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- 2026-05-17 11:18:12
- Company
- Reimb of SGLT-2i combos unclear... nears PMS expiry
- by Eo, Yun-Ho Dec 24, 2021 05:49am
- SGLT-2 inhibitors approved in Korea Anticipation has turned to tension. The companies that own SGLT-2 and DPP-2 combination therapies are facing hardships ahead of their post-marketing surveillance period expiry. At the diabetes expert meeting that was held by the Health Insurance Review and Assessment Service in September, the members concluded that the authorities should integrate and accept reimbursement of 2-drug and 3-drug combinations that use DPP-4 inhibitors with SGLT-2 inhibitors. The conclusion harbored industry hopes of being granted reimbursement listing for their non-reimbursed combinations. However, no progress has been made since in extending the insurance benefits to the combinations so far, putting pressure on the Post Marketing Surveillance (PMS) results. The PMS results of combination therapies such as Boehringer Ingelheim Korea’s ‘Esglito (empagliflozin/ linagliptin), AstraZeneca’s Qtern (dapagliflozin/saxagliptin)’ that is sold by Ildong Pharmaceutical, and MSD Korea’s ‘Steglujan (ertugliflozin/ sitagliptin) is due to the MFDS by 2023-2024. Only 1-2 years are left until the deadline. However, hundreds to thousands of patients need to enroll and register to conduct PMS, and due to the nature of the diabetes treatment market, it is difficult to recruit and attract prescriptions for non-reimbursed drugs. In other words, unless the drugs receive reimbursement, the companies will not be able to meet the number of patients required for PMS that was set by the Ministry of Food and Drug Safety. An official from a pharmaceutical company with an SGLT-2 inhibitor said, “In this pace, the license will inevitably be revoked. With the government policy supporting the active use of combinations, treatment accessibility is hindered if patients cannot be prescribed the drug due to non-reimbursement. I hope reimbursement is extended to SGLT-2 inhibitor combinations as soon as possible.” Meanwhile, at the expert meeting, the authorities decided that TZD class drugs that have cardiovascular risks should be reviewed ‘case by case.’ Therefore, the use of TZD combinations will continue to be restricted depending on individual ingredients.
- Policy
- Govn’t to prepurchase 10 mil of SK Bio’s COVID-19 vaccine
- by Kim, Jung-Ju Dec 24, 2021 05:49am
- The government plans to purchase 10 million courses of domestic COVID-19 vaccine in advance this year. Also, the government will support a total of ₩545.7 billion on overcoming COVID-19 next year - ₩321 billion in the development of vaccines and treatments, ₩119.3 billion in the establishment of research and manufacturing infrastructure, ₩36.4 billion in the advancement of disease control and prevention material and devices, ₩69 billion in the advancement of basic research. On the 23rd, the government held the 12th meeting of the Pan-Government Committee for COVID-19 Treatment and Vaccine Development to review the progress and discuss ▲COVID-19 treatment and vaccine development status and support, ▲reinforcing R&D support for the development of COVID-19 treatment and vaccine, ▲budget allocation for COVID-19 treatment and vaccine development support. At the meeting, Minister of Science and ICT (co-chair) Hyesook Lim, Second Vice Minister of Health and Welfare Ryu Geun-hyuk, and other relevant ministries and domestic experts in the field of treatments and vaccines participated in the meeting. ◆ COVID-19 treatment and vaccine development status and support = Other than the COVID-19 antiviral treatment that was officially approved on September 17th, 16 companies are currently conducting clinical trials on 17 local COVID-19 treatment candidates. The government has been increasing the number of residential treatment centers, short-term·outpatient treatment centers, and long-term care facilities while conducting efficacy assessments of the antivirals developed on COVID-19 variants. The government has also prepared measures to improve clinical trials on COVID-19 treatments so that latecomer COVID-19 treatments can continue to be developed. Also, with the increased at-home COVID-19 treatment cases for trials, the government prepared measures to more easily accommodate these patients into clinical trials. Eligible patients who are treated from home may participate in clinical trials through outpatient care or researcher visits from research nurses or other researchers. The government will also pursue the advance purchase of 10 million courses of the local COVID-19 vaccine developed by SK Bioscience to support local COVID-19 vaccine development. SK Bioscience’s vaccine has met the pre-purchase requirements set by the government at the 10th Pan-Government Support Committee (announcement of Phase II trial at interim results and