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- 2026-03-17 23:19:11
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- Eliquis generics pull out from market after losing suit
- by Kim, Jin-Gu Sep 27, 2021 05:51am
- With major Eliquis (apixaban) generics products removed from the insurance benefit list after losing the patent suit, the Eliquis generics have now completely withdrawn from the market. As a result, the only dispute left between the original and generic companies for Eliquis is the claims for damages, and a fierce legal battle is expected on the calculation of compensation for damages. According to the pharmaceutical industry on the 23rd, 26 products (13 companies) of Eliquis generics were removed from the reimbursement list this month. The drugs include Chong Kun Dang’s ‘Liquisia,’ Samjin Pharm’s ‘Elxaban,’ Yuhan Corp’s ‘Yuhan Apixaban,’ Hanmi Pharm’s ‘Apixban,’ and Jeil Pharmaceutical’s ‘Jerixaban.’ The other generics that were left on the reimbursement list were drugs that haven’t been sold after listing. With the removal, the market withdrawal of Eliquis generics has been officially complete in 2 years since the generics were released in the market. Chong Kun Dang and others had succeeded in targeting Eliquis’ substance patent in February 2018 (first trial), then succeeded in nullifying Eliquis’ composition patient, which led to the sequential release of its generics from June 2019. However, the situation took a downturn with the Supreme Court ruling, which overturned the first and second trial and ruled in favor of the original company. Companies that sold Eliquis generics voluntarily discontinued sales of their products to reduce the claims for damages from patent infringement. With the exit of the generics, the only dispute left between the original and generic companies is the compensation suit filed by BMS against generic companies. BMS filed a claim for damages against generic companies in 2019. However, the progress of the damages suit was sluggish as the Supreme Court ruling remained. And after the Supreme Court ruling came out in April, not many further pleadings were held due to the influence of the COVID-19 incident. The pharmaceutical industry predicts that lawsuits for damages will speed up with the Supreme Court ruling. And a fierce battle between the two sides is expected over how the specific amount for damages will be set. In general, the amount of damages for patent infringement is set at 14.2% of actual sales sold for each generic, as the judiciary considers the operating profit of the industry to be around 14.2%. However, the calculation becomes much more complex when damages are specifically calculated by category because the 'profit' made from patent infringement is considered the amount that should be compensated for damages. For example, the cost of the raw material sand APIs is generally excluded from charges, because the ingredients would not have been purchased if not for the generics’ release. Calculation of labor, sales, and promotion expenses is more complex. This is the part where the two parties clash the most. As each generic company invests different amounts in labor, sales, and promotion expenses, the original company is having the most trouble calculating this amount. Also, some have mentioned that the original company is preparing new reasoning to increase the compensation that should be paid by generics companies. Until recently, generic companies have earned a total of 12.7 billion won in 2 years by releasing Eliquis generics. According to the pharmaceutical market research firm UBIST, Liquisia earned 4.1 billion won; Elxaban 2.4 billion won; Yuhan Apixaban 1.7 billion won; and Apixaban 1.1 billion won. An industry official said, “Based on previous rulings, the generic companies will have to pay around 1.8 billion won in compensation for damages incurred, so each company will be paying less than 0.6 million won. However, the companies may have to pay more under the new reasoning the original company is preparing.
- Company
- When does Sputnik ship in Korea?
