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- 2026-04-15 15:34:47
- Policy
- Janssen, to close Hyangnam plant in Korea
- by Lee, Tak-Sun Feb 15, 2021 06:16am
- Janssen Korea‘s factory in HyangnamWith the withdrawal of the Hyangnam factory this year, Janssen Korea is reorganizing its domestic product lineup of Tylenol and Ultracet The production of Tylenol 8 hours ER and Ultracet is undergoing a transition or shutdown procedure. According to the MFDS on the 8th, all Ultracet products, an analgesic combination drug containing Tramadol-Acetaminophen, which were produced in the Hyangnam factory, were all converted for export. Accordingly, Ultracet produced at the Hyangnam Plant will soon end its insurance benefits. Ultracet is largely divided into fast-acting tablet typed Ultracet, and sustained-release tablet typed Ultracet ER. It is also divided into Ultracet, Ultracet Semi, Ultracet ER, and Ultracet ER Semi according to the size (the dosage). Janssen Korea’s Ultracet and Ultracet Semi, which were previously produced at the Hyangnam factory, have been converted into export products within the last year. An export item is a product used only for export, not sold in the domestic market. When switching to export, insurance benefits are removed, and insurance claims can be made for six months to close inventory. It will not be sold in the domestic market. Ultracet was converted to an imported product produced at factories in Canada and Italy last May. Janssen of Korea recently sent an official letter to the distribution industry about Ultracet Semi, saying that the provider will be changed to Handok, and that it will be available in June after an administrative procedure. Accordingly, only Ultracet ER and Ultracet ER Semi are produced at Hyangnam Plant. Ultracet ER has a higher sales performance than Ultracet. Based on IQVIA, the cumulative sales for the first half of last year show that Ultracet ER was ₩4.7 billion, Ultracet ER Semi was ₩4.2 billion, Ultracet was ₩2.4 billion, and Ultracet Semi was ₩1.1 billion. As the Hyangnam plant operates until this year and the sale process to Whanin Pharm is completed by March next year, the manufacturer of Ultracet ER products is also expected to change. Janssen Korea is also promoting technology transfer to Handok. Janssen recently sent an official letter to the distributor, saying that it will supply Tylenol 8 hours ER 325mg by April and withdraw. Tylenol 8 hours ER 325mg will be terminated and only Tylenol 650mg will be distributed. Based on IQVIA, the cumulative sales of Tylenol in the first half of last year were ₩12.5 billion, and Tylenol 8 hours ER 325mg was ₩5.7 billion. In August of last year, Johnson & Johnson Korea received a license for Children's Tylenol 160mg from Canada. However, it is not yet known what will happen to Tylenol produced in Korea after the Hyangnam plant is closed.
- Policy
- Drug exempt from economic evaluation,cut to the lowest price
- by Lee, Hye-Kyung Feb 15, 2021 06:16am
- The NHIS continues to monitor foreign drug prices after signing and listing a drug price reduction contract linked to foreign prices for drugs exempt from economic evaluation in accordance with the drug price negotiation guidelines. In the past three years from 2018 to 2020, after 30 items of 14 pharmaceutical companies were listed on the list, they signed a contract stating that drug prices would be reduced if foreign prices lower than the domestic upper limit were confirmed. Among them, 6 items in 2018 and 15 items in 2019 received the lowest price. In particular, from 2019, the number of countries subject to foreign drug price linkages has been expanded from the lowest price of the newly listed country to the lowest price of all countries, and the price fluctuations of not only newly listed foreign drugs but also existing listed drugs have affected the domestic market. Japan, one of the A7 countries, implemented an ICER re-evaluation for registered drugs in April 2019, and drug price adjustments were made. If the price of the registered drugs fell to the lowest A7 due to drug price cuts, it is reflected in Korea,too. The NHIS uses the upper limit price in Taiwan, Singapore, and countries affiliated with the Organization for Economic Development Cooperation (OECD) as a reference price for drug price negotiation in accordance with Article 7 of the Drug Price Negotiation Guidelines. In the case of drugs exempt from economic evaluation, agreements have been made on drug price reductions, such as adjusting the upper limit in conjunction with the lower amount when it is confirmed that the adjusted price is lower than the upper limit for each A7 country. Foreign drug prices referenced by The NHIS can be checked on the website. The NHIS has created a bulletin board for foreign drug price inquiry guidelines since 2019, and has released sites in 38 countries, including OECD member countries and Taiwan and Singapore, which are referring to drug price negotiations.
