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- 2026-04-13 00:11:17
- Product
- Defective tablets of Lipitor were found
- by Kim JiEun Feb 08, 2022 05:54am
- (left) A case of powder mixing in 90 tablets of 20 mg of Lipitor at the end of last year, and (right) a broken drug was recently found in the same product Defective drugs have been found one after another in Lipitor, one of the most frequent prescription drugs, requiring caution when preparing. According to a pharmacist in Seoul on the 3rd, a defective tablet was recently found in a bottle of Lipitor again following November last year. The pharmacist said he found a suspicious substance while charging the drug to ATC in November last year. A broken tablet came out of the medicine container, and the manufacturing number of the drug in which the problem was found is 100005333068. The pharmacist said he could not confirm whether the number of tablets was insufficient due to other drugs that had already been charged, as he found in the process of filling ATC with drugs. The pharmacist estimated that foreign substances were mixed during the manufacturing process. The problem is that more than two months after this happened, defects were found again in the same product recently. One of the tablets was broken into half. The pharmacist saw that the tablet was broken during the distribution process and looked at the medicine container again, but did not find any remnants of the broken tablet. The manufacturing number of the packaging, where the defective drug was found this time, is 180164582867. The pharmacist said, "I think the powder was mixed before the drug was made into tablets," adding, "As defective drugs were found one after another in the same drug, I thought it was necessary to check whether there was a problem in the manufacturing process." This pharmacist said, "It's famous original medicine". He added that he doesn't readily understand that such a defective drug is found. Pfizer said a precise confirmation process is needed for related content. As related information has been received, the government plans to take action through a pharmacy to confirm the drug in question. A company official said, "There have been no cases of defective drugs such as powder mixing or tablet damage in Lipitor, especially similar cases in related lot numbers," adding, "We need to collect related drugs and check them accurately." In the case of refining damage, we regularly check whether the amount set during the production process meets the set acceptance standards such as the presence or absence of refining abnormalities, but it is possible that we have not been able to completely distinguish the damage control during the packaging stage, in the case of powder mixing cases, additional confirmation is needed, he added.
- Company
- Entresto's outpatient prescriptions exceed ₩30 billion
- by Feb 08, 2022 05:54am
- Pic. of Entresto Sales of Novartis’ chronic heart failure treatment ‘Entresto’ exceeded ₩30 billion only 5 years into its release. In the midst of drug price cuts and domestic patent challenges, Entresto is seeking greater growth this year by expanding the scope of indications and reimbursement benefits. According to the market research institution UBIST on the 29th, outpatient prescription sales of Entresto recorded ₩32.3 billion, a 37.3% growth from the ₩23.5 billion made in the previous year. The product made such growth in only 4 years since its release in October 2017. Entresto is a first-in-class angiotensin receptor-neprilysin inhibitor (ARNI) that combines the angiotensin receptor blocker (ARB) valsartan and neprilysin inhibitor sacubitril. The drug may be used as an alternative to an angiotensin receptor blocker (ARB) or an angiotensin-converting enzyme (ACE) inhibitor in patients with left ventricular (LV) dysfunction in combination with other heart failure treatments. Entresto received marketing authorization in April 2016 and was officially launched with reimbursement in October 2017. Entresto’s explosive growth was well expected. The drug demonstrated its efficacy and safety in acute heart failure in addition to chronic heart failure, and academic societies in Korea and abroad recommend Entresto as a standard of care. Also, the American Heart Association recommended Entresto as the standard of care for heart failure with reduced ejection fraction (HFrEF). Until now, ACE or ARB inhibitors were mainly used in patients with chronic heart failure. Replacing this demand, Entresto quickly increased its share in the market. Its outpatient prescription sales, which started at ₩300 million in 2017, increased 20 times to ₩6.3 billion the next year. In 2019, its sales doubled once more to ₩15 billion, then rose to exceed ₩30 billion only 2 years since then. To slow down such growth, pharmaceutical companies in Korea have aggressively set out to challenge Entresto’s patent. 