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- 2026-05-20 05:10:45
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- Generics for Betmiga competition gets fierce
- by Kim, Jin-Gu Jul 28, 2020 06:37am
- BetmigaFull-fledged competition began in the generic market of “Betmiga (Mirabegron),” which has annual outpatient prescriptions of ₩65 billion. Hanmi and Chong Kun Dang, which received generic for exclusivity, recently released generics. The two companies plan to focus on expanding the market until February next year when the trial period expires. According to the pharmaceutical industry on the 24th, Chong Kun Dang has released "Selebeta", which is a generic for Betmiga, from the 1st of this month. Hanmi has been launching and selling “Mirabek” since June, a month earlier. The overall prescription amount is a little higher than that of Hanmi, which was released a step ahead, but the two companies are said to be very similar. As the original market was so large, the officials said that the prescription performance was good. Since the launch of Betmiga, more than 40 domestic companies have filed for patent evasion. Since 2015, invalidity trials and passive judgments on the scope of rights have been requested for material patents, formulation patents, crystalline patents, and use patents. As a result, 11 companies succeeded in overcoming formulation patents, crystalline patents, and use patents excluding material patents. These are Hanmi, Chong Kun Dang, JW Pharma, Daewoong, Ildong, Intropharm, Alvogen Korea, Kyung Dong, Sinil, Hanwha, and Shinpoong. Only Chong Kun Dang and Hanmi have won the right of generic for exclusivity. They received the right of copyright in April. As the material patent expired on May 3, the two companies launched a series of products. Other pharmaceutical companies that have evaded patents are said to have been disrupted in bioequivalence tests. It is expected that the generic competition will get hotter after February next year. Other generic companies such as Kyung Dong, Sinil, and Shinpoong, which are currently undergoing bioequivalence testing, are predicting to join after February 3, next year, when the trial period ends. According to UBIST, Betmiga's outpatient prescription amounted to ₩65.7 billion last year. Betmiga became a blockbuster drug shortly after its release in October 2015. In 2016, it posted sales of ₩28.8 billion, ₩41.7 billion in 2017, and ₩54.8 billion in 2018.
- Policy
- Copayment of Choline alfoscerate other than dementia is 80%
- by Kim, Jung-Ju Jul 28, 2020 06:36am
- The government's commitment to the re-evaluation of the already listed Choline alfoscerate was clear, and the results of the re-evaluation of Choline alfoscerate, which had strong social demands, eventually ended up maintaining the benefits only for dementia. The government left only the task of applying the revision after making an administrative notice to revise the relevant notice. If it proceeds sequentially, it may be implemented at the end of next month. The MOHW held the 13th general meeting of the Health Insurance Policy Deliberation Committee this afternoon (24th), and proposed and reported the Amendment of the Pharmaceutical reimbursed list and the upper limit table. The Pharmaceutical Benefits Evaluation Committee conducted a deliberation by the Pharmaceuticals Post-Assessment Subcommittee on the 4th of June and the 11th of the Committee, gathered industry opinions such as pharmaceutical companies from the 12th to the 13th of this month, held a round-table meeting with the Pharmaceuticals Association on the 16th In addition to 81 pharmaceutical companies, the Korean Neurological Association, the Korean Neurosurgical Society, and the Pharmaceutical Society for Health Society submitted different opinions surrounding Choline alfoscerate to the HIRA. Pharmaceutical companies generally lowered the copayment for selective benefit from 80% to 50% for brain-related diseases in consideration of social needs ▲submitted severe brain-related disease literature ▲high-priced alternatives had no effect on financial savings ▲Procedure