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- 2026-04-13 08:54:33
- Company
- Hanmi's lung cancer drug Poziotinib has been applied for NDA
- by Kim, Jin-Gu Dec 08, 2021 06:00am
- The U.S. FDA marketing approval process for Poziotinib, a new lung cancer drug developed by Hanmi Pharmaceutical, has begun. Hanmi Pharmaceutical's partner Spectrum announced on the 6th (local time) that it has submitted an NDA to the U.S. Food and Drug Administration (FDA). This indication is NSCLC with local progression and metastatic HER2 Exon 20 insertion mutation with treatment experience. This NDA submission is based on the positive cohort 2 results of the ZENITH20 clinical trial that evaluated the safety and efficacy of Poziotinib. Poziotinib was designated as FastTrack by the FDA. As a result of this indication, there are no FDA-approved treatments so far. Spectrum President Joe Turgon said, "HER2 Exon 20 insertion mutation has reached an important stage for achieving the first treatment for lung cancer patients. We thank researchers, patients, and spectrum executives and employees for their passionate efforts to achieve important milestones in areas with high unmet medical demand."
- Company
- The kit for precocious puberty in Korea has been stopped
- by Moon, sung-ho Dec 08, 2021 06:00am
- The increase in the number of precocious puberty patients in Korea is unusual. As the number of patients, which was 80,000 in 2015, exceeded 130,000 in 2020, there are opinions that it should now be recognized as a social problem. In response, some in the medical community and clinical sites predict that the number of precocious puberty patients will increase further as outdoor activities decrease due to the prolonged COVID-19 pandemic. Amid this situation, it has been confirmed that confusion is occurring at front-line medical sites due to the recent suspension of the supply of "diagnostic reagents" that can identify patients with precocious puberty. With the suspension of the supply of diagnostic reagents, which were the only health insurance coverage targets, even the diagnosis of precocious puberty patients, which is rapidly increasing due to prolonged COVID-19, is developing. According to the medical and pharmaceutical industries on the 4th, clinical doctors are suffering from the suspension of supply of injection items that are prescribed precocious puberty as a "diagnostic reagent" since March. The item is Relefact LH-RH supplied by Handok in Korea. As Sanofi, the original developer, decided to suspend the supply of this item in March, stock of reagents for diagnosing precocious puberty has disappeared in Korea. According to the MFDS, the import performance of Relefact LH-RH in 2020 is about 1.132.26 billion won. Considering that it was 650.58 million won in 2015, the performance has increased, but it is lower than expected. The problem is that Relefact LH-RH is the only item as a diagnostic reagent for precocious puberty. Lutrelef of Perring Pharmaceutical Korea, which can be said to be the same ingredient, has already been withdrawn from the domestic market due to the expiration of its validity period. For this reason, medical sites are unable to diagnose precocious puberty patients due to a lack of diagnostic reagents. In the diagnosis of precocious puberty, LH and FSH are measured in the blood for 2 hours at intervals of 15 to 30 minutes after administration of "sexual stimulation hormone secretion hormone." If the maximum concentration of sulfonation hormone is 5 IU/L or higher, it is judged to be activated and diagnosed with precocious puberty. , that is, "sexual stimulation hormone secretion hormone" plays a role in the diagnosis process of precocious puberty, and it is Relefact that diagnoses it. As Relefact has not been imported into Korea, it is difficult to diagnose precocious puberty nationwide, said a professor of pediatrics in a province who asked for anonymity. "As the number of precocious puberty patients has already increased rapidly through the COVID-19 pandemic, I wonder what preparation the health authorities have made." It is prescribed as an "off label" for precocious puberty, which has become difficult to diagnose. If so, how is the medical field responding to the suspension of the supply of diagnostic reagents? As a result of the coverage, it was found that some hospitals and clinics are prescribing other drugs offline as the supply of Relefact has been stopped. In fact, it has been confirmed that some hospitals and clinics apply for approval for excessive use of Ferring's Decapeptyl Depot and use it as a reagent for diagnosing precocious puberty. Decapeptyl is a specialized drug licensed for hormone-dependent prostate cancer, endometriosis and uterine myoma, central puberty early onset in girls under the age of 9 and boys under the age of 10. Another professor who runs a clinic said, "As papers have been presented that they have obtained good results in Thailand, some hospitals in Korea are already receiving health insurance benefits by submitting approval to the HIRA for the use of non-reimbursed drugs beyond the scope of reporting." In fact, the HIRA official also said, "As the supply of Relefact injections has been suspended, off-label use through Decapeptyl is being carried out. Currently, we are considering approving the use of hospitals and clinics that submit overseas papers." It was found that the seriousness of the problem was recognized and countermeasures began to be prepared, focusing on related societies such as the Korean Society of Pediatric Endocrinology. If it is no longer possible to secure Relefact, the use of off-label for Decapeptyl is suggested as an alternative, and some pharmaceutical companies are requesting the re-import of related items. It is only hoped that the suspension of supply will end in a short period of time as a pharmaceutical company that resupplies the drug to Korea.
