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- 2025-12-24 10:01:32
- Policy
- Bayer begins development of high-dose of Eylea
- by Lee, Tak-Sun Aug 14, 2020 06:21am
- #The competition between Bayer and Novartis for the treatment of age-related macular degeneration (AMD) is intensifying. After Novartis recently received approval in Korea for a new drug 'Beovu', which improved the number of doses, Bayer also began to develop a high-dose of Eylea that extended the dosing period. On the 11th, the MFDS approved a multinational phase III clinical trial plan for 'High-dose of Aflibercept' applied by Bayer Korea. Aflibercept is generic name for Eylea. Eyleais a product that is injected once every two months (8 weeks), and is the No. 1 item in the market, recording ₩46.8 billion based on IQVIA last year. The next ranking is Novartis' Lusentis, which recorded ₩30 billion, which has to be given an injection once every 4 weeks, which is less convenient than Eylea. However, Novartis was approved for Beovu inj and Beovu PFS in June and July, but because BioVu is injected once every 12 weeks, it is showing superiority in the number of doses per year than Eylea. If BioVu is released on reimbursed item, it is expected to compete with Eylea. Bayer is also preparing the ace in the hole against Novartis. It is reported that the high-dose of Eylea, which has been approved for phase III clinical trials this time, is being developed in a manner that is injected once every 12 weeks, like Beovu. Macular degeneration, which can cause loss of vision due to damage to the macular area of the eye, is known as the number one cause of blindness in the elderly. As such, there is a lot of demand for treatment. In particular, biosimilar products are also being developed, which is expected to intensify market competition in the future.
- Policy
- 1 out of 8 Koreans prescribed with narcotic anti-anxiety
- by Lee, Tak-Sun Aug 14, 2020 06:21am
- In last year alone, one out of eight people in South Korea have been prescribed with narcotic anti-anxiety medications. On Aug. 12, Ministry of Food and Drug Safety (MFDS) informed a pamphlet on ‘Safe Use of Narcotic Anti-anxiety Medication’ would be disseminated with the relevant information found from its big data analysis on the use of narcotic anti-anxiety medications reported to the Narcotics Information Management System for year from April 2019 through March 2020. The informational pamphlet allows a prescriber to self-diagnose over-prescription of the narcotic anti-anxiety medication by comparing their number of patients with the medication prescription and the volume against the overall statistics. The pamphlet would provide 12 types of information to healthcare providers including overall prescription statistics (number and volume of prescription), top disorders and substances prescribed, comparison on prescription volume per patient, age limit on prescription, and overall prescription volume rank. In the past 12 months, total 6.6 million patients were prescribed with narcotic anti-anxiety drugs, which is about one-eighth of the population. In particular, more female patients (63.4 percent) were prescribed with the medication than male patients (36.6 percent), and the age group of 60s was using the medication the most (20.4 percent). Diazepam (3.19 million), alprazolam (2.66 million) and lorazepam (1.14 million) were the most prescribed substances, and total 1.05 million patients (15.9 percent) were prescribed with medication with a warning for either elderly patients or specific age group. MFDS official also stated the pamphlet would include information on propofol, zolpidem and appetite suppressant to promote adequate prescription of those narcotic medications. The official added an online pamphlet system would be established as well by coming December to provide prescription statistics and information to more medical professionals.
