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- 2026-07-03 02:23:39
- Company
- LG Chem will jointly sell Nesp & Regpara with Kyowa Kirin
- by Kim, Jin-Gu Apr 29, 2022 05:41am
- LG Chem announced on the 28th that it has signed a contract with Kyowa Kirin Korea to jointly sell two drugs, Nesp(Darbepoetin Alfa) and Regpara (Cinacalcet Hydrochloride)' in Korea. LG Chem is in charge of sales at the clinics level, and Kyowa Kirin Korea is in charge of sales at the general hospital level. Nesp is a continuous hematopoietic agent used to treat anemia in patients with chronic kidney disease. It is prescribed for hemodialysis or peritoneal dialysis patients or patients with chronic kidney disease before dialysis. LG Chem explains that treatment is highly convenient because it only needs to be administered once every one to two weeks. Since its release in South Korea in 2010, it has been steadily generating more than 20 billion won in sales. According to IQVIA, a pharmaceutical market research firm, Nesf's sales last year were 21.1 billion won. Regpara is a treatment for secondary parathyroidism in patients with chronic kidney disease. It can be treated with oral administration once a day. Secondary parathyroidism is a disease in which excessive production of parathyroid hormones continues due to decreased renal function and the size of parathyroid glands increases, and is known to be a progressive disease that intensifies as chronic kidney disease progresses. Regpara's revenue last year was 6.2 billion won. With the joint sales of Nesp and Legpara, LG Chem can expect about 27 billion won. LG Chem explained that the two drugs have the largest market share among drugs of the same family. Synergy with existing products is also expected. LG Chem has Espogen, the first-generation hematopoietic agent, and Nestykal, a treatment for hyperkalemia. Through this joint sale, the company plans to present expanded treatment options to medical staff with kidney disease. An official from LG Chem said, "We will continue to present various treatment options with customer value as the top priority. We will do our best to expand the market as soon as possible based on our strong national sales network and long business experience in the area of kidney disease." An official from Kyowa Kirin Korea said, "We expect that the joint sales partnership between Kyowa Kirin Korea and LG Chem will further increase the awareness of Nesp and Regpara to hospitals, clinics, and small and medium-sized hospitals. The two companies will make efforts to deliver higher levels of information and supply stable products to medical staff."
- Policy
- Combi of HBP+ Hyperlipidemia will be released again
- by Lee, Tak-Sun Apr 29, 2022 05:41am
- As Chong Kun Dang, Yuhan Corp., and GC Pharma, one of the top three traditional pharmaceutical companies in sales, are set to launch a combination of high blood pressure + hyperlipidemia, the market is expected to lead the prescription trend in the future. Currently, the market is led by improved complexes developed by Boryung, Hanmi Pharmaceutical, and Daewoong Pharmaceutical, and it is expected to rise further if Chong Kun Dang and Yuhan are joined. According to the MOHW on the 27th, as of May 1, Chong Kun Dang's Cantabell A, Yuhan Corp.'s Duowell Plus, and GC Pharma's Rozetel will be listed. Chong Kun Dang's Cantabell A is a combination of ARB-based Candesartan Cilexetil, CCB-based Amlodipine, and Atorvastatin, a component of hyperlipidemia treatment. Five dose products are available: price of Cantabell A(Candesartan 8mg, Amlodipine 5mg, Atorvastatin 10mg )is ,1318 won, Cantabell A 8/5/20mg,1320 won, Cantabell A 16/5/10mg, 1495 won and Cantabell A 16/5/20mg ,1497/10mg. It is expected that customized prescriptions for each patient will be possible as it has various capacities. Yuhan's Duowell Plus and GC Pharma's Rozetel are composed of ARB-based Telmisartan, hyperlipidemia treatment ingredients Rosuvastatin and Ezetimib. It's the first combination handled by Yuhan. Both products will have four different doses. Duowell Plus (Telmisartan 40)/ Rosuvastatin Calcium 5/Ezetimbe is listed at 1,518 won ; Duowell Plus 80/5/10 mg is listed at1,665 won; Duowell Plus 40/10/10 mg is listed at 1,784 won, and Duowell Plus 80/10/10/10 mg is listed at 1,931 won. GC Pharma further lowers the price, listing Rozetel 40/5/10mg at 1,199 won, Rozetel 80/5/10mg at 1,326 won, Rozetel 40/10/10mg at 1,516 won and Rozetel 80/10/10mg at 1,646 won. Currently, the products leading the high blood pressure-hypertension three-drug complex market are Dukaro (Amlodipine Besylate + Fimasartan Potassium Trihydrate Granule + Rosuvastatin Calcium), Hanmi Pharmaceutical's AmosartanQ, and Daewoong Pharmaceutical's Ollomax. Last year, the amount of outpatient prescriptions based on UBIST recorded 12.7 billion won for Dukaro, 11.4 billion won for AmosartanQ, and 8.8 billion won for Ollomax. Since most of them are new products that have been released for less than five years, it is expected that the market will be popular in the future from the combination of high blood pressure-hypertension. As Chong Kun Dang, Yuhan Corporation, and GC Pharma are also entering the market as a new combination, it is expected to quickly join the trend.
