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- 2025-12-22 23:03:22
- Policy
- Boryung Zepzelca, conditional approval with phase 2 data
- by Lee, Hye-Kyung Sep 29, 2022 05:49am
- It has been confirmed that Boryung's new small cell lung cancer drug Zepzelca has received conditional approval only with phase 2 clinical data. Based on the Ministry of Food and Drug Safety's notice, anti-cancer drugs have been subject to conditional approval for phase 3 since January this year, and the revision of the Pharmaceutical Affairs Act has clarified the criteria for conditional approval only with phase 2 data. The HIRA benefit evaluation will be available if the company applies for conditional approval. If the adequacy is evaluated in the HIRA, it can be converted into a reimbursed drug through drug price negotiations with the NHIS. Until the benefit is applied, patients will be able to receive Zepzelca on a nonreimbursed basis only for permits. On July 6, the Central Pharmaceutical Affairs Review Committee, which was unveiled by the Ministry of Food and Drug Safety on the 27th, discussed the efficacy of Zepzelca's conditional approval. According to the minutes, the Ministry of Food and Drug Safety judged that the number of patients was reasonable because the phase 3 clinical trial proposed by Boryung was a multinational clinical trial. In addition, Zepzelca submitted a risk management plan as a rare drug, and added that it focused on hematological toxicity and hepatotoxicity in safety items. At the meeting, Boryung said, "We plan to proceed only with global clinical trials at the moment, and if we believe that domestic clinical trials are necessary, we will decide after discussing with developers." "In the United States, discussions have been held with the FDA several times since the phase 2 clinical trial, and conditional items have been approved and are currently on the market," he explained. Phase 3 clinical trials are currently underway, and plans to submit phase 3 clinical data as soon as clinical trials are completed in the future. Boryung announced its plan to launch Zepzelca in the first half of next year, which is an indication of "metastatic small cell lung cancer that failed primary platinum-based chemotherapy." Zepzelca is a new anti-cancer drug developed by Spanish pharmaceutical company PharmaMar S.A., and Boryung has exclusive rights to develop and sell in Korea since 2017. After being designated as a rare drug by the U.S. Food and Drug Administration (FDA) in 2018, it was released in July of the same year with conditional rapid approval and priority screening approval in June 2020. In the United States, only small cell lung cancer is allowed. Boryung said, "Although it was a phase 2 result, it showed effectiveness compared to existing treatments, and showed a low tendency in hematological adverse reactions in terms of safety," and expected, "If it is marketed, patients' choice opportunities will be expanded."
- Policy
- Janssen's Talquetamab, approved for Phase 3 in Korea
- by Lee, Hye-Kyung Sep 28, 2022 06:05am
- While Janssen's Talquetamab is undergoing phase 3 clinical trials around the world, phase 3 approval has been granted to 44 patients in Korea. On the 26th, the Ministry of Food and Drug Safety approved the Talquetamab subcutaneous injection and Daratumumab subcutaneous injection (Tal-DP) or Daratumumab subcutaneous injection and Daratumumab subcutaneous injection (Dalatum-3) in clinical trial subjects with at least 1st prior therapy. Currently, multinational clinical trials are underway for patients with recurrent or refractory multiple myeloma, and the total number of clinical trials is 810. In Korea, clinical trials will be conducted at Severance Hospital, Samsung Medical Center, Hwasun Chonnam National University Hospital, Seoul St. Mary's Hospital, Seoul Asan Medical Center, Seoul National Cancer Center, Gil Hospital, Chonbuk National University Hospital, and Dong-A University Hospital. A double antibody is an antibody that simultaneously recognizes two different antigens. Treatments are characterized by targeting both factors that cause disease. For example, it can act on immune cells and cancer cells at the same time to catch two rabbits, strengthening immunity and attacking cancer cells. Representative double-antibody anticancer drugs include Amgen's acute leukemia treatment BLINCYTO (Blinatumomab) and Roche's hemophilia type A treatment HEMLIBRA (Emishzumab). Talquetamab targets both GPRC5D and CD3 of T cells, a new multiple myeloma target, with off the shelf T cell-redirecting double antibody. According to data released by ASCO last year by Janssen, subcutaneous administration of phase 2 recommended doses in 30 patients with recurrent or refractory multiple myeloma with a median value of 6 months or more was 70%, and 60% of patients achieved VGPR (very good partial response). Subjects of clinical trials previously received the sixth treatment at a median value, and 87% did not respond to the last treatment. Reactions were observed in 70% of patients, including 65% of patients who were non-responsive to three drugs and 83% of patients who were non-responsive to five drugs, and during the 6.3 months of the follow-up period, patients have not yet reached the median of the response period.