approval of Phase III trial protocol). After a comprehensive review of the safety, immunogenicity, and utilization of the vaccine based on the interim results of the Phase II clinical trial, the government decided to purchase the vaccine in advance. The advance purchase agreement will be made as soon as possible after the details on the practical terms of the agreement are discussed. ◆ Reinforcing R&D support for the development of COVID-19 treatment and vaccine = To government also plans to support clinical trials of COVID-19 treatments and vaccines to the end and reinforce R&D support of clinical trials to accelerate development and improve the probability of success. Also, in consideration of the public interest and potential of succeeding in the R&D of COVID-19 treatment/vaccine, the government also plans to strategically review measures to reduce corporate out-of-pocket expenses for clinical trial R&D projects. Companies that participate in the COVID-19 treatment·vaccine clinical trial support project need to cover a fixed proportion of the R&D expense (50-25% of the total R&D expense) themselves. The government plans to review measures to reduce the clinical expenses borne by small-and-mid sized companies by easing regulations made to support the rate borne by private companies in cash, but only for ▲(vaccine) Phase I-III trials and ▲(treatment) Phase II-III trial and new drugs (excluding repurposed drugs) ◆ budget allocation for COVID-19 treatment and vaccine development support= The government will be supporting a total of ₩545.7 billion for the development of COVId-19 treatments and vaccines. This is a 107.7% (₩283 billion) increase from the main budget that was set for COVID-19 in 2021. The government plans to reinforce research support at clinical and non-clinical stages and seek advance purchase of locally developed COVId-19 vaccines by investing ₩321 billion in the development of COVID-19 treatment and vaccines and the success of their clinical trials. More specifically, the Ministry of Health and Welfare is investing ₩89.3 billion in the clinical support of COVID-19 treatments and vaccines and ₩10.5 billion in the clinical support of mRNA vaccines; the Ministry of Science and ICT investing ₩10 billion in bio and medical technology development; and the Korea Disease Control and Prevention Agency investing ₩192 billion on the advance purchase of local vaccines. Also, the authorities plan to support ₩119.3 billion on the development of test methods for COVID-19 treatments and vaccines while establishing testing facilities and devices to lay the foundation for manufacturing. Specifically, the MOHW will invest ₩4.8 billion to establish a system for clinical trial support, KDCA ₩8.2 billion to establish a national healthcare research infrastructure, the MFDS ₩22.7 billion to strengthen the international competitiveness of biopharmaceuticals, the MSTI ₩12.2 billion to the Center for National Preclinical Trial Support, and the MOTIE ₩16.7 billion to support companies that promote the industrialization of vaccines using the vaccine demonstration support center. Ryu Geun-hyuk, Second Vice Minister of Health and Welfare, said, “We will reinforce support on clinical trials to provide support for vaccine and treatments to the end. Through this, we will establish a development system for biopharmaceuticals that can rapidly respond not only to COVID-19 but also to other infectious diseases that may arise in the future.”
- InterView
- Ibrance can be used regardless of underlying condition in BC
- by Dec 24, 2021 05:48am
- It has been 5 years since Pfizer’s breast cancer treatment ‘Ibrance (Palbociclib)’ was introduced to the Korean market. As the first cyclin-dependent kinase 4/6 (CDF 4/6) inhibitor, the drug had innovated the treatment paradigm for patients with metastatic and recurrent hormone receptor-positive (HR-positive) and human epidermal growth factor receptor 2-negative (HER2-negative) breast cancer. With 5 years' worth of accumulated data, Ibrance has settled in as a trusted and reliable drug for doctors. In particular, Ibrance is considered the ‘go-to drug’ for those who have underlying conditions or have side effect concerns. At a meeting with Dailypharm, Kyong-Hwa Park, Professor of Oncology and Hematology at Korea University Medical Center, said that “Ibrance is suitable for use in patients who have poor liver conditions, the elderly, and those with poor kidney functions as it demonstrated long-lasting effect with little side effects in the field. Detailed QA of Dailypharm’s interview with Professor Park is listed below. Professor Kyong-Hwa Park -What has the diagnostic status been like for breast cancer in Korea recently? =The number of breast cancer patients has increased greatly recently. Korea’s prevalence rate of breast cancer had surpassed Japan and is now ranked highest in Asia. One silver lining is that the