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- 2025-12-22 01:36:44
- Policy
- Verquvo will be listed for reimb at KRW 2,867 in KOR
- by Kim, Jung-Ju Aug 24, 2023 05:46am
- The 3 doses of Bayer Korea’s chronic heart failure treatment Verquvo Tab will be newly listed at KRW 2,867. The price of Abbott Korea’s Depakote Sprinkle Cap (divalproex sodium) will be raised by nearly 22% upon the company’s request and negotiations. According to industry sources on the 22nd, the Ministry of Health and Welfare is working on the ‘Amendment to the drug reimbursement list and reimbursement ceiling price table’ that contains the abovementioned changes that will become effective as of the 1st of the next month. First, 5 new that contain 3 ingredients are waiting to be listed after successful negotiations with the NHIS. The 2.5mg, 5mg, and 10mg formulations of Bayer Korea's Verquvo tablets will be listed at KRW 2,867. Two new melphalan hydrochloride drugs, a treatment for multiple myeloma, will also be newly listed. The price of Ace Pharma’s Megval Inj. 50mg and Korea HO Pharm’s Melpspal Inj. 50mg were set at KRW 110,000 per vial. A total of three drugs have succeeded in negotiations and will receive raise in drug prices. Among the drugs notified on the reimbursement list, these are drugs that successfully negotiated with the NHIS after requesting a price increase (application for adjustment) and passing deliberations by the Drug Reimbursement Evaluation Committee, and succeeded in negotiations with the NHIS. In order for the price adjustment application to be accepted, all of the following conditions must be met: the drug must be▲ essential for patient care ▲ no alternative drug exists ▲ the cost of administration is lower than its alternatives, and is supplied by a single company. In terms of the price increase by drug, Abbott Korea's Depakote Sprinkle Cap (divalproex sodium) will be supplied at a price of a 21.5% increase. In addition, Korea Orphan & Essential Drug Center’s Xenazine Tab (tetrabenazine) will be priced at a 19.6% increase, and DID Bio’s Leclean Solution (sodium phosphate enema) will be set at a 28.7% increase in price and supplied.
- Policy
- Generics for Januvia are deleted from the reimbursement list
- by Lee, Tak-Sun Aug 24, 2023 05:46am
- 6 While 239 drugs containing Sitagliptin, the active ingredient of DPP-4 diabetes treatment Januvia, will be registered for benefit on the 2nd of next month, six existing supplementary items will be deleted from the benefits list. It is interpreted that five items were excluded from the medical care benefit due to the newly created negotiation process. According to the industry on the 23rd, six supplementary items among sitagliptin generics will be deleted from the benefit list on the 1st of next month. These items were listed before June 2020, when the provisional registration system disappeared. The provisional listing system is a system in which generics approved by the Ministry of Food and Drug Safety are listed on the reimbursement list in advance during the original patent period. Through this, 9 items of sitagliptin phosphate hydrate were tentatively listed, but 6 items were deleted this time. In the case of Kwangdong Sitagliptin Phosphate Hydrate Tab 100mg, the pharmaceutical company expressed that it had no intention to sell it, and the list of benefits was deleted according to the last deliberation. Starvia 100mg, Janulinin S 100mg, Sitaliptin 25mg, 50mg & 100mg were not agreed upon as a result of the negotiations, so they are excluded from the medical care benefit after deliberation by the Health Insurance Policy Deliberation Committee. For these items, it seems that no agreement was reached in the negotiations related to the stable supply and quality control of drugs. Negotiations on this content were introduced in October 2020 for drugs subject to calculation, such as generics. It is interpreted that the provisional items had to be negotiated for stable supply on the premise of the actual launch, but this was not met. Instead, Kwang Dong, Daewon, and Vivozon are scheduled to be listed on the 2nd of next month as other items of sitagliptin. Among the tentatively listed items, only three items from Shinpoong Pharmaceutical Sitaglu will be listed on the 2nd of next month.
