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- 2026-04-13 23:21:32
- Policy
- Moderna apologized to the gov for the disruption in supply
- by Kim, Jung-Ju Aug 18, 2021 05:51am
- Kang Do-tae, the second vice minister of welfare, and other delegations visited the U.S. headquarters for an interview. The government visited the U.S. headquarters of Moderna that supplies the vaccine worldwide to protest against the supply disruption and ask for quick measures. The delegation, composed of Kang Do-tae, the second Vice Minister of health and welfare, and Ryu Geun-hyuk, secretary to the President for Social Policy, received an official protest and apology from the U.S. headquarters of Moderna today. After the meeting, Vice Minister Kang said, "The government asked for a faster supply of COVID vaccines," adding, "Moderna expressed its apology and promised to do its best." However, the company failed to respond to the government's request to move it up as soon as possible, so it plans to hold additional consultations. Therefore, detailed information is expected to be released on the 16th when the team returns back. "Today's meeting was an opportunity for the government and Moderna to enhance mutual understanding," Kang said. "I asked them to move up the schedule as soon as possible. We will make an official announcement after further consultation with the company after returning to Korea. Moderna is experiencing disruptions in supply not only to Korea but also to the world due to production disruptions. Some of its supplies were already delayed once last month in Korea, and this time, the supply was reduced by less than half. As a result, the government has extended the interval between 1st and 2nd vaccinations of mRNA-based vaccines such as Moderna and Pfizer from 4 weeks to 6 weeks. The KDCA signed a contract on the 13th to purchase 30 million doses of Pfizer vaccine and 30 million optional doses to secure the vaccine early. The optional doses is the amount of volume that can be added according to the mutually agreed period and conditions, if necessary. Up to 60 million batches could be supplied. In addition, 300,000 Janssen vaccines, which the U.S. government decided to donate, will arrive at Incheon International Airport on the 15th.
- Company
- Will GSK-SK Bioscience distribute flu vaccines?
- by Aug 18, 2021 05:51am
- It is not clear whether the distribution contract for Fluarix Tetra, a seasonal flu vaccine under way between SK Bioscience and GSK, will be distributed ahead of the inoculation season. According to the pharmaceutical industry on the 13th, SK Bioscience is likely not to market GSK's Fluarix Tetra this year. Sanogi's flu vaccine, Vaxigrip, is expected to be distributed only in part. Initially, SK Bioscience decided not to produce its flu vaccine SKY Cellflu this year to focus on producing COVID vaccine. Instead, it discussed a joint sales contract with its competitor GSK for Fluarix Tetra. Last year, GC Pharma distributed Fluarix Tetra. It also signed a Vaxigrip supply contract with Sanofi. If the contract is signed, SK Bioscience has planned to supply Fluarix Tetra since early October. SK Bioscience's sales marketing and consumer counseling office guided the supply schedule of Fluarix to hospitals and clinics and received inquiries to confirm the contract between the two companies. Suddenly, the two companies' contract discussions are on the verge of breaking up. Although no specific reason has been revealed, GSK is expected to find alternative partners. The flu season began in September, and GSK does not have much time. Clinics are also confused. "I was informed that SK Bioscience will supply Fluarix this year, but I am currently at a loss where to contact," said clinic A in Seoul. An employee of pharmaceutical company B, which distributes the flu vaccine, also said, "There are a lot of inquiries at the headquarters about supplying Fluarix Tetra instead of SK Bioscience." "It is true that the Fluarix Tetra supply contract is under discussion, but it has not been finalized," SK Bioscience said. "Sanofi's supply of Vaxigrip will be supplied in the fourth week of September as scheduled." GSK also said, "The final contract with SK Bioscience has not been finalized," adding, "We are continuously discussing various things to find Fluarix Tetra's partners."
