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- 2026-05-12 00:18:38
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- Neurofibromatosis Tx Koselugo makes progress for reimb
- by Eo, Yun-Ho Mar 23, 2023 04:45am
- Finally, reimbursement discussions for the new neurofibromatosis drug ‘Koselugo’ has made some progress. Results showed that AstraZeneca Korea’s new neurofibromatosis drug has passed the review by the Health Insurance Review and Assessment Service’s Drug Reimbursement Standard Subcommittee recently. Therefore, its reimbursement can now be deliberated by the Drug Reimbursement Evaluation Committee. After the drug received a non-reimbursement decision from DREC in March, the company worked promptly and prepared the supplementary data to restart listing discussions for the drug. As NF1 is a rare disease area with no available treatment option, whether Koselugao will be able to receive reimbursement approval this time remains to be seen. Until now, patients had to rely on symptomatic treatment for neurofibromatosis due to the lack of an appropriate treatment option. Neurofibromatosis is a rare disease, and 85% of the patients with neurofibromatosis have neurofibromatosis type 1 (NF1), which is caused by a mutation in the neurofibromin tumor suppressor gene located on chromosome 17. The incidence of NF1 is approximately 1 in 3,000. Its first symptom is café-au-lait spots 1 to 3 centimeters in diameter early in life. Since then, the patients experience Optic nerve gliomas (brain tumors) at age 6, and scoliosis around age 6-10. In adulthood, lisch nodules, or iris hamartomas, occur predominantly in patients with NF1. If possible, treatment includes surgical removal of affected sites or chemotherapy and radiation therapy. However, most recur even after surgery, and as the patient must undergo a major operation, its treatment puts an immense burden on both the medical staff and the patient. Recurrence is even more frequent among pediatric patients, which means the patients must live with painkillers and often suffer from speech and movement disorders even after receiving several operations. Meanwhile, Koselugo was jointly developed by AstraZeneca and MSD. The drug blocks the activation of MEK to inhibit the growth of cell lines. The Phase II SPRINT study that became the basis for Koselugo’s approval showed that Koselugo reduced tumor size by over 20% in 68% of the patients that received Koselugo, and achieved its primary endpoint of ORR. Also, 82% of the patients that showed a partial response had sustained responses lasting at least 12 months. In contrast to the non-treated patients, half of which experience disease progression 1.5 years after diagnosis, only 15% of patients using Koselugo showed disease progression at year 3.
- Company
- Promoting the extension of the term of drug patents
- by Kim, Jin-Gu Mar 23, 2023 04:45am
- Previously, patentees could legally extend the duration of a patent unlimitedly, but the government's plan is to promote it up to 'up to 14 years'. According to the pharmaceutical industry on the 21st, the Korean Intellectual Property Office recently prepared an amendment to the Patent Act to reform the system for the duration of drug patent rights. The amendment is expected to be submitted to the National Assembly through legislative acts. In the current drug patent term extension system, there is no separate upper limit (cap). In addition to the essential patent period of 20 years, it extends the time taken for clinical trials and approval and approval of drugs. In other words, the duration of drug patents can be 21 years, 27 years, or 37 years in the '20+α' method. However, the United States and Europe set an upper limit on the additionally recognized period. This means that even if it took a total of 23 years for clinical trials, licensing, etc., only 14 years (USA) or 15 years (Europe) are recognized. On the other hand, Korea and Japan do not have a separate upper limit for this period. As a result, criticism has been constantly raised in the pharmaceutical industry that the patent holder's patent term is excessively long. As part of the evergreening strategy, the original company takes a strategy of registering a new patent and extending the total duration before the patent expiration date. It is criticism.