- Policy
- Conflict rise over the need of the PE exemption system
- by Lee, Jeong-Hwan Aug 24, 2023 05:45am
- Experts are showing a sharp conflict of opinion over the effectiveness and need for the existence of Korea's system that exempts new drugs from receiving pharmacoeconomic evaluations. The PE exemption system, which was introduced in 2015, was implemented to improve access to new drugs for patients with severe and rare diseases. However, conflict has been rising on whether to abolish/reduce or continue the operation of the system after making improvements. Those who are in favor of the PE exemption system argue that the system should be more actively implemented but the process strengthened to increase patient access to treatments, while opponents argue that the system makes overseas drug prices be reflected as they are, wasting health insurance finances and only benefitting the pharmaceutical companies. On the 22nd, the pros and cons of the PE system were discussed by medical and pharmaceutical experts at a forum hosted by NA Rep. Hye-Young Choi of the Democratic Party of Korea to improve the PE exemption system that allows drugs to waive submission of pharmacoeconomic evaluation data during the reimbursement review process. Borami Kim, Co-chair of the Market Access Committee at KRPIA (Korea Research based Pharmaceutical Industry Association), which represents the global pharmaceutical industry, said that the PE exemption system has many advantages in expanding patient access to drugs within the limited health insurance budget. In other words, Kim’s point is that abolishment of the system is out of the question as it would impede patient access to new drugs. Kim said, “It is much more beneficial to operate the current system well according to its purpose, and it is also in line with the direction of the current government policy, which stresses the proper use of limited resources and the abolition of regulations. If we dismiss the benefits of the system and discuss its abolition or bring in more post-marketing control regulations than now, the door of opportunity for patients will only get narrower and narrower.” Dr. Young Chul Moon, Professor of Hemato-Oncolgoy at Ewha Womans University Mokdong Hospital, who actively treats patients in the field, also supported the improvement and maintenance of the PE exemption system. In particular, Moon’s diagnosis was that Korea’s new drug reimbursement speed was too slow despite the existence of the PE exemption track. His concern was that the speed of new drug reimbursement could be further delayed with the removal of the PE exemption system. Therefore, Moon proposed an improvement plan that raises the standards for submitting the PE exemption plan while further activating the system for its better management. Moon said, “New drugs that are in need of rapid reimbursement are not being introduced fast enough, even with the PE exemption system in place. It took over 6 months for Kymriah’s reimbursement, and patients and doctors are all concerned that reimbursement will further be delayed with the removal of the PE exemption system.” "Also, tighter pharmacoeconomic evaluations are made for drugs like anticancer drugs that are reimbursed through the PE exemption track. The Cancer Disease Deliberation Committee requests the companies to submit PE data to determine the price and request price cuts. Many drugs give up reimbursement even after applying for PE exemptions.” “We should encourage faster introduction of innovative drugs that improve patients’ lives, even if we bear the cost to some extent, and instead, we should establish a system to conduct reevaluations every 2-3 years. There is also a need for a policy to secure health insurance finances and stabilize drug prices by lowering the price of generics and biosimilars while encouraging their use.” Dong-Geun Lee, Director of the Korean Pharmacists’ Association for Healthy Society, objected to the system, claiming that it had changed into a system that maximized the benefits of pharmaceutical companies. Just as concerns were raised when the system was introduced in 2015, the price of new drugs has been set at a higher price due to the PE exemption system, and the system is becoming a chronic go-to regulation for companies rather than an exception. Lee said, "When the system was introduced during the Park Geun-Hye administration, civic groups opposed it because the system will accept the drug prices of advanced countries as is. We were concerned that it would have the effect of increasing the price of new drugs that should have been reimbursed through the positive listing system. We need to find out how much of these concerns have been resolved today.” “The purpose of the PE exemption system is to enhance patient access but it is used as a beneficial system for pharmaceutical companies that exempts the submission of safety and efficacy review data that pharmaceutical companies are required to submit. It was an exception at the time of introduction, but as it improved, the number of such exemptions continued to increase, and 17 drugs that have comparator drugs took the PE exemption track." Eun-Young Bae, Professor of Pharmacy at Gyeongsang National University also claimed the need to minimize the use of the system. Bae said the government should reduce the use of the PE exemption track to only when necessary to resolve its side effects such as how it adversely affects the reimbursement of of latecomer drugs.” In particular, Professor Bae dismissed concerns that access to new drugs for patients will decrease if the PE exemption system is abolished, saying, "We need to regard the two separately.” Professor Bae said “I do not mean that the PE exemption drugs should be non-reimbursed. "However, there is no decision-making measure available to use when clinical evidence is accumulated for PE exemption drugs that were approved through a simplified pathway. In order to make the best decision, we have to decide based on sufficient grounds, but the problem is that the PE exemption system does not allow this to happen.” “I don't think abolishing the PE exemption system will act as the main obstacle that hinders prompt reimbursement of new drugs. There are other ways to speed up patients' access to new drugs by conducting rolling evaluations even before the data is complete." Chang-Hyun Oh, Director of Pharmaceutical Benefits at MOHW, said that he agrees that there is a need to evaluate the pros and cons of the PE exemption system, and will collect various opinions and make efforts to make the best decision. Oh said, “The PE exemption system was established through social consensus, and the side effects of the system are just being discussed now, 6-7 years after its implementation. We conducted a preceding study last year, and we would need to simulate various scenarios after a system improvement plan is proposed based on the study, such as by adding a risk-sharing condition to the Pe exemption system, etc.”