- Company
- Dire need for a rational pricing system for new drugs
- by Nho, Byung Chul Dec 07, 2021 05:57am
- Improving the drug pricing system through social consensus has been proposed as a prerequisite for the government to achieve the 60 trillion won export and 300,000 job creation in the biohealth industry as one of its 3 new growth engine industries. In addition to the primary purpose of fostering the biopharmaceutical industry to create national wealth, there is no disagreement on the fact that the localization of vaccines and treatments as the nation’s key industry is essential to address the national need and respect and realize the right to life of the citizens in Korea in the COVID-19 pandemic. In particular, the emphasis Yong-Ik Kim, the President of the National Health Insurance Service, made at special lectures, in raising the will for R&D among biopharmaceutical companies through appropriate pricing of new drugs and the joint growth of the nation and its companies, has been interpreted as an exemplary blueprint for the soft landing of Mooncare. Seong-min Park, a lawyer from HnL law firm said, " An irrational pricing system for new drugs may infringe the Korean patients’ access to treatment as well as adversely affect the fostering of a health drug ecosystem with fair competition.” Essentially, 4 rational drug pricing measures were considered eligible for review/introduction through communication with the Ministry of Health and Welfare, as well as the Korea Pharmaceutical and Bio-Pharma Manufacturers Association and other industry pricing managers: ▲ reducing the scope of alternative drugs ▲flexible application of negotiations(diversifying types of pricing negotiations allowed to include refund system, etc) ▲price discount accumulation system ▲pricing premium for new drugs that have conducted Phase III trials on Koreans First, the system to reduce the scope of alternative drugs was proposed to improve the standards for selecting alternative drugs so that new drugs can be compared with each other. According to the industry, one issue in setting prices for new drugs is that the price of originals and generic drugs that have been discounted 53.55% due to patent expiry are all included in the standard used to set new drug prices and are continuing to be discounted due to post-marketing measures. If this intensifies, the price of new drugs could be set at a lower level than alternative generics, reducing the will for companies to research or develop new drugs and also inducing voluntary withdrawal of licenses due to loss of cost. In other words, Korea will not be able to leap forward and become a pharmaceutical powerhouse if the virtuous cycle of ‘R&D-new drug discovery- national wealth creation’ is broken. On this, Park said, “Special measures such as excluding patent-expired products from alternative drugs is necessary. Global competitiveness can be secured only when practical standards are established for the selection of alternative drugs such as those with therapeutic equivalence and the price set at 80-120% of the price in foreign countries.” Under the price discount accumulation system, pricing discounts that are accumulated during a new drug’s patent period after term expiry, effectively preserving the R&D value of a new drug to allow faster recovery of R&D expenses and induce reinvestment. The system does not provide preferential treatment by exempting drug price discounts but defers it, therefore retaining the effect of reducing insurance finances. The irrationality of lowering drug prices of new drugs that are more cost-effective than its alternatives with the price-volume linkage system and the discount applied when a drugs attempts to add indications that are within the scope held by its alternatives, has been constantly raised. For example, compared to other drugs of the same class, Zemiglo had been subject to numerous more price-volume linkage discounts than its number of sales since it was released in 2012. Its price had been discounted a total of 6 times. The pricing premium system for new drugs that have provided Phase III trials on Koreans allows the price of new drugs that conducted Phase III trials on local patients to be set at 95-100% of the market price of substitute drugs rather than at 90% when omitting pricing negotiations. The system does not conflict with international trade as it allows new drugs from multinational pharmaceutical companies that conduct multinational clinical trials to receive benefits while local new drugs that did not conduct Phase III trials of a certain size in Korea to become ineligible for such benefits. The system is already being applied and operated abroad. For example, in Taiwan, a 10% premium is provided for new drugs that conducted clinical