- Company
- Immunotherapy Opdivo reattempts reimb in gastric cancer
- by Eo, Yun-Ho Apr 28, 2022 06:07am
- The cancer immunotherapy Opidvo is again attempting to receive insurance benefits for its gastric cancer indication. According to industry sources, ONO Pharma Korea and BMS Korea’s PD-1 inhibitor immunotherapy drug ‘Opdivo (nivolumab)’ will be presented for deliberation by the Cancer Disease Deliberation Committee of the Health Insurance Review and Assessment Service on the 18th of next month. In Korea, Opdivo was approved ‘as first-line treatment in combination with fluoropyrimidine- and platinum-containing chemotherapy for advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma’ in June last year. With the added indication, the drug became the first and only domestically approved cancer immunotherapy for gastric cancer. However, Opdivo failed to receive reimbursement for the indication at the CDDC in February. At the time, the CDDC decided not to set reimbursement criteria for Opdivo in ▲ advanced or metastatic gastric adenocarcinoma, gastroesophageal junction cancer, and esophageal adenocarcinoma, and ▲ inoperable malignant pleural mesothelioma, Therefore, the industry’s eyes are on whether the company will be able to succeed in applying for reimbursement in gastric cancer this time. Gastric cancer is considered to be the most important field in need of extended reimbursement for immunotherapy drugs after lung cancer. Gastric cancer is the most prevalent cancer and the fourth most common cause of cancer deaths in Korea. Although gastric cancer has a favorable survival rate when detected in its early stages, the relative survival rate drops to 5.9% with distant metastasis. In particular, the current stand of care for HER2-negative gastric cancer is chemotherapy due to the unavailability of new drugs approved for first-line treatment for the past decade. Opdivo is expected to become a suitable alternative for these patients. Meanwhile, the efficacy of the combination therapy using Opdivo was demonstrated in the large-scale, Phase III CheckMate-649 trial. The median overall survival (mOS) of patients was 13.8 months for all patients randomly assigned to receive the Opdivo combination, a 20% reduction in risk compared to the 11.6 months in the control group. In PD-L1 positive patients (CPS ≥ 5), the Opdivo combination group’s mOS was 14.4 months, which was a 29% reduction in risk compared to the 11.1 months of the control group. Also, Opdivo improved the overall response rate (ORR) by 12% in the all-randomized population, and by 15% in PD-L1 positive patients (CPS ≥ 5). The complete response (CR) rate was also higher for the Opdivo combination group for both the all-randomized population and PD-L1 positive patients.