- Policy
- 157 single and 82 combo Januvia generics reimbursed in KOR
- by Lee, Tak-Sun Aug 23, 2023 05:46am
- TA total of 239 new drugs that contain ‘sitagliptin,’ the active ingredient of the DPP-4 inhibitor class drug Januvia (MSD), will pour out onto the market on the 2nd of next month. In terms of the number of companies, 59 companies will be releasing their single-agent generics and 63 will be releasing their fixed-combination generics. According to industry sources on the 22nd, a total of 239 items (157 single-agent drugs, 82 fixed-combination drugs) will be listed for reimbursement on September 2, the day after the expiration of sitagliptin’s substance patent. In the case of the single-agent drug, 157 items from 59 companies will be reimbursed. The highest insurance price for sitagliptin 25mg was set at KRW 261, and 37 items received the price. only 3 items have a price below KRW 261. The highest insurance price set for the 50mg formulation was KRW 393 and was applied to 55 items, with 4 items having a lower price. The highest insurance price set for 100mg was KRW 592, and 57 items received the price, with 4 items having a lower price In the case of the fixed-dose combinations, 82 items from 63 companies will be listed. Among them, there are 9 triple fixed-dose combination drugs. Hanmi Pharm, Daewon Pharmaceutical, and Chong Kun Dang will release a three-drug fixed-dose combination that contains sitagliptin. The remaining 73 items are two-drug combinations, most of which are sitagliptin (DPP4i) + dapagliflozin (SGLT2i) combinations. Only Chong Kun Dang and Hanmi Pharm’s generic Janumet (metformin HCI + sitagliptin phosphate hydrate) are listed this time. The other Janumet latecomers have a different salt and hydrate formation. Therefore, single-agent drugs that contain the same ingredient will be listed this time, and other combination drugs are expected to be listed in October.
- Policy
- 'No other country has a PE exemption system'
- by Lee, Jeong-Hwan Aug 23, 2023 05:46am
- Professor Eun-Young Bae “Korea is the only country that has introduced the use of the pharmacoeconomic evaluation exemption system. As an academic, I do not understand the logic of the PE exemption system. It is also difficult to explain to other countries. If a particular drug has received reimbursement at a non-cost effective price due to the system, it will continue to affect latecomers in the indication." An expert has pointed out that the use of the PE exemption system in place for the reimbursement of drugs approved in Korea should be reduced to a minimum. The analysis is that if a drug has demonstrated a significant level of clinical benefit or is an ultra-rare disease, the specificity of the drug, such as its impact on health insurance finances, should be closely reviewed to determine whether to apply for PE exemptions. Also, suggestions that the current standard, which allows drugs that should not be subject to PE exemptions to receive exemptions, should be reformed and a separate reimbursement standard should be set for National Essential Medicines were raised. Eun-Young Bae, Professor of Pharmacy at Gyeongsang National University expressed her opinion at a forum that was held on the 23rd to seek ways to improve the PE data waiver system (PE exemption system) of pharmaceutical economic evaluation data. The PE exemption system, which was introduced in 2015, reviews the listing status and listed prices of a drug in A8 countries (that the government uses to calculate the foreign adjusted average price of drugs) during the reimbursement review process rather than its cost-effectiveness. As of July 2022, 26 drugs have been reimbursed under the PE exemption system. Professor Bae pointed out that it is necessary to review how to resolve the uncertainties that arise due to the cost-effectiveness of PE exemption drugs. Bae explained that the issue should be resolved because high uncertainties remain about the clinical grounds of drugs that were reimbursed through the PE exemption system, and affects the evaluation of its latecomers. Bae stressed, “An initial evaluation should be made on PE exemption drugs. The effectiveness of the reevaluations that are conducted after the application of the PE exemption system is low because of the lack of initial evaluation. If a drug has been reimbursed through the system at a high price and is not cost-effective, this will continue to affect latecomers.” She added, "We also need to look at whether to keep the initial registration conditions during the 5 years until reevaluations said. "We need to check how to evaluate the latecomers of PE exemption drugs and what the appropriate price level should be for the PE exemption drugs." "The justification for the use of the system is weak. If the government seeks to maintain the system nevertheless, its use should be minimized to the extent necessary. The PE exemption drugs should submit pharmacoeconomic evaluation plans in advance and receive deliberations that can be used as the basis for price reevaluation or readjustments in the future.” The forum was cohosted by NA Rep. Hye-Young Choi of the Democratic Party of Korea and the Korea Alliance of Patients Organization
- Policy
- Envlomet SR is priced at 611 won, the same price as Envlo
- by Lee, Tak-Sun Aug 23, 2023 05:46am
