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- 2026-05-08 14:31:37
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- Dupixent shows marked effect in Korean severe asthma patient
- by Mar 30, 2022 06:09am
- Study analysis results on Sanofi’s allergic disease treatment ‘Dupixent (dupilumab)’ have shown that the drug has a superior effect on severe asthma patients in Korea. Based on the sub-analysis results, Sanofi is pursuing a reimbursement extension for Dupixent in asthma in Korea. At the webinar on the ‘Present state of severe asthma treatment in Korea’ that was held by Sanofi on the 29th, Professor You-Sook Cho, Division of Allergy and Clinical Immunology at Asan Medical Center, disclosed the first-ever Korean sub-analysis data from the global Phase III QUEST trial on Dupixent that was conducted on asthma patients. The QUEST trial compared the efficacy and safety of Dupixent and placebo in 1,902 patients with moderate-to-severe type 2 asthma. Its primary efficacy endpoint was were annualized rate of severe exacerbation events during the 52-week study period and changes from baseline in pre-bronchodilator FEV1 which is commonly used to test liver functions. Of the enrolled patients, 74 were Korean, and most were severe asthma patients who have experienced severe asthma exacerbation twice. 사노피 듀피젠트 온라인 미디어 세미나 캡처 The Korean subanalysis results showed that annualized severe exacerbation rates were significantly reduced with Dupixent compared to placebo (0.259 vs 1.942). Also, in patients with baseline blood eosinophil count of ≥150 cells/μL and baseline FeNO ≥ 25 ppb, the severe exacerbation rates fell 94% and 92%, respectively, compared to placebo with the use of Dupixent. Cho said, “I could feel the reduction in asthma exacerbations in the field while treating patients with Dupxient for the trial” In terms of Pre-bronchodilator FEV1, the Dupixent-treated group showed significant improvement from week 2, the effects of which lasted during the treatment period. At week 12, the Dupixent-treated group showed a mean improvement of 560mL, and a significant improvement of up to 380mL compared to placebo at week 52. Cho said, “We obtained very encouraging results that Dupixent can maintain lung function through the FEV1 test. Usually, patients feel an improvement from 120mL, and therefore the 560 mL improvement in the Dupixent group is very significant.” The incidence of treatment-related adverse events and serious adverse events in the Korean sub-analysis was comparable in the Dupixent group and the placebo group. Comparing the Korean sub-analysis results with the total clinical trial results, Dupixent showed a higher effect on Koreans. Cho said, “Korean asthma patients had shown less symptom control than in Western countries before Dupxient, I believe that’s why Koreans were able to get a greater effect using a good drug. Study results showed a very significant effect in Korean patients with severe asthma, and even compared to the results of the entire study, the severity of asthma exacerbation rate and FEV1 were more significantly improved in Korean patients.” Cho added, “Before the introduction of new biologics, we could only prescribe steroids to severe asthma patients. After using Dupixent for 3 years, not only did I experience a reduction in the use of steroids in my patients, but their lung function had also improved, with less symptom exacerbation. However, it is a shame that we cannot easily prescribe the drug due to limited reimbursement standards,” Currently, Dupixent is not reimbursed for severe asthma. Cho said, “I wish we could use this strong and effective weapon, Dupixent, in a more broad range of patients.” Sanofi said, “We have applied for the reimbursement expansion in March last year, and will make our best efforts to bring good news to our patients in Korea."
- Company
- Daewoong’s ‘Fexclu’ speeds up overseas market penetration
- by Kim, Jin-Gu Mar 29, 2022 05:54am
- Daewoong Pharmaceutical is working to target the global market with ‘Fexclu tab (fexuprazan),’ its new drug for P-CAB gastroesophageal reflux disease (GERD).’ The company had signed 6 export agreements with 15 countries in North America, Latin America, China, and the Middle East, which amounts to ₩1.2 trillion. In the case of the Southeast Asian market, the company plans to export directly through its own local subsidiary. On the 28th, Daewoong Pharmaceutical announced that it has applied for the marketing authorization of Fexclu through its local subsidiaries in the Philippines, Indonesia, and Thailand. As its local corporation in Southeast Asia is classified as a subsidiary of Daewoong Pharmaceutical, their sales are expected to be counted as Daewoong Pharmaceutical's exports. Daewoong Pharmaceutical expects its exports for Fexclu to amount to ₩520 billion in the 3 Southeast Asian countries and will be applying for its authorization in other Southeast Asian countries soon. Analysts believe Fexclu’s penetration into the global market will accelerate with its entrance into the Southeast Asian market. Since 2020, Daewoong Pharmaceutical has signed a series of contracts with North America, Latin America, China, and the Middle East to export its Fexclu technology or its finished drug. According to Daewoong Pharmaceutical, the company has 6 Fexclu export agreements in place, which amounts to ₩1.2 trillion. In January 2020, it signed a contract with the Mexican company Moksha8 for the technology exports of its finished exports worth $44.42 million (about ₩54 billion), followed by a series of contracts worth $72.58 million (about ₩89 billion) with Brazil's EMS in August. In March last year, it signed a $339.55 million (about ₩420 billion) contract with China's Shanghai Haini Pharmaceutical and a $430 million (about ₩530 billion) technology export contract with the U.S. and Canada's Neurogastrx in June. Separate from the technology export, Daewoong Pharmaceutical was able to secure a 13.5% stake in Neurogastrx. In the same month, Daewoong Pharmaceutical had signed a contract to transfer the local licenses and sales rights in four countries, Colombia, Ecuador, Peru, and Chile to 'Pharma Consulting Group (BIOPAS)’ in South America. Its figure amounts to $29.26 million (₩36 billion). In October, it then signed a contract with ‘Aghras Healthcare Limited’ in the Middle East to supply Fexclu to Saudi Arabia, the United Arab Emirates, Kuwait, Bahrain, Oman, and Qatar for the next 10 years. The 10-year sales volume as expected by the two companies is $82.97 million (about ₩100 billion). Through the exports agreement, the company expects it can earn up to ₩1.2 trillion with the agreements signed in 15 countries in North America, Latin America, China, and the Middle East. Seng-Ho Jeon, CEO of Daewoong Pharmaceutical, said, "We will submit an application for the marketing authorization of our product to another overseas country within this year. We will make efforts to accelerate Fexclu's entry into the global market in earnest." Fexclu is Daewoong Pharmaceutical’s new drug for P-CAB gastroesophageal reflux disease (GERD)’ that reversibly blocks the proton pump that secretes gastric acid from the stomach wall.