13 domestic companies including Hanmi Pharmaceuticals and Chong Kun Dang filed patent challenges last year. The Intellectual Property Trial and Appeal Board ruled in favor of the generic companies in the trial to confirm the passive scope of rights of Entresto’s crystalline patent. By overcoming the key patent among 5 of Entresto’s patents, the domestic generic companies are speeding up their challenges. Also, Entresto’s price will undergo additional price cuts. The Ministry of Health and Welfare is working to cut Entresto’s price by 6.6% as of February 1st under the ‘‘Amendment to the drug reimbursement list and reimbursement ceiling price table.’ Entresto is subject to pricing cuts under the ‘Use amount-price linkage-type B’ where a product whose use increased over 10% in an amount over ₩5 billion undergo price cuts. The price of Entresto, which was listed at ₩2,243 at the time of first listing, will be reduced to ₩1,910 through three pricing adjustments. Novartis plans to continue its strong growth by adding indications and expanding Entresto’s reimbursement standards. Its indication for HFpEF is one of the company’s key areas of interest. Although around half of all patients with heart failure suffer HFpEF, which is defined as a left ventricular ejection fraction of 40% or higher, no appropriate treatment had existed for the condition yet. Novartis demonstrated that Entresto can reduce the risk of hospitalization from heart failure and cardiovascular death through the PARAGON-HF trial. The UF Food and Drug Administration additionally approved the HFpEF indication for Entresto in January last year. In line with the added indication, Novartis is working to expand the scope of Entresto’s reimbursement to first-line therapy in HFrEF.
- Policy
- HPV vaccine expanded free vaccination for men and women
- by Lee, Jeong-Hwan Feb 08, 2022 05:54am
- It is estimated that about 200 billion won will be spent over the next five years to expand the national vaccination target of HPV vaccination to children aged 11 and 12 regardless of gender. Assuming that the target vaccination rate is 89%-100%, an annual average budget of about 40 billion won is needed. This is the result of Baek Jong-heon, a member of the National Assembly, entrusted with the cost estimation of some revisions to the Infectious Disease Prevention and Management Act proposed by the National Assembly's Budget Office on the 4th. Baek Jong-heon proposed a bill to expand the subject of HPV national vaccination (NIP) to children aged 11 and 12 regardless of gender. As a result of the cost estimation by the Ministry of Budget and Policy, a total budget of 2015 billion won to 210.5 billion won will be needed depending on the target vaccination rate. Specifically, the current HPV vaccine NIP is inoculating 12-year-old women. Accordingly, in the first year of implementation of the amendment, the cost of inoculation for 11-year-old women was estimated, and from the second year of implementation, the cost of inoculation for women was excluded from the estimation. The target vaccination rate was estimated by dividing it into two scenarios because the inoculation rate of 89.6% and 100% in 2020 were separately counted. The vaccine cost was 62,200 won for HPV4 at the public health center, reflecting the average increase in the number of vaccines over the past three years (2019-2021). As a result of the estimation, a total of 2015 to 210.5 billion won was estimated from 2022 to 2026 when HPV vaccinations were conducted for 11-year-old women and men aged 11 to 12 according to the revision of Baek Jong-heon. In the case of scenario 1 with an 89.6% vaccination rate, a total of 201594 billion won will be required for five years from 2022 to 2026, including 79.242 billion won in 2022 and 30.736 billion won in 2026. When the inoculation rate was estimated to be 100% scenario 2, it was estimated to be 210.512 billion won for five years from 2022 to 2026, including 88.439 billion won in 2022 and 30.787 billion won in 2026.
