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- 2026-05-11 17:34:30
- Company
- Anti-depressant Brintellix generic for exclusivity succeeded
- by Jan 20, 2023 06:07am
- Myungin Pharmaceutical (CEO Lee Dong-myung) and Unimmed Pharmaceutical (CEO Kim Gun-nam) announced on the 18th that they succeeded in invalidating the patent for the antidepressant Brintellix. The Korean Intellectual Property Tribunal recently made a decision to cite the claim on Brintellix purpose patents filed by both companies against Lundbeck Korea. Lundbeck Korea has a total of two material patents that expire in May 2027 and usage patents that expire in November 2028 related patents that expire in November 2028. Myeongin Pharmaceutical and UniMed Pharmaceutical have filed invalid and passive claims for patents for use. The decision also outlined generic for exclusivity for Brintellix's generics. Myungin Pharmaceutical and Unimed met the requirements for "first trial request" and "first item permit application" by filing a series of requests for judgment in March last year. In June, the Ministry of Food and Drug Safety applied for the first simultaneous generic item license. As both companies win the patent invalidation trial, only the two pharmaceutical companies are expected to acquire generic for exclusivity use of Brintelix. Brintellix was approved domestically in August 2014 as a multi-acting antidepressant through direct regulation of serotonin receptors involved in depression and inhibition of serotonin reabsorption. According to IQVIA, a pharmaceutical market research firm, Brintelix's annual sales continued to grow by double digits every year to 8.7 billion won in 2020, 9.7 billion won in 2021, and 10.4 billion won in 2022. Myungin Pharmaceutical and Unimed Pharmaceutical will be able to sell generic products exclusively for nine months after May 10, 2027, when the substance patent expires.
- Policy
- Rinvoq PR 30 mg & Fexuclu 10 mg listed
- by Lee, Jeong-Hwan Jan 20, 2023 06:07am
- The Ministry of Health and Welfare will overhaul Rinvoq, Procoralan, and Fexuclu (from left) standardsWith the new listing of high-content products of Rinvoq PR, a severe atopic drug, the salary standard changes. The angina drug Procoralan is a standard treatment drug and an angiotensin II receptor blocker is added. Fexuclu, a gastroesophageal reflux disease drug, will have four new benefits listed, including a low content of 10 mg oral medicine. On the 18th, the Ministry of Health and Welfare will collect opinions by the 27th after giving an administrative notice of "partial revision of the detailed (drug) on the application standards and methods of medical care benefits." The scheduled effective date is February 1. ◆ Rinvoq PR 30mg will be newly registered, adding '30mg' to the name of the notification. Considering that the permission matters for each drug are different, the phrase is changed to "dose within the scope of permission for each drug." Currently listed 15 mg has secured indications of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, atopic dermatitis, and ulcerative colitis. The newly listed 30 mg can only be used for atopic dermatitis and ulcerative colitis indications. ◆ Ivabradine= Ministry of Health and Welfare clarifies Procoralan as standard treatment drugs by referring to the Ministry of Food and Drug Safety's permits, guidelines, clinical papers, and expert opinions. Currently, the standard treatment drugs for oral drugs composed of Ivabradin are beta-blockers, ACE inhibitors, and aldosterone antagonists. The Ministry of Health and Welfare will add an angiotensin II receptor blocker to this. ◆Fexuclu=Procoralan, a treatment for improving gastric mucosal lesions of acute gastritis and chronic gastritis, will have a revised salary standard as 10mg is set to be newly registered. Specifically, the phrase "medical care benefits are recognized when administered within the scope of permits (treatment of erosive gastroesophageal reflux disease)" is changed to "medical benefits are recognized within the scope of each drug, and the patient pays the full price except for this recognition." The criterion refers to the treatment of erosive gastroesophageal reflux disease. In the case of "improvement of gastric mucosal lesions of acute gastritis and chronic gastritis", which is an additional permit from the Ministry of Food and Drug Safety, the entire amount is recognized at the expense of the person. As a result, the scope of benefit according to the content of Fexuprazan has become clear. Fexuprazan 40mg, which was listed in July last year, was approved to be used to treat erosive gastroesophageal reflux disease. Salary is recognized at the time of administration. The 10 mg product, which will be listed in February this year, has added indications of "improvement of gastric mucosal lesions of acute gastritis and chronic gastritis." When administered with the indication, the burden is recognized, not the benefit.