- Policy
- Generic for Acelex will be released
- by Lee, Tak-Sun Sep 27, 2022 05:51am
- A new domestic anti-inflammatory drug developed by Crystal Life Science Generic drugs of the domestic anti-inflammatory drug Acelex developed by Crystal Life Science will be on the market from next month. It has been seven years since Acelex was licensed in Korea, and attention is being paid to whether generic, like the original, will be able to expand its market. This is because Celecoxib has high market dominance among coxib families. According to industries on the 26th, eight Acelex generics will be listed on the 1st of next month. Generic companies are Daewoong Pharmaceutical, Hutecs, Ilhwa, CrystalLife Science, Kuhil, Edenpharma, CMG Pharma, and Hana. Except for Daewoong Pharmaceutical, seven items will receive an additional amount of 522 won for one year, including first generics, and will be adjusted to 470 won on October 1 next year. Daewoong will be listed at 597 won, but will also be adjusted to 470 won on October 1 next year. Generic is in competition with original, but Acelex generic is in partnership with original. This is because Crystal Life Science, an affiliate of Crystal Genomics, produces products like the original company. Therefore, the original company's production performance will expand only when generic sales increase. Original and generic market expansion, by having common goals. Cerebrex 400 billion won in annual performance record. 2016, patent expiration as a generic is reimbursed. Acelex is properly lost the use of force and with earnings of less than 10 billion won per year. The sluggishness of Arcoxia and Acelex is due to the fact that the indication is limited to osteoarthritis and that the marketing ability was not great to destroy Cebrex's position. Since large companies such as Daewoong Pharmaceutical are included in Acelex generics this time, generics are expected to expand the overall market size, allowing both original and generics to create synergy.
- Policy
- Hutecs targets pitavastatin market with its lowest-price
- by Lee, Tak-Sun Sep 27, 2022 05:51am
- Hutecs Head Office in Hwaseong City Hutecs Korea Pharmaceutical throws a winning bid in the hyperlipidemia treatment pitavastatin market represented by the original drug Livalo. As the 21st latecomer introduced to the market, Hutecs’ generic is putting pressure on other competitor companies, being listed at a price lower than 85% of the current lowest price. According to industry sources on the 26th, Hutecs succeeded in listing both Lovalow 1mg and Lovalow 4mg with reimbursement. The ceiling price was set at KRW 295 for the Lovalow 1mg, and KRW 527 for Lovalow 4mg. The two products are both listed at the lowest price among the listed products. In particular, the price of Lovalow 4mg was set 28% lower than the current lowest price (KRW 715). Lovalow 4mg is the 21st product to be listed. Under the drug pricing regulations, from the 21st generic listed in the system, the price is set at 85% of the lowest price. However, the price of Lovalow 4mg was set even lower. With the listing, the ceiling price of the already listed Lovalow 2mg will also inevitably be discounted. This is because when a product from the same company with an identical route of administration, ingredient, and formulation, but with a different strength is already listed, the ceiling price of the lower strength is adjusted to be lower than that of the higher strength under regulations. Therefore, the price of Lovalow 2mg was lowered to KRW516 from KRW561. This is KRW 1 lower than that of Lovalow 4mg. As a result, Lovalow 2mg, which was the lowest priced product among the same ingredient drugs, is expected to become the second lowest priced product. Competition in the pitavastatin market is fiercer for the 2mg products. A total of 48 same ingredient products are competing in the market. With its 1mg and 4mg formulations being listed later in the market, Hutex seems to be throwing in the winning bid and extending its price competitiveness to the 2mg formulation market as well. Pitavastatin is a steady seller that has been long beloved in the hyperlipidemia treatment market. Its original, Livalo, had recorded KRW 79.7 billion (Data: UBIST) in outpatient prescriptions last year.