- Daewoong Pharmaceutical's self-developed SGLT2i ingredient, Enavogliflozin, combined with Metformin hydrochloride will be released in September. In particular, even though metformin hydrochloride is added, the price is the same as the existing single drug Envlo. This is related to the drug price calculation structure for combination drugs. According to the industry on the 22nd, Daewoong Pharmaceutical's Envlomet SR 0.3/1000mg will be listed as a benefit at 611 won per party from the 1st of next month. This drug is a combination drug that combines metformin, an ingredient for treating diabetes, with Envlo, a new domestic SGLT2i drug released last May. Envlo It contains Enavogliflozin 0.3mg and Metformin HCl 1000mg and is administered as an adjunct to diet and exercise therapy to improve blood sugar control in type 2 diabetic patients for whom combined administration of Enavogliflozin and Metformin is appropriate. The price is the same as the single drug Envlo. The combination drug is calculated as the sum of 68% of the single drug, and even if you add 418 won, which is 68% of the single drug Envlo, and 119 won for metformin 1000mg, it costs 537 won, which is cheaper than the single drug. As this reversal phenomenon appeared, the same calculation was made with the single drug price. As a result, even if Envlo is administered at 611 won per tablet and then switched to Envlomet for blood sugar control, the patient does not have an additional financial burden. Compared to the same series SGLT-2 series Forxiga and Xigduo XR, Envlo or Envlomet are at a high level. This is because the patent for Dapagliflozin of Forxiga expired in April, and generics have appeared. Looking at the adjusted price, Forxiga 10mg is 734 won to 514 won, Xigduo XR 10/1000mg is 736 won, 512 won, and Xigduo XR 10/500mg is 736 won to 473 won. Forxiga and Xigduo's direct adjustment price is cheaper than Envlo or Envlomet. In the future, Daewoong Pharmaceutical plans to continue expanding its lineup of complex drugs, starting with Envlomet, as demand for complex drugs continues to increase in the domestic diabetes treatment market.
- Policy
- Will Pfizer rise to the top with once-weekly growth hormone?
- by Lee, Tak-Sun Aug 22, 2023 05:31am
- A new growth hormone with improved convenience in administration will be introduced to Korea’s annual KRW 240 billion growth hormone market with reimbursement in September this year. The drug is Pfizer's Ngenla Prefilled Pen Inj. Whether Pfizer will use the reimbursement of its new drug as momentum and be able to rise to the top in this market that is being led by domestic companies such as LC Chem and Dong-A ST, is gaining attention. According to industry sources on the 21st, the Ministry of Health and Welfare announced that it will be newly listing Ngenla Prefilled Pen Inj 24mg and Ngenla Prefilled Pen Inj 60mg with reimbursement from September 1st through the administrative notice of the drug reimbursement standard. Ngenla is a treatment for growth hormone deficiency in children. It offers a longer half-life through molecular modification of the company’s existing growth hormone, Genotropin, which was developed as a once-daily subcutaneous injection formulation. As a result, Ngenla improved the patients’ convenience in administration by requiring only once-weekly injections. Pfizer recorded sales of KRW 30.7 billion (based on IQVIA) last year with Genotropin. Although the company did make a mark in the market, it was considerably less than what LG Chem or Dong-A ST had raised with their respective growth hormone products. Last year, LG Chem’s Eutropin made KRW 84.8 billion, and Dong-A ST’s Growtropin KRW 47.3 billion. Merck’s Saizen also posted sales of KRW 33 billion last year and exceeded Genotropin’s performance. Eutropin is administered 3-6 times a week, Growtropin 5-7 times and week, and Saizen once-daily as injectables. Therefore, Ngenla Prefilled Pen is definitely ahead of existing products in terms of ease of administration. In terms of efficacy, its non-inferiority to Genotropin was observed in annual HV (height velocity) at 12 months, demonstrating the drug’s similar efficacy to Genotropin. The domestic growth hormone market has grown rapidly, nearly doubling in the past four years. This is because the reimbursement standards for the drugs have been partially lowered while the non-reimbursed drug market for growth hormones increased significantly. The analysis is that more children and adolescents are receiving growth hormone injections during vacation. Although Ngenla has better quality by improving administration convenience, industry analysis is that the company would need to have ample sales power comparable to that of domestic companies and must raise sales in the non-reimbursed drug market. In particular, multinational companies will have to ensure stable supply and withstand the supply flood of products being supplied by the domestic companies. Patients tend to have poor adherence to growth hormone therapy. However, long-acting treatments like Ngenla lower the treatment burden and improve adherence, and therefore are likely to offer better results. This is why the industry believes, long-acting recombinant human growth hormone (rhGH) injections are expected to take over the market in the long term.