- InterView
- The rebate effect is not just employee deviation
- by Kim JiEun Mar 22, 2023 05:47am
- The pharmaceutical company, which was suspended from sales due to the confirmation of the salesperson's suspicion of providing rebates, argued that there was no reason for the disposition, saying that it was only an employee's deviance, but the court did not accept it. The Suwon District Court recently dismissed a request for cancellation of a disposition to suspend sales of pharmaceuticals filed by a pharmaceutical company against the Gyeongin Food and Drug Administration. The reason for the disposition of pharmaceutical company A is as follows. Mr. B, who was a salesperson at this company, provided a total of 41 million won worth of economic benefits to the hospital administration manager several times from October 2013 to January 2016. As the charges were confirmed, Mr. B received a summary order of a fine of 10 million won for violating the Pharmaceutical Affairs Act around February 2017. The Gyeongin Food and Drug Administration issued a three-month suspension of drug sales to Pharmaceutical Company A in October 2021, four years after going through the prior notification procedure. The reason for the disposition was in accordance with Mr. B's summary order. Regarding this disposition, Pharmaceutical Company A argued that there was no reason for the disposition and that the KFDA's disposition violated and abused its discretion. First of all, the pharmaceutical company said the reason why there is no reason for disposition, "(Rebate) is only Mr. B's personal deviation, and the company has never been involved." "There is a legitimate reason for not being a person who provided economic benefits, or for not being able to blame for the neglect of duty." “It was difficult for the company to know Mr. B’s rebate act, and it was only after four years had elapsed since the summary order, in this case, was finalized,” he said. Considering that the education was conducted and Mr. B's act was an aberrant act, this disposition violates the principle of proportionality and responsibility, and is illegal as it deviates from and abuses discretion.” However, the court completely refuted the claim of pharmaceutical company A. First of all, it was emphasized that Mr. B's kickback behavior was not regarded as Mr. B's individual act and that the company was also responsible for it. The court said, “Mr. B, who was an employee of a pharmaceutical company A, committed an act in this case in which he provided economic benefits to medical personnel, etc. in the process of carrying out sales duties entrusted by the company.” is ultimately vested in the company. The responsibility for the violation of administrative obligations that occurred in the process is also acknowledged as partly attributable to the company.” The pharmaceutical company said that it did not fulfill its obligations even if it provided education related to fair trade self-compliance to its employees. While pointing out that the 3-month suspension of business was not excessive as the company claims, the court also effectively reviewed the precedent in which the company was previously suspended for 3 months due to illegal kickbacks. The court said, "It is acknowledged that the company conducted regular CP (Compliance Program) training for its salespersons, but the contents of the training only seem to be of a general level." It is difficult to admit a legitimate reason that cannot be blamed for neglect of duty based on circumstances alone.” The court continued, “Although all of the 35 million won in cash that Mr. B provided to the hospital administration manager does not appear to be a rebate to promote the drug sales of this pharmaceutical company, considering the purpose of the case that the standard, in this case, did not determine the degree of disposition in proportion to the amount of the rebate. If so, it is difficult to conclude that the disposition, in this case, is unfair.” Company A’s claim is dismissed without reason.”
- Company
- Forxiga's generics will be suspended until the 7th
- by Kim, Jin-Gu Mar 22, 2023 05:47am
- Manufacturing and sales of Dong-A ST's SGLT-2 inhibitor-type diabetes treatment Dapapro are expected to be suspended by early next month. According to the pharmaceutical industry on the 20th, the Seoul Central District Court recently cited AstraZeneca's request for an injunction to prohibit infringement of patent rights filed against Dong-A ST. As a result, Dong-A ST will not be able to manufacture and sell Dapapro until the 7th of next month, when Forxiga's patent expires. Dapapro is a follow-on drug to Forxiga. Among the SGLT-2 inhibitors of Dapagliflozin, the original diabetes treatment, it is currently the only one listed as reimbursement, except Forxiga. In November of last year, Dong-A ST succeeded in avoiding part of the duration of the material patent for Forsyga alone in the first trial by using a 'prodrug' strategy. With this decision, Dong-A ST obtained the right to release a follow-on drug before the patent expiration of Forxiga. In December, Forxiga released Dapapro, a follow-up drug, for reimbursement. It was five months before the expiration of the Forxiga patent. AstraZeneca appealed to the Patent Court immediately after the first trial. At the same time, it filed an application for a provisional injunction requesting a ban on infringement of Dong-A ST's patent rights, including the manufacture and sale of Dapapro, until the second trial verdict. The Seoul Central District Court cited AstraZeneca's application for a provisional injunction. An official from AstraZeneca Korea said, "We welcome the decision of the Seoul Central District Court. Substance patents for active ingredients must be respected for the development of the pharmaceutical industry in Korea." We will work hard to do so,” he said.