- Policy
- MFDS in discord regarding promotion of oral COVID-19 Txs
- by Sep 26, 2022 06:08am
- The government is encouraging the use of oral COVID-19 treatments in high-risk groups, however, accessibility to such has been limited for healthcare professionals due to limitations in emergency use approvals. The Ministry of Food and Drug Safety is being criticized for being passive in making legal interpretations for emergency use authorized drugs, which is in discord with the government’s disease control and prevention measures. According to industry sources on the 26th, pharmaceutical companies are disallowed from conducting academic marketing for their oral COVID-19 treatments as the subject drugs were approved under Emergency Use Authorizations. Usually, when new drugs are released, companies conduct various activities to raise awareness of the drugs, making visits to hospitals to explain their drugs and holding webinars or symposiums to provide educational material. The new drugs in the market can only be actively used after the healthcare professionals gain a better understanding of the drugs and accumulate prescription experience. However, as COVID-19 treatments were granted emergency use according to the Special Act on the Promotion of Development and Urgent Supply of Medical Products in Response to Public Health Crisis, the authorities deemed that the drug are not allowed the advertising privileges granted under the Pharmaceutical Affairs Act. According to Article 68-5 of the Pharmaceutical Affairs Act, the imported pharmaceutical product’s name, manufacture method, and efficacy cannot be advertised unless the drug product has been approved or reported according to Article 42-1 of the Pharmaceutical Affairs Act. As drugs granted Emergency Use Authorization was not approved under Article 42-1 of the Pharmaceutical Affairs Act, the MFDS’s interpretation was that such drugs are not allowed to conduct advertisements. Due to this, the government is solely in charge of providing the necessary information on oral COVID-19 treatments in Korea. The Korea Disease Control and Prevention Agency is in charge of training healthcare professionals to provide medication guidance to patients, etc. However, it has been pointed out that the government’s education sessions are not enough to cover the expanded scope of institutions and pharmacies approved to prescribe and dispense oral COVID-19 treatments. Also, the participation rate, frequency, and effect of KDCA’s education sessions are relatively lower than that of pharmaceutical companies due to lack of promotions among other reasons. There are also opinions that more explanation is needed because the sessions are not carried out by medical professionals. Many healthcare professionals and pharmacists who still have not received a prescription or medication guidance yet have reported experiencing confusion. However still, officials of pharmaceutical companies that can communicate most closely with healthcare professionals have been passive in dealing with the issue due to concerns about violating the Pharmaceutical Affairs Act. As an active explanation of the drugs was prohibited, the officials can only respond when receiving inquiries from healthcare professionals. This is why the prescription rate has not risen much even though the government has greatly expanded the number of institutions that can prescribe oral COVID-19 treatments. According to the Central Disaster and Safety Countermeasure Headquarters (CDSCH), the prescription rate of oral COVID-19 treatments in those over the age of 60 as of the 2nd week of September, remained at 27%. The prescription rate has more than doubled in 4 months with the encouragement of the disease control and prevention authorities, but the government believes it is necessary to further increase the prescription rate. The importance of prescribing oral treatments has risen after the prescriptions had significantly reduced the progression to severe disease in patients in the high-risk group over the age of 60 during the COVID-19 outbreak last summer. The CDSCH’s analysis of its disease control progress and response to the resurge of COVID-19 in the summer showed that the progression to severe disease decreased as the prescription rate for oral COVID-19 treatments increased for those aged 60 years or older. The rate of progression to severe disease, which had been 1.28% in February when the administrate rate was 6.4%, dropped to 0.42% with the rise of the administration rate to 21.7% in August. The disease control and prevention authorities are also busy preparing measures to address the issue of prescriptions being limited due to a lack of clinical information in the field. According to the 'Measures to Raise Prescriptions