trials over a certain size to demonstrate safety and efficacy. In Japan, a new drug that was first-ever to be approved in Japan receives a premium of 10-20% for early introduction (new drugs that explicitly include dosage regimens for pediatric patients area are applied a 5-20% premium, however, the premium is not applied if the clinical trial conducted in Japan do not include pediatric patients). The greatest advantage of the 'pricing premium system for new drugs that have conducted Korean Phase III trials’ is that it provides base data on the safety, efficacy, clinical utility of a drug in Koreans. It is also easy to track and manage, improves R&D ability by the full step of the trial being conducted domestically, provides a performance upgrade for domestic clinical trial institutions, creates jobs, and contributes to new drug development fit to match the condition and diseases of Koreans.
- Industry is nervous about strengthening quarantine guideline
- by Kim, Jin-Gu Dec 07, 2021 05:57am
- Private gatherings in the Seoul metropolitan area are limited to 6 people. With COVID-19 (step-by-step daily recovery) was suspended after a month of implementation due to the re-proliferation of COVID-19. The pharmaceutical bio industry is also nervous about the worsening COVID-19 situation. On the 6th, the government tightened quarantine guidelines again by reducing the limit on the number of private gatherings to six in the metropolitan area and eight in the non-metropolitan area. In fact, it is the suspension of With Corona. The strengthened quarantine guidelines will be applied until the 2nd of next month. The period can be adjusted depending on the trend situation. The pharmaceutical bio industry has also strengthened internal guidelines in line with these measures. In particular, it is recommended to refrain from public gatherings, including informal private gatherings, as the end of the year is approaching. Yuhan Corporation again urged executives and employees to conduct remind-level retraining and comply with personal quarantine rules. The company's rule is to wear a mask at all times while working and refrain from multi-use facilities and private gatherings. End-of-the-year events such as workshops will be refrained from as much as possible and will be held non-face-to-face only if inevitable. Efforts are also made to minimize contact within the company. The time to use the cafeteria is set differently for each department, and lunch boxes are provided to some. Last month, Yuhan Corporation changed its guidelines to work as all of them finished working from home before and after the implementation of With Corona. In the case of Hanmi Pharmaceutical, it is discussing whether to reapply telecommuting due to the re-proliferation of COVID-19. The results of the discussion are expected to come out as early as today (7th). Hanmi Pharmaceutical, like Yuhan Corporation, has terminated telecommuting since last month. Separately, all year-end official events will be canceled or replaced online. In the case of other private gatherings, executives and employees were informed to follow government guidelines. Most of the other domestic pharmaceutical companies, including Chong Kun Dang, Dong-A ST, and Ildong Pharmaceutical, have a similar rules. It is said that guidelines have been issued to replace year-end events such as year-end parties and closing ceremonies online only if necessary, and to refrain from small workshops and dinners by department. An official from a large pharmaceutical company said, "There are no separate guidelines. However, there is an atmosphere among most employees to refrain from private gatherings such as year-end dinners, he said. Another pharmaceutical company official said, "We did not prepare an official event at the end of the year. It will also be replaced online so that workshops that were planned on a small scale by each department can be used, he said. Multinational pharmaceutical companies maintain quarantine guidelines such as telecommuting, official meetings, and refraining from outside events regardless of the implementation of With Corona. Pfizer Pharmaceutical Korea, Novartis Korea, and AstraZeneca Korea plan to continue working from home, which have been doing since the beginning of COVID-19. Likewise, year-end workshops and seminars are held non-face-to-face. It is recommended to refrain from official gatherings or outside events as before. Since the implementation of With Corona, MSD has switched to allowing all employees to work from home twice a week. Since the government's quarantine guidelines have been strengthened, it has been recommended that in-office workers can voluntarily decide to work, and outside workers should refrain from visiting except in unavoidable cases.