- Company
- The Brain disease prescription market disappears
- by Chon, Seung-Hyun Jan 19, 2023 05:59am
- Pharmaceutical companies lost 30 billion won a year due to Oxiracetam. Prescription loss became a reality as it failed to prove its efficacy in an eight-year clinical re-evaluation. Following acetyl-L-Carnitin last year, the annual prescription market worth 100 billion won has disappeared due to the failure of clinical re-evaluation of cerebrovascular-related drugs over the past year. According to the Ministry of Food and Drug Safety on the 18th, prescription and preparation were suspended because Oxiracetam failed to prove the effectiveness of "improving symptoms of vascular cognitive impairment" as a result of clinical trial reevaluation. Oxiracetam has been licensed to improve cognitive impairment due to Alzheimer's type dementia, multiple infarction dementia, and organic brain syndrome caused by brain failure. Cognitive disorders include decreased memory, attention, and concentration, speech and behavioral disorders, emotional anxiety, and lack of motivation. The Ministry of Food and Drug Safety announced the clinical re-evaluation of Oxiracetam in March 2015. According to the clinical revaluation design, indications were adjusted in 2019 due to the improvement of vascular cognitive impairment. Oxiracetam's deadline for submitting clinical re-evaluation data was set in March 2019, but the deadline for submitting the data was extended twice and finally closed in June last year. As a result of reviewing the clinical trial data, it was concluded that it failed to prove its efficacy, and decided to discontinue the prescription. As a result, Oxiracetam is expected to lead to the deletion of indications and exit from the market eight years after the announcement of clinical re-evaluation. According to UBIST, a drug research agency, the number of outpatient prescriptions for Oxiracetam last year was 21.3 billion won. Oxiracetam formed a prescription market of 30.8 billion won and 31 billion won in 2017 and 2018, respectively. Since the adjustment of indications in 2019, the prescription volume in 2020 has decreased by 26.6% from two years ago to 22.6 billion won, and the decline has continued in 2021 and last year. According to the prescription amount by item, Korea Pharmaceutical's Neuromed showed the largest prescription performance of KRW 11.8 billion last year. This clinical re-evaluation means that Korea Pharmaceutical will lose 11.8 billion won annually. Samjin Pharmaceutical's Neuracetam recorded 5.1 billion won in prescriptions last year, while Hwanin Pharmaceutical's Neuoxitam and Kwangdong Pharmaceutical's Neuropia raised 2.8 billion won and 1.5 billion won, respectively. As a result, drugs related to brain diseases will be removed from the market for the second consecutive year following acetyl-L-Carnitin last year due to failed clinical re-evaluation. Dong-A ST's Nicetile, acetyl-L-Carnitin, has been approved for use in "primary degenerative disease" or "secondary degenerative disease caused by cerebrovascular disease." In 2013, the Ministry of Food and Drug Safety ordered a clinical re-evaluation of acetyl-L-carnitine drugs. The re-evaluation clinical trial was conducted in two groups according to indication. Dong-A ST took the lead in conducting a clinical trial of "primary degenerative disease." Hanmi Pharmaceutical was in charge of clinical trials of "secondary degenerative diseases caused by cerebrovascular disease." As a result of clinical trials, the indication was deleted in July 2019 because it failed to prove the primary degenerative disease. In August last year, it was concluded that the "secondary degenerative disease caused by cerebrovascular disease" also failed to prove its effectiveness. In other words, as a result of nine years of clinical re-evaluation, all indications were not proven, leading to the exit procedure. Acetyl-L-carnitine preparations also suffered from clinical design. It is known that it took about two to three years to set up a clinical design while designing a new clinical trial reflecting the latest scientific standards. At the request of the pharmaceutical company, the deadline for clinical re-evaluation of primary degenerative diseases was extended by two years, and the submission of clinical trial data for secondary degenerative diseases was extended by four years, which resulted in failure. Acetyl-L-Carnitin drugs formed an outpatient prescription scale of 72.6 billion won in 2017 and 74.8 billion won in 2018, but fell to 64 billion won and 51.1 billion won in 2019 and 2020, respectively. With the deletion of the first indication, the market size has been reduced. Last year, the prescription record was 31.6 billion won, but it finally disappeared from the market. As of last year, Hanmi Pharmaceutical's Carnitil left 11 billion won and Dong-A ST's Nicetile left 5 billion won in prescriptions. In 2017 and 2018, Oxiracetam and acetyl-L-Carnitin collaborated on a total of 103.4 billion won and 105.9 billion won in prescriptions. The pharmaceutical industry has become inevitable to lose about 100 billion won a year due to the failure of clinical re-evaluation of oxiracetam and acetyl-L-carnitine drugs.
