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- 2026-04-12 18:23:58
- Policy
- Yoon Seok-yeol was elected president
- by Lee, Jeong-Hwan Mar 15, 2022 05:57am
- Attention is focusing on the pledge to establish a global vaccine hub and quickly register health insurance for severe treatments. In the 20th presidential election, Yoon Seok-yeol, the power of the people, was confirmed to win the election, beating Lee Jae-myung of the Democratic Party of Korea. Candidate Yoon Seok-yeol won 48.56% (16,394,815 votes) as a result of the final vote counting, beating Candidate Lee Jae-myung with 47.83% (16,147,738 votes) by 0.73%p. With candidate Yoon's election, the domestic pharmaceutical bio industry will be able to positively predict the realization of pledges such as the establishment of a "pharmaceutical bio-innovation committee" directly under the Prime Minister. In the JTBC exit survey with the three terrestrial broadcasters released shortly after the end of the 20th presidential election at 7:30 p.m. on the 9th, candidate Yoon and candidate Lee showed a close race with a 0.6% to 0.7%. The situation between the two candidates continued to be close enough to gauge Yoon's election potential only at 2 a.m. on the 10th, a day after the voting day, when the nation's vote counting rate was close to 90%. Candidate Yoon was not sure of his election until after 3:30 a.m. on the same day. The end time of the vote counting was 6:18 a.m. on the 10th, with the final vote rate of 48.56% for candidate Yoon and 47.83% for candidate Lee. Candidate Yoon, who was elected president, pledged to establish a pharmaceutical bio innovation committee directly under the Prime Minister in the pharmaceutical bio field. This is evaluated as a pledge that actively reflects the "establishment of a pharmaceutical bio control tower directly under the President" proposed by the KPBMA to the government and ruling and opposition presidential candidates. Along with the national R&D expansion policy to build a global vaccine hub, candidate Yoon's pledge is to strengthen access to new drugs for patients by introducing expensive anticancer drugs and rapid registration of new drugs for severe and rare diseases. The COVID-19 infectious disease response system is expected to be reorganized quickly. Candidate Yoon plans to completely reorganize the COVID-19 response system within 100 days of power to conduct scientific and data-based quarantine. In addition, some expect that the policy pledge of the People's Party Ahn Cheol Soo, which agreed to dramatically unify with candidate Yoon before the presidential election, will be absorbed into candidate Yoon's pledge in the future. In an interview with Dailypharm, candidate Ahn Cheol Soo expressed his vision to enter the G5 country using the pharmaceutical bio industry as a new growth engine. The intention was to secure super-difference technology in the pharmaceutical bio sector to foster world-class pharmaceutical companies such as Pfizer and Moderna and discover new global blockbuster drugs. Candidate Ahn agreed to unify and merge with Candidate Yoon, handing over his policy pledge to Candidate Yoon. Shortly after the election, candidate Yoon said, "If we prepare for a new government as elected and officially take over as president, we will respect the constitutional spirit, respect Congress, cooperate with the opposition party, and try to serve the people well." The provisional turnout for the 20th presidential election, compiled by the Central Election Commission, was 77.1%. The figure is 0.1%p short of the final turnout of the 19th presidential election of 77.2%.