lack of transparency ▲After deriving the results of clinical re-evaluation from the MFDS, it was suggested to adjust insurance benefits. Subsequently, the HIRA hled a subcommittee on the 21st of this month and decided to maintain the re-evaluation and put it up on the 23rd. As a result of the review by the Pharmaceutical Evaluation Committee ▲selective benefit is considered in social needs, but the minimum benefit rate is required because the clinical usefulness is insufficient. ▲The submitted documents are already reviewed as data on patients with dementia that may occur due to stroke, etc. Data ▲ Among 5~6 prescriptions for inexpensive alternative drugs ▲Procedures such as public hearings, deliberation and review of health ratings, and opinions from pharmaceutical companies are undergoing legal procedures. The MOHW plans to announce and revise the proposed amendment to 'a partial revision of Criteria for Adjustment and Method on Reimbursed services' during next month as the report of the Deliberation Committee is completed. In this case, it can be applied even at the end of August. Therefore, according to the government's will, it is expected that the reduction of Choline alfoscerate benefit will be implemented in late August or September. On the other hand, the efficacy of this drug is ▲ secondary symptoms due to cerebrovascular defects and deterioration in memory, confusion, and decreased concentration due to degenerative or degenerative cerebral stromal syndrome ▲ emotional and behavioral changes ▲ sensible pseudodepressiveness, for clinical usefulness. The dementia-related disease with evidence (within the efficacy effect) maintains benefit, and other diseases with insufficient evidence are converted into selective benefit (copayment rate: 30→80%) and reevaluate the appropriateness of reimbursed services for selective benefit after 3 years. Choline alfoscerate has a high rate of increase in claims, but there are social controversies over clinical evidence and are sold as health functional foods in major foreign countries. This ingredient, listed in 2007, has 232 items listed as of May this year. In 2016, it was claimed to be ₩167.6 billion, and in 2019, it exploded to ₩352.5 billion. So far, the National Assembly and civic groups have constantly raised concerns about the abuse of this drug and the appropriateness of insurance benefits.
- Policy
- Multiple myeloma drug Farydak was revoked after approval
- by Lee, Jeong-Hwan Jul 28, 2020 06:33am
- Farydak (Panobinostat), which can be used for patients who have failed to administer Velcade (Bortezomib), was revoked after three years of domestic marketing approval. There are many domestically licensed multiple myeloma medications, and the track listings, such as Risk-Sharing Agreement (RSA), have had an effect on the cancellation of the permit. On the 27th, the MFDS announced that Novartis Korea's approval for three items of 'Farydak capsules 10, 15, and 20 mg' has been revoked. Farydak was approved by the MFDS on February 6, 2017. Farydak is used as a combination therapy of Bortezomib and Dexamethasone in the treatment of patients with multiple myeloma who have previously received at least two treatments, including Bortezomib and an immunomodulatory agent. At the time of marketing approval, Farydak was evaluated as the first drug approved as a 'Histone Deactylase Inhibitor' that restores cellular function in patients with multiple myeloma with epigenetic activity. Nevertheless, the drug was not officially administered because it was not listed for health insurance for three years after the approval, and it was finally canceled. There were 7 multiple myeloma drugs that were marketed in Korea, including Janssen’s Darzalex (Daratumumab), Takeda’s Ninlaro (Ixazomib), Celgene’s Revlimid (Lenalidomide), Pomalyst (Pomalidomide), Amgen’s Kyprolis (Carfilzomib), BMS’ Empliciti (Elotuzumab), and Farydak. Of these, Revlimid, Pomalyst, Kyprolis, and Darzalex are being applied as risk-sharing (RSA) benefits. Empliciti, Farydak, and Ninlaro were not listed, and Farydak was canceled on the list of multiple myeloma drug approvals in Korea. Currently, RSA benefits are excluded from drugs that are considered as alternatives compared to existing drugs. Some point to this as a monopoly on the benefits. Farydak also seemed to lead to withdrawal of permission because it was difficult to launch market
