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- 2025-12-26 13:07:30
- Policy
- Nabota, Phase III clinical trial will be conducted
- by Lee, Tak-Sun Jan 21, 2020 06:25am
- Daewoong's botulinum toxin preparation 'Nabota' is speeding up the indication of treatment as well as improving the wrinkles of the glans. Nabota, which has four indications, is in the final phase of clinical trials to prove the effectiveness of improving the square jaw. The Ministry of Food and Drug Safety approved the Phase III clinical trial plan to demonstrate the efficacy of improving Nabota's bilateral hypertrophy (square jaw). The clinical trial will be conducted at Chung-Ang University Hospital, which has undergone Phase II. When Nabota acquires the indication, there will have five effectiveness. Currently, Nabota is can be used to treat ▲a temporary improvement in moderate to severe severe glabellar wrinkles associated with corrugator muscle and/or proerus muscle activity in adults aged 20 to 65 years, ▲treatment of upper limb muscle stiffness associated with stroke in adults 18 years and older, ▲temporary improvement of moderate to severe external angular wrinkles (eye wrinkles) associated with orbicularis oculi activity in adults 18 years and over 65 years ▲ treatment of benign essential eyelid spasms in adults 18 years and older. Of these, eyelid spasm indications were obtained last June, the most recent. For 230 adults, Nabota demonstrated non-inferiority by comparison with Botox. After 4 weeks of administration, 96.15% of the Nabota group and 96.12% of the Botox group showed improvement of eyelid spasms. Daewoong expects that botulinum toxin has great potential not only in the beauty market but also in the therapeutic market, and thus, the acquisition of indications will increase competitiveness on the global stage. For reference, Botox (Allergan), which Nabota used as a reference, has eight indications. It has been recognized for its effects in various areas including strabismus and eyelid spasms, spinal malformations, treatment of cirrhosis, primary hyperatrophic hypertension, muscle stiffness, temporal improvement of worry lines, headache relief in migraines, and bladder dysfunction. Meditoxin of Medytox, which is fighting a legal battle on Daewoong about technology infringement, has five indications. Meditoxin targets domestic and international markets with the effects of benign essential eyelid spasms, treatment of acute malformations, temporal improvement of glacial wrinkles, local muscle stiffness associated with stroke, and temporary improvement of eye wrinkles. Botulinum preparations are expanding into treatment areas as well as basic wrinkle improvement. Daedal Research, a global market analyst firm, predicts that the global botulinum toxin market will reach $5.9 billion (about ₩7 trillion) in 2021, and the therapeutic market will account for about $3.2 billion (about ₩3.8 trillion). In Korea, more than 90% is used for cosmetic purposes, but in the US and overseas markets, it is known that botulinum toxin is used more for therapeutic purposes. Nabota is also investigating its potential as a treatment for male hair loss, triangular hypertrophy and tearing symptoms. Nabota was introduced to the US market last year through Evolus. Evolus reported that the first year of performance in the overseas market has raised about ₩40 billion.
- Policy
- Mothers joins competition to develop Orlistat tablets
- by Lee, Tak-Sun Jan 21, 2020 06:24am
- Original Product, XenicalOrlistat, generic for Xenical, a fat absorption inhibitor used in the treatment of obesity, is being actively developed to change the product from capsules to tablets. CMG & Motherspharm are accelerating product commercialization. The Ministry of Food and Drug Safety approved the Phase III trial plan of ZEROfat tablets on Motherspharm. ZEROfat tablets were developed after the development of fat absorption inhibitors, Orlistat. Motherspharm has ZEROfat capsules with the same ingredients. Currently all 24 Orlistat formulations approved in Korea are capsules. The reason Motherspharm develops a formulation change is that tablets are more convenient to store and higher medication compliance than capsules. Capsules contain gelatin, which can cause digestive problems, making patients less compliant with the medication. In addition, tablets are known to be resistant to higher temperatures and humidity than capsules, and have the advantage of being easy to store and carry. Tablets can also be divided. Orlistat is widely prescribed in the domestic obesity drug market, so if tablets with increased medication compliance are expected, the demand will be high. The domestic Orlistat market is estimated to be about ₩25 billion. Orlistat, unlike other psychotropic obesity drugs that stimulate the central nervous system and suppress appetite, inhibits the function of lipolytic enzyme lipase to reduce the body's absorption of fat. CMG Pharm is also developing Orlistat tablets. In last September, the company received a phase III trial plan for CMG Orlistat tablets 120mg and is working on commercializing products. Both CMG and Mothers are likely to have success in commercialization as they have entered phase III clinical trials with formulation changes. Of the two companies, it is noted who will receive the product license first.