- Company
- Moderna tackles the Omicron variant with booster shots
- by Dec 07, 2021 05:57am
- ” We are developing three vaccine strategies to rapidly respond to the much-concerned Omicron variant. We plan to soon release a booster shot that is most appropriate for the Omicron variant.” Randall N. Hyer, senior vice president of Global Medical Affairs at Moderna, replied so to an inquiry about the company’s plans on responding to the Omicron variant at a press conference that was held at the Somerset Palace in Jongno-gu, Seoul, on the 2nd. According to SVP Hyer, Moderna is preparing three different strategies to respond to the Omicron variant: ▲high dose booster shot; ▲new booster shot to respond to the Omicron and other emerging variants; and ▲an Omicron-tailored booster shot. For the first option, a high-dose booster shot, the company has already completed safety and immunogenicity tests on 306 adults with a 100μg dose that is twice the dose currently in use. As the second option, the company is testing 2 multivalent booster candidates – one that added the Beta variant to the existing vaccine (mRNA-1273.211), and the other that combined the beta and delta variant (mRNA-1273.213). The two candidates include the 4 and 8 variants found in the Omicron variant. As the third option, Moderna is developing the vaccine candidate mRNA-1273.529 that specifically targets the Omicron variant. The development is expected to take 2-3 months. Randall N. Hyer, Senior Vice President of Moderna Inc.i2Hyer said, “We have been developing various booster shots since earlier this year to respond to anticipatable variants. We are reviewing which strategy is most effective among the three. We will be able to identify the effect of the high-dose booster shot within a few weeks.” However, it would take some time for a booster shot that can prevent the Omicron variant to be available for inoculation in the field, as it requires clinical trials and approval by the regulatory authorities. Moderna believes that the benefits of vaccination outweigh the risk even in young adults and children. There were concerns over the risk of myocarditis in young adults with the Moderna vaccine, however, the company says its data demonstrates the fact that its vaccine’s risk is no different than that of Pfizer’s. Some Northern European countries have only allowed the use of Pfizer’s vaccine to children and young adults due to the risk of side effects such as myocarditis and pericarditis among youths and young adults. Korea has also made the same recommendation. Also, the US Food and Drug Administration has deferred extending approval of Moderna’s vaccination to those aged 12-17, saying that the risk of myocarditis in teenagers needs to be reviewed. On this, Hyer said, “The absolute risk of myocarditis after vaccination is very low. Some monitoring results showed that Moderna’s vaccine had a higher risk than Pfizer’s vaccine, but others have also shown that there was no difference at all between the two. The incidence of myocarditis and pericarditis in those 30 years or less who were vaccinated were no different for the two - 0.45(0.45 per 100,000) for Pfizer and 0.49(0.49 per 100,000) for Moderna.” He added, “Please bear in mind that the risk of myocarditis is higher if you are unvaccinated and confirmed with COVID-19 rather than from vaccination with COVID-19 vaccines. Of course, we fully understand the concerns of the health authorities as the results vary by each dataset. Moderna is also conducting its safety investigations to examine the association between myocarditis and mRNA vaccines.” Moderna also stressed the need for smooth communication with the Korean government. That day, Moderna had also announced that it had appointed Ji-young Sohn, former general manager of CSL Behring Korea, as its new general manager for its Korean subsidiary. Hee-Soo Kim, Country Medical Director of Moderna Korea, said, “After the Korean subsidiary was established in May, the general manager and medical director joined the company in November, and various departments have also been established since then.” Kim added, “We are hiring many employees now. Although we had issues communicating with Korean government authorities before, we hope that the establishment of our Korean subsidiary may contribute in various ways, including facilitating the smooth supply of vaccines and R&D partnerships.” As part of such efforts, Moderna has started a fellowship program under which young researchers can learn about the development of mRNA therapeutics, and encouraged active participation of Korean researchers. Hyer said, “We are pleased that 2 Korean professors have joined our Fellowship Promotion Committee. We hope many young researchers in Korea would join us to study mRNA-based therapeutics."