- Company
- Generic drugs occupy 41% of antidiabetics market in 9 mths
- by Kim, Jin-Gu Jan 19, 2023 05:58am
- Generic products of off-patent drugs are quickly increasing their influence In the DPP-4 inhibitor class antidiabetic drug market. The market share held by generic versions of the original Galvus (vildagliptin) that were launched after the patent expiry of the original drug in March last year increased to 41% at the end of last year. The market share held by generic versions of Tenelia (teneligliptin), which 37 companies jumped in to manufacture, increased to 32% only two months after its release. ◆Market share of Galvus generics increase to 41%...Kyongbo and Hanmi shows greatest advances According to the market research institution UBIST on the 19th, the total outpatient prescriptions for antidiabetic drugs that contain vildagliptin amounted to KRW 46.9 billion last year. Compared to the KRW 46.6 billion made in 2021, the market size itself remained largely unchanged from the previous year. However, when dividing the drugs into original vs. generic drugs, the prescription amount of the originals - Galuvs and Galvusmet - fell 30% in one year and was replaced by generic products. The combined prescription amount of Galuvs and Galvusmet fell 30% last year to record KRW 32.4 billion from the KRW 46.6 billion it had recorded in 2021. When considering how the drug price was reduced by 29.9% with the release of the generic, the prescription volume itself is expected to have remained similar to the previous year. In the market, generic drugs recorded combined prescriptions of KRW 14.5 billion last year. Galvus generics have been continuously increasing its influence in the market ever since its launch in January last year. Since recording KRW 1.1 billion in Q1 last year, sales increased to KRW 3.4 billion in Q2 last year, then to KRW 4.8 billion in Q3 last year, and KRW 5.2 billion in Q4 last year. In the vildagliptin-containing antidiabetics market, the share held by generics increased to 41% as of December last year. The market share of generic drugs increased rapidly until September last year, then remained in the early 40% range ever since. Last year, 15 domestic companies released Galvus generics. Among the generic companies, Kyongbo Pharmaceutical and Hanmi Pharmaceutical recorded the highest prescription performance. The combined prescription amount of the two products amounts to KRW 6.3 billion. The amount was followed by Hanmi Pharmaceuticals’ Vildagle and Vildaglemet which made KRW 3.9 billion, then by Angook Pharmaceutical’s Avus and Avusmet which made KRW 2.6 billion. The other generic companies made annual outpatient prescriptions that amounted to less than KRW 1 billion each. ◆ Tenelia generics’ market share surged to 32% only 2 months after release Tenelia generics are also rapidly increasing their influence in the market 37 domestic companies released Tenelia generics after its patent expired on October 25 last year. Since then, the companies recorded KRW 2.9 billion in prescriptions in two months. As of last year, the share of teneligliptin-containing drugs in the diabetes treatment market expanded to 32% as of December last year. However, the increased prescriptions for generics did not lead to a decrease in prescriptions for the original products. Rather, the prescription amount of Handok’s Tenelia and Tenelia M, the original products, increased slightly from KRW 47.7 billion in 2021 to KRW 48 billion last year. This is because the drug price of the original product has not been lowered despite the generic’s release. The generic companies developed products using salts that are different from the original, which allowed the original drug to maintain its previous price. No single product recorded remarkable performance among Tenelia generics. All 37 companies are recording prescriptions ranging around KRW 100 million. A pharmaceutical industry official said, “Fierce sales competition is ongoing between generic companies to secure a market share in the earlier stages of the generic release. We expect this competition to continue until the patent for another DPP-4 inhibitor, Januvia, expires in September this year."