- Policy
- Yoon Seok-yeol expands R&D for telemedicine & bio
- by Lee, Jeong-Hwan Mar 14, 2022 05:51am
- After the inauguration of the Yoon Seok-yeol administration, legal experts analyzed that the biohealth industry policy paradigm will shift, such as expanding digital healthcare and strengthening government R&D support in advanced medical fields of vaccines and treatments. It is predicted that the biohealth sector will be transformed compared to the Moon Jae In government, with elected Yoon Seok-yeol selecting biohealth as one of the five mega-tech and promising to establish a pharmaceutical bio-innovation committee directly under the Prime Minister. On the 13th, Shin & Kim's presidential TF team made the remarks in a special report that analyzed the results of the 20th presidential election and major pledges. Shin & Kim's presidential TF team judged that Yoon Seok-yeol's election will increase the possibility of the next government expanding digital healthcare and introducing telemedicine, and increase government R&D support in vaccines, treatments, and cutting-edge medical fields. It is expected that the biohealth industry market will also expand, including strengthening health insurance coverage. They predict that the new government will promote policies to foster the digital medical bio-industry, train digital hospitals, and digital medical professionals, and expand pilot projects for non-face-to-face treatment in islands and mountains. R&D related to healthcare ICT companies and policy support related to service development will be provided, and measures to alleviate personal information leakage and medical information concentration problems of large companies will be discussed. As the new government has pledged to double the size of R&D support from the biohealth industry government, a policy focusing on securing original technologies centered on pharmaceutical bio researchers is also expected. It is expected to expand government R&D on high-speed vaccine development and manufacturing technology, post-corona vaccine, treatment, and essential vaccines, and expand government R&D in state-of-the-art medical fields such as regenerative medicine, precision medicine, brain science, aging, gene editing, and synthetic biology. If the new government implements such a policy, it is expected that domestic pharmaceutical companies will perform government tasks, boost R&D investment expansion movements, and increase global pharmaceutical companies' interest in the domestic market. The new government has also promised specific measures to strengthen health insurance coverage. These include health insurance support for Continuous Glucose Monitoring, health insurance support for treatment using rehabilitation robots, expansion of national examinations for osteoporosis and depression, support for Gardasil 9, expansion of cochlear implant surgery, and reduction of health insurance for anticancer and severe disease treatments. As a result, consumer and business interest in biohealth is expected to increase and related markets will increase as measures such as health insurance registration and compensation expansion are expected to be taken to commercialize pharmaceuticals and medical devices and form markets. Shin & Kim's presidential TF team said that the adjustment of financial conditions and insurance premiums will be the primary focus of discussions on pension reform, which is an important pledge in the health and welfare sector, but discussions will also take place on changes in the fund management structure. In addition, their analysis is that discussions will be held on the development of ultra-high-priced new drugs, including RSA, which partially bears uncertainties in the efficacy of new drugs and insurance finances.
- Policy
- P3T for Sarepta’s DMD treatment approved in Korea
- by Lee, Hye-Kyung Mar 14, 2022 05:51am
- A Phase III trial for the Duchenne muscular dystrophy treatment 'SRP-4045(casimersen)’ and 'SRP-4053 (golodirsen)' will be conducted in Korea. The Ministry of Food and Drug Safety has recently approved Ppdd Velllovement Pte Ltd’s application for the double-blind, placebo-controlled, multicenter clinical trial to evaluate Sarepta Therapeutics’s casimersen and golodirsen. Ppdd Velllovement Pte Ltd is a contract research organization that conducts multinational clinical trials. The domestic Phase III trial will be conducted in Pusan National University Yangsan Hospital and Kyungpook National University Chilgok Hospital. DMD is a type of rare genetic disorder characterized by progressive muscle degeneration and weakness due to a defect in the p21 gene in the X chromosome that causes alteration of a protein called dystrophin that helps keep muscle cells intact. DMD arises 1 in 3,600 newborn males, and its age of onset is usually between 3 and 5 years of age. Children affected with DMD rely on a wheelchair in their early teenage years and progresses to experience loss of cardiac and respiratory muscle strength and die before reaching 20 years of age. Sarepta has been developing an exon-skipping medication that removes specific exons from dystrophin. Starting with its first DMD treatment ‘Exondys 51’ in September 2016, the company received approval for its ‘golodirsen’ in December 2019 and ‘casimersen’ in February 2021 from the US FDA. However, as golodirsen and casimersen were approved through the Accelerated Approval Program by the FDA, the company is required to additionally submit Phase III trial data to confirm the clinical efficacy of the two ingredients. According to the clinical trial protocol submitted by Sarepta, the company expects to complete the study by 2024.