- Policy
- The MFDS releases Metformin’s NDMA test
- by Lee, Tak-Sun Jan 20, 2020 06:26am
- The MFDS has prepared a test method to properly detect NDMA (N-nitrosodimethylamine), which is a carcinogen, in the diabetes drug 'Metformin'. Unlike Ranitidine or Nizatidine, the test conditions are GC (Gas Chromatography) -MS/MS. This is the same test used by Singapore health authorities that detected NDMA in Metformin. The MFDS unveiled the test method, saying that it is also collecting drugs for sale on the market. The MFDS released its NDMA test method for Metformin using GC-MS / MS on its website on the 15th. As publicly available test methods are released, pharmaceutical companies can conduct their own tests with the test method. An official of the MFDS said, "We have prepared a test method in consideration of the test method and material properties conducted in Singapore". However, a pharmaceutical's own tests, subject to LC (Liquid Chromatography), before the test release, are expected to be re-validated. The MFDS official said that in this case, he will look at whether the LC condition test is appropriate, but it is necessary to retest as the official test method is GC. The MFDS added that it is also conducting inspections of commercial distribution items with the release of the test method. An official from the MFDS said, "We started the inspection of the distribution items on the market as we proceeded with the system investigation last month and prepared the test method, and specific test subjects and results will be disclosed later". The industry believes that NDMA has been collected and inspected for products made from the same raw materials as those for Singapore. It is observed that the source of raw materials and finished products were collected after the systematic investigation was confirmed. This is due to the fact that it takes a long time to conduct a full survey as there are 640 approved Metformin products in Korea. As the MFDS has started a full-scale investigation, the tension in the pharmaceutical industry is expected to increase. However, there are many cases where NDMA has not been detected in its own investigation, and there is no detection case outside of Singapore, so it is optimistic that there will be no problem in Korea.
- Policy
- MFDS updates drug supply suspension list from Q2 2019
- by Lee, Tak-Sun Jan 17, 2020 06:22am
- Handok and Korea AbbVie are respectively suspending the supply of antiulcer treatment Gabet tablet (ecabet sodium), and hepatitis C treatment Viekira (paritaprevir-ritonavir-ombitasvir) and Exviera (dasaabuvir sodium) in Korea. According to the pharmaceutical industry on Jan. 15, Ministry of Food and Drug Safety (MFDS) recently disclosed a list of suspended drug supply suspension from the second quarter in 2019. To prevent pseudo demand (panic-buy) on the drugs, MFDS withheld immediate disclosure of the news and posted the list on the ministry’s pharmaceutical information website after six months. Accordingly, the website has been updating last year second-quarter’s drug supply suspension list from December last year. The updated list informed Handok is ceasing the sales of Gabet 500 mg tablet after its April stock goes out as its annual sales volume has been too low. The company explained, the supply of the medicine would be unaffected, because another product with the same agent (Jeil Pharm’s Ecat 500 mg tablet) is still available in the market. Moreover, the supply of hepatitis C treatment Viekira and Exviera imported by Korea AbbVie has been suspended since August last year. The decision was made as the company’s Mavyret with improved efficacy and better administration method has been released in September 2018. GlaxoSmithKline Korea also stopped supplying Haemophilus influenza type B (HIB) vaccine Vaxemhib from August last year. Apparently, the company has decided to shut down the manufacturing of the vaccine in Korea inevitably, due to the vaccine department’s plan to improve business efficiency and to integrate and check up production line. The company noted that even if Vaxemhib supply is suspended, an alternative option, LG Chem’s HIB vaccine Euhib, is still accessible. Jeil Pharm’s