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- 2026-04-14 06:50:27
- Company
- Hemlibra & Afstyla were released
- by Kim, Jin-Gu Jul 06, 2021 05:50am
- Domestic pharmaceutical companies have challenged the hemophilia treatment market one after another. JW Pharma released Hemlibra and SK Plasma released Afstyla in the last year. The domestic hemophilia treatment market is maintained by GC Pharma and Takeda. While Bayer, Sanofi, and Pfizer, which have challenged the market in the past, are struggling, attention is focusing on whether domestic pharmaceutical companies will produce meaningful results. ◆GC Pharma is virtually monopolizing the domestic market with a size of ₩230 billion According to the pharmaceutical industry on the 30th, SK Plasma started selling Afstyla to major general hospitals in South Korea after entering its benefit early this month. SK Plasma is a company that specializes in blood products that were separated from SK Chemical in 2015. In 2009, SK Plasma exported the drug, which was a candidate material at the time, to Australian pharmaceutical company CSL Behring. The development was completed by CSL Behring. SK Plasma CEO Kim Yun-ho (left) and CSL Behring Korea CEO Son Ji-young are signing a sales contract for Afstyla Prior to SK Plasma, JW Pharma has entered this market. JW Pharma was approved by Japan's Chugai Pharmaceutical in January 2019. It released its products in earnest in May last year. The two companies should target the hemophilia treatment market, which is dominated by the GC Pharma. The domestic hemophilia drug market is effectively monopolized by GC Pharma. GC Pharma co-sells its own items, GreenMono and Greenene F, as well as Takeda's Advate and Adynovate. They are all top sales products. Pharmaceutical industries estimate size of South Korea's hemophilia treatment market is about ₩230 billion. Among them, four products sold by GC Pharma are estimated to generate sales of ₩140 billion to ₩150 billion. ◆ Hemophilia medicine must be passed by the committe of the Korea Hemophilia Foundation Pfizer, Sanofi, Bayer and others challenged this market before JW Pharma and SK Plasma. Except for Pfizer, however, their performance does not meet expectations. This is because the proportion of prescriptions through the Korea Hemophilia Foundation is large. The Korea Hemophilia Foundation, which consists of patients with hemophilia, operates a separate drug review committee. This Committee shall deliberate on medicines that may be prescribed by members of the Foundation. It is necessary to pass this committee to prescribe. The drugs currently being prescribed by an associate doctor are Adynovate and Adynovate in Takeda, GreenMono in GC Pharma, Greengene F and Xyntha Solofuse in Pfizer. Bayer's Kogenate FS and Sanofi's Eloctate failed. Kogenate FS and Eloctate are prescribed only in general hospitals, which account for 40% of the total market. Bayer and Sanofi are not making as much sales as expected. Pfizer's Xyntha Solofuse took nearly five years to be reviewed after its release in 2014. "The domestic market for hemophilia is called the tomb of a new drug," said PM, a global pharmaceutical company. "That's how hard it is to overcome the wall of the Korea Hemophilia Foundation." ◆JW Pharma and SK are targeting general hospitals first In the case of Hemlibra and Afstyla, sales can be stable only after passing the Korea Hemophilia Foundation's deliberation committee in the long term. The two companies are not planning to directly target the Korea Hemophilia Foundation. JW Pharma emphasizes the advantages of SC (subcutaneous) injection for general hospitals and it emphasizes that administration is possible regardless of whether antibodies are produced or not. Patients also have high expectations for this. Hemlibra is the first SC formulation. Existing patients had to find their own veins and inject themselves. Moreover, many of the patients were children, making them uncomfortable. JW Pharma said it is convenient to inject under the skin, not by finding and injecting blood vessels on its own. Hemlibra has limited benefit standards. The National Assembly pointed out, and the MOHW said it would reconsider expanding the benefit range. SK Plasma is planning to focus on targeting general hospitals. SK Plasma is said to have started marketing activities at major general hospitals at the time of the release of Afstyla. "We have no specific plans right now, such as sponsorship for the Korea Hemophilia Foundation," an official at SK Plasma said. "We plan to focus on expanding our influence in general hospitals."