- Company
- MFDS collects acetaminophen to confirm impurity
- by Chon, Seung-Hyun Jul 28, 2020 06:33am
- 식품의약품안전처 전경 The South Korean government is initiating an investigation on impurity contamination in an active pharmaceutical ingredient (API), acetaminophen. As the risk of impurity contamination in API manufactured by a Chinese manufacturer was raised recently, the government started proactively collecting and testing the API used in Korea. If the widely used acetaminophen were to be found with unacceptable level of impurity, the pharmaceutical industry would be unable to avoid a heavy blow. According to pharmaceutical industry sources on July 27, Ministry of Food and Drug Safety (MFDS) has recently visited pharmaceutical companies and taken samples of acetaminophen to confirm the impurity contamination in the API. The government’s action seems to be a follow-up of the concern raised of impurity risk in acetaminophen manufactured and supplied by a Chinese-based bulk pharmaceuticals manufacturer Anqiu Luan Pharmaceutical. A Dutch daily newspaper NRC has reported a few weeks ago that three batches of acetaminophen Anqiu Luan Pharmaceutical manufactured last year have been found with carcinogenic substance, 4-chloroaniline. The substance is apparently genetoxic. Regarding the accusation, Anqiu Luan Pharmaceutical disseminated an official statement to their clients on 15 explaining “4-chloroaniline was not found in the samples from the batch the Dutch client received in the first quarter of last year.” The Chinese manufacturer official said the voluntary investigation result was sent to European Directorate for the Quality of Medicines (EDQM) and elaborated “The acetaminophen manufacturing procedure does not create a chemical condition to generate 4-chloroaniline, and the level of impurity risk can be managed during the procedure.” According to the manufacturer’s explanation, the carcinogen can hardly generate during the acetaminophen API production line. But MFDS presumably has decided to take a deeper look into the API used in Korea to proactively check the impurity risk. Sources confirmed a significant volume of acetaminophen manufactured by the Chinese company has been exported to Korea. MFDS’ Drug Master File (DMF) registration shows that total 100 items of acetaminophen are available in the Korean market. And 20 of the items use API supplied by Anqiu Luan Pharmaceutical. DMF registration of products using acetaminophen manufactured by Anqiu Luan Pharmaceutical (Source: MFDS) If the ministry’s investigation find impurity in Anqiu Luan Pharmaceutical’s API, the impact on the Korean industry would be inevitable. MFDS has reportedly collected acetaminophen manufactured by other Korean and global companies as well. Analgesic substance acetaminophen is widely used in OTC drugs, such as Tylenol, Penzal and Geworin. And for prescription drugs, the API is used in brands like Ultracet. Curretnly, total 120 Korean companies are in the Ultracet market. In worst case scenario, the general Korean pharmaceutical industry would be shaken to the core by the Korean ministry discovering unacceptable level of impurity in acetaminophen. Since the impurity risk incident with valsartan in July 2018, the substance contamination issue has been spreading through ranitidine, nizatidine and metformin. All the incidents started from a foreign country sources addressing an impurity risk in specific pharmaceutical substance, which led to MFDS investigating the collected API and finished products and banning the sales of certain product in the Korean market. This is why the pharmaceutical companies are closely watching the MFDS’ investigation and following actions. MFDS official said, “The ministry is collecting and investigating acetaminophen to proactively confirm the risk of impurity.”