- Company
- Medication imports in July are the largest ever
- by Kim, Jin-Gu Aug 17, 2021 05:53am
- Pharmaceutical exports of ₩700 billion have remained strong since last year. In July, domestic drug imports reached ₩1 trillion, the highest record ever. It is analyzed that it is a phenomenon caused by the full-fledged import of vaccines from Pfizer and Moderna. ◆Monthly import amount is close to ₩1 trillion, up 25% year-on-year According to the Korea Customs Service on the 16th, Korea's drug imports amounted to $819.58 million in July, the highest ever. Compared to $657.91 million in July last year, it rose by 25%. It is analyzed that the increase in COVID vaccines has affected. In fact, imports of vaccines (export and import codes 3002.20) in Korea averaged only $28.77 million (approximately ₩34 billion) last year, but this year, it started to increase rapidly. When Pfizer vaccine began to be imported in earnest, it increased to $49.82 million (about ₩58 billion) in March and ₩120 billion in June, when moderna vaccine began to be imported in earnest. In July, the figure nearly doubled to $211.62 million. Monthly drug imports, excluding vaccine imports, are maintaining around $600 million, similar to last year's. ◆₩710 billion in exports in July Drug exports amounted to $611.09 million, up 20% from July. Domestic pharmaceutical exports have been steadily rising since last year. The monthly average amount of drug exports last year was $574.46 million, which is more than $646.71 million until July this year. Like last year, biosimilar is leading drug exports. Celltrion recorded ₩789.5 billion in exports through Celltrion Healthcare in the first half of this year. Compared to ₩777.2 billion in the first half of last year, it increased by 2%. The sales of Remsima and Remsima SC totaled ₩337.3 billion, Truxima's sales of ₩273.3 billion, and Herzuma's sales of ₩102.2 billion. Although Samsung Biologics' sales performance in the first half of the year is not specific yet, considering that its provisional sales in the first half of the year increased 31% year-on-year, CMO exports centered on biosimilars are also expected to have increased significantly. In addition, domestic diagnostic kits were exported to $77.34 million in July, up 14% from a year earlier. Exports of diagnostic kits have been maintained at $70 million to $80 million this year. Exports of domestic botulinum toxin in July amounted to $16.67 million, which was not much different from the same period last year ($16.96 million).
- Company
- Insulin·GLP-1 combo Xultophy lands in ‘Big 5’ hospitals
- by Eo, Yun-Ho Aug 17, 2021 05:52am
- The insulin and GLP-1 receptor agonist combination drug ‘Xultophy’ can now be prescribed in general hospitals. According to industry sources, Xultophy FlexTouch inj., a fixed-ration combination of Novo Nordisk Korea’s insulin Tresiba (insulin degludec)’ and the GLP receptor antagonist ‘Victoza (liraglutide injection),' has passed the drug review of drug committees (DCs) of 50 medical institutions in Korea, including the Big-5 general hospitals - Seoul National University Hospital (SNUH), Asan Medical Center (AMC), Seoul St. Mary’s Hospital, Samsung Medical Center (SMC), and Severance Hospital. The drug is reaching practice quickly after being listed for insurance benefits in May. Xultophy was approved in August 2019 in Korea for the treatment of patients with insufficiently controlled type 2 diabetes even after taking a combination of GLP-1 receptor agonist and oral hypoglycemic agents or basal insulin and oral hypoglycemic agents. The drug demonstrated superiority or noninferiority in reducing HbA1c levels, reduced incidence of hypoglycemic episodes, and better weight control in various DUAL clinical trials (DUAL I ~ IX) over control groups using the unique complementary mechanism of action brought from the insulin degludec and liraglutide combination. In particular, In the 26-week DUALⅤstudy that was conducted on 557 Type 2 diabetes patients with type 2 diabetes inadequately controlled by insulin glargine U100 and metformin, Xultophy showed superior HbA1c lowering effect over basal insulin, significant weight loss control effect, and a significant decrease in the incidence of hypoglycemia events with a lower dose of daily insulin. In the DUAL V study, the Xultophy-administered group showed a superior HbA1c level reduction effect of -1.81% over the insulin glargine U100-administered group’s -1.13%. Also, in weight change, the Xultophy arm's weight loss was -1.4kg compared to the +1.8kg of the insulin glargine U100 arm, amounting to a total of -3.2kg weight loss in total. Also, Xultophy reduced hypoglycemic episodes by 57% compared to the insulin glargine U100 arm. Xultophy is a pen-type injector that contains a combination of basal insulin and GLP-1 analogue that can be administered once daily at any time of the day, with or without meals. The maximum daily dose of Xultophy is 50 dose steps, and for those transferring from insulin therapy that includes a basal insulin component, the recommended starting dose of Xultophy is 16 dose steps, after which dose adjustment is required based on the individual’s fasting blood glucose level.