- Company
- Pharma·Biopharmas make or break COVID-19 CMO deals
- by Ji Yong Jun Mar 14, 2022 05:51am
- Domestic pharmaceutical companies are experiencing mixed results regarding their CMO businesses for COVID-19 vaccines. Samsung Biologics and SK Bioscience are already in the process of manufacturing COVID-19 vaccines. On the other hand, GC Pharma and Huons Global gave up their COVID-19 vaccine CMO business. In addition, uncertainties continue in Hanmi Pharmaceutical and Hankook Korus Pharm’s COVID-19 CMO businesses. ◆Korea-US CMO likely to dismantle due to discontinuation of Genexine’s COVID-19 vaccine development According to industry sources on the 12th, Genexine applied to discontinue its ongoing Phase II/III trial for its COVID-19 vaccine, GX-19N, on the 11th. In other words, Genexine is virtually letting go of its COVID-19 vaccine development business. (From the left) Genexine CEO Young-Chul Sung, Hanmi Pharmaceutical President & CEO Se-Chang Kwon Accordingly, Hanmi Pharmaceutical’s plan to CMO Genexine’s vaccine has been disrupted. Hanmi Pharmaceutical has signed a CMO agreement with Genexine for Genexine's vaccine candidate in May last year. An official from Genexine said, “With the trial withdrawal, it seems that the CMO deal the company made with Hanmi Pharmaceuticals for the COVID-19 vaccine would also be terminated." With the CMO deal virtually dismantled, the only card left in Hanmi’s hand is the CMO deal for the Indian Zydus Cadila’s COVID-19 vaccine, ZyCoV-D. Hanmi Pharmaceutical had signed a CMO agreement with Enzychem Lifesciences and Zydus for the COVID-19 vaccine ZyCoV-D in January. Hanmi Pharmaceutical expects to sign the formal deal in the second quarter of this year. Once the contract is signed, Hanmi Pharmaceutical will be in charge of the global supply of ZyCoV-D. ◆GC Pharma and Huons gives up… Korus lot release of ‘Sputnik’ delayed indefinitely The CMO decisions for companies other than Hanmi Pharmaceutical have already been finalized. Huons Global had closed its CMO business for the Sputnik V vaccine due to the Russia-Ukraine war. Huons Global said, “In consideration of the unstable international situation, we have decided that it will be impossible to maintain the contract and decided to discontinue the business.” Previously, GC Pharm had also been continuing discussions with CMO Janssen's COVID-19 vaccine since August last year. The discussions went on for 4 months until GC Pharm discontinued the discussions in December of the same year. Hankook Korus Pharm’s CMO deal on Russia’s COVID-19 Sputnik V vaccine has also not been finalized yet. The uncertainty around its CMO business is growing with the international and social direction set to impose financial and logistics sanctions on Russia. The company is currently waiting for a supply request from Russia. Pic. of Samsung Biologics’ Plant 3, SK Bioscience◆Samsung Biologics·SK Bioscience enters second year into CMO deals for their COVID-19 vaccine businesses In Korea, three types of COVID-19 vaccines - vaccines developed by Moderna, AstraZeneca, and Novavax - have been approved and are being produced. in Korea. Moderna’s COVID-19 vaccine is being supplied in Korea and abroad by Samsung Biologics under the CMO agreement that was made in May last year. SK Bioscience is in sole charge of the CMO of Novavax’s vaccine to supply in Korea and abroad. SK Bioscience’s CMO deal for AstraZeneca’s vaccine has been terminated in December last year. Samsung Biologics plans to sign additional CMO deals for other mRNA vaccines in addition to the one made for Moderna. The company has already signed a CMO deal to produce the API for US company GreenLight Bioscience's COVID-19 mRNA vaccine and is set to manufacture the product in the second quarter of this year. SK Bioscience plans to concentrate on manufacturing Novavax’s COVID-19 vaccine. SK Bioscience secured three Novavax vaccine consignment production lines at L House in Andong. The company will be in charge of direct sales of Novavax’s vaccine in Korea, Thailand, and Vietnam.