long-term survival rate of Korean patients is very good. Although there are some drugs that are not reimbursed, Korea’s breast cancer treatment environment in terms of treatment, medical service, and accessibility is quite good. - After Ibrance, other CDK4/6 inhibitors have also been started to enter the market. Nevertheless, Ibrance seems to be considered as the drug that can be stably used due to the immense amount of accumulated data and prescription experience. = That is true. Ibrance is the first CDK4/6 inhibitor that was approved in Korea and owns the most amount of long-term data as well as clinical experience. This is why it is a good choice for patients with various concerns. For example, patients who are at risk of side effects due to underlying diseases, old age, etc, may require a period of adaptation when using a drug or take various medications. It would be difficult for the doctor to opt for other CDK4/6 inhibitors in these cases. - Ibrance demonstrated consistent efficacy in patients with underlying diseases in clinical trials. Were you also able to observe this in the field? = A more diverse range of patients always exist in the real world. Some patients are very old, there are those who have poor kidney function, those with bad heart function, and even liver cirrhosis. The number of patients with such underlying conditions increase immensely if we add those who have diabetes or high blood pressure. All of these patients may use Ibrance. For example, I have a patient who has rheumatoid arthritis. She had a fatty liver due to long-term use of rheumatoid arthritis drugs. By using Ibrance with liver condition management, the patient is currently on Ibrance for 4 years with stable liver function. The drug can also be stably used in patients with bad kidney function as well. Also, in Korea, there are patients who have bad liver due to hepatitis B or C. In these patients, we first use the drug and then adjust the dose if they develop leukopenia/neutropenia or thrombocytopenia. - A total of 3 CDK4/6 inhibitors including Verzenio, Kisqali, and Ibrance are available in the market. What other considerations do you make other than the patient’s underlying condition when selecting the kind of CDK 4/6 inhibitor for use? = ECG monitoring is required for the use of Kisqali, at least up to its second cycle, due to its influence on heart activity. Also, the drug may not be used in patients with observed QT prolongation. However, Kisqali is the only drug reimbursed for premenopausal patients who have never received endocrine therapy in Korea, and we induce menopause in such patients to allow the use of various drugs with the same indication. In the case of Verzenio, patients adapt quickly to the drug if educated well on the treatment process, but it is difficult to use in patients who may not be able to tolerate diarrhea. On the other hand, the advantage of Verzenio is that it is good for patients who have metastases to the liver or those who we would have considered using chemotherapy first in the past. -A large-scale real-world data on Ibrance was presented this year in the U.S. The study demonstrated PFS and OS improvement in combination with letrozole in the first-line. This may be similar or different in Korea’s case. How did you interpret the data? =The average age of breast cancer patients in the US is around 15 years older than those in Korea. Also, medical accessibly is not as good in the US as in Korea. However still, the real-world results were comparable to that of clinical trials. The median OS had not been reached yet, but I believe the results would show an improvement. With the younger patient population, better accessibility to treatment, and higher self-management ability, results in the Korean patient population in clinical trials has always exceeded the performance observed in the overall patient population. Therefore, I believe the real-world data in Korea would also come out similarly. -The role of CDK4/6 inhibitors is expected to continue to grow in the field of breast cancer treatment. What direction should Ibrance pursue in the aspect? =Ibrance is being frequently selected as a combination therapy option in novel endocrine therapy combination studies. Although it is currently used in combination with an aromatase inhibitor or faslodex in the first-line, many other 3rd generation oral endocrine therapies are also currently in development. And all of these oral therapies are being developed in combination with Ibrance, so I believe Ibrance will be able to solidify its position as a first-line treatment while switching its partner drugs. Also, PIK3CA mutation is a very important mechanism in endocrine resistance, and studies to tackle this with a three-drug combination are also being conducted using Ibrance. The toxicity of the three drugs does not overlap, so I believe it can be well used in this aspect as well.