of Oral COVID-19 Treatments’ that had been reported by CDSCH last month, healthcare professionals were reluctant to prescribe oral COVID-19 treatments due to a large number of contraindicated drugs and lack of clinical information. Accordingly, the authorities are contemplating ways to increase accessibility to information by preparing educational materials and prescription guidelines. To address the continued criticism over the limitations in information, the authorities recently partially granted pharmaceutical companies to produce and distribute materials containing drug information. As such partial activities have clear limitations, voices for proactive allowance of pharmaceutical companies to conduct academic marketing on EUA drugs have also been rising. Contrary to the government's stance, the MFDS had been passive in making legal judgments regarding EUA drugs. At the time of introductions, pharmaceutical companies had made several inquires to the MFDS on what scope of information provision activities is allowed for their drugs. At the time, the MFDS only responded that “It is difficult for the ministry to provide a definite answer due to lack of information in determining the necessity and validity of providing information." The pharmaceutical companies received the response as a “don’t.” Regarding this, the MFDS said, “The COVID-19 treatments that were granted EUA are directly managed by the KDCA, and the KDCA has been providing various information for healthcare professionals and patients. We will consult with the department in charge to see if academic marketing is allowed." The Advisory Committee on Infectious Diseases also agrees on the need for the government to make proactive decisions and improve and expand healthcare professionals’ accessibility to information. During a phone interview with Dailypharm, Gi-Seok Jeong, Director-General of Special Response of the Central Disaster and Safety Countermeasure Headquarters, said, “Despite the state’s efforts in encouraging the prescription of oral COVID-19 there are still many cases in which prescriptions are not available to patients who need them in the medical field. Adding pharmaceutical companies' information provision activities to the effort will help increase the prescription rate. It seems necessary that the government should take active action to overcome obstacles that may hinder engagement in such activities that would lead to an increase in the prescription rate, by requesting authoritative interpretation from the Ministry of Government Legislation.”
- Policy
- Lipiodol’s price reduced from 25th... 2-year suit dismissed
- by Kim, Jung-Ju Sep 26, 2022 06:07am
- The price of Guerbet Korea’s liver cancer contrast medium, Lipiodol Ultra-Fluid (iodized oil, 12.8g/10mL), which had been under legal dispute for the past 2 years after the government decided to remove the drug from the reimbursement list, will be reduced from the 25th this month. This is because the pricing discount that had been originally made by the government was reapplied upon the court’s dismissal of the lawsuit and the automatic termination of suspension of execution that followed. On the 19th, the Seoul High Court’s Administrative Court Department 6-1 decided to dismiss the administrative lawsuit filed by Guerbet Korea and notified the company and the MOHW of the termination of the suspension of execution. Accordingly, the MOHW announced that it would reduce the drug price as of the 25th as it had decided in 2020. Earlier in July 2020, the MOHW decided to lower the price of Lipiodol through ex officio adjustment upon the listing of its generic, Dongkook Pharmaceutical’s Fattiodol. Under the government’s pricing formula, the upper limit of the first product can be lowered by the government through ex officio adjustments when a generic with the same route of administration, ingredient, and formulation as the original listed. Guerbet Korea immediately filed a suit against the government, and the dispute continued until recently. The Seoul High Court’s Administrative Court Department 7 had previously decided to extend the suspension of execution that had been ordered by Administrative Court Department 12 so that the company could keep its original price. The suit was then passed on to Department 6-1, where it was dismissed. The scope of its reimbursement had also expanded in the long course of the continued litigations. As of July 6th, Lipiodol is reimbursed for lymphography, hysterosalpingography, and transarterial chemoembolization (TACE) in liver cancer. However, the price cut that will be made this time is irrelevant to the reimbursement extension, and the final price of KRW 133,000 will be applied per ample as it was originally reduced in July 2020.