- Policy
- Generics for Bridion are being released one after another
- by Lee, Tak-Sun Feb 07, 2022 05:58am
- Generic drugs are being released one after another ahead of the patent expiration in April, with the drug Bridion (Sugammadex Sodium, MSD), which helps wake up from anesthesia during surgery. As the domestic market size of the drug alone is around 40 billion won, domestic generic companies are expected to aggressively target the market. According to the MFDS on the 6th, six generics of Sugammadex Sodium have been approved so far since Hanlim was first approved on December 29 last year. Bridion is a drug that directly acts on the relaxation of the muscles used for patient anesthesia and restores them to their original state. In patients over the age of 2, it is used in reverse of neuromuscular blocking induced by Vecuronium or Rocuronium. These are muscle relaxants used for patient anesthesia during surgery. Bridion, approved in Korea in October 2012, is also a new anesthetic antagonist drug that came out in 20 years. In particular, this drug is widely used because it can provide a stable surgical environment to medical staff in that it acts directly on muscle relaxants and acts within 3 minutes. Existing drugs were indirectly applied to muscle relaxation drugs, resulting in slow recovery of relaxed muscles. Bridion's rapid action not only enhances surgical stability, but also relieves concerns about muscle relaxation remaining after surgery. In particular, existing anesthetic antagonists have the advantage of being used even for patients with respiratory or cardiovascular diseases that are highly likely to have side effects. With this differentiation, Bridion is maintaining high growth in the domestic market. In the second quarter of last year based on IQVIA, its performance was 11.2 billion won. The drug, which recorded 39.1 billion won in sales in 2020, is said to have surpassed 40 billion won last year. Market sales were so high that other generic companies also paid attention early on. However, material patents are valid until April 12 this year. Since 2018, pharmaceutical companies such as Daewoong Pharmaceutical and Chong Kun Dang have been challenging patents, but all of them have been dismissed by the Intellectual Property Tribunal. As the patent expiration time is imminent, generic drugs are preparing to be released with permission. First of all, Hanlim was approved for the first generic under the product name Briturn on December 29 last year. In January, products from Sandoz Korea, BMI Korea, and Huons were approved. On the 4th, Boryung Pharmaceutical and Jeil Pharmaceutical were then approved by Huons for items that were commissioned. These generic drugs are expected to be released on the market from April 13, when patents are terminated. As it is such a large-scale drug in the market, expectations for sales performance are high, but the prevailing opinion is that it will be difficult to win the competition of the original drug. In the case of general hospitals that perform a lot of surgery, the reliability of original is much higher. It remains to be seen whether generic drugs will overcome this and set meaningful records in terms of market share.
- Company
- Celltrion begins global P3T for its inhaled COVID-19 therapy
- by Ji Yong Jun Feb 07, 2022 05:57am
- Celltrion HQ Celltrion has begun global Phase III trials on its ‘inhaled antibody cocktail therapy’ that is in development to respond to major variants of the COVID-19 virus, such as the Omicron variant. According to the clinical trial registry ClinicalTrials.gov operated by the US National Institutes of Health (NIH), Celltrion newly registered a clinical trial protocol on initiating a Global Phase III trial for its ‘inhaled antibody cocktail therapy’ on the website on the 4th. The trial will assess the therapeutic efficacy of the combination of ‘CT-P63’ and ‘CT-P66’ in an inhaled form to patients that were infected with mild-to-moderate COVID-19. After enrolling patients who experienced symptom onset within 7 days of COVID-19 diagnosis, participants will be divided into two groups and be administered the ‘CT-P63’ and ‘CT-P66’ combination or placebo for 14 days to assess the combination’s clinical efficacy. The patients who were administered the CT-P63’ and ‘CT-P66’ combination will be monitored for 90 days for adverse reactions. Celltrion plans to start the trial in April and expects to complete the trial by January next year. CT-P63 is an antibody cocktail therapy developed by Celltrion to respond to the emerging COVId-19 variants. CT-P63 demonstrated strong neutralizing activity against various major variants including the alpha, beta, gamma, and delta variant, and also showed strong neutralizing activity against the Omicron variant in a pseudovirus testing that Celltrion conducted with NIH. Also, a Phase I clinical trial that was conducted in Poland in 24 healthy subjects since September last year showed that CT-P63 was safe and well-tolerated, with no significant drug-related adverse events (AEs). CT-P66 is an inhaled formulation of Regkirona that is being analyzed in a Phase I trial after completing administration. The inhaled antibody cocktail therapy is considered to be more convenient in administration compared to the existing Regkirona formulation that is administered through intravenous infusion. IV infusions like the existing formulation had to be administered at the hospital for over an hour, but an inhaled formulation can be administered by the patients at home, therefore being well utilized. Celltrion said, “After developing our COVID-19 antibody treatment Regkirona, we have been developing our ‘inhaled antibody cocktail therapy’ for over a year and a half now. We expect our treatment to become a convenient and economic treatment that can respond to various COVID-19 variants, including the Omicron variant.”