- Policy
- Detailed screening for α -GPC begins in earnest next year
- by Moon, sung-ho Dec 07, 2021 05:57am
- Tensions are rising as the government announces the review of the revised supplementary budget bill starting next year amid deepening concerns among pharmaceutical companies over the issue of Choline Alfoscerate. According to the pharmaceutical industry and the medical community on the 1st, it has been confirmed that the MOHW has decided to strengthen the screening of prescriptions for hospitals and clinics starting next year in accordance with the clinical re-evaluation policy for Choline Alfoscerates. Over the past two years, the MOHW has set the first target of strengthening screening according to the drug clinical re-evaluation policy as the Choline Alfoscerate formulation. In fact, the Choline Alfoscerate drug is recognized as a drug in Italy, while it is sometimes used as a health functional food in other countries, so controversy over its efficacy has continued. The MFDS ordered a "clinical re-evaluation" last year to re-evaluate the Choline Alfoscerate formulation on its own, and 57 companies, including Daewoong Bio and Chong Kun Dang, have begun clinical re-evaluation. At the same time, the MOHW reduced the benefit of Choline Alfoscerate. Since August last year, patients who have not been diagnosed with dementia have raised the drug price burden rate from 30% to 80% when using Choline Alfoscerate. Then, pharmaceutical companies actively took legal action and began to defend their sales. However, unlike the pharmaceutical industry, which is preparing such a defense strategy, some say that the actual medical field has little impact on the reduction of benefits. It was expected to have a big impact as the government decided to reduce benefits, but the actual feeling at the medical field is quite low. "In fact, the HIRA is currently not cutting according to the reduced benefit policy," said a professor at University Hospital A belonging to Korean Dementia Association, who requested anonymity. "There is no big problem with maintaining similar billing guidelines," he said. In the end, the MOHW and the MFDS have strengthened their guidelines following the reduction in benefits, but they are actually prescribing them without paying much attention to them in the actual clinical field. This is why The HIRA has announced cuts through specific screening starting next year. An official from the HIRA said, "Strengthening the screening is a situation in which we have to go through the Central Review and Coordination Committee, an organization within the institution. He said, "It is not easy to apply a specific examination yet, but we will proceed quickly and strengthen the examination of prescriptions by medical institutions from next year."