- Company
- 10 years of the global launch of K-biosimilars
- by Chon, Seung-Hyun Mar 22, 2023 05:47am
- The cumulative exports of biosimilar products developed by Celltrion and Samsung Bioepis recorded 13 trillion won. Celltrion's Remsima is rapidly expanding its territory 10 years after entering the European market. Celltrion's biosimilars posted cumulative exports of 9 trillion won, and Samsung Bioepis' overseas sales of more than 4 trillion won. ◆Celltrion Health, accumulated exports of 9 trillion won by selling 4 similar types since 2013 According to the Financial Supervisory Service on the 22nd, Celltrion Healthcare's four biosimilars, Remsima, Remsima SC, Truxima, and Herzuma, posted a total of 1.71 trillion won in exports. It increased by 9.2% from the previous year and broke the record for the largest export. Celltrion Healthcare is an affiliate of Celltrion, and Celltrion Healthcare Holdings is the largest shareholder (24.3% stake). Celltrion Healthcare receives antibody biosimilar products from Celltrion and sells them to global distributors. Celltree Healthcare is selling four biosimilars in overseas markets: Remsima, Remsima SC, Truxima, and Herzuma. Remsima is a biosimilar product of Remicade. Remsima SC is a subcutaneous formulation of Remsima. Truxima and Herzuma are biosimilar products of anticancer drugs Mabthera and Herceptin, respectively. Last year, Remsima recorded the largest export of 859.3 billion won. It increased by 6.1% from 809.6 billion won in 2021 and produced the most exports since obtaining European permission in 2013. Despite intensifying competition in biosimilars, Remsima continues to increase exports as more than 100 countries obtained item approval last year. Remsima recorded exports of 145.3 billion won in 2013, and the cumulative amount of exports for 10 years until last year totaled 5,163.1 billion won. Remsima SC exported 236.9 billion won last year, more than double the previous year's 89.6 billion won. With only two products, Remsima and Remsima SC, the joint venture achieved 1.96 trillion won in exports last year. Remsima SC made its first export of 34.8 billion won in 2020 and recorded a cumulative export performance of 361.4 billion won over the past three years. Truxima showed exports of 436.5 billion won last year, down 4.9% from the previous year. It is the second consecutive year of decline since recording 786.8 billion won in 2020. It is analyzed that the growth rate has slowed somewhat as the competition for biosimilars intensified. Truxima posted its first export of 383.2 billion won in 2017 and achieved a total of 2.6148 trillion won in overseas sales over the six years until last year. Herzuma's export volume last year was 181.7 billion won, down 13.9% from the previous year. After posting overseas sales of 211 billion won in 2021, the growth trend has slowed down. Herzuma recorded a cumulative export performance of 865.6 billion won from 2017 to last year. Celltrion's four biosimilars jointly exported a total of 9.49 trillion won for 10 years from 2013 to last year. Samsung Bioepis is also breaking new records every year. Samsung Bioepis' operating profit was 231.5 billion won, up 20.1% from the previous year, and sales were 946.3 billion won, up 11.7% from the previous year. Both operating profit and sales are the highest since its launch in 2012. Sales increased by 21.7% in two years from 777.4 billion won in 2020, and operating profit increased by 59.6% during the same period. The operating profit to sales ratio last year was 24.5%, the highest ever. Starting with the Enbrel biosimilar in January 2016, Samsung Bioepis received approval for six and five biosimilars in Europe and the US, respectively. Biosimilars of five biosimilars of Samsung Bioepis, Enbrel, Remicade, Humira, Herceptin, and Lucentis, have been approved in Europe and the United States. In Europe, it has additionally obtained approval for the sale of Avastin biosimilars. Samsung Bioepis is selling five biosimilars in Europe and three biosimilars in the US. Samsung Bioepis started selling Enbrel and Remicade biosimilars in Europe in 2016. In 2018, it introduced biosimilars to Herceptin and Humira markets and started selling Avastin biosimilar AYBINTIO in Europe in 2021. In the US, among the five licensed products, Remicade biosimilar RENFLEXIS was launched in the US market in 2017, and Herceptin biosimilar Ontruzant was launched in the US in 2020. Last year, it started selling Lucentis biosimilar BYOOVIZ in the US. Established in 2012, Samsung Bioepis generated sales of 43.7 billion won for the first time in 2013. In 2016, when the biosimilar overseas targeting began in earnest, it recorded sales of 147.5 billion won, and has continued to grow every year since. Since its launch in 2012, Samsung Bioepis has recorded cumulative sales of 4,311.2 billion won. Most of Samsung Bioepis' sales come from overseas sales of biosimilars or royalties. Domestic sales volume is negligible. According to IQVIA, a pharmaceutical research institute, Samsung Bioepis' five biosimilars sold a total of 42.5 billion won last year. In other words, the biosimilars of Celltrion and Samsung Bioepis have exported more than 13 trillion won in total over the past 10 years.