- Policy
- Grace period for foreign API mfg site registrations ends
- by Lee, Hye-Kyung Jan 19, 2023 05:58am
- Starting on the 21st, the foreign manufacturing site for all pharmaceuticals (including APIs) imported to Korea from abroad must be registered in advance. The Ministry of Food and Drug Safety announced that the grace period that had been granted in consideration of the industry’s state of preparations in registering foreign manufacturing sites for APIs imported to manufacture of finished products, will end as of January 20th. The mandatory registration of overseas manufacturing sites for all pharmaceuticals went into effect on July 21st last year after the amendment of the Pharmaceutical Affairs Act on July 20th, but a grace period on its immediate implementation was granted until January 20th. Therefore, from January 21st, companies not only would need to register the foreign manufacturing sites for their imported finished drugs and Drug Master File (DMF) drugs but would also need to register the foreign manufacturing sites for imported APIs that the companies use to manufacture their own finished products. The MFDS urged the companies to thoroughly make preparations in advance to prevent disruptions in domestic drug supply and production. The foreign manufacturing site registration system, which took effect in December 2019, was designed to promptly respond to relevant imported drugs in the event risk is identified overseas and mandates the registration of the workforce, facility, and GMP status of the overseas manufacturing site. Information on the overseas manufacturing site is systematically registered, updated, and managed for the latest information, and is used for risk assessment of overseas manufacturing sites and selection of sites subject to on-site inspection. The number of registered overseas manufacturing sites has been steadily increasing, from 1882 sites in 2020 to 2208 sites in 2021, then 2531 sites in 2022. The MFDS said, “We expect the overseas manufacturing site registration system to increase reliability in the quality of imported drugs and contribute to the more thorough and safe management of the drugs. We will continue our efforts to manage the safety of imported drugs to allow our people the safe use of high-quality drugs.”
- Product
- Viatris Korea, "Viagra's supply expected on Jan 23"
- by Kim JiEun Jan 19, 2023 05:58am
- Viatris Korea announced short-term out-of-stock for some products, including Viagra, while predicting normal supply this month. On the 16th, Viatris Korea sent a notice to hospitals, pharmacies, and drug wholesalers on the 16th, saying, "Viagra, Viagra Film, Cardura-XL, Detrusitol Short-Term Out of Stock." In the announcement, the company said, "Based on the currently available information, we mainly expect the time when normal supply is possible on January 23, 2023." He added, "We deeply apologize for the inconvenience caused to medical treatment or work due to this short-term out-of-stock," adding, "We will continue to do our best for a stable supply." The items subject to the announcement have been out of stock not only at online malls for drugs but also at wholesalers since the end of the sales rights of Jeil Pharmaceuticals at the end of last year. The industry expected Menarini Korea to take over the next batch of sales rights for these items, but negotiations with Viatris Korea have not been completed so far.
