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- 2025-12-24 23:30:07
- 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”.
- Policy
- Company executives were accused of vaccine bidding bribe
- by Lee, Jeong-Hwan Jan 15, 2020 06:32am
- Foreign pharmaceutical company executives who received ₩ billions from drug wholesalers for trials of vaccine distribution such as bidding, supply, and price setting are tried. Employees of a large domestic pharmaceutical company accused of committing the same type of crime were also prosecuted. Both employees are accused of receiving payments in connection with the National Immunization Program (NIP). The prosecution is suspected that pharmaceutical companies set up wholesalers to supply vaccines to the Public Procurement Service to secure volume or price. According to the complaint filed by the Justice Department to Democratic Party of Korea's Representative's Office of Tae-Seop Geum on the 13th, the Seoul Central Prosecutor's Office recently filed employee Mr. Lee (57), a global S Pharmaceutical company and an employee Mr. An(48), a large domestic company, with dereliction of duty. Mr. Lee is accused of receiving a total of ₩1,694,400,000 from two wholesalers in return for convenience such as designation and unit pricing of pharmaceuticals and issuance of a supply letter of approval when bidding vaccines from 2004 to last August. Mr. Lee took a profit by handing a ATM card from a wholesaler and then remitting the money back and withdrawing. In addition, Mr. Lee has been receiving cash from the other wholesalers over nine rounds of cash, including the wons, euros and dollars. Mr. Ahn was charged with receiving the same purpose from 2010 to last November and gaining property benefits worth ₩262 million from a wholesaler. Mr. Ahn received a corporate credit card from a wholesale company to take advantage of his property and freely received a car worth ₩60 million. The prosecution arrested them on 17th last month and restricted them on 20th to continue the investigation. The prosecution is suspecting that pharmaceutical companies such as Korean vaccine, Yuhan, Guangdong Pharmaceutical, Boryung Pharmaceutical, and GC Green Cross will offer wholesalers as vendors to provide vaccines to the Public Procurement Service to secure volume or price. In particular, Korean vaccines were caught by the Fair Trade Commission after discontinuing the supply of intradermal BCG vaccine, also known as 'fire-injection', in order to increase sales of expensive transdermal BCG vaccines monopolistically. The prosecution is also investigating allegations of collusion and back-trade in the vaccine supply process, including tuberculosis, cervical cancer and pneumococcus, after taking over the findings from the FTC and PPS.
- Policy
- What criteria does the Pharmaceutical Committee judge?
- by Lee, Hye-Kyung Jan 14, 2020 08:49am
- 12 of 24 new drugs were successful in listed drugs, Unfortunately, there are four drugs that have failed the reimbursement challenge. The HIRA evaluates the adequacy of a drug through a review by the Pharmaceutical Benefits Evaluation Committee in accordance with Article 11 (2) of the Rules on National Health Insurance Benefits. Dailypharm analyzed new drugs that passsed by the HIRA's Pharmaceutical Benefit Committee from January to December last year. Of the 24 drugs, only 11 received reimbursed. The remaining 10 drugs were non-reimbursed, and 3 drugs were managed-entry. .Non-reimbursed drugs include 'Duodopa intestinal gel' (levodopa)' by Korea's AbbVie, 'Neuronata-R(autologous bone marrow-derived mesenchymal stem cells)' by Corestem, and 'Zerbaxa' (Ceftolozane/Tazobactam) by MSD Korea .Radicut(Edaravone), the treatment of amyotrophic lateral sclerosisby Mitsubishi Danabe, chose to withdraw its reimbursement during the drug price negotiations with the HIRA .◆Duodopa intestinal gel=This drug is Progressive Parkinson's disease drug with severe motor ups and downs despite Parkinson's drug treatment,and it was approved on April 6 2015, went through the Pharmaceutical Benefits Subcommittee on July 23 2015 and it was put on the Pharmaceutical Benefit Committee on March 21, 2019, four years later .However, the clinical data submitted by the pharmaceutical did not qualify as 'medical drugs deemed necessary for medical treatment' because clinically meaningful improvements such as prolonged period of survival have not been proved .As a result, it was concluded that ICER was impossible due to insufficient evidence, and drug prices suggested by the company were difficult to accept due to uncertainty .On the other hand, the related academics said that patients who are not controlled by existing Parkinson's disease drugs because they do not have adequate treatment in Korea are necessary for patients suffering from mental and physical pain and severe diseases due to exposure to medical blind spots .This drug is listed in the US, Germany, France, Italy, the UK, and Japan excluding Switzerland among A7 countries ◆Neuronata-R= This drug is used in combination with Riluzole to slow the progression of the disease in amyotrophic lateral sclerosis, went through the Pharmaceutical Benefits Subcommittee on March 21 2018, and it was put on the Pharmaceutical Benefit Committee on last April 25 .In patients with amyotrophic lateral sclerosis, clinical necessity was acknowledged by slowing functional decline than without Neuronata-R, The cost was higher than that of the alternative, and the corresponding cost effectiveness was unclear, and A non-reimbursement decision was made .The domestic neurology textbook mentions the approval of rare drugs in the applied products, and the stem cell treatment is introduced as a treatment under study in the ALS in clinical guidelines .However, Yakyeong said, “Riluzole is being given to Amyotrophic lateral sclerosis, and considering the possibility of substitution, it is hard to say that it is an essential drug for medical treatment” .The related academics also suggested that it would be advisable to review the Neuronata-R strains after the results of phase II and III studies have been reported .