- Product
- AZ-Pfizer vaccine mix is "confirmed safe and effective"
- by Jul 05, 2021 05:54am
- With community pharmacists who have received their first vaccination of AstraZeneca’s COVID-19 vaccine awaiting their second jab with the Pfizer vaccine this month, the health authorities announced that there are no safety concerns regarding the ‘mix-and-match' of the vaccines. The authorities explained that though mild side effects were observed, no severe adverse events were reported after receiving the vaccine mix, therefore, there are no safety issues pertaining to mixing doses of the two vaccines. Guidelines with the said information was issued by the COVID-19 Vaccination Promotion Team in response to the safety concerns raised by some ahead of the ‘temporary mixed-dose inoculation’ that will be provided to the 76,000 people who are working in vulnerable facilities, flight attendants, healthcare workers, and essential workers that already received their 1st dose with the AstraZeneca vaccine from April to May. The move for this mix and match schedule passed deliberation of the Korea Advisory Committee on Immunization Practice (KAICP) with a review on the efficacy and safety of the mixed-dose vaccination to address the delay of the 835,000 vaccine doses that were initially scheduled to arrive by the end of June through the COVAX facility. In other words, the mixed two-dose schedule that uses the Pfizer vaccine as a second dose is a temporary measure decided upon in consideration of the current supply shortage. Community pharmacists under the age of 50 (born after January 1st, 1972) who already received their first vaccinations will have to receive their second shot with the Pfizer vaccine due to age restrictions that were set on using the AstraZeneca vaccine. However, pharmacists who are 50 years or older (born before December 31st, 1971) may receive the AstraZeneca vaccine if they desire. Reservations for the second dose are automatically made to the same institution at which the individual received their first dose, on the 7th day of the 11th week after his/her first vaccination. Individuals may change their vaccination date in the 11th-12th week period after their first vaccination. They may postpone the date by 1 week at most from the originally scheduled date, and it may not be pulled forwarded to an earlier date. “Other countries such as Germany, France, Canada, Norway, Sweden have been recommending mixing use of mRNA vaccines to those who were first vaccinated with the AstraZeneca vaccine. Also, the safety and efficacy of using the Pfizer vaccine as a second dose was confirmed in people who were first vaccinated with the AstraZeneca vaccine in Canada and Spain,” said the COVID-19 Vaccination Promotion Team. Studies from Spain and Germany have shown that vaccinating with the AstraZeneca-Pfizer mix showed a better immune effect with increased neutralizing activity against the COVID-19 variants than one or two shots of the AstraZeneca vaccine. The team added that a study on this mixed-dose vaccination is also currently underway in Korea and that the initial results will be shared in early July. Regarding the adverse events of the dose-mixing, the team added, “Dose-mixing studies abroad have shown that fever increased when the AstraZeneca vaccine was administered first and followed by Pfizer compared to when a same vaccine was administered both times. The results were also the same for the occurrence of mild adverse events such as fatigue, injection site pain, headaches, and muscle pain, but no serious abnormalities were confirmed." The inoculation schedule for the administration of the mixed second dose will follow the period set during the first vaccination. The mix currently planned is the 1st AstraZeneca-2nd Pfizer vaccine mix, and will be administered with an 11-12 week dosing interval according to the AstraZeneca vaccine’s dosing interval. People who must postpone receiving their second shot while following the AstraZeneca-AstraZeneca vaccine schedule are recommended to receive their shots within 16 weeks, which means the second dose should be administered from July 26th to July 31st. In cases where ‘an individual does not receive their second dose due to fear of mixing vaccines,’ the team said, “The second vaccination, as in the first vaccination, will be administered based on each individuals’ consent, so we cannot force an individual to vaccinate with a different vaccine if he/she is not comfortable receiving the AstraZeneca-Pfizer mix. Those who wish to receive the AstraZeneca vaccine rather than Pfizer’s may be able to receive their shots after August 1st, depending on the supply situation.”