- Policy
- Domestic approval of EU-approved Novavax is imminent
- by Lee, Tak-Sun Dec 24, 2021 05:48am
- As the European Union (EU) approved the conditional sale of the NovaVax COVID-19 vaccine, attention is being paid to when it will be approved in Korea. As the MFDS is known to be preparing for Novavax's approval for national lot release, analysts say that approval is imminent in Korea. On the 20th, the European Commission (EMA) approved the conditional sale of the COVID-19 vaccine developed by Novavax. A few hours ago, the European Medicines Agency (EMA) recommended conditional sales approval. The EMA recommended approval for the use of the vaccine to prevent COVID-19 over the age of 18. Novavax was found to have a preventive effect of 90% in clinical trials of about 45,000 people in the United States, Mexico, and the United Kingdom. Side effects are also mostly mild symptoms such as pain in the inoculation site, muscle pain, and fatigue.On the 17th, Novavax, which is produced in India, was approved for emergency use by the WHO. Approval screening is currently underway in Korea. On the 15th of last month, SK Bioscience, a consignment producer in Korea, applied for permission to manufacture and sell items to the MFDS. However, while EU-approved products are multi-use vials, domestic products have different methods which is PFS type. As it has been approved by the WHO and the EMA, the MFDS is also expected to speed up approval. The MFDS has established a policy to process the COVID-19 vaccine as soon as possible. Existing licensed AstraZeneca and Pfizer vaccines were approved within 40 days of application. Therefore, it is predicted that permission can be obtained at the end of this month, around 40 days after application. Some analysts say that the MFDS has recently set up a major test item for Nuvaxovid PFS, and that approval may be imminent. This is because the national lot release is the last quality inspection for the market after approval of biological products such as vaccines. The MFDS is planning to proceed with the national lot release of the COVID-19 vaccine within 20 days of approval as soon as possible. Even if it is approved at the end of the year, it will be difficult to use it immediately in Korea. It is interpreted that it will only be available at the end of the third inoculation because the third vaccination is being conducted with Pfizer or Moderna. Hong Jung-ik, head of the COVID-19 vaccination response vaccination management team, also said in a media briefing on the 21st, "The entire amount of Novavax vaccines signed this year will be carried over," adding, "If approved by the MFDS, we will apply for supply next year."
- Company
- GI Innovation·A/Z, a study on immuno-cancer drugs combined
- by Nho, Byung Chul Dec 24, 2021 05:48am
- The appearance of GI Innovation clinical team members challenging large-scale global clinical trials. (Photo provided = GI Innovation)GI Innovation (CEO Hong Joon-ho) announced on the 17th that it has signed a clinical supply contract with AstraZeneca in the UK to develop a combination therapy with GI-101, an immuno-cancer drug, and Impinzi (Durvalumab). With this contract, GI Innovation will conduct clinical trials with AstraZeneca to evaluate the combination of immuno-cancer drugs GI-101, Impinzi, and chemotherapy. This clinical trial targets patients with small cell lung cancer, gastric/gastroesophageal junction cancer, biliary tract cancer and triple-negative breast cancer in the United States, Australia, and Korea. GI Innovation will be provided with Infinzi necessary for this clinical trial from AstraZeneca, and it will gain the driving force to conduct successful clinical trials by jointly designing clinical trial designs based on AstraZeneca's expertise in developing immuno-cancer drugs. The clinical trials of both companies aim to treat patients with combination therapy with GI-101, an immuno-cancer drug, in addition to the current standard treatment, chemotherapy, in metastatic and advanced cancers. Despite the use of immuno-cancer drugs in clinical settings, small cell lung cancer, gastric/gastroesophageal junction cancer, biliary tract cancer, and triple negative breast cancer did not show sufficient efficacy alone. To compensate for this problem, a combination of chemotherapy and immuno-cancer drugs has recently been attempted, and some carcinomas have shown encouraging therapeutic effects. A typical example is that a combination of chemotherapy and Imfinzi in small cell lung cancer has been approved as a primary treatment. GI Innovation is a strategy to maximize the treatment effect through the combination of GI-101, chemotherapy, and Imfinzi. The IL-2 site of GI-101 not only directly proliferates and activates apoptotic T cells and natural killer cells in the tumor microenvironment, but also effectively inhibits CTLA-4, an immune gateway expressed in immune cells through CD80. Through CD80-CD28 interaction, it is also possible to activate the immune response of cell killing T cells. Finally, it also has a mechanism to relieve immunosuppression by regulatory T cells that express CTLA-4, an immune gateway, in large quantities. Another immune gateway, PD-L1, can be expected to have excellent anticancer immunity when used in combination with Imfinzi, which activates immune cells. GI Innovation's clinical trial was designed as an adaptive and basket trial to confirm the anticancer activity of four solid cancers in one clinical trial and to register more patients in solid cancers that are effective depending on the results of interim analysis. The clinical trial will be conducted at about 20 medical institutions in Korea, the United States, and Australia. Yoon Nari, head of GI Innovation's clinical division, said, "GI-101 is a bispecific fusion protein that has a complex immune regulation function that proliferates and activates cell-killing T cells and natural killer cells only with monotherapy. The combination of GI-101, Imfinzi, and chemical anticancer drugs is designed to fully utilize the inherent mechanisms of the drug to recover the degraded immune response in cancer patients, respectively. Through this clinical trial, we will do our best to secure meaningful clinical differentiation data.