- Policy
- Securing Paxlovid's inventory for 120,000 people
- by Lee, Jeong-Hwan Mar 14, 2022 05:50am
- Paxlovid's inventory in Korea is about 120,000 people, it said on the 11th. The response is to the point that there is no shortage of prescriptions for confirmed patients, which has been on the rise recently, and that there is no inventory of Paxlovid at front-line pharmacies or medical sites. More and more patients want Paxlovid due to the explosion of COVID-19 confirmed patients. Contrary to the quarantine authorities' explanation that the stock of treatments is sufficient, complaints are growing that local pharmacies and other sites do not have them in stock. First controller Lee Ki-il (CDSCHQ) of Central Disaster and Safety Counters (CDSCHQ), disclosed the inventory and introduction status of Paxlovid in response to this point. He said on the 8th that an additional 45,000 people of Paxlovid were introduced and a total of 163,000 people have been introduced so far. He explains that the amount of Paxlovid prescribed so far is about 40,000 people, and the domestic inventory is about 120,000 people. Regarding the shortage of treatments at the site, the quarantine authorities explained that they recently expanded prescription medical institutions to actively utilize oral drugs. As of the 8th, it is interpreted that oral prescriptions may increase to upper general hospitals, general hospitals, and mental hospitals, which may temporarily lead to a shortage of supplies. The quarantine authorities said they would try to provide sufficient supply of additional Paxlovid inventory in the future. When looking at the introduction and usage, about inventory for 120,000 people was prescribed on the 9th, and for 4,472 people were prescribed on the 10th. Paxlovid have been expanded to actively utilize treatments. If the introduction of additional supplies is confirmed, it will be released later, he said.
- Policy
- Yoon Seok Yeol's generation
- by Lee, Jeong-Hwan Mar 13, 2022 08:03pm
- Yoon Seok-yeol, the power of the people, was elected in the 20th presidential election, signaling significant changes in the health care and pharmaceutical bio industries as a whole. Some keywords that are drawing attention right now are "promoting remote non-face-to-face treatment" and "the establishment of a pharmaceutical bio-control tower." Yoon Seok-yeol, elected candidate, previously announced the advancement of the industry by promising to start telemedicine in earnest and establish a pharmaceutical bio-innovation committee directly under the Prime Minister during the election process. Yoon, who confirmed his election on the 10th, predicted health care and pharmaceutical bio policies to be implemented as president over the next five years. Yoon has pledged several health care policies differentiated from the Moon Jae In government. Yoon said he would improve and upgrade temporary telemedicine to the "realization of non-face-to-face treatment" stage through regulatory reform, and resolve the health insurance bomb problem through Moon Jae In Care reform. The pharmaceutical bio industry also declared securing super-gap technology. This is why attention is drawn to specific movements surrounding the pharmaceutical bio-innovation committee directly under the Prime Minister. Pledges related to pharmacist and pharmacy management were relatively dim, but just before the presidential election, the Korean Pharmaceutical Association and the people's power subrogation signed a policy agreement to form a consensus on the long-cherished desire of pharmacist society. ◆ Telemedicine in earnest= Yoon plans to expand digital healthcare through service innovation and introduction and support of a private business revitalization system. In particular, it announced the expansion of non-face-to-face treatment pilot projects for islands, mountainous areas, and the underprivileged. Yoon narrowed down telemedicine to "a reality that we should accept." The vision is to implement policies that do not conflict interests between the medical community and non-face-to-face care providers seeking new innovations so that everyone can enjoy innovative systems and high-tech benefits in the field of non-face-to-face care. Non-face-to-face treatment, which was temporarily allowed due to the prolonged COVID-19 Pandemic, had a significant impact on the pharmacy industry as well as front-line hospitals and clinics. After non-face-to-face treatment, a platform dedicated to non-face-to-face preparation and drug delivery has been industrialized, and drug delivery applications have been activated. If elected Yoon begins non-face-to-face treatment in the future, the drug delivery platform is also expected to continue to grow. In the process, attention is expected to be paid to whether elected Yoon will be able to establish