- by Kim, Jin-Gu Sep 27, 2021 05:51am
- SputnikShipment of the domestic finished product of the COVID-19 vaccine Sputnik developed in Russia will begin as early as next month. The consortium centered on Korus has already secured 10 million finished products, and the Huons Global Consortium plans to start producing finished products by the end of this year. ◆Prospects of shipment of finished products next month, Russian media also report "imminent" According to Korus on the 17th, the Korus consortium, which consists of seven companies and institutions, plans to ship the finished product of Sputnik as early as next month. Korus has already started producing finished products and has completed the production of undiluted solutions for 10 million people. An official from the company explained that if a request is received from RDIF, it can be shipped immediately after filling. Korus has completed the submission of relevant data and is waiting for certification from the Russian government. It explains that initial shipments are possible as soon as authentication is completed. There have also been reports in Russia that shipments are imminent. Russian news agency TASS reported on the 16th (local time) that GL Rafa will ship Sputnik Light in the near future, and RDIF is planning a commemorative event related to this. Huons Global product production has begun, "The forecast of production of finished products by the end of this year Korus signed a contract with RDIF for consignment production of Sputnik V in September last year. Since then, Korus has formed a consortium with six companies and one institution, including Binex, Boryungbio, Isu Abxis, CKD Bio, Quratis, and Andong Animal Cell Demonstration Support Center. The consortium plans to build production facilities of more than 100 million doses per month. However, as product production and local approval were delayed due to local circumstances in Russia, questions were raised over the specific timing of shipment of finished products. An official from Korus said, "We signed the first Sputnik V consignment production contract, but with the release of Sputnik Light, which was improved with one inoculation, the originally planned schedule has been slightly delayed," adding, "We expect to be able to ship as early as next month." ◆Huons Global product production has begun, The forecast of production of finished products by the end of this year Huons Global Consortium also predicts that it will be possible to produce finished products within this year. Prestige Biopharma, Humedix, and BoranPharma are participating in the Huons Global Consortium. Huons Global announced on the 17th that it has started production of Sputnik V's products since this week. Prestige Biopharma is in charge of this production. Prestige Biopharma is in charge of manufacturing undiluted solutions at the Huons Global Consortium. After a Russian official checks the product, a Huons Global official predicted that production of the finished product will be from November to December. A meeting with Russian officials last August with Huons Global Consortium An official from Huons Global said, "It is expected that the validation confirmation process will be completed within this month. We will be able to start producing finished products within this year, he said. The produced products will be supplied to more than 70 countries that have approved Sputnik at the request of Russia, he said. Huons Global signed a contract with RDIF for consignment production of SputnikV in April.
- Company
- Celltrion signed a contract with the U.S. for DiaTrust
- by Lee, Seok-Jun Sep 24, 2021 05:56am
- Celltrion will supply DiaTrustTM COVID-19 Rapid Test, co-developed with Humasis, an in vitro diagnostic company, to the United States through Celltrion USA. According to the company on the 23rd, Celltrion USA was finally selected as a supplier in a purchasing project conducted by DLA under the U.S. Department of Defense. As early as the 1st of next month, it will begin supplying DiaTrust to 25,000 designated procurement sites in the United States, including military facilities, nursing homes, regional inspection centers, and major facilities. The contract period is until September 16 next year. The contract amount can increase by up to 738.2 billion won depending on the situation, the largest among the selected suppliers. An official from Celltrion emphasized, "The fact that we participated as a supplier in the U.S. defense procurement project, which has strict standards, has been recognized for Celltrion's technology and supply capabilities." Unlike other rapid diagnostic kits, DiaTrust is a product that improves sensitivity and specificity by applying two antibodies that bind to the N protein and S protein of the COVID-19 virus, respectively, and can check for infection within 15 minutes. It is possible to check for infection immediately after examination without additional equipment, and it shows accuracy of 93.3% sensitivity and 99.0% specificity. DiaTrust is divided into POCT and OTC that can be used with the help of medical experts under permission to use. This contract is supplied as POCT.