- Company
- Sales of SGLT-2 diabetes drugs increased by 15%
- by Apr 28, 2022 06:06am
- The SGLT-2 inhibitor market, which surpassed 150 billion won in annual prescriptions last year, also grew 15% in the first quarter, surpassing 40 billion won in quarterly prescriptions. single and combination drugs have grown evenly. According to UBIST, a pharmaceutical market research firm, on the 28th, the total amount of outpatient prescriptions for SGLT-2 inhibitors in the first quarter was 40.2 billion won, up 15.0% from 34.8 billion won a year earlier. The quarterly prescription for SGLT-2 inhibitors, which was in the early 20 billion won in 2019, has nearly doubled in two years. The SGLT-2 inhibitor has been released as a type 2 diabetes treatment, expanding the disease group to the heart and kidneys, and indications are expanding. The SGLT-2 inhibitor is a mechanism that inhibits the reabsorption of glucose from the kidneys and releases glucose into the urine. This not only reduces blood sugar, but also reduces weight, kidney function, and blood pressure. This is why SGLT-2 inhibitors can also be used as heart and kidney drugs. Sales of AstraZeneca's Forxiga recorded the highest prescription amount of 11.6 billion won in the first quarter. This is an increase of 16.7% compared to 9.9 billion won a year earlier. Forxiga is leading the market with the most indications among competing drugs. It obtained indications of chronic heart failure in 2020 and expanded its scope to chronic kidney disease in August last year. All of them are the first of the SGLT-2 series. Beringer Ingelheim's Jardiance's prescription amounted to 10.3 billion won in the first quarter, up 5.2% from 9.8 billion won a year earlier. The gap with Forxiga widened in the first quarter of this year. In the first quarter of last year, Jardiance (9.8 billion won) had almost the same prescription as Forxiga (9.9 billion won), but it made a difference of 1.3 billion won. In November last year, chronic heart failure indications were added, and it is trying to expand its scope due to kidney disease. In particular, at HFpEF, Jardiance first released positive data. Handok's Suglat and MSD's Steglatro continue to perform poorly with quarterly prescriptions of less than 1 billion won. Prescription sales of Suglat and Steglatro in the first quarter were 900 million won and 400 million won, respectively. Compared to the same period last year, Suglat increased by 100 million won and Steglatro decreased by 100 million won. Unlike Forxiga and Jardiance, the two products are limited to type 2 diabetes, and clinical trials have not been conducted to expand their indications. They accounted for only 3.3% of the SGLT-2 inhibitor market. Xigduo achieved 10 billion won in prescription in the fourth quarter of last year. In the first quarter of this year, it also increased its prescription amount by 18.2% compared to the same period last year. During the same period, Jardiance Duo also increased its prescription amount from 5.4 billion won to 7 billion won, growing 28.5%. Jardiance Duo appeared in the market a year later than Xigduo, showing a difference of about 3 billion won. In the first quarter, prescriptions for SGLT-2 complex drugs amounted to 16.9 billion won, up 21.6% from 13.9 billion won a year earlier. Combination drugs have higher sales than single systems. In the first quarter of 2019, the prescription amount was 5.7 billion won, which was only one-third of the single system, and the quarterly prescription amount exceeded 10 billion won a year later, and 15 billion won last year. The gap between sales and single products has also narrowed significantly. Last quarter, the proportion of combination drugs and single drugs was 42:58.
- Policy
- Reviewing the removal of outdoor masks
- by Lee, Jeong-Hwan Apr 28, 2022 06:06am
- Photojournalists of the Presidential Transition CommitteeThe presidential transition committee announced its position to examine the COVID-19 situation in late May, a month after the launch of the new government, and then decide to release the outdoor mask. The new government plans to promote quarantine policies based on scientific evidence and prepare governance to respond to infectious diseases centered on experts' opinions and on-site judgment. Ahn Cheol Soo, the chairman of the transition committee made the remarks at a briefing on the announcement of comprehensive measures by the Health and Medical Division of the COVID-19 Emergency Response Committee at a joint press conference in Tongui-dong, Jongno-gu, Seoul on the morning of the 27th. Chairman Ahn announced four key tasks, including ▲strengthening compensation due to side effects of vaccines, ▲ scientific quarantine using big data, ▲reorganization of the medical system, including the establishment of hospitals specializing in infectious diseases, and▲ preparation of measures to protect the elderly and medical staff. Chairman Ahn has defined the government's quarantine as "non-scientific political quarantine." He emphasized that it is "scientific quarantine" to automatically calculate the severity and quickly process bed allocation by establishing a platform that collects data on infectious diseases. Chairman Ahn also came up with a plan to reform the medical system that responds to infectious diseases at all times. He said he would secure 7,700 beds in advance and establish a method of treating patients centered on general hospitals. Protection for high-risk groups and vulnerable groups of COVID-19 will be strengthened. The transition committee said that hospitals and facilities have been vulnerable to infection, but it will significantly improve the ventilation structure in the future and convert them into safe facilities for infection through infection education for workers. In the case of high-risk groups, a medical response fast-track policy is prepared to enable rapid testing and rapid treatment. The transition committee said it will secure enough treatments to relieve public anxiety and increase its responsiveness to infectious diseases. The new government will secure a total of 2.071 million people by introducing an additional 1,009,000 treatments and expand the scope of administration to those with underlying diseases aged 12 or older so that they can receive prompt treatment. It will also expand compensation and support for adverse vaccine reactions. Support for medical expenses will be increased from 30 million won to 50 million won, and death compensation will be increased from 50 million won to 100 million won. Support will be provided after basic reviews such as reducing the burden on the public and the causal agenda for the responsibility to prove abnormal reactions. It also plans to shorten the processing period to 120 days. Chairman Ahn said, "People must be most curious about when they take off their masks outdoors, but they are trying to judge by looking at the situation in late May." He explained, "Now, the number of confirmed cases in Korea is still the largest worldwide, making it difficult to compare directly with other countries that can take off masks outdoors." Chairman Ahn said, "We will make a decision around late May on whether to make it mandatory to take off the mask outdoors but wear an indoor mask when entering the building." He said, "The mandatory indoor masks will continue for the time being. If raking off a mask indoors, it will be evidence that our daily life will almost completely recover, he said.