- Policy
- The PV guideline amendments may not be applied on Jan. 1st
- by Lee, Hye-Kyung Dec 23, 2021 05:42am
- It is believed that the improvement of the detailed guidelines for the Price-Volume agreement negotiations (PV) prepared by the National Health Insurance Service may not be implemented on January 1st of next year. This is in part due to the authorities’ internal affairs including its reorganization schedules, but also due to the strong opposition shown by the industry regarding the amendment. However, the NHIS plans to finish the guideline amendments through discussion with the Ministry of Health and Welfare by February next year when the selection of pharmaceuticals subject to monitoring for PV negotiations begins. The NHIS had presented a plan on improving the PV negotiation reservation (exclusion) system at the 10th public-private consultative meeting that was held on the 2nd. The improvements proposed included the revision of Article 6.1.1 of the guideline that calls for expanding the "same product group with an annual claims amount of less than ₩1.5 billion" to "less than ₩2 billion" and Article 6.1.2 that reduces "items with an upper limit of less than the arithmetic average of the main component code” to “less than 90% of the arithmetic average”. The increase of the claims amount from ₩1.5 billion to ₩2 billion was made based on the reference standards used when legislating the guidelines in 2014. At the time, the average claims amount in 2012 was ₩1.52 billion. Products that are less than 90% of the arithmetic average follow the negotiation conditions set for new drug negotiations Among new drugs, drugs that are listed without pricing negotiations usually accept a price at 90% of the weighted average of alternative drugs, therefore, the standards for PV negotiations were also set in line with this standard to less than 90% of the arithmetic average to be exempt from negotiations when the company voluntarily cuts its drug price by 10%. Upon the announcement, the pharmaceutical industry submitted a statement opposing the PV guideline improvements. The industry conveyed its position that the amount subject to exclusion from PVA that is set for the same product group with an annual claims amount of less than ₩1.5 billion should be set to ₩10 billion or less, and items whose price is less than the arithmetic average should be maintained at the present state. The Korea Pharmaceutical and Bio-Pharma Manufacturers Association said, “In line with the purpose of implementing the price-volume linkage system, the negotiation endeavors need to focused on mid-to-large sized items whose use increased to exceed ₩10 billion and the amount subject to exclusion from PVA be set to all drugs below ₩10 billion. The arithmetic average is a social convention and an absolute standard for judging whether the insurance finances can be saved, and therefore, it is in line with the system to exclude drugs that cost under the arithmetic average from negotiations.” Meanwhile, the NHIS plans to first review the opinion statement submitted by the pharmaceutical industry, then discuss it with the MOHW to prepare a plan for the final PV guidelines. However, it seems that it will take some time for the PV guideline improvements to be prepared and announced as personnel transfers of Deputy Ministers and Director-Generals in HIRA's Drug Price Management Office may occur this week or early next week at the latest.