- Company
- Trelegy Ellipta can be prescribed at general hospitals
- by Eo, Yun-Ho Sep 23, 2021 05:44am
- The COPD treatment Trelegy Ellipta can be prescribed at general hospitals. According to related industries, GSK Korea's COPA treatment Trelegy Ellipta (Fluticasone Furoate, Umecridinium Br, Villanterol Trifenate) passed DC at 38 medical institutions including Big 5 General Hospitals such as Seoul National University Hospital and Asan Medical Center. Since the insurance benefits in June, prescriptions have become possible quickly. Trelegy Ellipta is the first COPD complex approved in Korea in May 2018. It is prescribed as a maintenance therapy for moderate and severe COPD that is not properly controlled by persistent β2 agonist and inhalation corticosteroid combination therapy or LABA and LAMA combination therapy in adults. As for the benefit criteria, despite ▲ persistent beta 2 agonist and LAMA combination therapy, if FEV1 value is less than 60% of the normal prediction or acute exacerbation occurs more than twice a year, ▲If symptoms such as dyspnea are not properly controlled despite persistent beta 2 agonist and inhalation corticosteroid combination therapy, ▲If a patient who is simultaneously administering Vilanterol trifenate/Fluticasone furoate and Umecridinium Br satisfies each individual examination, this is the case when pt wants to switch to Trelegy. The validity of Trelegy Ellipta has been reaffirmed through a recent INTREPID phase 4 study. The study was conducted at 147 centers in five European countries, including the UK and Germany, with a total of 3,092 COPD patients participating. Patients were assigned to the Trelegy Ellipta treatment group and the multiple inhalation type three-drug combination treatment group on a one-to-one basis. The primary efficacy evaluation variable was the COPD Assessment Test (CAT) score, which is the COPD evaluation test, to evaluate patients' health status. As a result of measuring the ratio of patients whose CAT score decreased by more than 2 units to baseline at the 24th week of treatment, the median CAT score in the patient group treated with Trelegy Ellipta was 18.0 (8.0), and the median CAT score in the multiple inhalation groups was 19.1 (7.9), significantly improving overall health. The secondary efficacy evaluation variable based on the sub-analysis was the change in FEV1 identified at week 24 of treatment and the proportion of patients who committed more than one serious error when using each inhaler. As a result of the analysis, FEV1 in the Trelegy Ellipta treatment group was 77 mL, which showed statistically superior lung function improvement compared to the multiple inhalation treatment group (28 mL).
- Company
- It surpassed ₩1 trillion in monthly drug imports
- by Kim, Jin-Gu Sep 23, 2021 05:43am
- In August, pharmaceutical imports surpassed ₩1 trillion for the first time. This is due to the fact that imports of Pfizer, Moderna vaccines were reflected in statistics following July. Drug exports rose 10% year-on-year to ₩700 billion last month. However, as imports increased sharply around the COVID-19 vaccine, the deficit in the drug trade balance hit the highest level since December 2019. ◆In August, vaccine imports amounted to ₩340 billion, the highest ever According to the Korea Customs Service on the 15th, imports of domestic medicines in August were $870.81 million. This is the first time that monthly drug imports have surpassed 1 trillion won. Compared to $50.32 million in August last year, it jumped 64%. It renewed its highest import amount ever for two consecutive months following July. In July, drug imports amounted to $819.58 million. As imports of COVID-19 vaccines began in earnest, the total amount of medicines imported increased significantly. Domestic vaccine imports were only $34.45 million by February this year, but as COVID-19 vaccine imports began in earnest, they surged to $49.82 million in March, $54.91 million in April, $58.88 million in May, $15.51 million in June, and $211.62 million in July. It recorded $291.53 million in August, once again breaking the record for the highest amount set in July. Considering that the domestic supply of Moderna vaccine has been disrupted in July and August, it is predicted that vaccine imports may increase further after September. Excluding vaccine imports, monthly drug imports remain around $600 million, similar to last year. ◆Pharmaceutical exports amounted to ₩690 billion, the largest trade deficit in 20 months Exports of medicines in August amounted up to 10% from$50.303 million a year earlier. As imports increased significantly compared to pharmaceutical exports, the domestic pharmaceutical trade deficit increased significantly. The drug trade balance recorded a deficit of $277.78 million in August. The deficit is the largest in 20 months after recording $317.24 million in December 2019. The domestic drug trade balance has steadily recorded a surplus from August last year to March this year, except for October last year, due to increased biosimilar exports. However, since the import of COVID-19 vaccines began in earnest, the deficit has gradually increased.