- Policy
- Januvia generics to be listed for reimb on Sept 2nd
- by Lee, Tak-Sun Aug 21, 2023 05:37am
- Competition in the diabetes treatment market is expected to heat up again next month. Following the patent expiry of the SGLT-2 inhibitor class drug Forxiga, which stirred the market in the first half of the year, the patent of Januvia, the leading DPP-4 inhibitor class drug, is set to expire next month. Accordingly, a large number of same-ingredient generics and salt-modified versions of Januvia will enter the market in line with its patent expiry date, September 2. According to the industry on the 18th, Januvia's substance patent expires on the 1st of next month, and generic companies have applied for reimbursement of their latecomers accordingly. Januvia generics have been approved since 2015. Currently, there are 766 approved single and combination drugs that contain sitagliptin as an active ingredient. Among those, 55 products obtained generic exclusivity and are approved to be sold in advance from September 2 to June 1 next year. The drugs succeeded in avoiding or invalidating all the other patents except for those that expire on the 1st of next month. Since Januvia has been approved for more than 10 years, some items also have disappeared from the reimbursement list. 9 items including Daewon’s Januritin S Tab. 100mg (ceiling price KRW 618) are currently tentatively listed. According to UBIST, the single-agent Januvia recorded KRW 40.5 billion in outpatient prescriptions last year. The fixed-dose combinations Janumet recorded KRW 68.9 billion and Janumet XR 48.2 billion. Both the single-agent and fixed-dose combinations are performing evenly in the market. Combined, the market adds up to be worth KRW 157.6 billion. Therefore, it is safe to say that most domestic pharmaceutical companies will be jumping into the competition. Therefore, there is a high possibility that the heated competition that arose in the diabetes treatment market due to the introduction of Forxiga generics may arise again for Januvia. A total of 149 items (89 single-agent drugs, 60 combination drugs) of drugs were simultaneously listed for reimbursement on April 8. Due to such heated competition, illegal marketing activities by contract sales organizations, which had raised their commission significantly, had also arisen, signifying how heated the competition had been in the market. Competition by Januvia generics will be the same or greater than that of Forxiga, so there is a high possibility that companies will conduct fierce sales and marketing activities to preoccupy the market. Meanwhile, Chong Kun Dang will protect the original Januvia family’s share against generics. Chong Kun Dang purchased the license for the Januvia brand last May for KRW 45.5 billion. With Chong Kun Dang, a strong sales force in Korea’s clinics, guarding the sales of the original Januvia family against generics, expectations are that it will not be easy for generics to penetrate the market and take over sales of the original.