UFT-E 0.5 g granule supply has been cut as well since August last year due to the partner company’s decision to suspend supply in Korea. The company informed patient’s access to treatment would not be affected significantly as other capsule products with the same substance are available. Also, the company added it would hold on to its product license until the stock is completely out in the market and cancel it after confirming the stock-out. Supply of an original antibiotics, Finibax 0.25 g injection (doripenem monohydrate) marketed by Ildong Pharmaceutical, has been stopped from August last year. The importing company elaborated importing the product to Korea has been unfortunately ceased due to increasing deficit made by the high production cost. JW Pharmaceutical stopped importing enteral nutrition solution Encover from June last year as the Japanese manufacturer has stopped supplying the product. The Korean company has recently informed the product’s supply would resume from February. A pharmaceutical company is required to report MFDS of suspension of d any rug supply 60 days prior to the time. Apparently, the ministry is considering on disclosing the drug suspension information immediately to the public.
- Policy
- Chong Kun Dang's development of IMD is accelerating
- by Lee, Tak-Sun Jan 16, 2020 06:07am
- Chong Kun Dang is targeting the market for SGLT-2 inhibitors, a well-known drug for losing weight. Currently, MSD's original drug `` Steglatro '' is being jointly sold, and it is speeding up the development of other drugs such as Forxiga and Jardiance. In particular, post-development of Jardiance is avoiding the crystalline patent of the original drug alone, Chong Kun Dang is expected. The Ministry of Food and Drug Safety approved the Phase I study plan for Chong Kun Dang’s CKD-375 on the 24th of last month. This trial is a randomized, open-label, single-dose, cross-design trial to compare the pharmacokinetics and safety/tolerability of oral administration of high doses of CKD-375 and D390 in healthy adults. In a recent published study, the clinical reference is Jardiance Duo (Empagliflozin-Metformin). Accordingly, CKD-375 can be inferred as Empagliflozin, the main ingredient of Jardiance, and D390 can be inferred as Metformin. CKD-375 received approval for the Phase I clinical trial in last February. The trial at that time was also a randomized, open, single-dose, crossover study to compare pharmacokinetics and safety/tolerability with single doses of CKD-375 and D387, respectively, in healthy adult volunteers. Chong Kun Dang is accelerating a late-release drug of Jardiance because it seems to be due to the fact that PMS is scheduled to expire on August 11 this year. If applying for a permit at the end of the PMS, it will be the first applicant. Chong Kun Dang avoided the Jardiance crystalline patent (which is due to expire on December 14 2026) in last May as a domestic pharmaceutical company, so if it meets the conditions for the first applicant, it can obtain a generic exclusivity. A Generic exclusivity is expected to have a generic monopoly for nine months after March 11 2025, when Jardiance material patents expire. Chong Kun Dang is also in the process of authorizing the commercialization of CKD-387, another SGLT-2 inhibitor for Forxiga. Forxiga is reported to have already filed a permit application by many pharmaceutical companies after the PMS expired on last November 25. SGLT-2 inhibitors, which have a mechanism of selectively inhibiting SGLT-2, which is involved in glucose resorption in the renal glomerular filtration process, have a blood sugar strengthening and weight loss effect, and the size of the market is growing rapidly. On the basis of UBIST, cumulative prescription amount in the first half of 2019 exceeded ₩10 billion, which is a blockbuster, in the first half of the year, including ₩14.7 billion for Forxiga and ₩12.8 billion for Jardiance. Currently, only the original SGLT-2 products such as Forxiga, Jardiance, Suglat, Steglatro and Invokana are sold in Korea. Accordingly, domestic pharmaceutical companies are actively conducting patent challenge and product development in order to release generic drugs early.