- Company
- Paclitaxel copyright transfer
- by Kim, Jin-Gu Jan 19, 2023 05:58am
- Taxol & GenexolThe domestic copyright of Paclitaxel anticancer drugs has shifted one after another. Samyang Biopharmaceuticals' Genexol, the No. 1 item in the market, will be jointly sold by HK inno.N instead of Boryung. Boryung will jointly sell BMS Taxol, the original product, for the first time in seven years instead of Genexol. The annual sales of the two products are worth 21 billion won for Genexol and 9 billion won for Taxol. According to the pharmaceutical industry on the 16th, Boryung will jointly sell BMS Taxol in Korea from January 1 this year. Taxol is a cytotoxic anticancer drug composed of Paclitaxel. It is widely used for various cancers such as ovarian cancer, breast cancer, lung cancer, and gastric cancer. It has been nearly 30 years since it was approved in Korea in 1996, but it is still widely used. According to IQVIA, a pharmaceutical market research firm, Taxol's sales in 2021 are 9 billion won. In the case of last year, it generated 5.8 billion won in sales by the third quarter. Boryung is associated with Taxol. BMS and Taxol have been jointly sold for eight years from 2008 to 2015. The joint sales contract will bring Boryeong back to its original products for the first time in seven years. Boryung co-sold its rival Genexol until just before. Boryung jointly sold Samyang Biopharmaceuticals Genexol for six years from 2016 to last year. Since 2018, the second year after Boryung took charge of sales, Genexol has risen to the top market share of the Paclitaxel ingredient. Since then, Genexol has steadily maintained its No. 1 sales in the Paclitaxel market. In 2021, Genexol's sales were 21.7 billion won. Last year, it recorded cumulative sales of 16.5 billion won in the third quarter. From Boryung's point of view, there is a situation in which they have to compete with the products they have grown to be the No. 1 in the market. HKinno.N was in charge of Genexol, which Boryung was selling. HKinno.N and Samyang Biopharmaceuticals recently signed a joint sales contract for domestic sales and marketing. At higher general hospitals in Seoul and the metropolitan area, the two companies are jointly in charge of sales and marketing, while HKinno.N is in charge of other areas. HKinno.N also has a deep connection with Genexol. Samyang Holdings co-sold the product for 13 years from 2001 to 2013, when it developed Genexol with Paclitaxel Generics. The joint sales deal reunited the two companies for the first time in 10 years. For HKinno.N, the key is how solid Genexol's market share is. As Boryeong has recently put a strong drive into the anticancer drug business, a fierce competition is expected in this market. HKinno.N has CalmTOP, Aloxy, and Akynzeo in the anticancer field. Through this Genexol partnership, HKinno.N plans to further increase its status in the anticancer drug market and actively expand its pipeline. Kwak Dal-won, CEO of HKinno.N, said, "Just as the two companies have collaborated for a long time and made good results, we expect this Genexol to lead to positive results." Lee Young-Joon, CEO of Samyang Holdings, said, "HKinno.N has been selling Genexol for more than 10 years, so it has a high understanding of the product and has a professional anti-cancer drug sales organization." "We will firmly maintain our No. 1 position in the domestic market through a partnership with HKinno.N," he stressed.
- Policy
- Generic for Dukarb to be released next month
- by Lee, Tak-Sun Jan 18, 2023 06:04am
- DukarbGeneric for Dukarb, a compound combined with Amlodipine in the new hypertension drug Kanarb developed by Boryung pharmaceutical, is expected to release in time for the expiration of the patent next month. Eight items from four companies approved last month will go to the market first, and they will be calculated at 53.55% of the initial price of every single ingredient. Among the same ingredient products approved this month, consignment items will be 15% cheaper depending on the standard requirements, and salary registration is expected to be possible only in March. According to industries on the 17th, as generics for Dukarb, which was approved in December last month, applied for benefits, the salary is expected to be applied from February 2, the day after the patent expires. Items licensed in December last month are Dunarb 30/2.5mg, Dunarb 60/2.5mg, Fimadipine 30/2.5mg, Fimadipine 60/2.5mg, Hana Pharmaceutical Fimaone-S 30/2.5mg, Fimaone-S 60/2.5mg, Aliko Pharmaceutical Ardewka 30/2.5mg, and Ardewa. All of these products are produced on consignment by Alico Pharmaceutical, and since they applied for drug prices in the same month, they are all considered data-submitted drugs, and the upper limit is expected to be 53.55% of the first price of a single ingredient. The original Dunarb, which was added as an innovative pharmaceutical company, is also expected to go down at the same price. Dunarb's first generic is different from amlodipine. The original Dunarb is Amlodipine Besylate, whereas the late drugs are S-Amlodipine Besylate 2.5. Since it is not the same ingredient as Dunarb, the drug price is calculated at the highest price according to the drug price standard. However, the drug price of the product approved in January is different. Products licensed in January are also 2.5 mg of S-Amlodipine Besylate, which are considered generics of the four products listed first, and consigned items without direct BA will be 15% cheaper as the standard requirements are applied. Of course, entrusted items with direct BA and DMF requirements are expected to be equally calculated at 53.55%. There was a difference in drug prices depending on the time of approval. None of the items released this time have the same active ingredients and content as Dukarb 30/5mg. This is because Dukarb 30/5mg is registered separately as a patent, and the composition patent lasts until August 8, 2031. Late pharmaceutical companies filed a passive trial to confirm the scope of rights to avoid the patent, but it was rejected in March last year. As a result, an appeal is currently underway in the Patent Court. Due to the failure of patent avoidance, the license of the capacity item is being delayed. Since Dukarb 30/5mg is the flagship capacity of about half of the market along with Dukarb 60/5mg, generic pharmaceutical companies are expressing regret over the failure of the first trial to evade patents. In addition to the approved generics, Fimasartan salt change generics are also reportedly preparing for approval.