and promote a reasonable non-face-to-face treatment policy to minimize conflicts with the medical community and the pharmaceutical society. ◆The establishment of the Pharmaceutical Bio Innovation Committee Yoon also issued a blueprint to create new native blockbuster drugs and build a global vaccine hub by establishing a pharmaceutical bio-innovation committee directly under the Prime Minister. It plans to significantly strengthen national R&D support so that it can protect the lives and health of the people by establishing sovereignty over pharmaceutical bio. In addition, Yoon promised to create an ecosystem that can cultivate key talents in the pharmaceutical bio industry and create jobs to grow the national economy and realize a pharmaceutical bio powerhouse. Accordingly, the pharmaceutical bio industry seems to expect a lot of administrative and financial support from elected Yoon. The KPBMA has been urging the pharmaceutical industry to strongly support the pharmaceutical industry by establishing a direct presidential organization to establish sovereignty over vaccines and drugs since 2017. Shortly after candidate Yoon was elected, the KPBMA demanded again to specify the establishment of an organization directly under the Prime Minister. The association believes that the way to establish health security and find a way to create new national wealth is to foster the pharmaceutical bio industry. Yoon also expressed sympathy for the pharmaceutical industry's opinion. Depending on when and how the Pharmaceutical Bio Innovation Committee will start its activities, national policy directions such as pharmaceutical bio R&D, policy financing, tax support, regulatory reform, and manpower training are expected to materialize.
- Company
- Roche,set to establish a Korean precision medical ecosystem
- by jung, sae-im Mar 13, 2022 08:01pm
- Roche Korea announced on the 7th that it has signed term sheet with the KSMO to form a partnership with four organizations, including the KCSG, NCC, and the KHIDI, to establish a Korean precision medical ecosystem. Turnsheet is the process of specifying and agreeing on major contract conditions such as goals, scope of cooperation, roles and responsibilities by institution prior to partnership contracts. It is an extension of the Memorandum of Understanding (MOU) signed by these institutions and companies earlier. With the signing of termsheet, they plan to conduct KOSMOS II, an expanded study of the KOSMOS Study on genomic mutation-based customized drug therapy for patients with advanced solid cancer, which began in 2020. KOSMOS II is a study for the development of personalized cancer treatment, and aims to evaluate the effectiveness and stability of drugs and create a treatment platform tailored to genetic mutations by collecting NGS-based genetic test results and real world data for mid- to long-term clinical studies. Through this study, the government plans to improve patient access to genome-based customized treatment, collect and integrate genetic data and clinical data of 1,000 cancer patients to establish a national "public clinical genome database" that can be used for new drug development. The KSMO and the KCSG design KOSMOS II studies, provide customized treatment according to the results of the "Molecular Oncology Board (MTB)" and establish an actual clinical genome database. MTB is a multidisciplinary expert consultative body that recommends optimal customized treatment policies for patients by interpreting genetic test results. Society and research associations have already issued MTB treatment recommendations in December and provided customized treatment to about 100 patients in accordance with the guidelines. As a national cancer data center designated by the MOHW, the NCC provides the technology and infrastructure necessary for the development of the first clinical genome database. The KHIDI promotes cooperation with the MOHW and supports the recruitment of domestic and foreign pharmaceutical companies to participate in clinical research partnerships. Multinational pharmaceutical companies, including Roche Korea, provide research medicines and other services for patients registered in the KOSMOS II study. Meanwhile, the KSMO, the KCSG and Roche Korea signed an MOU to establish a Korean precision medical ecosystem in November 2019, strengthening the experience and expertise of domestic medical staff based on ▲ comprehensive genetic profiling and genetic tumor boards, ▲ deriving a plan to provide customized treatment for cancer patients who no longer have standard treatment options, ▲ establishment of a database within the scope of related laws and regulations in Korea, ▲ the government, academia, and pharmaceutical companies have cooperated to expand partnerships to establish a precision medical ecosystem.