- Policy
- The original patent's negotiation period will be reduced
- by Kim, Jung-Ju Dec 07, 2021 05:57am
- The period of ex officio adjustment drug price negotiations for the original drug that expires patents collectively cut drug prices will be reduced to one-third. It is aimed at improving cases of health insurance financial leaks by abusing the prescribed negotiation period as much as possible when the legal drug price cut rate is set. The MOHW announced that it held a Health Insurance Policy Deliberation Committee this afternoon (25th) and reported on the "improvement of the drug negotiation system." The government is currently negotiating all reimbursed drugs. This is in accordance with the policy to expand the negotiated drugs from the application of new drug insurance to the entire drug from October 2020 to strengthen the quality control and stable supply management of insurance drugs after detecting Valsartan impurities in 2018. For example, in the past, negotiations between the government and companies were conducted to register new drugs, adjust drug prices, and expand the scope of use. However, since the reorganization, negotiations have been underway to adjust the original drug price (100 → 70%) and re-evaluate according to the first generic insurance application. Although the negotiation system has been expanded in this way, the problem of confusion in the operation of the system has been exposed due to insufficient detailed procedural regulations. In the case of supply and quality management contracts, unnecessary overlapping negotiations were held, such as drug price adjustments, and some pharmaceutical companies delayed the negotiation deadline of 60 days to delay the timing of drug prices falling. Some also pointed out that there are no renegotiation and procedural regulations when negotiations break down. It was pointed out that the drug negotiation procedure under the narrow law was unclear about the regulations on follow-up measures, such as exclusion of benefits, in the event of a final breakdown. The improvement plan largely sets ▲ the target to be omitted when negotiating drugs, ▲ to adjust part of the negotiation period of , ▲ to prepare renegotiation procedures in the event of a breakdown of negotiations, and ▲ to clarify that benefits are excluded in the event of a final breakdown of. Specifically, the negotiations will be omitted if there is a contract between the corporation and pharmaceutical companies. In the case of ex officio adjustment negotiations due to the application of a package reduction in drug prices, it will be shortened from the current maximum of 60 days to 20 days. This is a measure designed to reasonably shorten the negotiation period in the case of original ex officio adjustment. When negotiations broke down, renegotiation procedures were also in place. In order to prevent confusion in the clinical field, the government asked to renegotiate the drug characteristics and the progress of negotiations after deliberation by the Drug Benefit Evaluation Committee. In addition, in the case of drugs whose final negotiations have broken down, grounds have been established to exclude benefits. The government has decided to push for the standard rules for medical care benefits and the individuality of notification sometime next month. Considering administrative procedures such as legislative notices, the implementation of the amendment is expected to be possible in the first half of next year.
- Company
- Five companies give up challenging Dukarb’s patent
- by Kim, Jin-Gu Dec 06, 2021 05:54am
- Pic. of Boryung Pharmaceutical Five out of the 45 companies that set out to evade the patent of Boryung Pharmaceutical's antihypertensive combination drug ‘Dukarb Tab. (fimasartan+amlodipine)’ decided to give up challenging the patent. The industry has pointed to the fierce competition in the two-drug fixed-dose combination market as one of the causes for the companies’ decision to give up their patent challenge. According to industry sources on the 6th, PharmGen Science voluntarily withdrew the trial to confirm the passive scope of patent rights that it had recently filed for the Dukarb composition patent. If the companies succeed in avoiding the composition patent for Dukarb which is set to expire on August 2031, the companies may release their latecomer drugs for Dukarb after February 2023 after the substance patent for the Kanarb ingredient expires. According to the pharmaceutical market research institution UBIST, outpatient prescription for Dukarb recorrect 36.1 billion last year. Prescriptions amounted to 30.2 billion won by Q3 this year. Other than the single-drug pill Kanarb, Dukarb has made the most prescription performance among the Kanarb family. Due to the outstanding performance of the drug, many companies have filed challenges to the drug’s composition patent. Starting with Arlico Pharm, a total of 45 companies have filed a trial to confirm the passive scope of patent rights. However, Yuyu Pharmaceutical was the first to drop the suit on August 24th. Since then, Hanwha Pharma, Daehan New Pharm, Kims Pharma, PharmGen Science voluntarily dropped their challenges. As a result, a total of 5 companies have now given up challenging Dukarb’s composition patent. The industry’s focus is now on whether more companies will follow suit. Due to the ongoing fierce competition in the antihypertensive drug market for the ARB+CCB class two-drug combo, there is still the possibility that more companies will be giving up patent challenges. In this context, the companies may have determined that the release of a latecomer Dukab generic may not have great marketability. Also, with the strong presence held by Boryung Pharmaceutical, some predicted that the market will be hard to penetrate with the release of several same-ingredient generics at the same time. However, one variable that remains is the impurity issue in the sartan ingredients. In addition to the growing concern over azido impurities in the losartan ingredient in Korea, azido impurities have also been found in irbesartan and valsartan ingredients abroad. If the impurity issue grows to exceed expectations, some expect that this will increase demand for a different ARB-class drug, fimasartan. No impurity has been detected in fimasartan up to date.