- Company
- Who will follow SK Bio with its homegrown COVID-19 vaccine?
- by Kim, Jin-Gu Apr 28, 2022 06:06am
- The marketing authorization for SK Bioscience’s homegrown COVID-19 vaccine 'GBP510' is nearing approval. If the drug is approved within the first half of the year as planned, GBP510 will become the first homegrown vaccine to be ever approved. With the developer of the first vaccine set, who will be the No.2 and No.3 in line is gaining attention. Currently, Eubiologics, Cellid, and Geneone Life Science are speeding up trials for their COVID-19 vaccines. The issue at hand is how the companies will secure a comparator vaccine for comparative trials. SK Bioscience had been able to quickly conduct a Phase III trial after securing the necessary comparator vaccines early on, other companies are having trouble securing comparator vaccines. ◆Eubiologics secures comparator vaccines and prepares to initiate global Phase III trial According to the pharmaceutical industry on the 27th, Eubiologics received approval to initiate its Phase III trial for ‘EuCorVac-19’ in three countries in Africa. Eubiologics’s COVID-19 vaccine in development is a synthetic antigen vaccine, the same as SK Bioscience’s GBP510 or Novavax’s Nuvaxovid. The company’s procurement of comparator vaccines played a decisive role in the initiation of the company’s Phase III trial in Africa. The latecomers in the COVID-19 vaccine development industry have been conducting Phase III trials by comparing the efficacy and safety of its vaccines with previously approved vaccines rather than with large-scale clinical trials. SK Bioscience had also conducted a Phase III trial by comparing its vaccine with AstraZeneca’s vaccine. The comparator vaccine secured by Eubiologics for the African trial is not one of the 5 vaccines (Pfizer, Moderna, AstraZeneca, Janssen, Novavax) that were approved in Korea. Eubiologics plans to conduct a clinical trial that compares the efficacy and safety of its vaccine with a comparator vaccine and expects to receive approval for a trial in the Philippines as well. An official from Eubiologics said, “The clinical trial will start at the local site within the month. If the Phase III trial is completed in Africa, it will be listed for Emergency Use Listing by the WHO, and then be supplied around low-income countries after obtaining export approval. ◆Have entered Phase III trials in Korea but have trouble securing ‘comparator vaccines’ Securing comparator vaccines is an issue in conducting Phase III trials in Korea as well, as Korea requires ‘vaccines approved in Korea’ to be used as comparators for domestic trials. A pharmaceutical industry official explained that although SK Bioscience was able to secure a comparator vaccine relatively easily because of its past CMO agreement with AstraZeneca, the situation is different for other vaccine developers. Global vaccine developers are showing a lukewarm reaction to being selected as a comparator vaccine for domestic companies due to concerns over technology leakage. However, if a comparator vaccine is not secured, the domestic companies’ concern is that it would take that much longer for the companies to develop their vaccines. An official from EUbiologics said, “If SK Bioscience receives approval for GBP510, we may use the vaccine as a comparator, but this is not our immediate plan as we would need to change our clinical trial protocol to enable this. We are working closely with the government to secure a comparator vaccine among those that are already approved in Korea.” ◆Companies change paths or give up development strategies due to difficulty securing comparatorvaccines Other companies are also having difficulty securing comparator vaccines. Companies are changing the development strategy or abandoning the development itself due to difficulty in securing comparators and the increased global vaccination rates and the smooth supply of vaccines already available in the market. Cellid received approval for a Phase IIb trial for 'AdCLD-CoV19-1' in Korea in January this year. If the Phase IIb trial is completed, the company would also need to secure a comparator vaccine for comparative trials. Its approval will depend on how well the company procures a comparator vaccine. Cellid had applied for the Phase IIb and III trials at the same time in November last year but was only approved for the Phase IIb trial due to the lack of a comparator vaccine. After failing to conduct the Phase III trial, Celid has developed a two-track strategy to continue clinical trials of the vaccine for primary inoculation that was in development while developing vaccines for booster shots (additional inoculation). Geneone Life Science changed its strategy from developing a vaccine for primary inoculation to developing a booster vaccine. Earlier this month, the company announced that the company completed the registration of subjects for the Phase IIa clinical trial of 'GLS-5310', which is being developed as a DNA vaccine. After confirming the safety and efficacy of clinical trials in a Phase IIa trial, the company plans to continue studying its vaccine through Phase IIb and III trials exclusively as a booster vaccine. HK Inno.N completed Phase I trials for its ‘IN-B009’ in development as a synthetic antigen vaccine. However, the company is pondering whether to proceed with Phase II trials. An official from HK Inno.N said, “We have