- Opinion
- [Reporter’s view] Request for suspension of execution
- by Kim, Jin-Gu Jul 05, 2021 05:54am
- The MOHW has announced that it will improve the system so that drug costs paid during the suspension of the enforcement of the drug reduction can be recovered. The plan calls for improvements to numerous revocation litigation and request for suspension of execution. request for suspension of execution in drug prices includes a lawsuit filed by pharmaceutical companies to cancel the reduction after the MOHW announced a reduction in the upper limit of insurance benefits. Pharmaceutical companies request for suspension of execution in the reduction of the drug price until the results of the lawsuit are released. The court accepts the request for suspension of execution. It follows the outcome of Lawsuit on the Merits. Each time the request for suspension of execution is repeated. The court accepts as well. This process takes up to five years. The court cites most of the request for suspension of execution because the outcome of lawsuit on the merits is unclear. So far, the only case in which the application for suspension of execution has been rejected is the case of a reduction in eyedrops. For pharmaceutical companies, the suspension of investment citation is as important as drug price reduction. The drug price maintained during the proceedings is much higher than the cost of the lawsuit. If pharmaceutical products with annual performance of ₩50 billion are subject to a reduction due to the launch of generics, they can keep more than ₩70 billion for five years during the lawsuit. Even if a pharmaceutical company loses at lawsuit on the merits, it already benefits enough. The pharmaceutical industry opposes the government's announcement of system improvement. It is argued that it is unconstitutional for the administration to effectively restrict the rights guaranteed by the judicial system. It is argued that the MOHW should not arbitrarily judge whether pharmaceutical companies abuse the disposition of the reduction of drugs. In April, the Supreme Court sided with the original company in patent suit of Eliquis. Generics were released based on the verdict of the first trial, and the reduction of drug price was taken accordingly. The MOHW is aware of this situation. "We are considering compensation for damages and recovery at the same time. "If it is not systemized, we will consider more ways to respond to the lawsuit results." The pharmaceutical industry should look at why the MOHW is worried. The MOHW believes that there are too many applications for suspension of execution. It is judged that pharmaceutical companies are abusing their rights guaranteed by the judicial system. The pharmaceutical and distribution industries believe that there is a lot of confusion in this process. The MOHW stresses, "So far, the government has never lost in a drug-price lawsuit." The pharmaceutical industry should think about why the MOHW is even reforming the system by limiting its jurisdiction.
- Policy
- Suspension of Execution for Xarelto price cut continues
- by Kim, Jung-Ju Jul 05, 2021 05:54am
- Despite the two price cuts that were previously notified from the ex officio adjustment and expiry of the premium pricing application period, the price of the 4 strengths of Bayer Korea’s Xarelto tab. products will continue to be maintained as is for the time being. The company, which filed a suit against the government regarding the price cut, also requested for a suspension of execution of the price cut during the trial period, which the court accepted. On the 2nd, the 11th division of the Seoul High Court ordered the suspension of execution of Xarelto’s price cut until the 30th day from the date of the judgment made for the case the company filed against the Ministry of Health and Welfare to cancel the price cut disposition for Xarelto (No. 2021 Guhap 765811). The suit was filed after the Ministry of Health and Welfare included the 4 strengths of the Xarelto tab. products as items that will undergo price cuts as an ex officio adjustment and be up for termination of premium pricing in May. The government has been making ex officio adjustments to the original drug as well as the generic with the same route of administration, ingredient, and formulation when generics are listed. When the first generic is listed, the price of the original is adjusted to 53.55% of the original price but given a premium of 70% of the original price for 1 year. Previously, the government had issued a notice confirming the price cut of Bayer Korea’s Xarelto, effective as of June 1st. Prices of Xarelto tab. (rivaroxaban) 10mg, 20mg, 2.5mg were to be cut by 30% each, and then further lowered by 23.5%-23.6% one year later, from May 1st, 2022. With the court's decision to suspend execution, the drug price of the Xarelto tab. will remain the same for the time being, and no change will be made in medical institutions as well. However, if the government wins the case, the price cuts will again be in effect, which will once more be restored to the original price if the company appeals the case. Therefore, the possibility of price fluctuation remains. According to the government, the MOHW has never lost drug price-related lawsuits like Xareolto's. Due to this, price fluctuation of drugs during the back-and-forths has been trending in similar suits. The MOHW announced that the price maintenance will be applied as of the 2nd and that the ministry will share additional information if any further changes are made.