◆Zerbaxa=this drug received an item permit on April 7 2017 for complex intraperitoneal infections (with Metroidazole) and complex urinary tract infections (including Pyelonephritis) .The deliberation was conducted on November 21 2018, through the Pharmaceutical Benefits Subcommittee, and the deliberation was conducted by the committee on last June 20 .As a result of the deliberation, the clinical necessity is hardly considered inferior to the clinical treatment rate, but it was concluded by non-reimbursement due to the higher cost than the alternative drug .The relevant academics suggested that the introduction of an inferior therapeutic agent compared to Carbapenem has a clinical significance in the case of limited antibiotics against MDR-infected Gram-negative bacterial infections .Among A7 countries, Zerbaxa is registered in the US, Italy, the UK, and Japan .◆Radicut=This drug failed the reimbursement threshold in the 2018 but was reevaluated by the Third Committee in 2019 and was recognized for its adequacy .Radicut was approved as a drug that could slow the progression of dysfunction caused by amyotrophic lateral sclerosis, but the clinical necessity was recognized, but the cost was high .However, there are no drugs or treatments with the same therapeutic position, and it has passed the severity and social impact of the disease according to the risk sharing plan and the policy to strengthen health insurance coverage as a rare disease treatment drug .The problem was that Mitsubishi Danabe Pharma had been discussing reimbursement in Canada at the same time as Korea .However, Canada decided to refer to Korean drug prices, and withdrew Korea's reimbursement entry to enter Canada's reimbursement .At that time, Radicut was listed in the US and Japan among A7 countries .On the other hand, in order to be reimbursed again, submissions of new cost-effectiveness data should be evaluated and submitted to the Pharmaceutical Benefit Committee .
- Policy
- New patent evasion strategy for Galvus follow-ons?
- by Lee, Tak-Sun Jan 14, 2020 06:28am
- A creative strategy to evade patent is attracting the pharmaceutical industry’s attention. If the strategy is found successful, pharmaceutical companies in Korea would be able to use it to evade the extended effective term of substance patent protection, as an alternative to the strategy of changing saline base of the original drug affirmed ineffective by the court. According to an industry source on Jan. 12, Korean companies preparing follow-on drugs of dipeptidyl peptidase-4 (DPP-4) inhibiting anti-diabetes treatment Galvus has presented a unique patent evading strategy unlike preceding ones. The companies are challenging the original’s patent by excluding an indication used as an evidence to extend the patent term. For instance, the follow-on drug would omit one out of five indications of Galvus Met 50 mg/850 mg tablet, specifically the indication for ‘treating a patient when sufficient blood sugar level control is impossible with metformin monotherapy.’ The industry claims follow-on drug without the indication would not infringe the extended term of the patent as it was used to extend the Galvus’ substance patent term for 26 months and 23 days. In fact, it was reported the vildagliptin-metformin 50 mg/850 mg tablet applied for approval on Dec. 24 last year, without the particular indication. And apparently, the follow-on drug developers, Korea United Pharm and Hanmi Pharmaceutical have filed defensive confirmation trial for the right of Galvus patent with the same strategy. The call would be made when Korea Intellectual Property Office (KIPO) decides whether or not to accept the follow-on drug developers’ claim. If KIPO affirms the companies’ claim, then United Pharm and Hanmi Pharmaceutical would be able to release their follow-on drugs within this year. It would be possible as Galvus’ other substance patent rejected from extension was expired Dec. 9 last year. And also those two companies may launch products regardless of Ahn-gook Pharmaceutical’s generic approved with preferential sales rights. After nullifying 187 days out of the extended patent term of 26 months and 23 days, Ahn-gook Pharmaceutical can legitimately start selling follow-on drug from Aug. 30, 2021. The company also won the preferential sales right to exclusively supply the vildagliptin generic from Aug. 30, 2021 to May 29, 2022. As a result, other drugs in the same class cannot be launched. However, the exclusive sales right is not effective on drug that completely evaded extended patent term. In other words, the follow-on drug developers could release their products before Ahn-gook Pharma. And this is not the first time the strategy has been used. Chong Kun Dang Pharmaceutical used the strategy to release benign prostatic hyperplasia (BPH) and hair loss treatment Avodart’s generic, Dutesmol, before the original’s extended patent was expired. Initially, however, Dutesmol’s indication did not include treating BPH as it was an evidence to extend the original’s patent. And after the substance patent was expired, the generic won the BPH indication and now the drug is available for prescription on treating BPH. Galvus follow-on drug developers are likely to exclude indication used to extend the original’s patent, but they are also likely to seek for approval on the omitted indication when the patent expires completely. As the old patent evasion strategy of changing saline base has been blocked by the Supreme Court’s decision made in January last year, the industry experts predict pharmaceutical companies in Korea have high chances of evading the extended term of the original’s patent protection by dropping an indication for their product. Currently, pharmaceutical companies that commercialized follow-on drugs with switched saline base from the original overactive bladder medication Vesicare and smoking-cessation treatment Champix have suspended their sales due to the Court of Appeals’ decision to affirm patent infringement.