completed Phase I trial for our vaccine but haven’t submitted a clinical trial protocol for Phase II trial plan yet. We haven’t decided on our direction from there.” Genexine withdrew its development. Genexine was the first among domestic companies to start the development of a COVID-19 vaccine in June 2020. Although it has completed the Phase IIa trial for 'GX-19N' in Korea, the company gave up proceeding with Phase II and Phase III trials last month. GX-19N was being developed through a DNA vaccine platform. No other vaccine approved around the world had adopted the use of this platform. As comparative clinical trials require the use of a control vaccine from similar platforms, it was virtually impossible to secure a control vaccine. For this reason, a large-scale Phase III clinical trial was inevitable for the company, which was why Genexine decided to stop the development of its vaccine determining that its business feasibility was low.
- Product
- Aftermath of Revlimid of primary benefit multiple myeloma
- by Whang, byung-woo Apr 28, 2022 06:06am
- As Revlimid (Lenalidomide Hemihydrate) based chemotherapy enters the benefit, changes in RRMM prescription patterns are inevitable. Kyprolis-centered KRd therapy (Carfilzomib+Revlimid+Dexamethasone) and Ninlaro-centered IRd therapy ( As both Ixazomib+Revlimid+Dexamethasone) contain Revlimid, there are concerns at the clinical site about how to take follow-up prescriptions. Revlimid's benefit has been reimbursed for RVd therapy (Lenalidomide + Bortezomib + Dexamethasone) and R2 therapy (Lenalidomide + Lituximab) since April. RVd therapy was recommended as the primary treatment for multiple myeloma in the NCCN and ESMO guidelines, but benefits were not applied until April in Korea. For this reason, clinical sites have expressed opinions on the need for benefits of RVd therapy and R2 therapy. As RVd therapy becomes available for primary treatment, discussions on the use of KRd therapy and IRd therapy, which were prescribed in RRMM, continue In the case of multiple myeloma, there is a possibility of continuous recurrence, so it is prescribed by taking a different combination of treatments that can be used for each order. It was impossible to prescribe IRd therapy if KRd therapy was used in the past, so a treatment strategy was used to use KD therapy in the next order of treatment after using IRd therapy at the discretion of the medical staff. Experts believe that as RVd therapy is used for primary treatment, the use of KRd therapy and IRd therapy containing Revlimid will also be reduced. Professor Kim Seok-jin of the Department of Hematology and Oncology at Samsung Medical Center said, "If RVd is used as the primary treatment, KRd and IRd will inevitably be affected." "This benefit is meaningful," he explained. It is not that IRd therapy cannot be used when RVd therapy is used in primary treatment and KRd therapy on which Rd therapy is based. After diagnosis, multiple myeloma is divided into a "transplant target group" and a "non-transplant target group" depending on whether hematopoietic stem cell transplantation is possible, and Takeda explains that patients can be treated with the same benefit as now after recurrence even if VRD is applied as the primary treatment. The prerequisite is that VRd therapy is transplanted after 6 cycles and recurrence after maintaining the reaction for more than 6 months. In the case of non-transplantation groups, the use of VRD as Until Progression as primary treatment makes it difficult to apply both R-based treatments, including IRd and KRd, which are currently available for benefit prescriptions, in the second. #Will it be established as KRd/IRd therapy maintenance therapy in non-transplant patients? Then, how many patients can use KRd and IRd therapy according to the entry of RVd therapy into primary treatment? Lee Je-joong, a professor of hematology at Hwasun Chonnam National University Hospital, said, "In the group of patients who can be transplanted, RVd is performed for about four cycles and most of them react, so most of the patients can use both KRd and IRd as secondary therapy. In terms of the total number of patients with multiple myeloma, 55% of them can be transplanted, and 90% of them will be able to use KRd and IRd therapy." There is no significant difference from the previous one in patients who can be transplanted, but experts predict that it will be Kd therapy for Cypriot and maintenance therapy for ninjas as it is difficult to use KRd and IRd in secondary treatment for non-transplant patients. Both options are continuously confirmed through current research to expand indications and confirm their efficacy. Kd therapy has the result of extending the survival period compared to Vd therapy by another 12 months in RRMM patients who previously received one treatment, including elderly patients, who are the main patients with multiple myeloma. Since May last year, Kyprolis has obtained additional indications for the dose of Kd once a week in the treatment of RRMM patients, and the fact that both Kd once a week and twice a week are covered by insurance benefits is also expected to have a positive effect. In addition to IRd therapy, Ninlaro has indications for maintenance therapy for patients who received autologous hematopoietic stem cell transplants and those who did not receive them in March and September last year, respectively. However, in the case of maintenance therapy, it was not reimbursed.