- Company
- MSD's Delstrigo can be prescribed in general hospitals
- by Eo, Yun-Ho Dec 23, 2021 05:42am
- Delstrigo, an HIV combination that succeeded in registering insurance benefits, is preparing to enter the market in earnest. According to related industries, the HIV combination Delstrigo ( Doravirine 100 mg, Lamivudine 300 mg and Tenofir Disoproxil Fumarate), which is taken once a day by MSD Korea, has now passed the DC of medical institutions such as Sinchon Severance Hospital. The drug was approved in Korea in January last year, submitted a benefit application at the beginning of this year, and was listed in January. Delstrigo's benefit indication is "the treatment of HIV-1 infection in adults who have no previous anti-retrovirus treatment experience." Among the ingredients, Doravirine 100mg was approved by the MFDS under the brand name Pipeltro as of November 22, 2019, and is required to be administered in combination with other anti-retroviral drugs. Both Pipeltro and Delstrigo received indications for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients who had no previous anti-retroviral treatment experience. Delstrigo was confirmed its validity through DRIVE-AHEAD clinical trials. In the clinical trial, Delstrigo proved non-equivalence compared to therapy of Efavirenz ·Emtricitabine·Tenofovir. The proportion of patients who reached viral inhibition (less than 40 copies/mL of HIV-1 RNA) at 48 weeks was 84% in Delstrigo treatment group and 80% in EFV/FTC/TDF treatment group. The rate of discontinuation of treatment due to adverse reactions was 3% and 6.6%, respectively, which was lower in the Delstrigo treatment group. Meanwhile, Gilead, GSK, MSD, Janssen, AbbVie, and BMS are currently competing in the HIV sector, of which Gilead and GSK account for about 90% of the market.
- Company
- [2021 Pharmaceutical Patent Settlement] The target is Dukarb
- by Kim, Jin-Gu Dec 23, 2021 05:41am
- Generics' challenge was found to have been concentrated on patents for Boryung's hypertension complex "Dukarb," Novartis' heart failure treatment "Entresto," and Hanmi Pharmaceutical's asthma treatment "Monterizine. The number of companies targeting the patent alone amounts to 45 Dukarb companies, 24 Entresto companies, and 22 Monterizine companies. ◆Focus on requesting a trial on Dukarb, Entresto, and Monterizine patents According to the pharmaceutical industry on the 22nd, referees have been filed for 20 patents for 9 drugs so far this year. A total of 68 companies have requested patent trials. Patent attacks were concentrated on Boryung's Dukarb. After Arlico filed a passive trial to confirm the scope of rights for patents for complex composition in February, 44 more companies challenged. Analysts say that as the expiration of material patent of Kanarb (Fimasartan) is just two years away, it is scrambling to target patents for composite drugs. The material patent expires in February 2023. If the Dukarb patent's challenge is successful, generic companies will be able to release generics early in time for the expiration of the material patent. Dukarb has the highest prescription sales among Kanarb combinations. According to UBIST, a pharmaceutical market research firm, Dukarb was prescribed 36.1 billion won last year, followed by 30.2 billion won by the third quarter of this year. Five companies in the second half of the year gave up their challenge. Yuyu Pharmaceutical, Hanwha Pharmaceutical, Daehan New pharm, Kims, and PharmGen Science chose to give up their challenge one after another. The pharmaceutical industry is paying keen attention to whether more companies will give up patent challenges, citing the fierce competition in the ARB+CCB-based high blood pressure second-drug market. Twenty-four companies challenged Novartis' Entresto. In January, after Elyson Pharmaceutical filed a passive rights scope confirmation trial for a decisive patent, a passive rights scope confirmation trial and invalidation trial were filed for five patents registered in Entresto. In the case of Entresto, Hanmi Pharmaceutical, Daewoong Pharmaceutical, Daewon Pharmaceutical, Dasan Pharmaceutical, Shinil Pharmaceutical, MFC, Kyperions and Corepharmbio voluntarily withdrew the passive trial to confirm the scope of rights filed in the decisive patent. Hanmi Pharmaceutical, Daewoong Pharmaceutical, and Daewon Pharmaceutical plan to continue challenging patents for use, composition patents, and pharmaceutical patents. In the case of Entresto, there is no separate material patent. Instead, patents for use and composition, which expire in 2027, are serving as material patents. Twenty-two companies have also challenged Hanmi Pharmaceutical's asthma treatment Monterizine. Monterizine is protected by four patents that expire in 2032. In September, Hanwha Pharmaceutical filed a passive rights scope confirmation trial for all four patents, followed by 21 companies joining the dispute. However, as Genuonescience voluntarily withdrew, the dispute is expected to lead to a showdown between 21 companies and Hanmi Pharmaceutical. ◆Genuone, Kyung Dong, Mothers; Tenelia MSR patent avoidance, generics can be released next year Alvogen Korea and Samsung Bioepis have filed for invalidation of three patents for Roche's targeted anticancer drug Avastin (Bevacizumab). Both companies are participating in the development of Avastin biosimilars. Alvogen Korea is said to be developing biosimilars at the global headquarters level, not at its Korean subsidiary. Daewoong Pharmaceutical filed a passive trial to confirm the scope of rights in Amgen's psoriasis treatment Otezla drug. Daewoong Pharmaceutical also filed a request for a trial on one other drug patent and a patent for use last year. At that time, Daewoong won the first trial in the patent trial. However, the case is still underway with Amgen's appeal. The dispute over patents for use has not yet ended. A patent challenge on BMS's leukemia treatment "Sprycel" also continued. Daewoong Pharmaceutical filed a trial for invalidation of the Sprycel patent in January. Boryung Pharmaceutical filed a trial on the same patent last year, and in December this year, it filed a passive trial to confirm the scope of rights for a crystalline patent. Genuonescience, along with Mothers Pharmaceutical and Kyungdong Pharmaceutical, requested a passive rights scope confirmation trial for a patent for Handok's diabetes complex "Tenelia M SR." With the victory of the dispute in May this year, they can launch generics after October 2022 when the material license of Tenelia, a single drug, expires. BCWORLD challenged Chong Kun Dang's two patents of Telminuvo. They won in October and November.