- Company
- Dupixent likely to expand reimb to pediatrics from April
- by Eo, Yun-Ho Mar 22, 2023 05:46am
- Reimbursement of the atopic dermatitis treatment ‘Dupixent’ is expected to be expanded for pediatric and adolescent patients from April. According to sources from related industries, Sanofi-Aventis Korea recently concluded a drug price negotiation with the National Health Insurance Service for the low dose (200mg) of Dupixent (dupilumab). Thus, Dupixent will be presented to the Health Insurance Policy Deliberation Committee tomorrow (23rd). On the 23rd, JAK inhibitors such as Abbvie Korea’s ‘Rinvoq (upadacitinib)’ and Pfizer Korea’s ‘Cibinqo (abrocitinib)’ will also be discussed. Unless otherwise, treatment options for pediatric atopic dermatitis patients will be drastically expanded in April. Dupixent's journey to expand reimbursement has seem many twists and turns. Being an RSA (Risk Sharing Agreement) drug, and having added a separate dose of 200mg, Dupixent had to go through an additional cost-effectiveness review procedure with the Health Insurance Review and Assessment Service, and complete drug price negotiation with the National Health Insurance Service. If approved, Dupixent will finally see results after two years since applying for an expansion of reimbursement in April 2021. Although the specific indications may differ, the difference in speed of progress is evident when compared to JAK inhibitors such as Rinvoq and Cibinqo, which also have applied for expansion of reimbursement in atopic dermatitis. The price of JAK inhibitors are relatively lower than that of Dupixent. Rinvoq and Cibinqo were both listed for reimbursement in May last year and Rinvoq is also attempting to expand its reimbursement to pediatric adolescent patients. Meanwhile, Dupixent is the first and only biologic to specifically target and inhibit the signaling of IL-4 and IL-13, which is the fundamental cause of atopic dermatitis. As Dupixent does not have a black box warning from the US FDA, which addresses the most severe side effects, and does not require monitoring for organ toxicity during administration, it was approved without any requirement for testing when starting treatment or regular safety monitoring during treatment.