- Policy
- IMD-generic drug price differential regulation is revised
- by Lee, Jeong-Hwan Jan 16, 2020 06:07am
- Expectations are growing in the news that the Ministry of Health and Welfare is announcing the reform of the generic drug price regulation, which recognizes the value of IMD and maintains the premium pricing clause. In particular, the revised plan will postpone the regulation of IMD next year instead of this year, and if there are not many new drugs of the same class released, it is likely to include a plan to maintain the current drug price. There is an evaluation that the Ministry of Health and Welfare has signaled that it will implement a policy based on advanced IMD. According to the industry on the 13th, the reform of the drug price regulation of the Ministry of Welfare will not stop at simply easing the price regulation of IMD. Some experts believe that it can also be seen as a ‘game changer’ that will stop the current bitter generic competition and serve as a cash generator to lead the pharmaceutical industry ahead of new drug development. The Ministry of Health and Welfare is expected to proceed with some revised administrative notices of the Amendment and Adjustment Criteria. It contains the Ministry of Welfare's policy to adjust the price of IMD, unlike simple generics, to exempt regulations. The Welfare Ministry will release it as early as this week. In this case, the basic framework of some amendments announced by the government last year is likely to be implemented in July of this year, and the revised parts will be implemented afterwards through administrative procedures. The industry's proposed amendment is to revise the revised synthetic and biopharmaceutical adder system to guarantee the addition maintenance period of IMD. This means that they will be differentiated from generics in recognition of their efforts to develop IMD. This is due to the consensus that the government, the pharmaceutical industry, and the National Assembly's Health and Welfare Committee created a consensus on maintaining IMD’s premium pricing policy. There are two additional scenarios that the industry anticipates: delaying the implementation of IMD price regulations and premium pricing policy demonstrating progress. As a kind of methodology, the postponement of implementation is intended to give a period of preparation for IMD development capabilities for generic pharmaceutical companies. Demonstrating progression In the case of advanced IMD, if a number of IMD of the same type are not developed and released, there is a possibility that a policy will be prepared to maintain the current price advantage. If a IMD can't be released by anyone, it is determined that it is a medicine that has proven to be somewhat progressive. Source: Korea Pharmaceutical Bio Association Specifically, experts in the pharmaceutical industry classify the criteria for the IMD into ▲the improvement of patient medication convenience through the change of administration route, ▲the improvement of patient medication compliance through the change of dosage forms such as sustained-release tablets, and ▲the improvement of dosage and usage through the change of salt. For example, the famous antivirals, Tenofovir by Gillead Science replaces the existing TDF (Tenofovir disoproxyl fumarate, Viread) with TAF (Tenofovir alafenamide fumarate, Vemlidy). This proved progressive. TAF with altered TDF salt improves renal and bone cell side effects and is equally effective with a 10% dose of TDF. It is estimated that 90% of the drug used to obtain the drug is reduced, and the size of the pill is smaller, improving patient safety and medication convenience. The industry understands that the policy of the Ministry of Health and Welfare is to ease the drug price restrictions on the IMD. The pharmaceutical industry is in full agreement with this view. A pharmaceutical company official in Korea said, “IMD proves to be progressive will in some way inspire the development of pharmaceutical companies and encourage the advancement of the entire industry, in particular, the Ministry of Health and Welfare was convinced of the exception of the regulation on the price of IMD, and it seemed to signal the generic developer to turn to overseas market by turning to IMD”. A official said, “But at present, no specific proposals are disclosed, so we cannot expect too much IMD price regulation positively, and The Ministry of Health and Welfare will need to be unveiled on which price exceptions will apply”. Another B Pharmaceutical official said, “We believe that the Ministry of Health and Welfare has largely embraced the claims of the pharmaceutical industry. Both probation and preferential treatment are more than expected, and we wonder how the IMD standards will be proven and many pharmaceuticals will go ahead and improve the constitution”. The official said, “When the government's drug price regulation was first released, it was burdened with the licensing and restriction of the addition system, and the biggest meaning is that the Ministry of Health and Welfare agrees that the IMD is more valuable than generics”.