- Policy
- AstraZeneca vaccine authorized for use in Korea on Feb. 10
- by Lee, Tak-Sun Feb 15, 2021 06:16am
- The COVID-19 vaccine developed by AstraZeneca was finally approved by the South Korean health authority on Feb. 10. The approval is valid for the age group over 18, including elders older than 65. On Feb. 10, South Korea’s Ministry of Food and Drug Safety (MFDS) convened a Final Inspection Committee to make a decision on authorizing AstraZeneca’s COVID-19 vaccine, and officially announced the result. Similar to Celltrion’s anti-COVID-19 monoclonal antibody treatment, the Final Inspection Committee gathered and agreed on a final decision for the vaccine on the same day. Expert Committee meetings were held twice prior to the final meeting and gave a positive result. Previously, the Central Pharmaceutical Affairs Deliberation Committee recommended the vaccine should be given to adults over the age of 18, and the Korea Advisory Committee on Immunization Practices (KACIP), associated under the Korea Disease Control and Prevention Agency (KDCA), should discuss the inoculation for elders aged over 65 due insufficient clinical data. Agreeing to the committees’ recommendation, the Final Inspection Committee authorized the vaccination for the age group over 65. However, the committee also decided to label a warning stating ‘a vaccine user aged over 65 should carefully consider on using the vaccine.’ According to the decision, AstraZeneca’s vaccine became the first COVID-19 vaccine to be officially authorized in South Korea.
- Company
- Generics for Xeljanz are being approved one after another
- by Kim, Jin-Gu Feb 10, 2021 06:05am
- Xeljanz Generics for Xeljanz (Tofacitinib) are being approved one after another. After crystalline form patent was deleted from the list, it seems that domestic companies are competitively receiving generic licenses. According to the MFDS on the 9th, until this day, a total of 42 generics for Xeljanz have been licensed. Since Boryung's generic was first approved in August of last year, it has continued steadily. Generics have increased rapidly since last December. After GL Pharma on December 23, in about a month or two, 31 companies were granted generic licenses. About half of these are companies that commissioned production to Boryung. Boryung plans to consign products from 16 companies including Korea Prime at Ansan Plant 1. Xeljanz has product patent that expires in November 2025 and crystalline form patent that expires in November 2027. Many domestic companies have challenged the patent. The challenge for crystalline form patent developed in two tracks. 20 companies, mainly Chong Kun Dang, requested an invalidation trial, and 16 companies, including Boryung, requested a passive trial to confirm the scope of rights. In January 2018, as a result of a trial for the passive scope of rights, generics succeeded in evading patent for Xeljanz. The result of the invalidation trial was also won by generics in November 2019. This decision was confirmed in January 2020. Following the decision of invalidation, crystalline form patent for Gelzanz was deleted in March last year. The barrier to the Crystalline Form Patent, which expires in November 2027, has disappeared. Companies that have succeeded in developing generics will be able to release generics after November 2025, when the product patent expires. Considering that there are more than four years left until the expiration of the product patent, there is a high possibility that generic licenses from other pharmaceutical companies will be added. Xeljanz is a JAK inhibitor family of autoimmune diseases. It is released as an oral preparation in the autoimmune disease treatment market, which is mostly an injection, and has overcome the limitations of existing TNF alpha inhibitors. According to UBIST, the amount of outpatient prescriptions last year was ₩12.6 billion. Since its launch in the domestic market in July 2015, Xeljanz has rapidly increased its prescription performance to ₩1.7 billion in 2016, ₩3.3 billion in 2017, ₩8.3 billion in 2018, and ₩12.6 billion in 2019. However, compared to 2019, in 2020, it was stagnant, and this is analyzed due to the addition of Olumiant (Baricitinib) from Lilly. And, no domestic companies have challenged patent of Olumiant.