- Product
- Losartan's re-prescription & re-dispensing are imminent
- by Jung, Heung-Jun Dec 06, 2021 05:54am
- While the government's follow-up measures based on the results of Losartan impurity detection are expected to be announced this week, attention is being paid to the work guidelines for re-prescription and re-prevention. Items with problems with all manufacturing numbers are expected to be re-prescribed and re-manufactured, and items with problems with some manufacturing numbers will be exchanged. Earlier, the MOHW and the MFDS held two meetings with the Korean Medical Association and the KMA, the KHA, and the KSHP. In addition, meetings with the KPBMA and the KPDA were held and plans were made for follow-up measures such as cost settlement. According to the government's discussions with organizations so far, exchanges are likely to take the same measures as the detection of Azido impurities in September. If exchanged at a pharmacy according to patient needs, it will be changed to a normal lot number, and 110% of the drug price will be added to the drug price to settle by the pharmaceutical company. Since the Korean Pharmaceutical Association already has a related system and the exchange rate was low earlier, it is expected that there will be few problems with the exchange again this time. In the case of re-prescription, it will be a method in which the pharmaceutical company that received the claim details is reimbursed to the nursing institution every month. When a hospital or clinic re-prescribes the remaining amount of the patient's possession, the pharmacy proceeds with the claim through the existing claim program. It plans to assign a specific code to claims for re-dispensing. The HIRA and the NHIS check and deliver them to pharmaceutical companies every month. Since then, pharmaceutical companies have to pay hospitals, pharmacies, etc. within a set period (about a week). Detailed guidelines for the payment of expenses to nursing institutions of pharmaceutical companies are expected to be guided by the government through a confirmed guide. If mixed preparation is performed with powdered medicine, it is expected that drugs other than those subject to recovery will be exchanged. The size of the impurity detection items finally announced by the migrant government is expected to determine the impact on pharmacies.
- Policy
- KB Pharm's generic for Vildagliptin nitrate will be approved
- by Lee, Tak-Sun Dec 06, 2021 05:54am
- The post-inflammatory drugs of the diabetes treatment Galvusmet (Vildaglipin-Metformin Hydrochloride), which the Supreme Court ruled invalidating part of its extended duration, are appearing one after another. These items will be able to be released early in January next year if some of their duration is confirmed to be invalid. On the 30th of last month, three dosage products of Vildagliptin-Metformin HCl, a compound of KB Pharm, were approved. It is the seventh company to launch generic for Galvusmet. However, this is the first salt-changing drug containing Vildagliptin nitrate. Pharmaceutical companies participated in the development one after another. At first, only An-gook and Hanmi Pharm, which claimed invalidation of their duration, were developed, but when the Patent Tribunal achieved results, KOREA UNITED PHARM and KB Pharm also participated in the development. The lawsuit for invalidation of the extension of the duration ended on October 28 when the Supreme Court recognized 55 of the 1,068 extended days as invalid. If some of the invalidity of the duration is finalized, material patent of Galvusment will expire on January 9 next year. In this case, other pharmaceutical companies that have not participated in the lawsuit can also launch products on the market as their substance patents are terminated. Currently, generics for Galvusmet have been approved by Hanmi Pharm, KOREA UNITED PHARM, Ahn-gook, Ahn-gook Newpharm, Shinpoong, Samjin, and KB Pharm. However, Hanmi Pharmaceutical and KB Pharm are the only pharmaceutical companies that have been approved for three doses. The rest of the pharmaceutical companies were granted only 50/500 mg. In the case of generic for Galvusmet, there are no restrictions on selling products because there are no products that have received general for inclusion. In the case of single-drug Vildagliptin, Ahn-gook Newpharm has acquired generic for exclusivity, and the same drug will be banned from selling until May 29, 2022. Last year, Galvusmet recorded 36.4 billion won in outpatient prescriptions, continuing its popularity in the diabetes treatment market. Competition is expected to intensify when the generic market opens next year.