- Policy
- 1 ‘Soliris’ and 4 ‘Ultomiris’ cases seek prior approval
- by Lee, Hye-Kyung Feb 07, 2022 05:57am
- The 3 applications filed for preliminary approval of reimbursement to use ‘Ultomiris (ravulizumab)’ in new patients with paroxysmal nocturnal hemoglobinuria (PNH), and 1 application for re-deliberation were approved, and 2 cases of appeals that were filed were dismissed by Health Insurance Review and Assessment Service’s Healthcare Review and Assessment Committee. In the same disease class, no new applications were filed for newly reimbursed administration of ‘Soliris (eculizumab),’ but 1 of the new preliminary approval applications filed for reimbursement in new patients with atypical hemolytic uremic syndrome (aHUS) was approved. This January, the Healthcare Review and Assessment Committee deliberated cases for Soliris, Ultomiris, mid-to-long-term hospitalization due to external injury, etc., mid-to-long-term hospitalization for pain control, short-term hospitalization due to external injury, F-18 FDG PET for liver cancer, internal nasal splints used for endoscopic transnasal transsphenoidal hypophysectomy of pituitary tumor, ventricular assist device treatment, medical and selective insurance benefit for hemopoietic stem cell transplantation, and medical insurance benefit for immune tolerance induction therapy. Results that were disclosed on the 4th show that for Soliris, 22 PNH monitoring requests were approved, 1 new request for aHUS indication approved, 4 disapproved, 1 re-administration approved, and 4 monitoring cases approved. For Ultomiris, 3 requests to reimburse new patients with PNH were approved, 1 re-deliberation approved, and 2 appeals were dismissed. Soliris, which has an insurance cap of 5,132,364 won per vial (30ml), costs around 400 million won per year in drug expenses if 3 vials are administered bi-weekly for a year. Ultomiris was listed for reimbursement at 5,598.942 won per vial on June 7th last year, and patients must receive a maintenance dose every 8 weeks 2 weeks after receiving the initial dose. As Soliris and Ultomiris are both ultra-high-priced drugs, a preliminary approval system is conducted to determine eligibility for medical care benefits. Institutions that apply for the preliminary approval must administer the said Soliris or Ultomiris within 60 days of receiving notification of the deliberation results, and must resubmit an application if it wishes to administer the drugs after 60 days. Also, the long-term care institutions that receive the approval for Soliris or Ultomiris’s medical care benefit need to submit a monitoring report every 6 months, with those using Soliris for aHUS being required to additionally submit initial monitoring reports 2 months into treatment. Further details of the deliberation can be found on HIRA’s website (www.hira.or.kr) or business portal (biz.hira.or.kr.>comprehensive review criteria service > criteria > review criteria > Open deliberation cases).
- Company
- Hugel's Letybo has been approved in France
- by Feb 07, 2022 05:57am
- Hugel announced on the 3rd that it has obtained an item license for botulinum toxin formulation Letybo from the ANSM on the 27th of last month (local time). Earlier on the 25th, Hugel received an opinion from the HMA to approve Letybo's item license. Upon receipt of the opinion, Hugel entered a national phase to enter 11 European countries, including France, Britain, Germany, Spain, and Italy. Starting with this approval, Hugel aims to ship Letybo within the first quarter and launch it in major local markets. This is the first case of Korean botulinum toxin formulations entering Europe. Hugel plans to complete its entry into 36 European countries by next year based on its entry into 11 major countries this year. An official from Hugel said, "As major countries are expected to complete the approval process quickly starting with France, we will do our best to enhance the status of the Korean medical aesthetic industry in the local market by spreading treatment solutions for healthy beauty to European practitioners and consumers."