- Policy
- Combination drugs with Januvia to be released in September
- by Lee, Tak-Sun Aug 21, 2023 05:37am
- With the expiry of Januvia's patent on the 1st of next month, the three-drug combination is expected to be launched in earnest in the domestic oral diabetes treatment market. In particular, since the revised reimbursement standard in April recognizes only three drugs, it is noteworthy whether the three-drug complex with improved ease of use will become mainstream. According to the industry on the 20th, the material patent for DPP4-type diabetes treatment Januvia will expire on September 1. As a result, Januvia's generics are expected to emerge. This is because the market size of the domestic Januvia series alone reaches 157.6 billion won (based on UBIST in 2022). In particular, the 3-combination system, which has not been listed on the benefits list, is scheduled to be released. The main character is the combination of metformin + SGLT2i + DPP4i and metformin + SGLT2i + TZD, for which the reimbursement standard was prepared in April. Since the reimbursement standard was established in April, several products for SGLT2i+DPP4i and SGLT2i+TZD two-drug combinations have entered the market and are competing. However, the 2nd drug had the disadvantage of having to take metformin together. The combination drugs containing metformin are evaluated to be much better in terms of ease of administration because they are covered with just one pill. In the third-party market, the products of Hanmi and Daewon, which quickly developed related products, are expected to be the first to start. Daewon Pharm received approval for four doses of drugs consisting of DPP4i + SGLT2i + MET in May and June. Hanmi Pharm also received approval for two doses of SGLT2i + DPP4i + MET in May. These generics will not have any major barriers to market release as the Januvia patent expires next month. Attention is focused on whether the market will respond right away to the three-agent complex with convenience. Chong Kun Dang is also launching a three-agent complex that contains Sitagliptin. However, it is not related to the newly established 3rd system salary standard. Chong Kun Dang received approval for Duvimet XR, a combination of Sitagliptin and metformin hydrochloride, in Duvie, a new diabetes drug developed by Chong Kun Dang, in May. In addition, Duvie S, a combination of Lobeglitazone Sulfate+Sitagliptin Phosphate Hydrate, was approved in June. Both items are expected to be released on the 2nd of next month.
- Policy
- Lower drug dose options trending in chronic diseases
- by Lee, Tak-Sun Aug 18, 2023 05:20am
- Low-dose drugs are trending in the field of chronic diseases. This is because their use in combination with other drugs can be more effective than using a single-agent drug when used to produce fixed-dose combinations or prescribed in combination with other drugs, while reducing the safety risk, compared to high-dose products. Already, three low-dose drug formulations have received reimbursement this month. According to industry sources on the 17th, Sam Chun Dang Pharm’s ARB-class hypertension drug ‘Mirtel Tab 20mg,’ which contains telmisartan 20mg was listed for reimbursement at KRW 284 as of the 1st of this month. Chong Kun Dang released the first telmisartan 20mg, Until now, the only telmisartan 20mg available in the market was Chong Kun Dang’s ‘Telmitrend Tab 20mg,’ which was released in 2021. In the field, there is an opinion that it is effective to reduce the dose of telmisartan when patients experience orthostatic hypotension after being prescribed combinations that contain telmisartan, for example, by reducing the prescribed 40mg to telmisartan 20 mg. However, an unmet need existed as only two doses -40mg and 80mg – of telmisartan were available in the market before the release of Telmitrend 20mg. This is why, the performance of the Telmitrend brand has also risen after the release of Telmitrend 20mg. Last year, according to UBIST, Telmitrend’s sales rose 34% from the previous year, recording KRW 15.2 billion. This is a 98% growth over the last 3 years. In other words, Chong Kun Dang's strategy that accurately saw the demand for low-dose telmisartan worked well. Sam Chun Dang Pharm, which received reimbursement for its new product this time, became the second to receive reimbursement for a low-dose version of its drug, following Chong Kun Dang's precedent. Yuhan Corp recently introduced a new low-dose atorvastatin (5mg) combination drug. Its ‘Atovamibe 10/5mg', which is a combination of atorvastatin 5mg and ezetimibe, was listed at an insurance price ceiling of KRW 637, at a price the same as its 10/10mg product. Atovamibe demonstrated superior LDL-C change rate at Week 8 from baseline compared with atorvastatin 5mg monotherapy and ezetimibe 10mg monotherapy in a clinical trial. In addition, the drug minimized the risk of side effects such as diabetes and myopathy, which can occur with high-dose statins. Hyperlipidemia combination drug that contains low-dose rosuvastatin Hanmi Pharm was the first to start this low-dose statin strategy. The company had widened the market with the low-dose rosuvastatin (2.5mg)+ezeimibe, ‘Rosuzet 10/2.5mg.’ Rosuzet 10/2.5mg was released in December 2021 and has been generating more than KRW 10 billion per year. Daewoong Pharmaceutical, Yuhan Corp, Mother’s Pharmaceutical, Shinpoong Pharm, Jeil Pharmaceutical, GC Biopharma, and HK Inno.N also released their same-ingredient products. On the 1st of this month, Yuhan Corp’s incrementally modified drug (IMD) developer Add Pharma listed Rowroze at KRW 750.