- Company
- Ipsen established a union led by MZ generation
- by Jul 05, 2021 05:54am
- A labor union led by MZ generation (1980-2000s) is also being established in the pharmaceutical industry. According to the pharmaceutical industry on the 2nd, a labor union consisting of Ipsen sales workers officially launched on the 2nd after reporting on the 29th of last month. The union leader is Choi Chang-woo (35 years old), a young employee who has been employed for three years. "It was established to improve the unreasonable and closed company policy implemented by senior managers," he explained. "Ipsen Korea is using sexual harassment, harassment at work, violations of the Labor Standards Act, power abuse, and disadvantages to certain employees," the union said in a statement. "We are creating working conditions and corporate culture that are inconsistent with Ipsen Global." The labor union set the goal of ▲ establishing labor's three primary rights ▲ democratization of corporate management and establishing fairness and transparency in performance distribution ▲ improving working conditions equivalent to multinational pharmaceutical companies. "The top priority is to normalize Ipsen Korea, which is operating abnormally," Chairman Choi said. "We will gradually increase the number of union members to form a majority union."
- Policy
- The price of 7 Seretide products will be reduced
- by Kim, Jung-Ju Jul 05, 2021 05:53am
- The government won the suit. But there is a possibility of change depending on the company's decision. Insurance prices for 7 items of asthma treatment Seretide by GSK will be lowered from the 2nd of next month. The government won the lawsuit against the company to cancel the reduction of the price. If the company disagrees with the ruling, there may be another change in drug prices. The sixth part of the Seoul Administrative Court sided with the MOHW in a lawsuit filed by the company. Therefore, suspension of execution, which had maintained the previous price without lowering the drug price during the lawsuit period, was lifted. The lawsuit was taken by the Ministry of Health and Welfare on June 1, 2019, in line with the end of the additional period of these products, on May 28, 2019. The company filed a suspension with the court and applied for a suspension of execution to keep the drug price intact during the lawsuit period, but it was lifted with the ruling. These drugs include Seretide 125 Evohaler(120 doses), Seretide 100 Diskus(60 doses), Seretide 250 Diskus(60 doses), Seretide Evohaler 250(120 doses), Seretide 250 Diskus(28 doses), Seretide 500 Diskus, Seretide 50 Evohaler(120 doses) . The MOHW said it would apply the reduction as of July 2 in accordance with suspension of execution. However, there is a possibility of change if the company disagrees. In response, the MOHW has decided to provide additional guidance if there is any change in the future.
- Company
- Metformin with excess NDMA was removed from the market
- by An, Kyung-Jin Jul 03, 2021 05:56am
- Most of the prescriptions for 31 types of Metformin, which had been suspended for detection of excess impurities a year ago, have disappeared. Sales of drugs, including Metformin, rose, but some companies were virtually kicked out from the market. There are many opinions that the government should take a more careful suspension of sales. According to the drug research agency UBIST on the 1st, JW Pharm's Guardmet had no outpatient prescription until May this year. It posted ₩4.2 billion in prescription performance during the same period last year, but has not sold since June. Guardmet is a combination of JW Pharma's DPP-4 inhibitor Guardlet(Anagliptin) and Metformin. Although it emerged as JW Pharma's main product as prescription performance rose sharply to ₩5.6 billion in 2017, ₩8.2 billion in 2018, and ₩9.7 billion in 2019, all three doses, including "Guardmet" 100/500mg, 100/850mg, and 100/1000mg, disappeared from the prescription market in May last year. Sales amounting to ₩10 billion a year have been lost due to unexpected detection of impurities. In the case of Hanall's Glucodaun OR, the company posted a cumulative sales of ₩3.3 billion from January to May last year, but no sales this year. Glucodaun OR has been temporarily suspended. It recorded ₩8 billion in accumulated prescriptions in 2019. The MFDS said on May 26 last year that it has temporarily suspended manufacturing and sales and imposed prescription restrictions as 31 items were found to contain excess carcinogenic N-nitrosodimethylamine (NDMA). It has been about six months since the risk of impurities erupted in Singapore. Singapore's Health and Science Administration (HSA) recalled three products in December 2019 on the grounds that more than NDMA was detected as a result of investigating 46 items of Metformin on sale locally. The MFDS is applying the maximum daily allowance of based on NDMA 96ng provisional management standards. 