- Company
- Despite COVID-19 and NDMA metformin prescription surges
- by Chon, Seung-Hyun Feb 10, 2021 06:04am
- Metformin-based antidiabetic drugs showed exceptional growth in the prescription drug market. Both metformin combination and single agent drugs expanded their prescription volume and maintained the credibility in the clinical scene, regardless of the novel coronavirus disease (COVID-19) outbreak and impurity contamination incident. On Feb. 9, a pharmaceutical market research firm UBIST told the outpatient prescription volume in metformin last year marked 535.7 billion won growing 9.5 percent from the previous year. The year 2019 showed a growth of 7.3 percent. Metformin, a type of biguanides, is used vastly on Type 2 diabetic patients as a first-line treatment to control the blood sugar level. Amid COVID-19 pandemic last year, the general prescription drug market fluctuated but the metformin market growth surged. Both metformin and single agent drugs showed definite growth. In last year, metformin single agent drug generated 77.3 billion won, showing a 4.1-percent growth compared to the year before. The growth was increased steeply compared to 2.9 percent growth made in 2019. Meanwhile, the metformin combination drug market had even higher growth. The last year’s metformin combination drug prescription volume grew by 10.5 percent from the year before and made 458.4 billion won. In 2019, the volume grew 8.2 percent compared to previous year. The combination drug market surged by 96.8 percent throughout five years from 2015 making 232.9 billion won. Currently, there are metformin drugs combined with dipeptidyl peptidase 4 (DPP-4) inhibitors, sulfonylureas, glitazone and sodium-glucose co-transporter-2 (SGLT2) inhibitors available in the South Korean market. Among all combination drugs, DPP-4 inhibitor plus metformin drug market had a notable growth. In last year, the DPP-4 inhibitor plus metformin drug prescription volume generated 380.5 billion won, growing by 5.8 percent compared to the year before. In five years from 2015, the market expanded exponentially by 90.5 percent. The DPP-4 inhibitor plus metformin drugs dominates 71.3 percent of the metformin combination drug market share. The SGLT-2 inhibitor plus metformin drug prescription volume also surged by 59.1 percent in last year and made 44.4 billion won. Although metformin drug market suffered a detrimental hit by the impurity contamination, the prescription market firmly consolidated its ground. South Korea’s Ministry of Food and Drug Safety (MFDS) ordered temporary manufacturing and sales suspension and prescription limitation on 31 metformin active pharmaceutical ingredient and complete products supplied in South Korea, as the ministry discovered unacceptable level of N-Nitrosodimethylamine (NDMA) carcinogen in the drugs. The sales ban was imposed on JW Pharmaceutical’s Guardmet, Hanall Biopharma’s Glucodaun OR Tablet and Hutecs Korea Pharmaceutical’s Gluless-M. The order was issued six months after the Singaporean health authority raised an issue of metformin impurity contamination. In December 2019, Singapore’s Health Sciences Authority (HSA) investigated 46 metformin-contained items on sale and recalled three items as they found NDMA exceeding the acceptable daily intake level. Since then, MFDS also started investigating metformin ingredients and complete products in South Korea. The relevant industry was concerned when the South Korean health authority initiated the investigation as it could affect the metformin prescription market. In fact, an anti-hypertension drug valsartan was also found with unacceptable level of impurity and the general market was impacted by the authority’s sales ban order. In July and August 2018, MFDS banned the sales of 175 valsartan single agent drugs and combination drugs using ingredients found with NDMA. Valsartan containing anti-hypertension treatments generated 381.9 billion won in 2017, but the volume continued to slip for two consecutive years in 2018 and 2019 at 376.4 billion won and 332 billion won, respectively. But in last year, the volume increased by 4.0 percent compared to 2019 making a positive growth after three years. Metformin is the only oral antidiabetic drug used for first-line treatment. Basically, the absence of alternative option has protected the drug’s credibility against the impurity incident. Also the sales ban on metformin drugs was limited compared to the overall market. MFDS reported the 31 items banned from sales generated production volume of 22.8 billion won in 2019. It was only 6 percent of the overall production and import volume. And other plenty of options were available, besides the banned items, for the prescription market to have avoided confusion. The industry evaluates the previous experiences of impurity contamination in valsartan, ranitidine and nizatidine have taught the market such incident’s risk is insignificant. When announcing the list of impurity-contaminated metformin items to be banned, MFDS concluded “The harmful risk on human body by long-term exposure to drugs found with unacceptable level of NDMA is miniscule.”