- Opinion
- [Reporter’s View] Our expectations for ADC technology
- by Jan 18, 2023 06:04am
- Professor Park Yeon-hee of the Hematology and Oncology department at Samsung Medical Center who recently spoke at the press conference held to celebrate the launch of ‘Enhertu’ in Korea said, “I have never seen such data in breast cancer.” This goes to show the superior efficacy of Enhertu in breast cancer. She added, “During the Enhertu clinical trial, I was inspected by the Ministry of Food and Drug Safety due to the large number of patients enrolling in the trial. And during inspections, my sole concern was, ‘what if a fault I didn’t know about is found that disallows patients from using the drug?’ This was how essential Enhertu is to the patients.” At the American Society of Clinical Oncology meeting last year, Enhertu received a standing ovation from the audience. ASCO is one of the three major global academic conferences in oncology. At the meeting, Enhertu became the first drug to demonstrate an effect in HER2-low breast cancer patients that account for half of all breast cancer patients but have difficulty seeing an effect with existing drugs. The drug lowered the risk of disease progression and death by over 50% compared with chemotherapy and emerged as the star of the ASCO meeting last year. Enhertu is an antibody-drug conjugate (ADC). ADCs are drugs made by connecting antibodies that bind to specific target antigens on the surface of tumor cells to cytotoxic payloads with a linker. Although various ADC drugs existed in the past, Enhertu gained particular interest as it improved the shortcomings of existing ADC drugs by applying next-generation technology. Contrary to concerns that ADCs are highly toxic, Enhertu did not produce dose-limiting toxicity (DLT), and the drug's high cell membrane permeability also affected surrounding tumor cells, producing a bystander antitumor effect. With the spotlight on Enhertu, many Korean pharma and bio companies have also joined in the competition to develop ADC drugs. Biotechnology companies generally develop key platform technology, and large-scale companies pursue equity investments or joint development. Major biopharmaceutical CDMO companies in Korea have also set out to build ADC manufacturing facilities. Various biotechs and mid to large-sized pharma and bio companies including Dong-A Socio Group, LegoChem Biosciences, Lotte Biologics, Samsung Biologics, Samjin Pharm, Celltrion, Ahn-Gook Pharmaceutical, Yuhan Corp, Pinot Bio, Hanmi Pharmacuetical have started developing of ADCs. As in any field, not all of them will see good results. In areas like ADC where cutting-edge technology is applied, and many tasks remain unresolved, fierce technology-based competition is required. There was a time when Big Pharma's interest in ADC wavered after clinical trials were discontinued due to serious side effects such as toxicity that arose due to technical limitations. If these drugs fail to prove the effect equivalent to high cost, marketability for these drugs that apply cutting-edge technology is low even with approval. For example, the new ADC drug ‘Trodelvy,’ which was introduced at the same time as Enhertu, was evaluated to have fallen short of expectations. As a drug, Enhertu established itself as a success case where its company, Daiichi Sankyo set up a future-oriented strategy in the midst of a crisis and fully utilized its technology specialized in the development of small molecule drugs. Dae-Jung Kim, President of Daiichi Sankyo Korea, mentioned in a contributory article he sent to a paper last year that " We will be able to accumulate success stories in Korea by being true to the basics of 'solving unmet medical needs based on science and technology,’ showing persistence, and devoting ourselves to new drug development in the long run..” In the growing field of ADC technology, there is still room for the technology to leap to the next level with steady development. As Kim said, it is the reporter’s wish that the current wave of developing ADCs in the industry will continue to become greater waves in the future.