- Company
- Novartis' anticancer drug/Rx division will be merged
- by Eo, Yun-Ho Apr 27, 2022 06:04am
- A change is expected in Novartis' subsidiary. Above all, the anticancer drug division and the Rx division, which have been operated independently, will be integrated. According to related industries, Novartis' Asia-Pacific Regional Headquarters has already been appointed as a representative of the integrated corporation. As a result, corporations such as Novartis Korea will also integrate their business units within this year. The anticancer drug division is led by CEO Shin Soo-hee, and the Rx division is led by CEO Yoo Byung-jae, who was appointed last year. The company consists of two business units, not only marketing and sales, but also support departments such as drug prices, rental, and permission. Therefore, if the integrated general manager is determined, manpower adjustment will be inevitable. Novartis' headquarters announced in April that it would introduce a new organizational structure and operating model designed to support innovation, growth and productivity goals as a pharmaceutical company looking forward to a new decade. As part of the reorganization, Novartis plans to merge its pharmaceutical and anti-cancer operations and create two independent commercial organizations, the U.S. Department of Innovative Medicine and the International Department of Innovative Medicine. Both organizations will have full profit and loss liability and customer experience, marketing, sales, sales ownership, and market access to each market across all treatment areas.
- Opinion
- [Reporter’s View]Recall the purpose of regulating biologics
- by Apr 27, 2022 06:04am
- The Ministry of Food and Drug Safety visited 3 pharmaceutical distributors on the 21st to prepare a new guideline that reflects voices in the field and the realistic difficulties of the industry in preparing to comply with regulations on the distribution of biological products. The government is resetting the guideline after the revised version of the ‘regulation on the Manufacture and Sales Management of Biological Products’ was implemented in January last year faced with strong opposition from the pharmaceutical distribution industry on the sudden rise in the distribution standards of biological products without considering the cost or preparation period. The raised standards increased the cost of transporting biologicals that already have low distribution fees to the extent that many companies decided rather not to distribute them. Also, the industry pointed out the difficulties in managing the temperature of biological products that have to be frequently shipped in small amounts to pharmacies like insulin. Under the revised regulations, it is necessary to maintain 2-8 degrees at all times using transport containers equipped with automatic temperature recording devices when delivering biological products, and the record must be kept for two years. Unlike the regulations that forbid even a single deviation from the designated temperature, there are times when the temperature may suddenly jump out of the reference range for unknown reasons in reality. Although this has no effect on the efficacy of the drug because the temperature does not deviate for a long period of time, they are subject to punishment under the regulations. This is why the distributors are struggling with the issue. A representative of a company has been testing various transportation containers every day, including custom-made containers, but has not been able to find a solution even now. It also depends on which and how many refrigerants are added. This is why the industry is making complaints and requesting that the MFDS should suggest the type and number of refrigerants and containers used that are not too heavy, not too expensive, and have good temperature control for 24 hours. This is the result of overlooking the fact that it takes a lot of money and a long preparation period to prepare a perfect cold chain. More than 90% of pharmaceutical distributors are small and medium-sized enterprises (SMEs) that cannot afford to spend a lot of money on the cold chain of biologics. However, the government implemented the revised regulations in just 6 months since it was announced, in a hurry to implement the regulations within the year. Faced with backlash from the industry, the authorities granted a 6-month guidance period, but the end of the guidance period is now less than three months away. The MFDS said it will include the details in the guidelines, but the problem is time. If the companies do not abide by the regulations, they will be subject to punishments starting on July 17th. There is not enough time for the authorities to rewrite and announce the guidelines and for the companies to complete preparations accordingly. The original purpose of strengthening the regulations for the transport of biological products was to enable the safe delivery of drugs that are directly related to the people's right to health. However, such hasty measures that are focused on administrative procedures and written deadlines leave much room for issues in the regulations that were made with good intentions. This is why the government should show patience and take the right steps step by step so as not to defeat the purpose of strengthening the regulations.