- Policy
- Opdivo's RSA renewed… benefit extended for use with Yervoy
- by Lee, Hye-Kyung Aug 17, 2021 05:52am
- ‘Opidivo inj. (nivolumab),’ the first cancer immunotherapy approved in Korea has successfully extended its contract ahead termination of its risk-sharing agreement (RSA) term. In addition to Opdivo, the breast cancer treatment ‘Kisqali (ribosiclib) was also included in the list of drugs that completed negotiations with the National Health Insurance Service (NHIS) that was recently disclosed by NHIS. The RSA contract term for Opdivo, which was granted reimbursement through the RSA scheme since August 21st, 2017, was set to expire by August 20th this year. Before expiry, Ono Pharma Korea and Bristol-Myers Squibb Korea Pharmaceutical had applied to the NHIS to extend Opdivo's RSA contract and to expand reimbursement for its use in combination with ‘Yervoy(ipilimumab)’ in first-line kidney cancer. The combination of the PD-1 inhibitor Opdivo and CTLA-4 inhibitor Yervoy was approved as a first-line treatment for renal cell carcinoma (RCC) in August 2017. The indication passed NHIS’s Cancer Disease Deliberation Committee review in June last year. In April this year, 9 months after the CDRC review, the combination’s indication for the ‘treatment of patients with moderate- and high-risk, previously untreated advanced renal cell carcinoma (RCC), was recognized appropriate for reimbursement by HIRA’s Cancer Drugs Benefit Appraisal Committee. Since then, the company has been in pricing negotiations with the NHIS. However, in the first 60-day negotiation period, negotiations fell through with the NHIS and pharmaceutical companies being unable to reach an agreement. The two parties finally signed an agreement in the second negotiation that followed. Specifics of the RSA extension for Opdivo and use in combination with Yervoy will be disclosed after amendments to the notice are deliberated and passed by the Ministry of Health and Welfare’s Health Insurance Policy Deliberative Committee. In addition to Opdivo, the NHIS announced that it had also completed negotiations for Kisqali. Kisquali is approved in combination with an aromatase inhibitor in pre-, peri-, post-menopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer; or with fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy in postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.
- Policy
- SK Chemical will sell Zemplar
- by Lee, Tak-Sun Aug 17, 2021 05:52am
- The original Zemplar (Paricalcitol) will be sold by SK Chemical in Korea. It is imported and supplied by AbbVie Korea, and SK Chemical has been in charge of distribution, sales and marketing in Korea since July. SK Chemical is expected to compete fiercely with generic companies. According to industries on the 12th, SK Chemical has been distributing and selling AbbVie's Zemplar in Korea since July. Sales of Zemplar ampules, which had previously been distributed, were discontinued. Zemplar is used to treat and prevent secondary parathyroidism associated with chronic renal failure. It is especially used to treat complications in dialysis patients. Last year, IQVIA was sold at ₩7.9 billion, which is widely used in dialysis complications markets along with Kyowa Kirin Korea's Regpara. Last year, generic for Zemplar was launched for the first time in Korea. Boryung's Pacitol was granted permission on January 30 last year. Pacitol has been on sale since April of that year. As of last year's IQVIA, sales amounted to ₩1.3 billion. Since then, Huons' Hucitol has expanded its consignment production with permission. This change in Zemplar's domestic sales company is interpreted as a response to the generic's offensive. Its strategy is to win the competition with Generic through SK Chemical, which has a well-established distribution network in Korea. The reason why the ampule formulation was discontinued is because of the lower price due to the launch of generic products. Zemplar ampule formulation was twice as expensive as vial formulation, but since April, when generic items were released, both original and generic have become the same price. As a result, competition between original and generic companies is expected to intensify.