- Company
- The once-daily Xeljanz XR lands in general hospitals
- by Eo, Yun-Ho Sep 17, 2021 05:56am
- The new extended-release formulation of Xeljanz, Xeljanz XR, has started its landing process in general hospitals. According to industry sources, Pfizer Korea’s rheumatoid arthritis treatment ‘Xeljanz XR 11mg’ passed the Drug Committees (DCs) of the Big-5s general hospitals in Korea - Seoul National University Hospital (SNUH), Asan Medical Center (AMC), Seoul St. Mary’s Hospital, Samsung Medical Center (SMC), and Severance Hospital – as well as other major medical institutions in the nation. Xeljanz XR, which was listed for insurance benefit since April last year, can be used in adult rheumatoid arthritis patients that meet the ACR/EULAR criteria whose: ▲DAS28 is more than 5.1, or ▲DAS28 is between 3.2 to 5.1 with radiographic damage progression in the joints, that have been treated with over 2 types of DMARDS (including MTX) for 6 months (3months each) but had inadequate treatment effect or discontinued treatment due to side effects of the drugs. However, Xeljanz XR was approved only for the rheumatoid arthritis indication and was unable to add indications for psoriatic arthritis or ulcerative colitis. The new approval hold significance as the Xeljanz 5mg that was previously approved for the treatment of rheumatoid arthritis in Korea was administered twice daily, but the new 11mg dose that was approved allows for once-daily dosing. Meanwhile, Xeljanz XR 11mg demonstrated non-inferiority with Xeljanz+methotrexate (MTX) in the ORAL SHIFT study. The study was conducted on 533 patients with rheumatoid arthritis who achieved low disease activity (LDA) with a Clinical Disease Activity Index (CDAI) of 10 or less after 24 weeks of treatment with Xeljanz+MTX combination to assess the non-inferiority of Xeljanz monotherapy (11mg, once-daily) in comparison to Xeljanz+MTX. The primary endpoint of the study was least squares (LS) mean changes in DAS-28-4(ESR) from weeks 24 to 48, which was deemed non-inferior if the difference between the two arms was less than 0.6. Results showed that the mean change in DAS-28-ESR from weeks 24 to 48 was 0.33 for the Xeljanz monotherapy group and 0.03 in the Xeljanz+MTX groups, demonstrating Xeljanz XR’s non-inferiority with an LS mean difference of 0.30 (95% CI; 0.12~0.48).
- Company
- Blockbuster anticancer drug series 4 - Avastin
- by Sep 17, 2021 05:55am
- "By blocking blood vessels generated to proliferate cancer, cancer is starved to death.There is a drug that realizes the theory of a professor at Harvard University in the U.S., who caused a "sensation" in the 1970s. Avastin, a Vascal Endothermic Growth Factor (VEGF) inhibitor, which is also considered a good partner for immuno-cancer drugs. It's the first anti-VEGF event to surpass 100 billion won. Avastin was launched when Genentech in the United States was interested in angiogenesis research and discovered VEGF and genes. Avastin has greatly succeeded along with new antibody drugs such as Rituxan and Herceptin. After Avastin's approval, Roche completely acquired Genentec. Avastin received a lot of expectations and concerns at once. Avastin, which started as a treatment for colorectal cancer, had indications for various carcinomas such as breast cancer, lung cancer, and kidney cancer. In particular, Avastin significantly increased the treatment effect in carcinoma. However, side effects such as high blood pressure, blood clots, and heart failure caused by excessive inhibition of angiogenesis have become controversial. Indications for breast cancer have been withdrawn in the United States due to ambiguous effects against toxicity. Controversy also arose in unauthorized indications. Wet macular degeneration, which causes blindness, is also caused by excessive proliferation of new blood vessels under the retina. Avastin preference was much higher because of the low cost. Avastin was widely used in the treatment of macular degeneration. In Korea, Avastin has expanded its indications relatively smoothly to breast cancer, non-small cell lung cancer, kidney cancer, glioblastoma, ovarian cancer, and cervical cancer since it was approved as a treatment for colorectal cancer in 2005. It was used as a primary treatment in all indications other than glioblastoma and became essential for chemotherapy. With the first registration in 2014, Avastin surpassed 100 billion won in sales for the first time in 2018, 13 years after approval based on IQVIA. Last year, it posted 118 billion won in sales. This is the third-highest selling figure in the entire drug market in Korea. Will Avastin find a new opportunity? Avastin is a good drug to use with other anticancer drugs due to its mechanical nature. It is used with conventional chemotherapy in all indications other than glioblastoma. Targeted anticancer drugs have obtained primary treatment indications for EGFR-positive non-small cell lung cancer with good effects with Tarceva, an EGFR target treatment. It is also used in primary maintenance therapy for ovarian cancer in combination with the PARP inhibitor Lynparza. Roche received primary treatment indications for liver cancer and non-small cell lung cancer through combination therapy with its anti-PD-L1 immuno-cancer drug Tecentriq and Avastin. Keytruda and Opdivo are also exploring the possibility of being used in combination with Avastin in various carcinomas. It is expected that anti-VEGF drugs will compensate for the limitations of cancer immunotherapy alone. Some clinical trials have failed, but combination of cancer immunotherapy and Avastin is still a good strategy. Avastin is widely