- Policy
- The right age to use KRW 2.5 billion SMA drug Zolgensma
- by Lee, Tak-Sun Aug 13, 2020 06:27am
- Novartis Prior to the South Korean health authority’s approval on Zolgensma, known as the most expensive drug in the world, Central Pharmaceutical Affairs Deliberation Committee discussed the appropriate age of the drug user. The manufacturer Novartis has applied for an indication to treat patients under the age of two, but the committee concluded the age bracket should be lowered due to lack of clinical data. Unlike the U.S. and Japanese health authorities indicated the drug to be used on children under age two, the Korean health authority would likely to indicate the drug to treat infants under one year or six months. The Ministry of Food and Drug Safety (MFDS) disclosed the minutes from Central Pharmaceutical Affairs Deliberation Committee meeting in last May discussing the designation of Zolgensma as an orphan drug. Developed by Novartis, Zolgensma is a spinal muscular atrophy (SMA) treatment and the company priced the drug initially at 2.5 billion won, which gave the drug the title of ‘the most expensive drug in the world.’ The U.S. Food and Drug Administration (FDA) granted approval on the drug in May last year. In Korea, Novartis Korea has submitted the health authority approval application in last February and it awaits the final approval. SMA is an autosomal recessive genetic disorder caused by mutations in survival motor neuron 1 (SMN1) gene that encodes the SMN protein. It is a severe disease that usually occurs in infants, which leads to death. The diagnosed patients are in dire need of treatment at the moment. Categorized into three types, the two-thirds of type 1 result in death before the age of two, and type 2 patients may survive until pre-school, but most of them needs assistance in wheelchair due to muscular disability. Infants with type 3 seem normal but the disease advances slowly. At the moment, the existing SMA treatment in the market is Biogen’s Spinraza. Approved in 2017, Spinraza was also a vastly expensive drug priced at about 100 million won per administration. Although Spinraza has to be administered three to four times a year for a number of years, Zolgensma is a gene therapy administered only once. In last May, Central Pharmaceutical Affairs Deliberation Committee reviewed the subject patient’s age and treatment initiation period as requested by Norvatis. The company suggested using the drug on SMA patient under the age of two, but the committee members were against it. A committee member noted, “For clinical purposes, a variety of options is always welcomed, but Spinraza has been developed and the government should carefully decide whether to indicate the drug for ‘age under two’ or not, as the long-term clinical data on the drug’s efficacy and safety are insufficient.” Another committee member explained, “It would seem more appropriate to set the subject patient’s age as under one year or six months.” The chair of the committee also said the manufacturer’s request was not appropriate, so the patient age and type should be limited more. Instead of conventionally deciding the treatment period based on the types, the committee saw it would be appropriate to use a new categorization to administer the drug in patient with or without the symptom (diagnosed by gene testing). The committee also urged MFDS to consider the drug significantly improving the convenience of administration method as a gene therapy, although it cannot clearly prove improvement in safety and efficacy compared to the existing treatment option. Currently, about 17 patients under the age of two are diagnosed with SMA annually in Korea. The next concern for the drug is its high price. As the reimbursement listing process for Spinraza was a long and tough race, the health insurance authority would also have to expect the world’s most expensive Spinraza to bring even a tougher process.
- Policy
- There are 13 COVID-19 treatments in domestic clinical trials
- by Lee, Tak-Sun Aug 13, 2020 06:25am
- Currently, there are 9 antiviral drugs and 4 immunomodulatory drugs for COVID-19 treatments currently in clinical trials in Korea. As antiviral drugs and immunomodulatory drugs have different mechanisms of action, treatment methods are also different. The MFDS said that two clinical trials (Rebif, GX-I7) were added since the announcement on July 22, and a total of 20 (18 treatments and 2 vaccines) were approved in Korea by the 11th. Of these, five clinical trials for treatment have ended and there are currently 15 clinical trials in progress (13 treatments and two vaccines). COVID-19 treatments that have been developed so far are largely divided into 'antiviral agents' and 'immunomodulators' depending on the mechanism of action. Antiviral drugs are most commonly developed as medicines that remove viruses that cause infection. A representative example is 'Remdesivir', which was recently approved. Immunomodulators are drugs that show therapeutic effects by regulating the immune function, and are being actively developed as the main cause of death of COVID-19 patients is acute respiratory distress