- Company
- More options for ankylosing spondylitis including Taltz
- by Feb 09, 2021 06:04am
- The interleukin 17A (IL-17A) inhibitor drugs are taking over the spotlight in the ankylosing spondylitis treatment market. Besides the first-in-class Cosentyx (secukinumab), Taltz (ixekizumab) was released to the South Korean market with its strong evidences. Some specialists predict the guideline, initially recommending the drug to be used after using tumor necrosis factor-alfa (TNF-α) inhibitor, could be changed. One of the most frequently diagnosed rheumatic diseases, ankylosing spondylitis mostly uses a nonsteroidal anti-inflammatory drug (NSAID). But a biologic drug is recommended for patients with high disease activity. Humira (adalimumab) and Remicade (infliximab) are TNF-α inhibitors, a most commonly used biologic treatment type. Although the drugs are recommended first with their credible amount of clinical data, 30 percent of the patients apparently do not respond to TNF-α inhibitor. Professor Hong Seung-jae at Kyung Hee University Medical Center (Department of Rheumatology) says only one out of three patients maintain the treatment, two years after using biologic treatment. 40 percent of the patients suspend the treatment before starting the second cycle, because of insufficient efficacy. And now IL-17A inhibitors are emerging as a new option. 16 years after a first TNF-α inhibitor was approved, Novartis’ Cosentyx was released as a new drug to treat patients with ankylosing spondylitis. And Eli Lilly’s Taltz followed with a same indication, and joined the competition in the South Korean market as received the National Health Insurance (NHI) reimbursement in last October. Taltz’s strengths in treating ankylosing spondylitis are exceptional level of efficacy and safety. To confirm the efficacy and safety in treating the disease, the COAST-V study had patients who are biologic disease-modifying antirheumatic drug (bDMARD)-naïve, and the COAST-W study had patients who previously had an inadequate response or were intolerant to TNF inhibitors. Both studies chose more stringent primary endpoint, unlike other preceding clinical trials on ankylosing spondylitis, which was the Assessment of Spondyloarthritis International Society 40 (ASAS40) response showing over 40 percent improvement in the patients’ symptoms. The trials were the only and first studies to have set ASAS40 as a primary endpoint. Patients achieving ASAS40 at week 16 The Taltz group in two studies achieved 48 percent and 25 percent of the ASAS40 response at week 16, respectively, and 53 percent and 34 percent at week 52. The results indicated statistically meaningful improvement compared to the placebo group. Taltz also resulted in statistically significant outcome in secondary endpoints—objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), as well as patient-reported outcome (PRO). And a head-to-head COAST-V study compared the drug against a TNF-α inhibitor Humira, frequently used to treat patients with ankylosing spondylitis. Ultimately, the Taltz patient group showed higher response rate compared to the Humira patient group. Moreover, Taltz has notable safety profile. A TNF-α inhibitor is banned on patients with severe heart failure, whereas Taltz can be used regardless of the underlying condition. Professor Hong Seung-jae elaborated, “Once-biweekly administered Taltz is more convenient than other once-weekly drugs, and it is known for its high ASAS40 response proving the efficacy. And because it does not have the safety issue the TNF-α inhibitors, the drug can be administered to patients with heart failure.” When the clinical records of Taltz accumulate in the future, the professor thinks the reimbursement and treatment guideline can be easily changed. Currently, Taltz is indicated for use in both first and second-line treatment, but the NHI reimbursement is granted only for using when a patent shows no response to a TNF-α inhibitor. Also, the guideline by the Assessment of SpondyloArthritis International Society/ European League against Rheumatism (ASAS/EULAR) recommends using TNF-α inhibitor with more extensive clinical data, and then recommends an IL-17A inhibitor if the patient does not react to the TNF-α inhibitor. Professor Hong expressed his anticipation in the prospective changes in the reimbursement standards, and said “The healthcare reimbursement standard and overseas guideline categorize the drug as a second-line treatment, as it lacks sufficient amount of clinical data in South Korea. But the data is accumulating globally, and some experts claim the drug should be used at a same level with TNF-α inhibitor.” Meanwhile, relevant experts project other biologic treatment could become a variable in the expansion of an IL-17A inhibitors in the ankylosing spondylitis treatment market. Currently, various Janus kinase inhibitors, such as tofacitinib and upadacitinib, are in process of conducting clinical trials targeting ankylosing spondylitis. Specifically, upadacitinib (brand name Rinvoq) was indicated in EU to treat patients with ankylosing spondylitis, showing off its intention to join the scene. Unlike other biologic treatments, orally taken JAK inhibitor could be preferred more.