- Policy
- Atozet generic’s gold rush unaffected by new regulation
- by Lee, Tak-Sun Jan 16, 2020 06:07am
- The Korean pharmaceutical industry is keeping a close eye on a series of generics following MSD Korea’s blockbuster combination drug for hyperlipidemia, Atozet (ezetimibe/atorvastatin calcium hydrate), in development with individual bioequivalence test, as the government has enforced new regulation on joint bioequivalence test. Despite the already-saturated statin-ezetimibe combination drug market and increased cost of developing generic with individual bioequivalence test, the industry experts analyze the industry’s needs for the hyperlipidemia treatment generic is still high. According to Ministry of Food and Drug Safety (MFDS) on Jan 13, total 21 cases of bioequivalence test protocols have been cleared for Atozet generics. 18 cases were approved last year alone, and additional two cases were approved this year. Expecting Atozet’s post-marketing surveillance (PMS) period to expire on Jan. 22 next year, Korean pharmaceutical companies are in a hurry to develop follow-on drugs. The industry has expected many generics would be developed after the blockbuster Atozet generating accumulated prescription sales of 44.8 billion won (according to UBIST) as of third quarter in 2019. 21 bioequivalence test protocols have been approved so far proves the drug’s height of popularity. However, some industry insiders once predicted the popularity of Atozet generic development would subside soon as Ministry of Health and Welfare (MOHW) has announced March last year of a plan to lower pricing of generics developed with joint bioequivalence test from July at earliest. The insiders also hinted the ezetimibe-statin combination drug market being excessively saturated with 202 items approved including Atozet, would affect companies developing follow-on drugs. But it turns out those predictions have completely missed the mark. The number of joint bioequivalence tests has dropped due to the revised pricing regulation, but individual companies seem to be conducting their own tests to develop their generics. After nine companies—Medica Korea, Daewoong Bio, Samik Pharm, Ahn-gook Pharmaceutical, Union Korea Pharm, Intro Bio Pharma, Korea Prime Pharm, Hawon Pharm, Youngil Pharm and Wooridul Pharmaceutical—have been approved for joint bioequivalence test on passed Jan. 30, no other joint test protocol has been approved. The sudden fall in joint bioequivalence test approval is because Atozet generic can apply for approval listing from Jan. 22, 2021 when the original’s PMS expires. But generic based on the joint test would probably take the reduced pricing. Although Wooridul Pharmaceutical and Korea Prime Pharm initially planned to conduct a joint test, they respectively received approval for individual tests on Sept. 20 and Jan. 10 last year. Individually conducted bioequivalence test is more financially burdening for each company, compare to co-conducted test with two or more companies. Nevertheless, the companies are jumping on to take individual tests with no hesitance as they are running out of the list of potential generic development. A pharmaceutical industry personnel noted, “The number of new generics would descend with the healthcare authority regulating joint bioequivalence test, but markets with popular original would be affected far less. A ten-billion-won worth original with soon expiring exclusivity is getting even rarer these days. So it is not surprising Atozet is attracting many companies to develop follow-on drugs.” Meanwhile, some criticizes Korean pharmaceutical companies blindly developing profitable original’s generic, despite the super-saturated market.