- Company
- Dong-A ST submitted an appeal against patent dispute
- by Kim, Jin-Gu Mar 13, 2022 07:59pm
- AstraZeneca SGLT-2 inhibitor-based diabetes treatment ForxigaThe battle over material patent of Forxiga (Dapagliflozin Propanediol Hydrate), an SGLT-2 inhibitor-based diabetes treatment, will head to the third round. The opportunity for Dong-A ST's generic for Forxiga to release is also expected to vary depending on when and how the Supreme Court decides. ◆ Dong-A ST, a letter of appeal was submitted According to the pharmaceutical industry on the 7th, Dong-A ST objected to the patent court's ruling on material patent of Forxiga and filed an appeal on the 4th. Battle over the patent is now finalized by the Supreme Court. The key is whether the Supreme Court ruling will be made before April next year, the expiration date of this material patent. From Dong-A ST's point of view, the generic for Forxiga can only be released a day earlier than other generic companies only if it is ruled in favor of the Supreme Court before April next year. If the Supreme Court loses or a ruling is made after April next year, the opportunity for Dong-A ST's exclusive early launch of the generic product will disappear. At this time, the remaining 14 companies that succeeded in overcoming another material patent and received general for excellence will have an opportunity to release the generic early. ◆ According to the Supreme Court's ruling, 14 generic companies may dominate the market The reason why the number of cases is so complicated is that AstraZeneca has double-registered Forxiga material patents. AstraZeneca has registered two material patents: "C-aryl glucoside SGLT2 inhibitor (expired on April 7, 2023)" and "C-aryl glucoside SGLT2 inhibitor and inhibition method (expired on January 8, 2024). Generics first challenged patents that expire in January 2024, which are relatively easy to overcome. 14 companies, including Kyungdong Pharmaceutical, Kukje Pharmaceutical, Daewon Pharmaceutical, Donghwa Pharmaceutical, Boryung Pharmaceutical, Samjin Pharmaceutical, Shinil Pharmaceutical, Alvogen Korea, Youngjin Pharmaceutical, Ildong, Jeil, Jong Kun Dang, and Hanwha Pharmaceutical, won all the first and won the generic for exclusivity. This patent awaits the Supreme Court ruling with AstraZeneca's appeal. Unless a reversal ruling is made by the Supreme Court, they can sell generic products when their first substance patent expires in April 2023. ◆ Dong-A ST which brought up the prodrug strategy, mixed judgment in the first and second trials In April 2018, Dong-A ST filed a passive trial against AstraZeneca to confirm the scope of rights in Forxiga's first material patent. Dong-A ST is the first in Korea to try to overcome Forxiga's material patent using the "Prodrug" strategy. Prodrug is evaluated as a different drug, such as an original drug. The original drug and chemical structure differ in some parts of the substituent until immediately before taking it after the drug is produced. However, when a patient enters the body after taking it, it has the same effect as the original drug. The salt can be converted into a simple ionic bond. The chemical structure of the substance itself does not change. Prodrug has to change the substituent in a more demanding way called covalent bonds. The chemical structure is different from the original drug. There were mixed judgments in the first and second trials on whether prodrucg could be viewed as a completely new substance. Dong-A ST won the first trial and AstraZeneca won the second trial, respectively.