- Company
- Patent extension system for drugs to be reorganized…
- by Kim, Jin-Gu Mar 22, 2023 05:46am
- A plan to reorganize the patent term extension system of biopharmaceuticals in a manner similar to those of the US and Europe is being reviewed. In the pharmaceutical industry, it is predicted that if the reorganization plan passes the National Assembly, the patent term of some original drugs will be reduced to about one year. According to the pharmaceutical industry, the Korean Intellectual Property Office recently prepared an amendment to the Patent Act to reform the system for the patent term of drugs on the 21st. The amendment is expected to be submitted to the National Assembly in the form of legislative acts. The main point of the amendment is to set the upper limit on the remaining (valid) patent term to 14 or 15 years from the time a new drug receives approval. The pharmaceutical industry's attention is focused on how much the original drug's patent term will be shortened. In this regard, the US and Europe have systems that limit the effective patent term. This method allows the patent to be effective for up to 14 or 15 years from the time the drug has been approved. For example, even if a pharmaceutical company 'A' has been granted approval for a patent for 20+5 years (basic patent term + extended period), the entire patent term is shortened 'up to 15 years from the time of approval' by setting an upper limit. On the other hand, Korea does not have a separate limit on the patent term that is applied from the time of approval. In the current system, there are only regulations that limit the extension of the patent term to a maximum of 5 years, but no upper limit on the effective patent term. As a result, the Korean patent term of pharmaceuticals is longer than the US and Europe, with the same product and same patent. Taking Pfizer’s ALK-targeted anti-cancer drug Xalkori (ingredient: crizotinib) as an example, its remaining patent term is limited to 14 years after approval by the FDA in the US. Under the upper limit, only 1 year and 6 months (547 days) of the patent term extension was recognized for Xalkori in the United States. The situation is similar in Europe. Europe has an upper limit of 15 years from the date of initial marketing authorisation. As a result, only 2 year and 2 months (799 days) of the patent term extension was recognized for Xalkori in Europe. Since there is no separte regulation that states the upper limit in Korea, the extended patent term of Pfizer's Xalkori was fully recognized. The extended patent term approved for Xalkori in Korea is 2 years and 10 months (1034 days), which is about 8 months longer that that of Europe and about 16 months longer than that of US. If the amendment passes the National Assembly, the effective patent term of the original drug will be shortened to about 1 year. In other words, the timing of generic release in Korea will be accelerated. The key is whether the amendment will be applied only to newly introduced drugs or to existing drugs as well. If the amendment is applied to existing drugs, quite a number of drugs will be affected by the new system. According to the Korean Intellectual Property Office, as of the end of 2021, 360 drugs still have effective patent term remaining in Korea. In terms of number of patents, there are 612. Among them, 60 drugs (83 patent rights) are expected to become subject to the new system, having 'effective patent term of 15 years or more.' While the Korean Intellectual Property Office is reportedly considering the 14-year regulation, the US model, the pharmaceutical industry predicts that the effective patent term for 40 to 50 drugs may be shortened if the amendment is applied to existing drugs as well.
- Opinion
- [Reporter's view] PVA improvement plan & domestic drugs
- by Lee, Tak-Sun Mar 21, 2023 05:58am
- There is also concern about the proposal for improving PVA through research service. Last year, researchers (Bae Seung -jin, Ewha Womans University, etc.), who studied PVA's performance evaluation and improvement plan, ordered the screening management of drugs with high financial impacts. As a result, the selection criteria for the usage type 'Ka' were proposed to expand by adding 5 billion won and a 10% increase in the existing claims. Drugs with low financial impacts, such as a plan to raise the exclusion of negotiations from 2 billion won to 3 billion to 5 billion won, are required to ease management. The proposal for improvement will be discussed in May and institutionalized from January next year. In summary, the system improvement is expected to be promoted in the direction of a high -financial reduction rate, low drug reduction rate, and lowering the cut-rate. In the industry, there are many voices in favor of the system improvement direction. It is efficient to differentiate the upper limit according to the number of claims. However, there is a concern that the type of new drug will be added to the 'negotiations', and the burden will be increased to multinational pharmaceutical companies or domestic new drug development companies. In particular, domestic new drugs have been concerned about the improvement plan as the pharmaceutical industry has insisted on easing the PVA in order to ease development and encouragement. As the government uses biotechnology as a next-generation growth engine and declines domestic new drugs, it is also necessary to support the drug price. Domestic new drugs enter the low price without preferential treatment from the time of listing, and if the drug price is increased due to active sales and marketing, the new drug development company, which spends large-scale costs, ' If it was, only regret will remain. Although the government cannot discriminate against domestic and overseas new drugs, the domestic new drug preferential policy is inevitable to protect and foster our industry. Therefore, from May, we should focus on preparing more sophisticated measures in consideration of concerns about the domestic pharmaceutical industry.