- Policy
- Government “Concerned of COVID-19 vaccine monopolization”
- by Lee, Hye-Kyung Jul 27, 2020 09:41am
- The South Korean government says it is closely following up with international sources to timely access the COVID-19 treatment and vaccine. At a regular briefing on July 23, Kwon Jun-wook, a deputy director of the Central Disease Control Headquarters, said “The disease control authority is paying a close attention to the global cases of COVID-19, because of unpredictable difficulty in accessing COVID-19 treatment and vaccine due to possibility of countries with high number of confirmed cases or pharmaceutical manufacturing countries attempting to monopolize the pharmaceuticals when they are developed.” Deputy Director Kwon added, “The headquarters is following up with the global situation also to strictly evaluate risk and to control special immigration to block off international inbound travelers infecting the local community.” Although remdesivir and some other drugs are currently used as treatment, the director stressed the importance of individual effort to prevent infection until an effective vaccine is available. The deputy director elaborated, “The disease control authority would continue to track confirmed patients and warn people of relying on misguided precautions,” and “the country can manage to have the daily life and disease control at the same time, if we maintain the effort to keep the masks on and follow the correct precautions.” Moreover, the disease control headquarters official mentioned of ongoing R&D. The government is currently collecting the second batch of the outstanding convalescent plasma from nationwide regions including Daegu, Daejeon and Sejong, initially excluded from the first Korea National Health Nutrition Examination Survey (KHANES). When the plasma collection is completed, the antibody count result would be unveiled in late August. The government is also conducting a cosigned research on antibody investigation in 3,300 people from Daegu and Gyeongsan region in August. As of July 23, the number of new COVID-19 confirmed cases in Korea marked 39. Including 20 new cases confirmed from overseas traveler, the accumulated number of confirmed cases reached 13,938. 60 people have been lifted from quarantine, while 883 people are still in quarantine. Total 18 are in serious state requiring intensive care.
- Policy
- Betmiga’s price is temporarily on hold due to lawsuits
- by Kim, Jung-Ju Jul 27, 2020 09:41am
- Betmiga products by Astellas Korea, which are at risk of dropping more than 30%, are temporarily on hold due to lawsuits filed by Astellas. The court decided to keep the price before the adjustment for the time being until the ruling of Betmiga trial is over as requested by the company. The Seoul Administrative Court decided to extend the suspension of the decision on the Betmiga's ruling in the 'Pharmaceutical reimbursed list and the upper limit table (Notification No. 2020-124)' promoted by the MOHW in June. The government lowers the upper limit of the product with the same route, ingredient, and formulation as the first listed product. Originally, the drug was decided to be cut by 30.1% every year due to the adjustment of authority on July 1st. Betmiga 50mg was expected to drop by 30.1% to ₩498 and Betmiga 25mg to ₩332, respectively. the company raised the government's decision, and the court will finally decide. According to the suspension of execution, the drug price of Betmiga 50mg per tablet is ₩712, and Betmiga 25mg per tablet is ₩475. It will remain temporarily until the 30th day from the date of the court decision. The final date has not been set.
- Policy
- Lipiodol's suspension of price cuts has been extended
- by Kim, Jung-Ju Jul 27, 2020 09:41am
- The court decided to extend the suspension of drug price cuts against Guerbet Korea's Lipiodol Ultra Liquid (Iodized oil, 12.8g/10mL). The court set the suspension period to 30 days from the date of the sentence of judgment in preparation for prolonged litigation. Seoul Administrative Court decided to suspend execution of a decision related to Lipiodol in the 'Pharmaceutical reimbursed list and the upper limit table (Notice No. 2020-124)' promoted by the MOHW in June. Earlier, the MOHW planned to lower the drug price on the 1st of this month at the same time as Fattiodol (generic for Lipiodol) by Dongkook was listed. According to the government’s drug price formula, the MOHW lowers the upper limit of the product with the same route, ingredient, and formulation as the first listed product. If the government cuts the drug price as planned, Lipiodol 12.8g/10mL will drop 30% from ₩19,000 to ₩133,000. It will be regulated once again from ₩13,000 to ₩101,745. However, the court will make a final decision as the company raises issues with the government's decision. According to the suspension, the previous drug price of ₩190,000 will be temporarily held until the 30th day from the date of judgment. The final date has not been set.