31 items from 22 companies, which were suspended from sale at the time, accumulated ₩10.3 billion in five months from January to May last year, but only ₩800 million this year. It is down 91.8% year-on-year. There were no sales of 25 items except for Jeil's Lipito-M, HKinno.N's Atomet SR and Daewoong Bio's Diformin XR. Products from 19 companies, including JW Pharm, Hanall and Jinyang, have virtually left the market after the impurity measures. Several companies have induced prescription changes to other drugs or similar products of their own that have not been suspended from sale. For example, Daewoong Bio's "Diaformin" made a prescription record of ₩25 million for five months this year. Although the three capacities, Diformin XR 500 mg, Diformin XR 750 mg and Diformin XR 1000 mg, were suspended for NDMA provisional over-detection, Diformin 250 mg, Diformin 500 mg and Diformin 1000 mg products were available for sale. However, compared to ₩546 million in the same period last year, the amount of prescriptions decreased 62.5% in a year. In the case of Lipito-M and Atomet, only some of them were suspended, recording prescription results of more than ₩300 million and ₩100 million, respectively, this year. Except for JW Pharma and Hanall, of course, the rest of the companies are not losing much. Of the 31 items, Hutecs' Gluless-M and Nelson's Glutamin, which were among the top prescriptions, managed to exceed ₩200 million in cumulative prescriptions by May last year. During the same period, Hanmi's Grimefol SR, Shin Poong's Dybis and Unimaryl M have less than ₩200 million in prescriptions. The prescription loss is only less than ₩1 billion. Metformin had little influence on the entire pharmaceutical market. Last year, the prescription amount of a single metformin drug was ₩77.3 billion, up 4.1% from the previous year. Considering that it increased 2.9% year-on-year in 2019, the increase was even greater. Last year, the amount of prescriptions for Metformin combined with DPP-4 inhibitors was ₩458.4 billion, up 10.5% from the previous year. Similarly, it rose 8.2% year-on-year. Despite the spread of COVID-19 infections and the detection of impurities, there was little damage to the prescription market. The reason is that discontinued products account for a small percentage of the product and that there is no drug to replace Metformin that can be prescribed for type 2 diabetics. It is diagnosed that some of the learning effects of the high blood pressure treatment Valsartan, Ranitidine, and Nizatidine have been shown to have minimal harmful effects. However, some say that the MFDS should be more careful in taking measures related to impurities. The MFDS suspended the sale of the entire product if even one lot number of NDMA excess raw material was found for Metformin agents. They say they will allow sales if the problematic product is recovered and proven suitable for carcinogens by lot numbers. However, it has been a year since the temporary suspension of sales, but it is confirmed that no companies have attempted to sell them. Due to the characteristics of generics, it is recognized that it will be kicked out of the market once it is suspended. They say that the unexpected detection of impurities and suspension of sales during manufacturing process are damaging pharmaceutical companies. An official from the pharmaceutical industry said, "In the U.S., in the case of Valsartan and Ranitidine, only the lot numbers that used impurities detection raw materials were recovered. they did not suspend sales of the entire item," He said. "We need to be more careful about temporary sales suspension measures due to the detection of impurities."
- Company
- Lilly applies for listing of its fast-acting insulin Lyumjev
- by Eo, Yun-Ho Jul 03, 2021 05:56am
- The reimbursement benefit listing process for Lilly’s fast-acting insulin ‘Lyumjev’ will begin. According to industry sources, Lilly Korea had recently applied for the reimbursement of Lyumjev (insulin lispro). The drug, which has been approved in Korea on the 28th of last month, is attempting quicker market entry using the Drug Approval – Benefit Evaluation Linkage System. Lyumjev is a mealtime insulin that contains the fast-acting active ingredient, ‘insulin lispro’ which helps patients with Type 1 and Type 2 diabetes control their high blood sugar levels after meals or maintain their blood sugar in the target range. The domestic approval of Lyumjev was based on the results of the PRONTO clinical trial program that was conducted on adult patients with Type 1 and Type 2 diabetes. The PRONTO-T1D and PRONTO-T2D trials evaluated the safety and efficacy of Lyumjev compared to Humalog in people with type 1 and type 2 diabetes, respectively. The studies were designed as treat-to-target trials in which each arm was treated to achieve the same level of blood glucose control and evaluated for other important treatment effects, such as rates of hypoglycemia and post-meal glucose control, as well as maintenance of appropriate blood sugar levels. Results from both studies showed that Lyumjev was found to be non-inferior to Lilly’s existing fast-acting insulin ‘Humalog (insulin lispro) with regard to HbA1c reduction from baseline to week 26 (primary endpoint) when administered after meals. Also, Lyumjev demonstrated a superior reduction in blood glucose spikes at both one hour and two hours after a test meal compared to Humalog. Results of Phase 1 clinical trial on Type 1 diabetes patients had also shown that Lyumjev is absorbed faster than ‘Humalog,’ ‘insulin aspart’ and ‘fast-acting insulin aspart.’ Also, blood glucose excursions over the first 3 hours after administration of Lyumjev were comparable to those in participants without diabetes.