- Company
- Sales of oral contraceptives rebound…4th gen Yaz sales up 2
- by Ji Yong Jun Mar 11, 2022 06:04am
- The oral contraceptive market grew greatly last year. Sales of the fourth-generation contraceptive Bayer Korea’s Yaz increased greatly, and the return of the third-generation Dong-A Pharmaceutical’s Mybora and the release of GC Pharm’s Dearmesoon had also contributed to market expansion. According to the market research institution IQVIA on the 8th, the oral contraceptive market size increased 19.6% YoY to record ₩38.4 billion last year. The oral contraceptive market grew from ₩32.8 billion in 2017 to ₩34.9 billion in 2019. In 2020, the market size reduced slightly to ₩32.1 billion but then made a rebound last year. The oral contraceptive market, which consists of hormone therapies that contain estrogen and progesterone can be categorized into 4 generations. The first-generation drugs have withdrawn from the market due to their side effects. The second-generation and third-generation drugs are being distributed at pharmacies as general drugs. In particular, third-generation drugs have minimized the side effects of second-generation drugs such as acne, body hair growth, and weight gain. Fourth-generation drugs are also effective in reducing acne but are specialty drugs that require doctors’ prescriptions as it contains drospirenone, which could cause thrombosis. The significant increase in sales of Yaz, the leading product in the oral contraceptive market, also increased the size of the overall market. Yaz’s sales rose 24.5% from the previous year to record ₩19.8 billion last year. Despite being a specialty drug, Yaz has been growing its influence in the market with its advantages in weight control and acne improvement. Also, the release of new third-generation oral contraceptives and the return of some products contributed to the market expansion. Mybora, returned to the market after a one-year gap recorded ₩1.5 billion last year. Mybora discontinued its supply in the market due to difficulty in procuring raw materials due to COVID-19 and a change in its manufacturing facility in Q4 2019. Due to this, Mybora virtually did not generate any significant sales in 2020. The company was only able to resolve the raw material issue in its local plant last year and start to generate sales in May. Dearmesoon, which was released in Q2 last year, recorded ₩0.5 billion last year. Its score was not bad for the first year in the oral contraceptive market. Clockwise from the left Mybora, Dearmesoon, Senseday, Senslibe, Mercilon, Alesse Sales of Mercilon, the lead product in the market decreased 9.5% from the previous year to record ₩7 billion last year. The return of its competitor Mybora and the release of Dearmesoon is interpreted to have led to decreased sales. Mercilon had boasted annual sales of ₩10 billion a year, but its influence had shrunk in the recent two years. In 2019, Mercilon sold ₩9.1 billion, an 8.1% reduction from the previous year, and then again dropped 15.4% in 2020 to record ₩7.7 billion. Sales of Dong-A Pharmaceutical’s Melian increased 6.1% YoY to record ₩1.9 billion last year. Sales of Pfizer’s Alesse were maintained at a similar level to the previous year at ₩1.8 billion.
- Company
- Global lead Humira’s sales drop... biosimilars occupy 16%
- by Chon, Seung-Hyun Mar 11, 2022 06:04am
- The ₩200 billion autoimmune disease market has finally revealed its form in Korea. The growth of the global leading product ‘Humira’ had fallen somewhat due to the introduction of its biosimilars. The 5 biosimilars by domestic companies Celltrion, Samsung Bioepis, LG Chem, etc. are also increasing their influence in the market, but their total market share remains in the 10% range. ◆ TNF-α inhibitor market shrinks for the first time… aftermath of Humira’s drug price cut According to the market research institution IQVIA on the 9th, sales in the domestic TNF-α inhibitor market was ₩233 billion, a 0.4% decrease from the previous year. TNF-α inhibitors are antibody drugs that suppress the expression of tumor necrosis factor TNF alpha in the body and are prescribed for autoimmune diseases such as rheumatoid arthritis, Crohn's disease, and ulcerative colitis. Products from multinational pharmaceutical companies such as Humira, Remicade, Simponi, Enbrel, and Enbrel Myclic are leading the market, and biosimilars from