- Company
- Samsung BioLogics acquired ₩2.8 trillion stake in Epis
- by Ji Yong Jun Feb 07, 2022 05:57am
- View of Samsung BioLogics Plant 3 (Photo = Samsung BioLogics)Samsung Biologics will acquire all of its shares in Samsung Bioepis held by its partner Biogen. Stock purchase funds are raised through a paid-in capital increase in shareholder allocation. Samsung BioLogics announced on the 28th that it has decided to acquire all 10,341,852 shares of Samsung Bioepis held by Biogen in the U.S. for $2.3 billion (about 2.7655 trillion won). Of the $2.3 billion cost of purchasing a stake in Samsung Bioepis, the acquisition price will be paid in installments over the next two years, excluding $50 million in "earn-out" costs, which will be additionally paid if certain conditions are met after the contract is signed. The contract will take effect from the time the first payment of $1 billion is completed. Biogen invested 15% of its stake when Samsung Bioepis was established in 2012. In June 2018, Biogen chose a call option to take over 9,226,068 shares of Samsung Bioepis held by Samsung Biologics. Biogen paid $700 million to Samsung Biologics, adding 50,000 won per share and interest. As a result, Samsung Biologics and Biogen shared 50%+1 shares and 50%-1 shares of Samsung Bioepis, respectively. Samsung Biologics also decided to raise 3 trillion won in paid-in capital. The paid-in capital increase will be carried out in the form of a general public offering for forfeited shares after allocation of shareholders, and the number of issued shares is 5,009,000 shares. Samsung Biologics plans to use 1.798 trillion won of the funds flowing into the paid-in capital increase as facility funds, and the remaining 1.2024 trillion won as funds to acquire shares in Samsung Bioepis. Under the decision to purchase the stake, Samsung Biologics will secure 100% of Samsung Bioepis shares. The company predicted that the acquisition of shares will accelerate preparations for the bio business. This is because the autonomy and agility of decision-making are improved compared to the current equity structure, which can quickly promote mid- to long-term growth strategies such as the development of new pipelines, open innovation, and new drug development of Samsung Bioepis. Samsung Bio's business has secured ▲CAPA No. 1 Samsung Biologics' CDMO business, ▲Samsung Bioepis' ability to independently develop proven biosimilar products, and ▲ the possibility of entering the new drug business, laying the foundation for a leap into a "global pharmaceutical company". Samsung Bioepis is currently recognized for its competitiveness by launching a total of five biosimilar products, including three autoimmune disease treatments and two anticancer drugs, and one more is about to be released with permission, and four biosimilars are in phase 3 clinical trials. The global biosimilar market is expected to continue to grow more than 8% annually from $10 billion in 2021 to $22 billion in 2030. The antibody biosimilar market, which Epis focuses on, is expected to grow about 11% annually, leading the growth of the biosimilar market. Samsung Biologics is currently constructing its fourth plant, the world's largest biopharmaceutical plant, and MultiModal Plant, which can produce various biopharmaceuticals at one plant, is also set to begin construction by the end of this yeear. Samsung Biologics plans to complete an additional 350,000㎡ site contract for the second campus, which is larger than the site currently in use (270,000㎡), at Songdo District 11 in Incheon, by the end of this year.
- Product
- Actinum is a troublemaker?