used. Big Pharma such as Amgen, Pfizer, and Beringer Ingelheim are participating overseas, and two biosimilars have been released in Korea this year. They are Onbevzi of Samsung Bioepis and Zirabev of Pfizer. Onbevzi, the first simulator sold by Boryeong Pharmaceutical, has been paid since this month, and is in the midst of preparing for prescriptions at general hospitals. However, Zirabev is more advantageous in indications. Onbevzi, did not receive some indications for ovarian cancer related to the patent for use. Celltrion and Prestige Biopharma are also developing biosimilar products, so competitive drugs are expected to increase further. When competition begins in earnest, Avastin sales, which amount to 120 billion won, are expected to be inevitable. Avastin sales have already declined as biosimilars have already entered the largest European and U.S. markets. Global sales fell 25% year-on-year last year. In the case of Korea, drug prices have been continuously lowered since Avastin was registered, and the actual difference between the original and biosimilars is expected to be insignificant as only 5% of the patient's burden is applied. The results may vary depending on the non-reimbursed item. In particular, there are biosimilars that are cheaper than Avastin in off-label diseases such as macular degeneration. Sales of expired patents are usually falling, but Avastin has new opportunities. It is an expansion of benefits in combination with Tecentriq. In the primary treatment of liver cancer, combined therapy passed the HIRA's Cancer Drugs Benefit Application Committee in February. In particular, it is more difficult to replace biosimilars with combination therapy with immuno-cancer drugs. The primary benefit for liver cancer is currently in the presumption stage for more than six months. The key is how quickly Roche Korea and the government will be able to reach an agreement over Avastin drug prices, which are burdensome at high prices.
- Company
- JAK inhibitors may fall to 2nd-line due to safety concerns
- by Nho, Byung Chul Sep 16, 2021 05:59am
- With the health authorities seriously considering changing the reimbursement standards for Janus kinases (JAK) inhibitors which have recently been caught up in controversy over its safety issues, what the results will be is gaining industry-wide attention. According to industry sources, the Ministry of Health and Welfare (MOHW) and the Health Insurance Review and Assessment Service (HIRA) have been collecting opinions from relevant academic societies on the clinical efficacy and sequential therapy (first-line·second-line treatment) of JAK inhibitors for consideration. Although there had been cases where the authorities had removed drugs from the insurance benefit list according to the revocation of licenses, the authorities’ preemptive and voluntary action to change and amend the prescription guidelines is very rare, to the extent that actual cases of such examples are difficult to find. This is interpreted as the health authorities’ determination to take a step closer to advancing regulatory science for public health and prioritizing the patient’s safety in drug intake in line with the vision set by the FDA, the authority that is considered the international standard for drug approval and regulations. Recently, the MFDS had issued a Dear Healthcare Professional Letter regarding the safety of JAK inhibitors such as Pfizer’s ‘Xeljanz (tofacitinib),’ Lilly's ‘Olumiant (baricitinib),’ ‘Abbvie’s ‘Rinvoq PR Tab (Upadacitinib),’ etc. The MFDS’ measure was made after reviewing the results of the FDA’s randomized, large-scale clinical trial on the safety of ‘tofacitinib’ that was released on the 1st. The FDA had announced that tofacitinib increased the risk of serious heart-related events such as heart attack, stroke, cancer, blood clots, and death. The drug that is receiving particular interest among the JAK inhibitors is Pfizer’s Xeljanz, which had already had a safety issue in 2019 in addition to the heart attack risk that was discussed this time. Xeljanz is an oral JAK inhibitor indicated for rheumatoid arthritis and ulcerative colitis. After discussions with Pfizer, the FDA had ▲changed the ulcerative colitis indication from first-line to second-line and ▲added warnings to refrain from prescribing the drug to patients at risk of embolisms, at the time of issue development. On why the health authorities have made such prompt measures to address the issue of JAK inhibitors is considered to be because this is the second time the safety issue of the JAK inhibitor Xeljanz rose in 3 years with concerns for two side effects - increased risk of heart attacks and the 'risk of embolism.'. The prospect is that the academic society will show neutral or tacit consent to the authorities' move to amend the other reimbursement standards after changing the scope of approval. As in the FDA’s case of restricting Xeljanz's indication from first-line to second-line, where academic societies abroad made changes to the prescription guidelines after taking a neutral stance in respect to the opinions set by the regulatory authorities, rather than showing strong consent. If the Korean health authorities and academia reach a consensus on changing the indication for JAK inhibitors from 1st line to 2nd line treatment, the market for injectable traditional biopharmaceuticals is highly likely to expand. The current market established for JAK inhibitors is around ₩30 billion, and the prescription market for biologics such as Humira, Remicade, Simponi, Mabthera, Actemra, Cosentyx, Kynteles, and Stelara is around ₩350 billion annually.