- Policy
- Daewoong-Merck faces new contender with metformin ER
- by Lee, Tak-Sun Jan 16, 2020 06:06am
- Once almost dominated by Daewoong Pharmaceutical and Merck, the high-dose (1000 mg) metformin extended-release (ER) tablet market has a new competitor. Dalim Biotech has joined the race with newly approved ER tablet. With extensive individual drug portfolio, Dalim Biotech has well-prepared for the competition, sources say. On Jan. 9, Korea’s Ministry of Food and Drug Safety (MFDS) has granted sales approval on Dalim Biotech’s Glupa XR 1000 mg tablet. This is not the first time a high-dose metformin tablet has been approved. The original’s manufacturer Merck and its co-marketing partner in Korea Daewoong Pharmaceutical had Glucophage XR 1000 mg tablet and Diabex XR 1000 mg tablet cleared, respectively, on Mar. 18, 2010. Since then Daewoong Pharmaceutical’s subsidiary Daewoong Bio and Hanall Biopharma also nabbed the approval. Currently, Daewoong Pharmaceutical and Hanall Biopharma are leading the individual metformin ER tablet market, followed by the original’s Merck. Basically, Merck and Daewoong Pharmaceutical are hogging the market. Other pharmaceutical companies have not dared to approach the high-dose metformin ER tablet market, as it requires tablet-size reduction technology. The patent for the technology was still protected until Mar. 10 last year. In July 2018, Dailm Biotech had its bioequivalence test approved and won the approval on high-dose metformin ER tablet after acquiring the drug equivalence. It was first time for a follow-on drug company to achieve the outcome, besides the Daewoong Group. Dalim Biotech actually has a fairly large share in the individual metformin drug market with Glupa tablet. According to UBIST’s data, the drug generated 4.2 billion won until the third quarter last year. Besides the immediate release tablet, Dalim Biotech now has a firm foundation to challenge the once-daily administered ER market with item approval received on ER 500 mg and 1000 mg tablets. The pharmaceutical industry is eyeing on the individual metformin drug market as GC Pharma has recently started supplying its original Glucophamage in Korea. With imminent changes approaching fast, Dalim Biotech’s high-dose ER tablet is expected to shake up the market landscape as well.
- Policy
- IMD, virtually confirmed without drug price restrictions
- by Lee, Jeong-Hwan Jan 15, 2020 06:44am
- The drug price reform plan, which excludes 'proven advancement IMD' from the scope of generic drug price regulation, has been virtually confirmed. The decision was made to maintain some of the existing provisions for drug price benefits, with the difference between IMD and general generics. According to the pharmaceutical industry and the National Assembly's Health and Welfare Committee on the 13th, Myung-seop Kwak, the head of the Insurance and Pharmaceutical Affairs Division of the Ministry of Health and Welfare, met with Hee-mok Won, the Chairman of the Korea Pharmaceutical Biotechnology Association this morning and explained the improvement of the generic drug price regulation, which is expecting in July. The Ministry of Health and Welfare is expected to re-administer the proposed drug price regulation, which contains the provisions for maintaining the premium pricing policy for incrementally modified drugs. The Ministry of Health and Welfare previously announced a partial revision of the ‘Determination and Adjustment Criteria for Pharmaceuticals’, which contains generic drug price regulations on July 2 last year. Since then, the pharmaceutical industry has repeatedly made claims that drug prices should not be regulated by treating generic drugs with equivalent IMD, which have demonstrated excellent advances in patient compliance and side effects. In particular, the National Assembly Health and Welfare Committee sympathized with the claims of the pharmaceutical industry, emphasizing the need to recognize the value of IMD in the domestic pharmaceutical industry that is targeting new drug powers. As a result, the Ministry of Health and Welfare is expected to reintroduce the revised plan of drug price regulation, which was announced last July through administrative procedures. In the re-notification notice, which conditions should be met by the IMD that will maintain the premium pricing policy and what level of premium pricing policy will be provided for the IMD that meets the criteria. An official of a large pharmaceutical company in Korea said, “I understand that the head of a pharmaceutical company met with the head of the Korea Pharmaceutical Association this morning to explain the exception of the regulation of IMD price and to obtain opinions and consent, and the government has partially acknowledged the necessity of the IMD in the pharmaceutical industry”. "In fact, unlike generics, we need a lot of resources to make advanced drugs that are proven to be progressive. We need to demonstrate proper efficacy and function through preclinical animal experiments and phase III clinical trials. “Fortunately, the government seems to have chosen a policy to encourage pharmaceutical companies' will of the IMD”.