- by Kim JiEun Feb 07, 2022 05:57am
- Actinum is out of stock due to lack of inventory. The key is to return distribution inventory after the 11th. Multivitamin Actinum, which ambitiously entered Korea, is in a position to become a headache. It is not expected to be easy to order at pharmacies for the time being. According to an official at Dongwha Pharm on the 14th, Actinum's sales ended in November. As of this day, the sales authority of Donghwa Pharmaceutical has expired. The problem is that domestic pharmaceutical companies that will take over the copyright of Actinum after Donghwa Pharmaceutical have not been decided, making it virtually unclear whether they will sell it in the future. Actinum is a domestic generic of Arinamin sold by Takeda. Immediately after its launch, aggressive marketing was conducted, such as conducting public advertisements through famous celebrities. However, it was directly hit by the boycott of Japanese pharmaceutical companies' drugs in 2019, and was pushed back by a series of competitive products. The industry believes that this situation has a direct impact on the selection of pharmaceutical companies after Dongwha Pharm. An official from Dongwha Pharm said, "I think Takeda is looking for a partner in a domestic pharmaceutical company." He said, "We also asked the headquarters to discuss inventory or settlement issues when the pharmaceutical company to be acquired is decided ahead of the end of the contract, but we are in a difficult situation as there has been little talk so far. The contract ended at the end of December, and we have agreed to sell it only until January 11th, he said. This situation has recently been reflected in front-line pharmacies. At major drug online malls, Actinum EX is currently out of stock and cannot be ordered. According to local pharmacy pharmacists, only a small amount of products can be ordered from some wholesalers. A local pharmacy pharmacist said, "Actinum is not a popular item, but we have secured inventory because there are cases where patients who have taken it before are looking for it, but it has not been easy to order recently," adding, "We have only ordered a small amount of it by asking the wholesaler." Dongwha Pharm said it is difficult to return or settle distribution inventory at the company level since the 11th when the sales contract expired. An official from Dongwha Pharm said, "It is frustrating that the copyright has not been clearly cleared up by the company," adding, "It will be difficult to settle or return inventory as it does not have its own authority on distribution inventory after January 11th. However, we plan to deal with all distribution products as much as possible in November, he said.
- Company
- Lorviqua can be prescribed at general hospitals
- by Eo, Yun-Ho Feb 04, 2022 05:57am
- Preparations have begun for the prescription of Lorviqua, a third-generation ALK that seeks to register insurance benefits. According to related industries, Lorviqua of Pfizer Korea passed DC of medical institutions such as Gangnam Severance Hospital, National Cancer Center, Chung-Ang University Hospital, and Hanyang University Hospital, as well as Samsung Medical Center and Seoul National University Hospital. It is aiming to settle down in the market quickly in case it succeeds in registering salaries. Lorviqua, which first passed the HIRA's cancer disease review committee in January 2022, is currently waiting for the introduction of the Drug Reimbursement Evaluation Committee. Since Lorviqua is a drug with strength in resistance, it is believed that it will be possible to attract prescriptions quickly if the registration is made. It remains to be seen whether Pfizer, the first developer of ALK anticancer drugs, will be able to increase its market share. It was designated as a rare drug in March last year and was approved in Korea for use in cases where Alecensa or Zykadia was previously treated with primary ALK inhibitors or Xalkori and at least one other ALK inhibitor as a monotherapy for adult ALK NSCLC patients in July. Lorviqua, a third-generation drug, can be an alternative to patients who have developed resistance since Xalkori, a first-generation drug, and Zykadia and Alecensa, a second-generation drug. If Xalkori is used in the first-line therapy, Lorviqua can be prescribed after using the second-generation drug, and if the second-generation drug is used, Lorviqua can be used in the second-line therapy. Until now, chemotherapy had to be used because there was no targeted treatment available for secondary drug resistance. Resistance mutations that appear mainly after second-generation drug treatment are G1202R, and depending on the drug, they also appear in F1174L (Zykadia), I1171T/N/S (Alecensa), and E1210K (Alunbrig). Lorviqua is effective in all known resistant mutations. Meanwhile, Lorviqua recently added a non-small cell lung cancer's first-line therapy indication in Europe. The approval was based on the results of a phase 3 CROWN study. In this study, Lorviqua demonstrated improvement efficacy in indicators such as mortality risk and ORR compared to Xalkori.