- Company
- The Canadian gov. has put the drug price system on hold
- by Kim, Jin-Gu Jan 18, 2023 06:04am
- Korea to add Canada to drug price reference country this year...The domestic drug price reduction variable disappears. The reorganization of the drug price system, which was promoted by the Canadian government, has been temporarily suspended. Analysts say that the Canadian Ministry of Health officially announced that it would come up with a new reform plan due to strong opposition from the local pharmaceutical industry and that the plan to reevaluate the prices of premium drugs has virtually been canceled. Canada's move is also expected to affect South Korea's decision on the price of salaried drugs. In Korea, Canada has been added to the drug price reference country since this year. ◆ Canada's Ministry of Health decided to temporarily suspend the implementation of the drug price reform plan According to the pharmaceutical industry on the 14th, Health Canada recently requested the PMPRB (Patented Medicine Prices Review Board) to suspend the implementation of the drug price guideline reform plan. PMPRB has pushed for a reform of the patented drug price system since 2019. The reform plan focused on lowering the price of excessively high patented drugs. The core of the reform plan is to give the authority to investigate and re-evaluate ex officio whether the price of previously listed patented drugs is not expensive. To this end, a new price regulation device was added. It adds pharmacoeconomic value, including cost-effectiveness analysis data, the size of the drug market in Canada, Canada's gross domestic product (GDP), and per capita GDP. 캐나다 보건부는 작년 6월 새로운 지침을 시행하겠다고 예고했으나(위), 최근 새로운 지침은 2023년 1월 1일에 시행되지 않는다고 밝혔다(아래). 캐나다 보건부 홈페이지 캡처 On top of that, the drug price reference countries were reorganized into 12 countries, including Korea, Japan, Australia, Belgium, the Netherlands, Norway, Spain, France, Germany, Italy, Sweden, and the United Kingdom. The existing U.S. and Switzerland were excluded. The intention is to lower the average price of foreign drug prices by excluding the U.S. and Switzerland, which have high drug registration prices. Ministry of Health estimated that $13.2 billion could be saved over the next 10 years by reforming the drug price system for the first time in more than 20 years. ▲Canada's Health Ministry announced in June last year that it would implement the new guidelines (above), but recently announced that the new guidelines will not take effect on January 1, 2023 (below). Capture Health Canada However, the implementation of such a reform plan has been delayed. It was originally scheduled to take effect in January 2020, but it was implemented on July 1 last year after four delays due to opposition from the Canadian pharmaceutical industry and the influence of COVID-19. The most strongly opposed part of the industry's re-evaluation of the price of such drugs was scheduled to take effect on January 1 this year after preparing a new plan with a grace period. The industry has consistently protested, and in the end, Canada's Ministry of Health has decided to suspend the reform of the drug price system, saying it needs more review. At the same time, he said he would come up with a completely new version of the reform plan. Temporary guidelines are expected to remain in place until a new reform plan is prepared. ◆The new drug price reference country Canada's drug price cut variable disappears There have been constant concerns in the domestic pharmaceutical industry that the implementation of the new drug price system in Canada will lead to a reduction in drug prices in Korea. Canada was added as a new drug price reference country this year. As of January 1 this year, the country subject to foreign adjusted average price calculation has been reorganized from A7 (Japan, France, Germany, Italy, Switzerland, the United Kingdom, and the United States) to A8 with Canada added. The government has expressed its willingness to refer to the drug prices of A8 countries for the reevaluation of quality medicines as well as the registration of new drugs. In this situation, concerns have been raised that if the Canadian drug price decreases, the Korean drug price referring to it will also decrease. However, as Canada's reorganization of the drug price system has been temporarily put on hold, it is interpreted that variables that will affect Korea's reduction in drug benefit prices have also disappeared. In response, a pharmaceutical industry official said, "It is welcome that the potential risk factors that will lead to a domestic drug price cut have disappeared," but added, "However, since the Canadian government is still willing to cut drug prices and has decided to come up with a new reform plan, we should carefully look at future changes."