syndrome (ARDS), which causes excessive immune and inflammatory reactions. Antiviral drugs remove or weaken the virus in order to block the infection of the virus that has entered our body. Looking at the virus' infection process, the virus introduced into the human body penetrates into cells through receptors on the cell surface, creates a large number of new viruses in the cell, and the newly created virus comes out of the cell and penetrates into other cells, Antiviral agents that are currently being developed show an effect by blocking the path through which the virus penetrates into the cell during this process or by blocking the proliferation process that makes genetic material within the cell. Alvesco, Levovir, Pyramax, Nafamostat (Futhan, CKD-314), Camostat (CG-CAM20, DW1248), CT-P59, and Interferon (Rebif), which are currently in clinical trials, are expected to block the COVID-19 virus. In the case of 'Alvesco', it is expected to exhibit both antiviral and anti-inflammatory mechanisms of action. Immunomodulators include anti-inflammatory and immune enhancing agents. Anti-inflammatory drugs suppress the inflammatory response by regulating excessive immunity caused by COVID-19 infection. When the immune response occurs excessively due to infection by the virus, a lot of substances (cytokines) that cause inflammation are secreted, and the inflammatory response increases abnormally, damaging normal cells such as lung tissue, leading to acute respiratory distress syndrome, resulting in insufficient oxygen in the body. Anti-inflammatory drugs prevent damage to normal cells by inhibiting substances (cytokines) that cause excessive inflammatory reactions, such as 'Baricitinib, Ferodil, EC-18, and Alvesco', which are currently in clinical trials. On the other hand, an appropriate immune response inhibits viral proliferation and removes cells infected with the virus, and it is reported that some patients with low immunity are vulnerable to virus penetration. In this case, immunity enhancing agents that increase autoimmunity can help prevent or recover from disease progression, and 'GX-I7' is currently approved for a clinical trial plan based on this mechanism. Antiviral drugs such as Ivermectin, Camostat, and Interferon, and immunomodulatory drugs such as Dexamethasone, Tocilizumab, and Sarilumab are being developed for the treatment of COVID-19 abroad. An official from the MFDS said, "We will continue to monitor development trends such as clinical trials of COVID-19 treatments and vaccines, and based on this, we can provide support for items required for domestic introduction, special imports, etc., and we plan to do our best to guarantee the treatment opportunities for our people."
- Policy
- 74% relying on imported substance at risk amid COVID-19
- by Lee, Jeong-Hwan Aug 13, 2020 06:25am
- While the domestic self-sufficiency of pharmaceutical substance has been constantly falling and 74 percent of the industry is relying on overseas-imported substances, experts warn the South Korean pharmaceutical industry may be at risk when the substance supply gets unstable amid COVID-19. They advise the Korean government should set out a plan to promote diversification of overseas substance supplier and domestic manufacturing of essential substances, as well as to tighten safety management of the imported substances. The experts also recommended the government to work on preventive measures as they had to revoke approved licenses on biopharmaceuticals like Kolon Life Science’ Invossa and Medytox’ Meditoxin. On Aug. 10, the National Assembly Research Service published Health and Welfare Committee edition of ‘National Assembly Audit Issue Analysis 2020’ and gave advices to the government. ◆Dependency on imported pharmaceutical substance worsens: Pharmaceutical substances can be categorized either as an ‘active pharmaceutical ingredient (API)’ expressing the drug effect or an ‘intermediates’ essential for making APIs. In last five years, Korea has been manufacturing 31.8 percent, 24.5 percent, 27.6 percent, 35.4 percent and 26.4 percent of pharmaceutical substances in year 2014 through 2018, respectively. Korea’s pharmaceutical substance dependency on imported substances is as high as about 74 percent. As of 2018, Korea has imported 33 percent of substances from China and 9.5 percent from India. The Research Service predicted the pharmaceutical substance supply in Korea would suffer a major setback if COVID-19 pandemic lingers longer and disturbs the supply. In fact, Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) conducted a survey in last February and reported Korean pharmaceutical and bio companies have stocks of pharmaceutical substances lasting two to four months. In particular, the Research Service pointed out carcinogen contamination incidents occurred as the pharmaceutical companies neglected safety management in pharmaceutical substances although it can critically affect quality and safety in finished products. In November 2019, Ministry of Food and Drug Safety (MFDS) has fully investigated valsartan, ranitidine and nizatidine when impurity in synthetic substances was discovered. The National