domestic companies such as Celltrion, Samsung Bioepis, and LG Chem have also thrown their hats into the market. This is the first year the domestic TNF-α inhibitor market’s size had shrunk. The market had continued to show high growth every year since making a twofold growth in 6 years from ₩120.2 billion in 2014 to ₩233.9 billion in 2020. However, the market showed sluggish growth after 2018, when it recorded a 23.2% YoY growth, then grew 11.2% and 4.5% respectively in 2019 and 2020. The market turned downwards for the first time last year. The recent sluggish market growth of the TNF-α inhibitor market is due to the sluggish sales of the lead product in the market - Humira. Humira sold ₩91.2 billion last year, a 12.3% decrease from the previous year. This is the first time Humira’s sales fell compared to the previous year. Since its release in 2006, its sales rose every year to exceed ₩100 billion for the first time in 2020 but then fell to a record ₩90 billion the next year. The sales decline is due to the introduction of biosimilars. Samsung Bioepis had registered its Humira biosimilar ‘Adaloche’ in May last year and released it in the domestic market. In principle, the insurance price cap of original drugs falls 30% with the introduction of biosimilars under the Korean drug pricing system. Humira’s price had been reduced by 30% from June 7th last year. With the price cut, prices of three drugs - Humira Pen inj. 40mg/0.4mL, Humira Prefilled syringe inj. 40mg/0.4mL, Humira inj. 40mg vial fell 30% from ₩411,558 to become ₩288,091, and Humira Prefilled syringe inj. 20mg/0.2mL fell from ₩224,002 to ₩156,801. Humira recorded ₩27.5 billion in sales in Q1 last year but dropped 24.9% to record ₩20.7 billion in just the one quarter since. Humira then made some recovery to ₩21.1 billion and ₩21.9 billion in Q3 and Q4 but wasn’t able to recover from the impact of their price cuts. Sales of other TNF-α inhibitor products of multinational pharmaceutical companies such as Janssen’s Remicade and Simponi, Pfizer’s Enbrel, and Enbrel Myclic have shown a continuous increase. ◆ Domestically developed similars make ₩36.8 billion... twofold increase in 4 years but occupy only around 10% of the market Although domestic biosimilar products are gradually expanding their market share in the TNF-α inhibitor market, their market influence is still not large. Starting with Celltrion’s Remisa, domestic products such as Samsung Bioepis’s Etoloce, Remaloce, Adaloche, and LG Chem’s Eucept have currently entered the TNF-α inhibitor market. Remsima and Remaloce are Remicade biosimilars. Originals of Adaloche and Eucept are Enbrel. Adaloche is Humira’s biosimilar. Last year, sales of the 5 TNF-α inhibitor biosimilars increased 13.9% from the previous year to record ₩36.8 billion. This is over a twofold increase in 4 years from the ₩18.2 billion in 2017. Remsima, which first appeared in 2013, is leading the growth of biosimilars. Remsima's sales last year were ₩24.4 billion, up 9.8% from the previous year. Remsima’s sales decreased 12.0% from ₩25.3 billion in 2019 to ₩22.2 billion the following year, then made a rebound last year. Biosimilars of Samsung Bioepis and LG Chem barely make less than ₩50 billion in annual sales. Samsung Bioepis’ Etoloce recorded ₩3.9 billion in sales last year, down 0.8% from the previous year. It recorded a high growth rate from the ₩700 million in 2017 to ₩2 billion in 2018, then to ₩4 billion in 2020, but then sales stalled the last year. Remaloce’s sales increased 10.1% from the previous year to record ₩3.6 billion but did not significantly influence the total market. LG Chem’s Eucept had also shown 30.7% growth in the market recording ₩3.6 billion in sales but did not exert much influence in the market. The 5 domestically developed biosimilars in the TNF-α inhibitor market only was able to occupy 15.8% last year. In 2020, its sales grew 13.8%, a slight increase, which is in stark contrast to its big success made in Europe and the US. In Korea, the difference in the insured drug prices between original drugs and biosimilars is not large, therefore the latecomers cannot penetrate the market as quick as in Europe or the United States. Some analysts say that it is not easy overcome the trust in original drugs with biosimilars that have been established for a long time as the drugs are used in critically ill patients.