- Company
- MFDS to tighten up regulations on appetite suppressant
- by jung, sae-im Jul 27, 2020 06:31am
- The South Korean health authority drafted regulations preventing the abuse of psychoactive appetite suppressants. The draft contains high-level of regulations like adopting active substance designation system used in narcotics control, which can heavily impact the relevant industry. According to pharmaceutical industry sources on July 24, Korea’s Ministry of Food and Drug Safety (MFDS) is planning to manage psychoactive appetite suppressants. Some of the approaches unveiled were introducing quarterly active substance designation system like the narcotics control, notifying amfepramone and mazindol as restricted substance, and designating psychoactive appetite suppressants as subjects to submit a risk management plan (RMP). Psychoactive appetite suppressant management plan drafted by MFDS First, the quarterly substance designation system is used by the government to control narcotic drugs in Korea in accordance to the Single Convention on Narcotic Drugs of 1961. The government intends to enforce the system to handle the appetite suppressant on the equivalent level to narcotic drugs. The current system designates each company on which narcotic substance to supply after reviewing the projected yearly use volume of narcotic substance and quarterly plan of active psychoactive drug use submitted by each supplier company from the previous year. When the result is notified to each company, the narcotic drug manufacturers are allowed to purchase the active substance strictly following the designation conditions. MFDS sketched out a plan to survey each company’s inventory this year, and enforce the new regulation from 2021 after finalizing and notifying the appetite suppressant manufacturing approval plan in November. When the new regulation comes in effect, the drug manufacturers can only manufacture the suppressant drugs as much as the government allows. Basically, the government would be invested with the power to set down the manufacturing volume of psychoactive appetite suppressant. Moreover, the government aims to newly restrict approval on amfepramone and mazindol. The official notification would be issued around August. In the past, the approval on phentermine and phendimetrazine has been restricted due to frequent reports of abuse. The ministry now plans to expand the restricted scope of substances and include amfepramone and mazindol. The designated substance drugs may be restricted when seeking for narcotic drug handling approval, manufacturing or importation approval. Lastly, the ministry plans to designate psychoactive appetite suppressants as drugs required to submit a RMP. The system usually targets new drug or orphan drug, but a drug the Minister of Food and Drug Safety acknowledges the need for RMP submission due to severe adverse reaction reported may also be designated. MFDS is shooting for early next year to enforce the designation. Pharmaceutical companies with drugs required to submit RMP have to comply with the plan and regularly submit evaluation result. Until the final designation is announced, the ministry is to recommend the companies to voluntarily practice risk minimization actions as a pilot program. Also the government body would soon survey demands on the pilot program from the participating companies. On July 21, MFDS convened a conference with the affected industry and shared the said details. The ministry would make final decisions after reviewing the industry’s opinion. Regardless of the abuse prevention and safe use policies enforced on appetite suppressants so far, MFDS has decided to take the stricter action as the drugs were still excessively prescribed. In 12 months time from July 2018 through June 2019, 24,000 healthcare institutes prescribed the appetite suppressants to 1.29 million patients, which adds up to 6.11 million cases of dispensing and use of the drugs. According to 2018-2019 technical reports published by International Narcotics Control Board (INCB), Korea’s phentermine and phendimetrazine substance importation volume is one of the highest in the world. Analyzing appetite suppressant prescription and administration data, the report confirmed frequent cases of abnormal use suspected of abuse. And apparently, these drugs have been globally criticized for the wide discrepancies between the submitted projection psychoactive drug substance use volume and the actual manufactured volume. However, the relevant industry points out the blueprint of the regulation do not match with the goal of preventing drug abuse. An industry insider who requested anonymity noted, “The government should rather actively promote drug administration instruction or safe use, if the drug abuse is the issue. Many of the industry associates say regulating and controlling the actual manufacturing and production of the drugs is inadequate.” Meanwhile, the obesity treatment market in Korea, including the psychoactive appetite suppressant market, is valued at approximately 150 billion won.