Assembly experts evaluate the pharmaceutical substance suppliers should be diversified and essential substances should be encouraged to be manufactured domestically. And they also advised the Korean pharmaceutical industry to enhance safety measure in imported substances as the industry is heavily dependent on overseas suppliers. The National Assembly Research Service recommended, “Some criticizes it is an excessive action to strengthen the management of substances imported from China and India, because of their low significance and risk. But if the pandemic prolongs or another novel infectious disease breaks out, then the lack of good quality substance supply could delay production of finished products in Korea,” therefore, “The government should induce the industry to diversify overseas suppliers to maintain a good flow of supply and to manufacture essential substances.” The researchers added, “MFDS has disclosed plans to reinforce imported pharmaceutical substance safety control by introducing pre-registration system on overseas substance manufacturer to confirm Good Manufacturing Practice (GMP) compliance and to perform on-site investigation for quality control and management,” and “These pharmaceutical substances need more attention as the industry is relying heavily on India and China for importation of 715 cases (25.6 percent) and 227 cases (9.9 percent), respectively.” ◆Tightening pharmaceutical assessment procedure: The National Assembly Research Service has also urged the government to draw up a plan to prevent incidents like revoking the license on osteoarthritis gene therapy Invossa and botulinum toxin medicine Meditoxin for manufacturing and selling drugs different from the verified item. The investigators not only reprimanded Kolon Life Science and Medytox for their unethical practices, but also criticized MFDS’ verification procedure. Accordingly, MFDS presented their plan to strictly investigate and penalize such data manipulation cases with zero tolerance policy. The researchers, however, pointed out the impact on patients’ safety should not be ignored regardless of MFDS stating the safety in Invossa and Meditoxin should not be a problem. As a solution, the researchers recommended the government to tighten the GMP compliance management and adding more information on precautions when license revocation and recall recurs. The National Assembly Research Service noted, “MFDS aims to conduct a randomized investigation even on drugs with first tier toxicity risk level to prevent data manipulation, and also raise the severity level of penalty on companies financially benefited from an item approved with data manipulation.”
- Policy
- 14 generics for Albendazole, were already approved this year
- by Lee, Tak-Sun Aug 12, 2020 06:00am
- Albendazole is on the rise this year. Albendazole is an anthelmintic ingredient that began to obtain domestic approval in the early 1980s, and only four products were approved from 2017 to 2019. However, as other effects other than the approval of Albendazole became known through social media, new licensed generics have rapidly increased this year. According to the MFDS, the number of Albendazole-based anthelmintic products licensed in 2020 was counted as 14 items (including two for export). There were 64 items approved as Albendazole by the 9th, and most of them were approved before 2010. In particular, from 2017 to 2019, there were only 4 licensed items. There are so many items, and the market size is limited, so the number of new items has not been much since 2010. However, this year, Albendazole has become so popular that there are out of stock, and attracting the attention of pharmaceutical companies. This is due to a phenomenon that occurred when rumors, such as that Albendazole has anticancer effects, spread through SNS such as YouTube. Following anthelmintic 'Fenbendazole' for dogs in last year, 'Albendazole' in this year has become the center of this phenomenon. Moreover, as information that it is effective against the COVID-19 spreads, sales volume is increasing rapidly this year. In particular, Albendazole is an over-the-counter drug, and because it can be easily purchased at pharmacies, more and more people believe in rumors to purchase. As demand exploded, it was difficult to obtain Albendazole at pharmacies for the past six months. Albendazole's popularity has not declined, even though the MFDS and the Medical Association warned in January that its use for purposes other than treating parasitic infections was very inappropriate. The MFDS said, "Albendazole is a drug that is approved for short-term use for anthelmintic purposes. It is not safe for the human body when taken for a long period of time. There is a risk of fatal side effects or seriously impairing the effectiveness of the existing treatment. Patients undergoing treatment for severe diseases such as cancer or chronic diseases such as diabetes are at risk of causing fatal side effects or seriously impairing the effectiveness of the existing treatment.” However, it is analyzed that the existing Albendazole supply shortage continues, and new product approvals are being followed.