- Policy
- On-site judgment is important
- by Lee, Tak-Sun Feb 09, 2021 06:04am
- COVID-19 vaccine by AZ, along with CMA, recommended that those over 65 years of age should review it by the Vaccination Specialist Committee, the Central Pharmaceutical Affairs Review Committee of the MFDS said it was because on-site judgment was important. In a briefing held on the 5th, Chairman Il-Hwan Oh said, "Because the data on the elderly are relatively limited, the MFDS has made a decision to carefully judge the benefits of vaccination and the risks that may occur if not." He said, "The clinical trial results so far are not statistically verifiable because the number of cases has been small. But it doesn't mean that this doesn't work or put a decision on hold" On this day, the Central Pharmaceutical Affairs Review Committee recommended CMA to be used for AstraZeneca’s vaccines over the age of 18, but suggested that vaccinations over 65 years of age should be discussed later at the Korea Advisory Committee on Immunization Practices (KACIP). Accordingly, vaccination for the elderly over 65 will be confirmed by the KACIP after final item approval. Chairman Oh said that the announcement of the results was delayed by one day. He said, “In consideration of the phenomenon that some European countries have various opinions on the administration of the elderly, it was delayed because there were many discussions to verify the level that all the people can understand.”
- Policy
- The Committee recommended AZ vaccine approval
- by Lee, Tak-Sun Feb 09, 2021 06:04am
- The Central Pharmaceutical Affairs Review Committee of the MFDS, which consulted on AstraZeneca's approval of the COVID-19 vaccine, recommended item approval, subject to the submission of ongoing clinical results. In addition, for vaccinations over 65 years of age, it was gathered that opinions should be made carefully in the matters of approval, and that it is recommended to be discussed later in the Korea Advisory Committee on Immunization Practices. The Central Pharmaceutical Affairs Review Committee held a meeting at the Osong headquarters of the MFDS on the 4th and made this decision. According to the MFDS, The Central Pharmaceutical Affairs Review Committee recognizes the need for the domestic COVID-19 prevention purpose of the applied item, and submits the results of clinical trials currently in progress when synthesizing the consultation results of the COVID-19 vaccine safety and effectiveness verification advisory group. It advised that item approval is possible on the condition of that. The dose and interval should be judged based on scientific verification, and it was possible to administer twice the applied dose at intervals of 4 to 12 weeks whose efficacy was confirmed, considering the standard dose and administration interval and two doses planned in the clinical trial. As for vaccination of elderly patients 65 years of age or older, the same as in Europe, they should be 18 years of age or older. It was also recommended to submit analysis data on the results of US clinical trials later. At the same time, and it is recommended to be discussed at the KACIP later. Regarding the safety of the vaccine, the safety profile (trend), such as adverse events that occurred in clinical trials, is acceptable, but the opinion that the occurrence of nervous system-related adverse events, including transverse myelitis, should be monitored after approval. Inoculation for pregnant women is not recommended, and for nursing mothers, it is appropriate to state in the precautions for use that'it is not known whether this drug is secreted into breast milk', he said. At the Central Pharmaceutical Affairs Review Committee meeting, 12 standing members of the Subcommittee on Biological Medicines, 5 verification advisors, 1 expert recommended by the Korea Medical Association, 7 members of the Vaccine Review Team, Clinical Review Team, and Quality Review Team attended the COVID-19 Crisis Response Support Division inside the MFDS. Previously, a verification advisory group composed of experts supported the approval of the AstraZeneca's COVID-19 vaccine, and recommended that elderly patients not be restricted. The Central Pharmaceutical Affairs Review Committee allows the administration of the elderly, but takes a more cautious approach and delays the decision to the Korea Advisory Committee on Immunization Practices in the future. Based on this consultation, the MFDS is planning to convene a final inspection committee to make a final decision on whether to approve AstraZeneca's COVID-19 vaccine.