- Company
- MNC employees enjoy 17 days maximum as year-end holidays
- by Eo, Yun-Ho Dec 22, 2021 05:57am
- As in any year, the multinational pharmaceutical companies are again closing down for a long-term year-end holiday. According to Dailypharm’s research of 23 major pharmaceutical companies in Korea, 6 companies have set a 10-day or longer year-end holiday. Also, more than 10 pharmaceutical companies will be closing down for nine days. Also, in consideration of the COVID-19 pandemic, many multinational pharmaceutical companies are allowing their employees and executives to use their annual leaves to extend their holidays. Abbvie and Takeda Pharmaceutical are taking the longest days off. The companies have been closed since the 17th, for 17 days until January 2nd, 2022. Amgen’s employees are given a 13-day break, the Sanofi group 12 days, AstraZeneca 11 days, and Astellas 10 days. Companies and associations including Daiichi Sankyo, Roche, Boehringer Ingelheim, Viatris, Organon, Otsuka, Pfizer, BMS, Korean Research-based Pharmaceutical Industry Association, MSD will start their annual year-end holidays from the 25th. This means that 16 pharmaceutical companies will close their doors on Christmas Day. Most other companies including Gilead, Lilly, Merck, Biogen, Bayer, Janssen, GSK will be taking their year-end holidays by using their annual leaves. Although the employees are advised to use their annual leaves as they please, these employees will also be enjoying over 10 days as year-end holidays. Regardless of the designated holiday period, many employees have already been using their annual leaves to start their break early from this week. A pharmaceutical company official said, “Many employees are enjoying over 20 days of the holiday by using their annual leaves before and after the set days. I am pleased to be able to take the time to recharge as this year has been particularly exhausting for us and the industry with the aftermaths of COVID-19, among others.”
- Policy
- Kyprolis succeeded in renewing the RSA contract
- by Kim, Jung-Ju Dec 22, 2021 05:56am
- LG Chem's Eutropin Plus 24mg (Human Growth Hormone, Somatropin) and Eutropin Pen are included in the PVA, falling from as little as 1% to as much as 4%. In addition, Amgen Korea's Kyprolis 60mg (Carfilzomib) and Kyprolis 30mg will be adjusted to 4-5% lower prices, respectively, after successfully renewing their RSA contracts. According to the industry, until recently, these companies agreed to cut insurance prices through negotiations with the NHIS and the PVA to renew their contracts with RSA. Based on this, the MOHW is pushing for a revision of the "drug benefit list and upper limit table." If the revision is finalized soon, it will be applied as of January 1. First, the price of Eutropin Plus 24mg and Eutropin Pen falls to PVA type Na. In PVA, type "Na" is used as a mechanism to reduce up to 10% through negotiations if the upper limit has been adjusted by type "Ka," the claim of the same product group, which has been increased by more than 60% or more than 10% from the previous year's claim, or more than 5 billion won. Eutropin Plus 24mg will be reduced by 3.9% to 148,861 won and Eutropin Pen will be reduced by 1.1% to 182,787 won. Two drugs were adjusted to the reduced price after negotiating again with the NHIS after the RSA contract was terminated. Kyprolis 60mg will be reduced by 5.6% to 975,950 won and Kyprolis 30mg to 488,443 won, respectively, by 4.5%.