- Policy
- GBP510 has been approved for Phase 3, the 1st time in Korea
- by Lee, Tak-Sun Aug 17, 2021 05:52am
- Domestic developed COVID-19 vaccine has entered the final stage of commercialization. A candidate for the COVID-19 vaccine developed by SK Bioscience will conduct phase 3 clinical trial. The MFDS announced on Tuesday that it approved phase 3 clinical trial plan for the first domestic COVID-19 vaccine after thoroughly verifying its safety and scientific feasibility. With the approval, COVID-19 vaccine developed by a Korean company will enter phase 3 clinical trial for the first time. GBP510 is a recombinant vaccine that injects surface antigen protein of the coronavirus created using genetic recombination technology to induce immune response, stimulating immune cells in the body and neutralizing and eliminating the virus when it enters the body. This vaccine has been developed to enhance immune effectiveness by generating a large number of antibodies, especially by utilizing techniques that increase antigen exposure. The three-phase clinical trial approved this time is a clinical trial to evaluate the immune origin and safety of GBP510 for adults aged 18 and older. phase 3 clinical trial is conducted in a comparative clinical manner using Astrazeneca COVID-19 vaccine stocks, which are licensed in Korea and used for vaccination, as a control group. As a control group, AstraZeneca COVID-19 Vacine was selected, considering the absence of a licensed COVID-19 recombinant vaccine. and was designed to confirm the superiority of neutral antibodies and the non-equivalence of serum reactions. Neutralized antibodies are the amount of antibodies that can neutralize a particular virus, and the serum reaction rate is the percentage of test subjects whose antibody price increases more than four times compared to before vaccination. The total number of test subjects is 3,990, 3,000 for the test vaccine, and 990 for the control group will be vaccinated twice every four weeks with 0.5 mg each, and safety and immunogenicity will be evaluated. Phase 3 will be conducted simultaneously not only in Korea but also in Southeast Asia and Eastern Europe. Phase 3 clinical trial is a test to verify the safety and validity of a drug, and its validity is reviewed based on the results of a prior clinical trial, quality of a clinical drug, non-clinical data, etc. In the case of GBP510, phase 2 is currently in progress, but phase 1 showed sufficient safety and immunogenicity, showing the possibility of entering phase 3. After phase 1 and phase 2 was approved on January 26, a phase 1 clinical trial was conducted on 80 healthy adults (ages 19 to 55 years old) and a phase 2 clinical trial is underway on 240 people. As a result of phase 1 intermediate analysis, neutralized antibodies were produced in all vaccinators in terms of efficacy, which was more than five times higher than that of the International Standard Serum (perfection and autoclave). No special side effects have been reported other than cases (injection pain, fatigue, muscle pain, headache, etc.) that are common when vaccinated. In addition, the MFDS explained that it reviewed non-clinical test data such as reproductive toxicity and animal model attack tests, and quality data such as batch analysis results. The MFDS held an advisory meeting with clinical experts on the 9th and consulted on the appropriateness of the evidence data and feasibility of the clinical trial plan to enter phase 3. The MFDS said the approval of the clinical trial is meaningful that it has taken the first step toward self-sufficiency of the domestic vaccine as the first domestic vaccine enters phase 3 amid the coronavirus epidemic. Even though there is no global vaccine leader, it approved phase 3 clinical trials for the development of the COVID vaccines in Korea, and even before the establishment of the Immunological Correlate of Protection (ICP), it introduced a comparative clinical method with active and close screening. Immunological Correlate of Protection(ICP) is most commonly defined as a type and amount of immunological response that correlates with vaccine-induced protection against a clinically apparent infectious disease and that is consider The MFDS stressed that it will continue to communicate with the clinical site after the product's clinical approval so that clinical trials can proceed smoothly, and other products that are undergoing clinical trials in Korea can quickly enter phase 3. It also added that it will thoroughly monitor safety issues such as unexpected adverse reactions of clinical trial participants and medication information that affects clinical trials, and make sure clinical trials are carried out safely.