- Policy
- Janssen launches clinical trial of Lazertinib-Amivantamab
- by Lee, Tak-Sun Jul 27, 2020 06:27am
- Janssen is conducting a clinical trial of Lazertinib for non-small cell lung cancer treatment with Amivantamab (JNJ-61186372). In 2018, Yuhan had transferred its technology of Lazertinib, a third-generation EGFR targeted anticancer drug to Janssen, to a total of ₩1.4 trillion. The MFDS approved IND for clinical trial for Phase Ib of Lazertinib-Amivantamab submitted by Janssen Korea on the 24th. Yuhan is currently leading the clinical trial of Lazertinib in Korea. Yuhan is conducting a phase III clinical trial of primary treatment for patients with locally advanced or metastatic non-small cell lung cancer with positive epithelial growth factor receptor-activating mutations. This clinical trial conducted by Janssen Korea is to evaluate the safety and pharmacokinetics of combination therapy with JNJ-73841937 (Lasertinib), the 3rd generation EGFR-TKI monotherapy or human bispecific EGFR and cMet antibody JNJ-61186372 (Amivantamab). As a multinational clinical trial, 8 of the 120 subjects were domestic. Clinical trials will be conducted at Bundang Seoul National University Hospital, Samsung Medical Center, Seoul National University Hospital, and Yonsei Severance Hospital. Janssen launched a large-scale global clinical trial in September last year to evaluate the combination of Amivantamab and Lasertinib. In particular, Johnson & Johnson (J&J) group has high expectations to point out the combination therapy as a promising pipeline. Janssen's goal is to complete the application for approval to the Food and Drug Administration (FDA) by 2023. In this combined clinical trial, Yuhan announced in April that it would receive a technical fee of $35 million from Janssen. It is noteworthy whether Janssen will succeed in debuting a new drug for non-small cell lung cancer developed by Korean pharmaceutical company.
- Policy
- No serious adverse effects for Duvie have been reported
- by Lee, Tak-Sun Jul 24, 2020 01:22pm
- After 6 years of post-marketing investigation of Duvie (Lobeglitazone sulfate), a new diabetes drug developed by Chong Kun Dang, serious adverse effects that cannot rule out a causal relationship with the drug has not been reported. The results of this PMS are positive because Thiazolidinediones (TZD) drugs had issue of side effects. The MFDS announced that it has prepared a proposal to change the permits according to the results of the recent re-examination of Lobeglitazone sulfate formulation, and will accept comments by August 4. Products including Lobeglitazone sulfate have a total of 5 items including Duvie 0.5mg by Chong Kun Dang in July 2013, and Duvimet XR (Lobeglitazone sulfate-Metformin HCl). Duvie was subject to reexamination (PMS) until July 3 of last year. The post-market investigation for Duvie was conducted on 3,056 people in Korea for 6 years. As a result, the incidence of adverse effects was reported as 7.10% (217/3,056 people, 341 cases) regardless of the causal relation. 1.11% (34/3,056 people, 37 cases) showed serious adverse effects that were not related to causality. It is GI related adverse effect (less than 0.1%) such as IBS. However, no serious adverse drug reactions were reported. 25 unexpected cases (20/3056 people, 0.65%) that cannot be excluded from causality were reported, and facial edema was sometimes found. TZD-based drugs can cause or worsen CHF in some patients and should be administered with the care by physician. The MFDS reflected this in the product package insert. As a result of the post-marketing investigation by Duvie, edema was found in 14 of 107 patients (13.08%) with congestive heart failure in NYHA class I or II who received this drug for more than 52 weeks. In addition, hospitalization and exacerbation due to CHF were reported to be 0.93% (1/107), respectively. Duvie received attention because it was a TZD-based drug, such as Avandia (Rosiglitazone), which was withdrawn from the side effects of cardiovascular disease at the time of approval. However, since TZD-based drugs such as Actos (Pioglitazone,Takeda) resolve issue of side effects through clinical research, they have recently recorded high sales in the diabetes treatment market. Dubie recorded ₩19.2 billion in outpatient prescriptions based on UBIST last year, and has established a reputation as a successful new drug developed in the market.