- Company
- What now for Vyndamax failing essential drug designation?
- by Eo, Yun-Ho Feb 08, 2021 06:08am
- A transthyretin amyloid cardiomyopathy (ATTR-CM) new drug Vyndamax (tafamidis) seems to be struggling to receive National Health Insurance (NHI) reimbursement in South Korea. A pharmaceutical industry source reported Pfizer’s new drug treating patients with ATTR-CM Vyndamax (tafamidis 61 mg) has failed to get a treatment-purpose essential drug designation. But as Vyndamax has comparatively normal patient size, it would be unlikely to get listed for reimbursement with the pharmacoeconomic evaluation (PE) exemption. Approved in South Korea to treat patients with transthyretin amyloidosis with polyneuropathy (ATTR-PN) in October 2018, Vyndaqel (tafamidis 20 mg) has highly limited patient size for the hereditary type, but its indication can cover wild type caused by old age. Now the problem is on patients. ATTR-CM is considered to have bad prognosis as the patients tend to only survive two to 3.5 years after the diagnosis, or sometimes they are misdiagnosed as simple heart failure and result in detrimental outcome. Vyndamax is basically a treatment option for ATTR-CM. The patient size is extremely limited and they rely or either liver transplant or allopathy. And a multicenter, placebo-controlled Phase III ATTR-ACT study confirmed Vyndamax lowering the risk of cardiovascular event and improving the results of 6-minute walk test. The next action for the expensive drug is up to the government and the pharmaceutical company. Although the subject criteria for PE exemption are widening, the industry still sees a room to grow. If an immediate regulation revision is difficult, the two parties should assertively talk about models fitting the unique quality of drug, such as using a variety of risk sharing agreement (RSA) types. The ATTR-ACT study randomly assigned 441 patients to be administered with 80 mg or 20 mg of tafamidis or placebo in 2:1:2 ratios. The primary endpoint evaluated the frequency of cardiovascular related death and hospitalization. The secondary endpoint was the change in the Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) score from 6-minute walk test taken and compared among the baseline time to 30-month point. In the study, the tafamidis statically improving the lowered risk of death by all causes and hospitalization, compared to the placebo group.
- Company
- Oncaspar for acute lymphocytic leukemia was approved
- by Eo, Yun-Ho Feb 08, 2021 06:08am
- According to the related industry, Servier Korea's Oncaspar (Pegaspargase) was approved from the MFDS as a rare specialty medicine as a combination therapy with other anti-tumor drugs when treating Acute Lymphoblastic Leukemia (ALL) in children and adults under the age of 8 years. Oncaspar is a drug that dramatically reduces the frequency of administration so that it is administered once every 14 days compared to L-asparaginase, which was previously administered once every other day by maximizing the drug circulation half-life through PEGylation. Considering the high incidence rate of acute lymphocytic leukemia, especially in pediatric patients, it is expected to alleviate the physical pain of pediatric patients suffering from frequent chemotherapy and hypersensitivity reactions from injection because it can be administered every 14 days. In addition, it is expected to have a positive effect on medical expenses such as hospital visits or hospitalization for injection treatment. First approved as a second line treatment for acute lymphocytic leukemia in the United States and Germany in 1994, Oncaspar was recognized as the first line treatment for all acute lymphocytic leukemia in the United States in 2006. Since its birth in Europe in 2016, it has been approved as a combination therapy with other anticancer drugs in 18-year-old children and adults with acute lymphocytic leukemia. Currently, it is recommended first in major international guidelines and treatment protocols such as NCCN, ESMO and Children's Oncology Group (COG) as a treatment for acute lymphocytic leukemia, and is being used in 62 countries. An official from Servier Korea said, "In Korea, patients or guardians have individually applied for Oncaspar through the KOEDC and received limited supply of Oncaspar. Servier Korea has provided Oncaspar to Korean patients with acute lymphocytic leukemia, so we are able to provide a stable supply.”