- Policy
- HCV treatment Epclusa·Vosevi start pricing negotiations
- by Lee, Tak-Sun Sep 23, 2022 05:52am
- The National Health Insurance Service is known to be conducting pricing negotiations with Gilead Science Korea for the company’s new Hepatitis C treatments, ‘Vosevi (sofosbuvir/velpatasvir/voxilaprevir)’ and ‘Epclusa (sofosbuvir/velpatasvir).’ The two drugs received conditional approval from the Drug Reimbursement Evaluation Committee in July this year. According to industry sources on the 22nd, the NHIS disclosed the negotiation status above while updating the list of new drugs subject to drug pricing negotiations on the NHIS webpage. Epclusa is a new drug that was approved in February, and Vosevi in March by the Ministry of Food and Safety. Gilead, which used to dominate the Hepatitis C treatment market with ‘Sovaldi,’ had been pushed down to second place due to Abbive’s ‘Mavyret.’ In an attempt to take back its throne, Gilead has released two new drugs – Epclusa and Vosevi. Like Mavyret, Epclusa can be used in all HCV genotypes 1 to 6, this is why Gilead believes that it has a winning shot against Abbvie. Gilead is planning to fuel its drive by adding another product, Vosevi, which contains an additional ingredient. Based on IQVIA, Mavyret recorded KRW 46.6 billion in sales last year. On the other hand, Gilead’s Sovaldi made KRW 0.2 billion, and Harvoni KRW 11.7 billion. Ironically, as HCV treatments have a high cure rate if the treatments are taken within the recommended treatment period, the sales performance of these drugs tends to decline over time. Therefore, pharmaceutical companies need to attract new patients to raise sales. Currently, the new influx of patients is concentrated around Mavyret due to its low price and its broad use in all genotypes. Mavyret’s insurance ceiling price is KRW 65,014 per tablet. Compared with the KRW 126,186 of Sovalidi and KRW 130,011 of Harvoni, this is around twice the difference. Therefore, if Gilead attempts to turn around the market, the industry sees that the company would need to set the price of Epclusa and Vosevi at the same level as Mavyret. When DREC announced the results of its deliberation in June, it said it would recognize the appropriateness of the drugs’ reimbursement if the two drugs will accept a lower price than the evaluated price. As the drugs have passed the reimbursement adequacy review by the Health Insurance Review and Assessment Service and are in pricing negotiations with the NHIS, Gilead would have had to accept a price lower than DREC’s evaluated price. Although DREC’s evaluated price was not disclosed, if Mavyret was used as the alternative drug in evaluations, Epclusa and Vosevi may likely be listed at a lower price than expected.
- Policy
- On-site inspections of overseas plants will resume next year
- by Lee, Hye-Kyung Sep 23, 2022 05:52am
- On-site inspections of overseas biopharmaceutical manufacturing plants, which have been suspended due to COVID-19, will resume. The Ministry of Food and Drug Safety's Biopharmaceutical Quality Management Division recently sent an official letter to representatives of biopharmaceutical importers, the KOBIA, the KPBMA, Korea Pharmaceutical Traders Association, and the KRPIA to announce the pre-GMP site implementation of biopharmaceuticals. Due to the prolonged COVID-19 situation, the Ministry of Food and Drug Safety revised the "Guidelines for Pre-GMP Evaluation of Biopharmaceuticals" on March 29 last year to convert overseas manufacturers that need on-site inspections into non-face-to-face inspections. Non-face-to-face due diligence targets include manufacturing plants located in corresponding areas such as exhibitions, infectious diseases, and natural disasters, the Ministry of Foreign Affairs and the Korea Centers for Disease Control and Prevention classifies it as a travel ban (cancellation, postponement), traveler's system (careful review), or travel significance. Through preliminary GMP evaluation, the Ministry of Food and Drug Safety is determining whether the manufacturing and quality management standards of biopharmaceuticals that have applied for permission to manufacture and report (hereinafter referred to as permission) and change permission are met. Document evaluation and fact-finding surveys include manufacturing plants subject to initial evaluation, manufacturing plants that have passed the period of omission of the fact-finding survey (aseptic 3 years, aseptic 5 years), manufacturing processes that are deemed necessary in the item approval stage, etc. As the on-site inspection will be conducted in more than two years, the Ministry of Food and Drug Safety will first gradually expand the number of items classified as new drugs to overseas manufacturers will not have a history of due diligence by the Ministry of Food and Drug Safety. The on-site inspection will be applied after January 1 next year, and even if the non-face-to-face inspection schedule is confirmed after January 1 next year, overseas manufacturers of new drugs will switch to on-site inspection. However, rare drugs and drug manufacturers subject to fast track are conducted through document evaluation and non-face-to-face investigation. The on-site inspection will be conducted by two or three GMP investigators from the Ministry of Food and Drug Safety within the deadline for responding to the relevant complaint. The deadline for reply refers to the maximum period during which the approval department notifies the requesting department of the evaluation results when requesting an evaluation from the GMP evaluation department according to the receipt of a complaint for drug item approval. If it is not possible to conduct it within the deadline for reply to the consultation due to the circumstances of the company (manufacturing plant), the workload of the Ministry of Food and Drug Safety, and the lack of manpower for the fact-finding survey, the period may be extended. The detailed schedule and due diligence method shall be notified in official letter after consultation.