- Company
- Nocdurna can be prescribed at general hospitals
- by Eo, Yun-Ho Sep 16, 2021 05:59am
- #iNight urination treatment "Nocdurna" has been settled on the prescription ticket of a general hospital. According to related industries, Nocdurna (Desmopressin), co-sold by Ferring and Chong Kun Dang, passed DC, drug committee of Big 5 General Hospital such as SNUH, SMC, Seoul St. Mary's Hospital, and except for Sinchon Severance Hospital. In addition, Korea University Anam Hospital, NMC, Inje university Busan Paik hospital, Inje university Ilsan Paik hospital, Ewha Womans University Medical Center, Pusan National University Hospital, Haeundae Paik Hospital, Ajou University Hospital, Chonnam National University Hospital, and Chungnam National University Hospital also completed the process Ferring and Chong Kun Dang have been jointly selling "Minirin," a treatment for night urination, since 2019. Nocdurna, which signed an additional contract, is said to have reduced the burden of hyponatremia, which was feared in elderly patients, with Minirin's low-dose product. Nocdurna improves night urination symptoms caused by night urination, which overproduces urine at night, accounting for up to 88% of the causes of night urination. As a new treatment that can reduce the number of night urination in adults and improve the quality of sleep, Nocdurna 50 μg is administered once a day for men and Nocdurna 25 μg is administered once a day for women. As a result of the phase 3 study, Nocdurna 25μg and Nocdurna 50μg were found to be effective in controlling night urine-related symptoms in women and men, respectively. Nocdurna reduced the average number of night urination compared to placebo, and extended the initial sleep period due to increased time until the first night urination. Compared to placebo, the quality of life and sleep related to night urine have increased significantly. Meanwhile, Nocdurna, like the existing anti-diuretic hormone drug (Desmopressin), is covered by insurance benefits to treat night urination symptoms caused by nighttime urination.
- Company
- Idiance reveals the results of Venadaparib
- by Kim, Jin-Gu Sep 16, 2021 05:59am
- Idience, a new drug development company of Ildong Holdings, announced on the 14th that it will announce the results of phase 1b clinical trials of the targeted anticancer drug Venadaparib (IDX-1197) at the ESMO conference to be held from the 16th to the 21st. Venadaparib is a new drug candidate for targeted anticancer drugs based on precision medicine with a PARP (Poly ADP-ribose polymerase) inhibitory mechanism. Currently, Idience is conducting phase 1b/2a clinical "VASTUS" to evaluate the safety, tolerability, and effectiveness of Venadaparib in solid cancer patients with homologous recombination recovery mutations. What will be announced this time is the first interim result of the VASTUS test released through the American Cancer Society (AACR) in April. According to the abstract released on the 13th, Venadaparib was administered to metastatic BRCA mutated breast cancer patients, and there were no nausea, fatigue, or loss of appetite corresponding to Grade 3, which is the main side effects of existing PARP inhibitors.In particular, excellent efficacy was observed, with an objective response rate (ORR) of 80% of 10 patients administered Venadaparib, Idiance said. The company explained that it plans to secure additional related data through follow-up research. Based on the results of the clinical phase 1b study, Idience is known to have initiated phase 2a clinical trials. The ORR levels of Venadaparib observed in breast cancer patients with BRCA mutations are very meaningful compared to conventional PARP inhibitors, an Idiance official said. "We will continue further clinical studies to prove the excellent anticancer effect of Venadaparib."