- Company
- Reimb. to be expanded for PARP inhibitor Lynparza and Zejula
- by Eo, Yun-Ho Aug 13, 2021 05:58am
- The PARP inhibitors ‘Lynparza’ and ‘Zejula’ both crossed the last hurdle in extending their insurance benefits. According to industry sources, AstraZeneca Korea and Takeda Pharmaceuticals Korea have both completed drug pricing negotiations with the National Health Insurance Service (NHIS) to expand their PARP (poly ADP ribose polymerase) inhibitor Lynparza (olaparib) and Zejula (niraparib)’s indications to first-line maintenance treatment in ovarian cancer. Negotiation for the two drugs concluded at the same time because Lynparza’s negotiation period had been extended once. Upon passing the Ministry of Health and Welfare’s Health Insurance Policy Deliberative Committee meeting this month, the insurance benefit of the two drugs is expected to be extended without difficulty. The approvals are also expected to quickly translate into actual prescriptions. In April, AstraZeneca has already completed the landing procedures for the Lynparza tablet formulation that will be used for the new extended indication in the ‘Big 5’ general hospitals - Seoul National University Hospital (SNUH), Asan Medical Center (AMC), Seoul St. Mary’s Hospital, Samsung Medical Center (SMC), and Severance Hospital. Zejula’s formulation does not differ by indication, therefore, its prescription code has already been inserted in most medical institutions. However, the expanded reimbursement coverage will not benefit the BRCA-negative patients that account for 80-90% of the total ovarian cancer population. The Lynparza tablet had been approved as a maintenance treatment in the BRCA-positive patient population from the start. Zejula had applied for an ‘All-Comer’ indication regardless of the BRCA mutation status, however, HIRA’s Cancer Disease Deliberation Committee only approved the BRCA-positive indication. Faced with the high barrier to reimbursement, Takeda Pharmaceuticals decided to take the safe road and be first listed for the BRCA-positive indication. Lynparza and Zejula both own the BRCA-negative indication as a second-line or later maintenance therapy, however, reimbursement for these indications was not passed yet. Professor Jae-won Kim of the Obstetrics and Gynecology Department at SNUH said, “Using a drug as maintenance therapy in the first-line and second-line or higher-line is very different, and using the drug earlier will increase the rate of survival. Personally, I believe that coverage for the PARP inhibitors as maintenance treatment should be extended to benefit as many patients as possible in the first-line.” Zejula was first listed for insurance benefit at ₩76,400 under the Risk-sharing agreement (RSA) scheme, and was determined cost-effective over its substitute, Astrazeneca’s ‘Lynparza (olaparib).’ However, as Lynparza was listed through the PE exemption track, both were applied the RSA Expenditure cap type of reimbursement.