- Company
- Additional formulations of Abbvie’s Skyrizi were approved
- by Eo, Yun-Ho Apr 27, 2022 06:04am
- The approval of an additional formulation of the IL-23 inhibitor ' Skyrizi' has increased the drug’s versatility in the field of plaque psoriasis. On the 22nd, Abbvie Korea announced that the Ministry of Food and Drug Safety additionally approved its Skyrizi Prefilled Syringe 150mg and Prefilled Pen 150mg formulations of its IL-23 inhibitor ' Skyrizi Prefilled Syringe Injection (risankizumab)’ for the treatment of adult patients with moderate-to-severe plaque psoriasis. With the approval, Skyrizi may additionally be administered 4 times a year as maintenance therapy in two formulations - Skyrizi Prefilled Syringe 150mg and Prefilled Pen 150mg. Skyrizi is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading the development and global sales of the drug. The 150mg formulation of Skyrizi is administered through a single shot of a 150mg injection. It is administered twice as a subcutaneous injection early on (at week 0, week 4), then every 12 weeks thereafter. The previously approved 75mg formulation was administered in two shots per visit. The approval of the new 150mg formulation would allow for the number of annual shots required by half. In other words, the newly approved dose of Skyrizi is 150mg (2 shots of 75mg prefilled syringe or 1 shot of Skyrizi Prefilled Syringe 150mg or Prefilled Pen 150mg) administered subcutaneously at week o and week 4, and every 12 weeks thereafter. Eun-Joo Park, Professor of Dermatology at Hallym University Sacred Heart Hospital said, “Skyrizi as a maintenance treatment demonstrated a consistent safety profile and a high skin improvement effect that can be maintained in the long-term with 4 doses a year in various clinical trials. The addition of the 150mg dose that allows for patients to receive the required dose with a single shot, would increase convenience among HCPs and patients as well as broaden their range of choices.” Skyrizi can be subcutaneously administered at hospitals or be administered at home after receiving training for subcutaneous injections. The new 150mg Prefilled Pen that was additionally approved was devised to improve the treatment experience for the patients. Abbvie explained that the additional approval of the new formulation was based on clinical results that demonstrated that a single shot of the Skyrizi Prefilled Syringe 150mg met the primary efficacy endpoint was bioequivalent to two shots of the existing 75mg formulation. The Prefilled Pen 150mg formulation also demonstrated its bioequivalence with the Prefilled Syringe 150mg. Skyrizi is an IL-23 inhibitor that selectively inhibits IL-23 by binding to its p19 subunit. IL-23 is involved in various chronic immune-mediated conditions including psoriasis. The 150mg formulation was approved by the European Commission in May 2021 to treat moderate to severe plaque psoriasis in adults after systemic or phototherapy. Phase III trials on Skyrizi in psoriasis, Crohn's disease, ulcerative colitis, and psoriatic arthritis are still ongoing. In Korea, the drug was approved in December 2019 as a treatment for adult patients with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy (including biological therapy). The drug then added the psoriatic arthritis indication on the 5th of last month. Skyrizi may be used to treat adult patients with active psoriatic arthritis who responded inadequately or were intolerant to disease-modifying anti-rheumatic drugs (DMARDs).