- Policy
- Janssen's CAR-T treatment Carvykti was approved
- by Lee, Hye-Kyung Mar 21, 2023 05:57am
- The Ministry of Food and Drug Safety (Director Oh Yu-kyung) announced that it has granted CARVYKTI, a CAR-T treatment agent, a rare drug of Jansen, a rare drug. CAR-T cells are called chimera because they modify the surface receptor to better recognize and attack cancer cells. Carvykti is an anticancer drug that injects the T cell into the patient's body after putting genetic information that can recognize the B cell mature antigen (BCMA) into the patient's immune cells (T cells). B-cell maturity antigen (BCMA) is an ideal target for transplanted cell carcinoma (multiple myeloma) because it is selectively expressed during transformed cell differentiation and is not expressed in other major organs. Carvykti has previously provided new treatment opportunities for patients with recurrence or dissatisfaction with at least four treatments, including Proteaums, immunomodulatory preparations, and anti-CD38 antibodies. The MFDS scientifically reviewed and evaluated the quality, safety and effectiveness, manufacturing, and quality control criteria of the drug in accordance with the screening criteria prescribed in the Act on the Safety and Support Act of Advanced Regenerative Medical and Advanced Bio. Carvykti is a long-term tracking survey under Article 30 of the Advanced Regeneration Bio Act and must be tracked over the case of more than 15 years from the date of administration. The MFDS said, "We will do our best to ensure that the therapeutic drugs that are fully confirmed with safety and effectiveness based on regulatory science are quickly supplied."
- Policy
- Which Vemlidy IMD among the 5 will rise to the top?
- by Lee, Tak-Sun Mar 21, 2023 05:57am
- Although failing to receive reimbursement in advance, many Vemlidy IMDs are awaiting entry into the Korean market. All the drugs are incrementally modified drugs that were developed with different salt formations. According to industry sources on the 20th, 5 more companies are waiting to enter the market with Vemlidy latecomers. These companies follow the earlier entrants, such as Dong-A ST, which received reimbursement approval in January, and Chong Kun Dang and Daewoong Pharmaceuticals, which received reimbursement approvals in February. Vemlidy (tenofovir ala fenamide) is an upgraded version of Gilead Science’s previous chronic hepatitis B treatment, ‘Viread (tenofovir).’ Vemlidy has been evaluated to have improved tolerance and nephrotoxicity over Viread. Same-ingredient Vemlidy generics are unable to enter the market because the drug’s hemi-fumarate patent is set to last until August 15, 2032, However, domestic companies have succeeded in releasing drugs in the market by avoiding the patent by changing the sodium ingredient of the drug. Starting with Dong-A ST’s release of ‘Vemlia (tenofovir alafenamide citrate)’ with reimbursement, Chong Kun Dang followed in February by releasing Tenofobell-A (tenofovir alafenamide succinate) with reimbursement and Daewoong Pharmaceutical also released Vemliver (tenofovir alafenamide hemitartrate) with reimbursement. Their ingredients show that all use different salts with Vemlidy. Donga ST, Chong Kun Dang, and Daewoong Pharmaceutical each developed their own salt-modified drugs. 2 more types of salt-modified drugs are set to follow. Jeil Pharmaceutical Tecavir-D (tenofovir alafenamide) was approved in the same month as those by Chong Kun Dang and Daewoong Pharmaceutical but was not granted reimbursement. On its reason, a company official said, “reimbursement had been delayed due to disruptions in the supply of the drug’s API,” he explained. With the normalization of the supply, it is highly likely that our product will also be released with reimbursement.” Also, 4 tenofovir alafenamide hemimalte products were approved on March 15th and are set to be released with reimbursement in June. The drugs are manufactured and supplied by Samjin Pharm but will be marketed by Bukwang Pharm, which has strong marketing strengths in the hepatitis B treatment market. Also, Dongkook Pharmaceutical, Hutecs Korea Pharmaceutical, and Samil Pharm will also receive products from Samjin and enter the market with individually approved products. As of now, a total of 5 salt-modified Vemlidy IMDs have been released to the market. The fact that so many salt-modified drugs were developed and released for one product shows the interest large companies have in this market. Large companies tend to develop and sell their own products rather than receive drugs upon consignment from other companies. This is why, large pharmaceutical companies that gross large sales, such as Donga ST, Chong Kun Dang, Daewoong Pharmaceutical, and Jeil Pharmaceutical, dedicated and developed their own salt-modified drugs to preoccupy the market. On the other hand, since it is difficult for small and medium-sized companies to develop drugs independently due to development costs, Samjin is known to have addressed the problem through joint development with other companies under the 1+3 regulation set for consigned bioequivalence tests. Therefore, which salt-modified product will be leading the market is gaining attention.