- Policy
- Genexine, conducts clinical trials of 'GX-I7'
- by Lee, Tak-Sun Aug 12, 2020 05:59am
- #Interleukin-7 anticancer drug candidate, being developed by Genexine, will conduct a clinical trial in Korea in patients with COVID-19. The MFDS announced on the 7th that it has approved a phase I clinical trial plan for 'GX-I7', a domestically developed COVID-19 treatment. As a result, there have been a total of 15 clinical trials (13 treatments, 2 vaccines) of treatments and vaccines currently in progress in Korea related to COVID-19. 'GX-I7', which was approved this time, is a 'gene recombined human interleukin-7' drug that is being developed as a new anticancer drug by 'Genexine' and was developed through drug Repositioning. The product will be evaluated for safety in a clinical trial in healthy people at the time of development of the anticancer drug, and in this clinical trial, the safety and preliminary efficacy will be evaluated in patients with mild COVID-19 infection. GX-I7 increases autoimmunity by proliferating immune cells (T cells) of COVID-19 infected patients, preventing serious progression or helping recovery. 'Interleukin-7' developed by company R in the United States is undergoing clinical trials in patients. An official from the MFDS said, "As there is great public interest in the development of COVID-19 treatments and vaccines, we will continue to promptly deliver information on the status of clinical trials of domestically developed products. We plan to support as much as possible so that it can be developed quickly.”
- Policy
- Administrative court rules against Lilly on Forsteo pricing
- by Lee, Tak-Sun Aug 11, 2020 06:03am
- The administrative court rejected Lilly Korea’s litigation against the government-authorized drug pricing reduction ordered due to the reimbursement listing of biosimilar. Lilly argued Daewon Pharmaceutical’s biosimilar Terosa cannot be considered equivalent to its original drug, the court rejected the argument. Accordingly, the upper limit pricing of Lilly’s original Forsteo would be lowered by 30 percent. Terosa and Forsteo are indicated to treat patients with osteoporosis. A pharmaceutical industry source reported on Aug. 10 that the Seoul Administrative Court ruled in favor of Korea’s Ministry of Health and Welfare (MOHW) on July 30 for the litigation filed by the company to revoke the ministry’s order to lower the upper limit pricing. MOHW has initially pre-announced its plan to bring down Forsteo’s (teriparatide) upper limit pricing from 326,358 won to 228,451 won as of last March. The pricing reduction was decided as a biosimilar version of the original was listed for healthcare reimbursement. In October last year, Forsteo’s biosimilar version by Daewon Pharmaceutical Terosa passed the government’s review and received the reimbursement in February. Opposing against the decision, Lilly requested a reevaluation but the company took the case to the court when Health Insurance Review and Assessment Service (HIRA) dismissed the request. The pricing reduction order has been postponed until Aug. 24 as the court accepted the request to halt the administrative action before the case concludes. At the court, Lilly consistently claimed the government’s action to lower Forsteo was unjust as the original is different from Terosa. Specifically, the company pointed out the two drugs hardly share the same substance and structure as they have different host and vector. However, the court ruled against Lilly’s claim by referring to the equivalence test conducted with the reference drug based on Ministry of Food and Drug’s (MFDS) standard. The court also elaborated it would be reasonable to evaluate the two drugs demonstrate equivalent effect and benefit from equivalent pharmacological mechanism with equivalent active pharmaceutical ingredient. In last May, Daewon Pharmaceutical released Terosa to the market. IQVIA data found Forsteo is a blockbuster drug that has generated 21.7 billion won last year. When the pricing reduction is enforced, the sales revenue would unavoidably drop as much as the decrease in pricing. And with Terosa entering the competition, Forsteo may lose its upper hand in the market.