- Policy
- Diverse response for premium pricing policy for IMD
- by Lee, Jeong-Hwan Jan 15, 2020 06:37am
- The Ministry of Health and Welfare has virtually confirmed the premium pricing policy of excluding incrementally modified drugs(IMD) from generic drug price regulations, and since then, subtle airflow has been detected in the domestic and overseas pharmaceutical industry. The expression of the reform of the Ministry of Health's Welfare on Drug Price Regulations is mixed between multinational companies with a large proportion of original new drugs and domestic companies centered on generic and incrementally modified drugs. it tends to take domestic industry’s side. According to the pharmaceutical industry on the 14th, the direction of the reform of the premium pricing policy for incrementally modified drugs by the Ministry of Health and Welfare was quickly delivered to domestic and foreign pharmaceutical companies RA (development and licensing) and MA (pharmaceutical and loan) agents. As the scope of drug price regulation is reduced to generics, some domestic pharmaceutical companies that have been strategically focused on incrementally modified drugs become practical targets, and global companies with original drugs complain about unfair drug price management. To review directly at the background of complaints, the Ministry of Health and Welfare does not maintain the premium pricing policy for incrementally modified drugs, but rather establishes a reasonable price-listing environment for original new drugs, which are heavily invested in cutting-edge technologies and clinical trials and are the source of development of new drugs. The Ministry of Health and Welfare, which cut its original drug price as much as possible every time it is listed, is inconsistent with maintaining the premium pricing policy by overturning the regulation that the Ministry of Health and Welfare had noticed. Indeed, some foreign companies dissatisfied with the domestic drug price listing process have decided to pass in other Asian countries so called, 'Korea Passing' such as China and Japan while skipping Korea. In the end, Korea's drug price estimates are too low, which is the argument of foreign companies. Only incrementally modified drugs with overwhelming domestic market share were decided as the preferential key, which led to the dissatisfaction of domestic drug price policies. Indeed, in 2016, the Korea Multinational Pharmaceutical Industry Association (KRPIA), a group of international multinational pharmaceutical companies, criticized the government's plan to improve insurance prices for global innovative new drugs as a 'differentiated drug price premium pricing policy excluding multinational companies'. At the time of controversy, the government took out the policy that domestically developed new drugs applied 100% innovative drug price premium policy while globally introduced new drugs did not apply regardless of innovation. An official of Global A, who asked for anonymity, said, “The fair price policy for new drugs, generics, and incrementally modified drugs is a claim that foreign companies have consistently demanded. The premium pricing policy for incrementally modified drugs is not wrong, but a corresponding original drug price policy should be prepared”. A official said, “The need for drug price policy to protect its own industry is recognized, but Korea needs a new drug price policy that covers both its own and other countries to become a pharmaceutical power. The original drug price policy needs to be improved to reflect this value”. On the other hand, it is too much for the original company to try to involve the premium pricing policy for incrementally modified drugs, rather than generics. Incrementally modified drugs, which have improved administration and dosage compared to the original by changing the route of administration, dosage form, and salt, and improved the convenience of patient medication, are marked by the progress and significant cost and effort for actual development. Although it is not as difficult as a new clinical trial, the incrementally modified drugs that have advanced properties require animal studies and small-scale phase III clinical trials. In their opinions, current pricing policy is reasonable. The head of the development team of the domestic B pharmaceutical company said, “Honestly, simple salt-modified generics adopt the safety and efficacy data of the original new drug as it is, and there is no progress and it is easy to reproduce, and this is why generic drug price policy is not fair. However, it is hard to accept the opposition to the premium pricing policy for incrementally modified drugs with sufficient progress compared to the original”. The head of the development team of the domestic B pharmaceutical company said, “Korea's original drug price calculation standard is too low. Some multinationals claim that the authority to control drug costs is the responsibility of the government, not the company, the characteristics are different and individualized policies are needed”.