- Policy
- Leclaza to receive first monitoring for PVA negotiations
- by Lee, Tak-Sun Sep 23, 2022 05:52am
- The National Health Insurance Service disclosed drugs subject to monitoring for Type A and Type B of the Price-Volume Agreement negotiations in the fourth quarter of 2022. The list is attracting attention as Yuhan Corp’s novel non-small-cell lung cancer drug Leclaza was also selected for monitoring, as well as domestic homegrown drugs such as Kanarb, Supect, and Pelubi. A total of 91 drugs that are subject to monitoring for PVA negotiations in the 4th quarter this year were disclosed in advance on NHIS’s webpage on the 20th. The NHIS selects drugs that are subject to monitoring for PVA Type A and B negotiations every quarter. Drugs receive negotiations under 'Type A' when the claims amount in their same therapeutic class exceeds the expected claims amount that the company had agreed upon with the NHIS through negotiations by over 30%. Leclaza will also be monitored for Type A negotiations. As Leclaza was listed on July 1st last year, its rate of increase will be calculated by comparing the claims amount accrued from July 1st last year to June 30th this year with the expected claims amount. Leclaza’s expected claims amount is known to be KRW 14.1 billion. However, based on IQVIA data, Yuhan Corp had earned KRW 11 billion in the period. Therefore, the analysis is that the drug will not be subject to negotiations, but as the amount of the actual claims may differ, it is difficult to prejudge whether it will be included in the negotiation list. Many novel homegrown drugs were also listed for monitoring for ‘Type B’ PVA negotiations, which are applied to drugs whose maximum amount had already been adjusted according to Type A PVA. Boryung Pharmaceutical’s hypertension treatment Karnab is one representative drug that will receive monitoring in Q4. Also, Il-Yang Pharmaceuticals’ leukemia treatment Supect, and Daewon Pharm’s antipyretic, anti-inflammatory, pain reliever Peluvi were included for monitoring this quarter. Among imported novel drugs, the oral anticoagulants Xarelto and Lixiana, and immunotherapy drugs Opdivo and Yervoy whose use has increased greatly recently were listed as monitoring subjects. The claims amount of the previous year and the year before are compared for drugs that are subject to ‘Type C’ PVA negotiations. 172 items have received negotiations under Type C and unilaterally discounted on the 1st of this month.
- Policy
- Janssen's Imbruvica succeeded in setting a standard
- by Lee, Tak-Sun Sep 22, 2022 06:02am
- Janssen's anti-cancer drug Imbruvica, which has started to expand its benefit, has succeeded in setting standards for now. The HIRA announced that it held the 8th Cancer Disease Review Committee in 2022 on the 21st and made the decision. Through this deliberation committee, Imbruvica has set benefit standards for monotherapy in patients with chronic lymphocytic leukemia and small lymphocytic lymphoma, who are 65 years of age or older and have never been treated before. Since April 2018, Imbruvica has been receiving benefits for secondary therapy for recurrent and refractory chronic lymphocytic leukemia. Brukinsa, which challenged MCL benefit at this cancer screening, failed to set standards. This is the second failure following the Cancer Disease Review Committee in April. Bruckinsa of BeiGene has set a standard for monotherapy in adult patients with mantle cell lymphoma, MCL (MCL), who have previously received more than one treatment, but the Cancer Disease Review Committee has not recognized it. In April, the establishment of benefit standards for MCL indications failed. However, standards have been set for Waldenström's macro-globulinemia (WM).