- Opinion
- [Reporter's view] Unstable supply of imported vaccines
- by Lee, Tak-Sun Aug 13, 2021 05:58am
- Moderna's unstable supply and demand disrupted the vaccination. Moderna's vaccine was originally scheduled to come in 8.5 million doz in August, but Moderna informed that it would supply less than half of the vaccine due to laboratory problems related to production. As a result, not only Moderna but also the first and second vaccinations of the same mRNA vaccine, Pfizer vaccine, will temporarily increase inoculation interval from four weeks to six weeks. The quarantine authorities, which are preparing for the final vaccination in their 40s or younger due to the sudden supply disruption notice by Moderna, are also in trouble. However, since Pfizer vaccine is being supplied properly, it is expected that there will be no change in the primary vaccination plan for 70% of the nation until September. However, it is not known when the second vaccination will proceed normally because the supply and demand of modalities or vaccines will be resolved.. AstraZeneca vaccine is produced at SK Bioscience' Andong plant by several million doz at a time. It is much more stable in terms of supply and demand than Pfizer and Moderna vaccine, which are imported by airplanes below 1 million doz per week. The quarantine authorities used the amount of AZ vaccine contracted because the number of people aged 60 to 75 exceeded 10 million. However, since all of them are imported vaccines except for AZ, we should have prepared for possible supply accidents. It is the quarantine authorities that have not used the AZ vaccine well. In February, when AZ vaccine was first approved, the MFDS allowed the elderly to be vaccinated despite a lack of clinical data, but quarantine authorities failed to ensure administration of the age of 65. Since then, data has been accumulated abroad such as the UK, allowing vaccinations for older people aged 65 or older, but the government has decided to vaccinate the elderly aged 75 or older. In April, people under the age of 30 were excluded from the inoculation list due to rare thrombosis, and in July, people under the age of 50 were not allowed to be inoculated. As a result, those under the age of 50 who took the first AZ vaccine before July will be cross-inoculated with Pfizer vaccine during the second round. Such inoculation policies are largely responsible for the unstable public opinion and quarantine authorities created by the media. Of course, there are some reflections that reflect cases from other countries such as advanced countries, but it is questionable whether the conclusion was made based on public opinion rather than science. Although AZ vaccine played a role in preventing infectious diseases among the elderly, the quarantine authorities should reflect on the fact that it is recognized as the next-order mRNA vaccine due to negative public opinion. Also, for those aged 50 and 75 and older who can use AZ vaccine, it was changed to Moderna and Pfizer respectively, which prevented the use of AZ vaccine produced in Korea. If AZ had been used for these age groups according to the inoculation criteria, it would have dealt with both modalities and supply and demand instability. Quarantine authorities should think about the utilization of AZ vaccine. Although there are no vaccines developed in Korea yet, it is fortunate that there are vaccines produced in Korea. If the supply of imported vaccines such as Moderna is uncertain, it should take advantage of the fact that AZ domestic vaccine is being secured.
- Company
- Alvogen is targeting patents for Roche's Avastin
- by Kim, Jin-Gu Aug 13, 2021 05:58am
- Avastin Alvogen Korea has started patenting Roche's blockbuster anti-cancer drug Avastin (Bevacizumab). Two types of Avastin biosimilar are already licensed in Korea. According to the pharmaceutical industry on the 12th, Alvogen Korea recently filed an invalid trial on Roche's two patents of Avastin. Roche is registering a total of four patents with Avastin, including one material patent and three use patents. Material patent registered in Korea has already expired in April 2018. Two out of three patents are related to ovarian cancer treatment, and the other one is related to combined therapy. There are two patents related to single therapy that Alvogen is targeting. If Alvogen overcomes this patent, it will be able to release its product in Korea. Two Avastin biosimilars have been licensed so far. Samsung Bioepis' Onbevezy and Pfizer's Jairabeve. Boryung was in charge of domestic sales of Onbevezy. Both companies are expected to officially release them in the second half of this year. More companies are competing in the global market. Mvasi, co-developed by Amgen and Allergan, is competing with Avastin. In addition, Boehringer Ingelheim, Biocon, Astrazeneca, Kyowa Kirin Korea, Celltrion, Prestige BioPharma, and others are developing biosimilars. Avastin is used for metastatic colon or rectal cancer, non-squamous, non-small cell lung cancer, metastatic breast cancer, glioblastoma (GBM), metastatic renal cell carcinoma. As of 2019, it recorded about ₩8.8 trillion in sales in the global market. It recorded ₩118 billion in sales in the domestic market last year.