- Policy
- GC Pharma begins clinical trial for new type of Fenofibrate
- by Lee, Tak-Sun Aug 11, 2020 06:03am
- In the triglyceride treatment market, GC Pharma, which is running on top of the Fenofibrate 'Lipidil supra', has begun clinical trials for a new formulation of the same ingredient. It seems to be an attempt to improve the shortcomings of Lipidil supra, which should be taken after meals. The MFDS approved a phase I clinical trial protocol to evaluate the safety and pharmacokinetics of GC7009 in healthy adult volunteers submitted by GC Pharma on the 3rd. GC Pharma used Abbott's Tricor 145mg as a reference drug in this clinical trial. Tricor 145mg is a new formulation of Fenofibrate that was approved in 2004, and unlike conventional formulations, it is absorbed quickly in the gastrointestinal tract, so it can be taken regardless of meal. However, existing Fenofibrates such as Lipidil supra are mainly 160mg, and must be administered orally immediately after meals to promote absorption. In order to improve these disadvantages, Hanmi and Daewon have released improved new drugs that can be taken regardless of meals. The drugs are Hanmi's Fenocid ( Fenofibric acid) and Daewon's 'TG Fenon' (Fenofibrate choline). Looking at the amount of outpatient Rx for the first half of 2020, based on UBIST, Lipidil supra recorded ₩7.7 billion, Fenocid ₩4.8 billion, and TG Fenon ₩4.9 billion. In particular, Fenocid and TG Fenon continued to grow after their launch in 2013 and 2017, respectively, putting pressure on the No. 1 item, Lipidil supra. Lipidil supra is a drug introduced from Abbott. GC Pharma is continuing its relationship with Abbott by selling Abbott's licensed Simvastatin-Fenofibrate combination 'Cholib'. Cholib’s Fenofibrate 145mg can be taken regardless of meals. Previously, Abbott had been approved for 'Trilipix' of Fenofibrate choline that can be taken regardless of meals in Korea, but it was withdrawn due to termination of the expiration date in January 2018. Daewon’s TG Fenon is a product that has been improved from Trilipix capsules into tablets. GC Pharma submitted a plan to conduct this clinical trial in 40 healthy adults from this December to next December. If GC Pharma has Fenofibrate tablets that can be taken regardless of meals, it is expected that it will be able to dominate the competition between Hanmi and Daewon and continue its market position established as Lipidil supra.
- Policy
- The HIRA deliberated on benefits for Rinvoq & Kisqali
- by Kim, Jung-Ju Aug 11, 2020 06:02am
- The HIRA (Director Sun-min Kim) deliberated on the adequacy of benefits for these two new drugs at the Pharmaceutical Benefits Advisory Committee held on the 6th and concluded that AbbVie Korea's new drug for rheumatoid arthritis 'Rinvoq ER 15mg (Upadacitinib)' was to be eligible for reimbursement, and Novartis’ advanced or metastatic breast cancer drug 'Kisqali 200mg (Ribociclib)' gives reimbursed benefit if the evaluation amount is received or less. Rinvoq ER 15mg is a drug used for the treatment of moderate to severe active rheumatoid arthritis in adults who do not respond adequately to one or more antirheumatic drugs (DMARDs) or tolerate it. It is a drug that is administered orally at 15mg once a day regardless of meals, and its ease of use is improved compared to the TNF alpha-blocking injection, which is often used in patients with rheumatoid arthritis. The drug has proven effective in patients with rheumatoid arthritis in 5 cases of phase III clinical trials. In addition, it showed a better response rate compared to control drugs such as MTX monotherapy or placebo group. Kisqali 200mg was approved in Korea on October 30 last year as a combination therapy ▲with aromatase inhibitors as the first endocrine therapy in pre-menopausal, postmenopausal, or postmenopausal women, ▲ with Fulvestrant when the disease progresses after the first endocrine therapy or endocrine therapy in postmenopausal women in advanced or metastatic breast cancer patients with hormone receptor (HR) positive and human epidermal growth factor receptor 2 (HER2) negative. According to this result, Rinvoq ER 15mg will immediately enter into a drug price negotiation with the HIRA in accordance with the order for drug price negotiations from the MOHW. They may step on or remain non-reimbursed or challenge themselves to be reimbursed again.