- Company
- Takeda's Susoctocog alfa has been designated as a rare drug
- by Jul 03, 2021 05:56am
- Korea Takeda's "Susoctocog alfa," a bleeding treatment for patients with acquired haemophilia A, was designated as a rare drug by the MFDS on the 1st. Hemophilia is a major hemorrhagic disease caused by a lack of clotting factors in the blood due to mutations in genes located on the X chromosome. Hemophilia A, caused by lack of coagulation factors, accounts for about 70% of all hemophilia patients. Among them, acquired hemophilia A is an autoimmune antibody to coagulation factor VIII, which is a very rare condition in which coagulation factor VIII in the blood is suppressed and depleted, resulting in bleeding-related complications. It is reported that 0.2 to 1.48 out of 1 million people occur per year. Unlike congenital haemophilia, which usually occurs in boys, most of them appear at a similar rate for both men and women aged 65 and older. Kim Na-kyung, general manager of Takeda's Hematology BU, said, "We are pleased that the designation of rare drugs will help patients with acquired hematology A more stable treatment of the disease.""We will not only research and develop innovative treatments to positively change the lives of patients with rare hematopoietic diseases, including patients with acquired hemophilia A, but also do our best to improve the treatment environment." Rare drugs are treatments used for diseases with a population of less than 20,000 patients in Korea, meaning drugs that are used for diseases without proper treatment methods and medicines, or that have significantly improved safety or effectiveness than existing alternative drugs.
- Company
- Martín Corcoll, Boehringer Ingelheim Korea's new GM
- by Jul 03, 2021 05:56am
- Boehringer Ingelheim Korea announced the appointment of Martín Corcoll as the company’s new GM and Head of Human Pharm as of July 1st. Since joining Boehringer Ingelheim in 2006, the new GM Corcoll had accumulated extensive experience and expertise in the industry, serving in various positions and divisions for over 15 years. After graduating from the University of San Andrés in Argentina with a Bachelor’s degree in Business Administration, he obtained an MBA from ESADE Ramon Business & Law School in Barcelona, Spain. In 2006, Corcoll joined Boehringer Ingelheim Mexico as a central nervous system (CNS) and urology brand manager. After establishing a solid foothold as a cardiovascular marketing leader until February 2010, Corcoll moved on to the Boehringer Ingelheim's headquarters in Germany as a global brand manager of the company’s diabetes division. During his time in Germany, Corcoll was recognized for his expertise and successful contribution to the company’s growth in establishing international alliances for its diabetes division and leading the global launch of the company’s diabetes products. Until 2018, Corcoll served as the Marketing Head of Human Pharma at Boehringer Ingelheim Spain and oversaw the primary care and specialty care brands, after which he moved to the Austrian branch to serve as the Regional Business Manager and as became the Head of Human Pharma and GM of Boehringer Ingelheim Austria in 2019. “I am pleased to be joining Boehringer Ingelheim Korea. I had a great interest in our Korean branch as I often heard of the performance and growth it has made during my time in Boehringer Ingelheim.” said Corcoll. “Based on the company’s corporate vision, ‘create value through innovation,’ the company will strive to improve the health of our patients and animals in Korea by providing effective new drugs and healthcare solutions for diseases with a high unmet need.”
