets the initial registration price for new domestic drugs can it competitively receive drug prices in overseas countries when exporting," he stressed. Pharmaceutical companies expressed serious concern about the fact that even after the ordered study was successfully completed, it could not be introduced or reflected as an actual policy or could be privately cultured. Even if the MOHW and the promotion agency come up with a drug preferential measure without trade friction in the study, pharmaceutical companies are nervous about the possibility that other government ministries, including the Ministry of Commerce, Industry and Energy, will not be reflected as the final policy. If the research agency and the MOHW, which are working-level government ministries enacting subordinate laws, fail to empathize and communicate with the health industry promotion department, the research was completed, but the drug preferential policy could lead to negative results. "In the actual research service process, the Promotion Agency and the MOHW should have a common goal with close consultation," said an official at drug price management at Pharmaceutical B, which owns new domestic drugs. An official from Company B said, "It is difficult to improve the basic evaluation method that only some innovative pharmaceutical companies can preferentially treat new drugs, and it is not easy to avoid controversy." The official said, "In the end, sophisticated sub-laws are needed in the research process to prevent the MOHW from wanting to provide drug preferential treatment," adding, "Efforts should be made to create a drug preferential law that does not differ in opinion between the pharmaceutical field and the government policy."
- Policy
- Janssen, granted permission to import advanced bio medicines
- by Lee, Tak-Sun Oct 21, 2021 05:14am
- Janssen Korea has obtained the second approval for the import business of advanced bio medicines after Novartis Korea. Janssen is also expected to introduce related products in the near future because advanced bio-medicine items designated by the MFDS can only be approved if it is approved for the advanced bio-medicines import business. On the 18th, the MFDS approved Janssen Korea as an advanced bio-medicine importer. Advanced bio-medicine is a new category of medicines created when the Advanced Regenerative Medicine and Advanced Bio-medicine Safety and Support Act was enacted and enforced in August last year. Cell and gene therapy mainly belong to advanced bio medicines. Existing cell and gene therapy drugs have been approved by the Pharmaceutical Affairs Act, but a separate management system has been established in accordance with the new law. All items approved as new items after the enforcement of the law are Novartis products. Previously, Novartis was the only importer to obtain advanced bio-medicine import license. Novartis has been approved for Kymriah, the No. 1 domestic CHIMERIC anti-gen receptor-T cell (CAR-T), as well as Zolgensma and Luxturna. All of these are expensive and "one-shot" treatments that can be treated with one use. Attention is currently being paid to benefit negotiations in that it is a new concept of medicine and is being sold at high prices. Janssen is also expected to rush to introduce related products in Korea as it has acquired a high-tech biopharmaceutical import business this time. Janssen is in the process of overseas listing of products such as "Cilta-cell," a CAR-T treatment that treats multiple myeloma. The MFDS designated the drug as a rare drug in August last year. It is also developing gene therapy for rare retinal diseases. Luxturna, approved by Novartis, is also a gene therapy that treats rare retinal diseases. As Novartis preoccupies advanced bio-medicine in Korea, Janssen is also preparing for approval. With the gradual introduction of advanced biomedics overseas in Korea, serious discussions on drug prices and follow-up management seem to be needed.