- Company
- Wakix, a narcolepsy tx, can be prescribed at hospitals
- by Eo, Yun-Ho Mar 29, 2022 05:53am
- Wakix, a narcolepsy treatment, can be prescribed at general hospitals. According to related industries, Mitsubishi Tanabe Pharma's Wakix passed the Drug Committee of Seoul National University Hospital and other medical institutions. Wakix has been competing with Handok Teva's Nuvigil since last month as insurance benefits have been available. This drug is a new mechanism for increasing histamine concentration in the brain as a counteractive and antagonist that selectively binds to histamine H3 receptors. Nuvigil, an active isomer of sleep seizure treatment Provigil, is a drug that promotes awakening by activating dopamine in the brain and improves the duration of existing drugs. Hypnosis, a rare and intractable disease, has limited treatment options in Korea. In the United States and Europe, Modafinil, Sodium oxybate, Solriamfetol, and Pitolisant are used as narcolepsy treatments, but only Modafinil and isomeric Armodafinil are licensed in Korea. Narcolepsy is a sleep disorder disease characterized by confusion in the sleep awakening cycle and abnormal expression of REM sleep due to the loss of neurons that produce a neurotransmitter called Hypocretin in the brain. Symptoms include EDS (Excessive Daytime Sleepiness) and cataplexy, where REM sleep is expressed in awakening. Cataplexy is known to occur in 70% of narcolepsy patients. Wakix is the first drug approved in Korea to prove its clinical efficacy and safety. Wakix, a new drug developed by French pharmaceutical company Bioprojet Pharma, has been prescribed to narcolepsy patients in European countries such as the UK, France, and Germany since it was first approved as a rare drug by the EMA in March 2016. In August 2019, it was approved by the FDA.
- Company
- Expanding Entresto benefits/maximizing tx for inpatients
- by Mar 29, 2022 05:53am
- Entresto, Novartis' chronic heart failure treatment, has expanded both indications and benefits. Enresto can be used even in patients with more than 40% and less than 60% of the ejection fraction, which has been in great demand. In addition, it is expected that Entresto's position will be further strengthened as hospitalized heart failure patients can use Entresto as a primary drug. Novartis Korea held an online press conference on the 24th to commemorate the expansion of Entresto benefits and indications. Kang Seok-min, a professor of cardiology at Yonsei University's Sinchon Severance Hospital, and Cho Hyun-jae, a professor of circulatory medicine at Seoul National University Hospital, attended to share the meaning of expanding benefits. rom the left, Park Soo-jin, director of the Cardiovascular Metabolism Division of Novartis Korea, Kang Seok-min, professor of cardiology at Yonsei University Sinchon Severance Hospital, and Cho Hyun-jae, professor of circulatory medicine at Seoul National University Hospital Entresto is the first Angiotensin receptor-Neprilsysin inhibitor (ARNI) treatment in Korea and the only new drug that works directly on the heart. It acts on cardiac nerve hormones in two ways to activate NP nerve hormones that are beneficial to cardiovascular systems, while suppressing RAAS that is harmful to cardiovascular systems. In February, Entresto added an indication of 'reducing the risk of death from cardiovascular disease and hospitalization due to heart failure' in patients with chronic heart failure with lower left ventricular systolic function than normal. Starting this month, for patients who have been hemodynamically stabilized after hospitalization due to acute non-compensatory heart failure, salaries have also been expanded to those without ACE inhibitors or angiotensin II receptor blocking. Entresto can be reimbursed as a primary drug for inpatients. According to Professor Kang Seok-min, 83% of patients with chronic heart failure are hospitalized more than once for acute heart failure, and one in four patients is hospitalized again for 30 days after discharge. Up to 10% die. Effective initial treatment that can reduce re-hospitalization is important. Entresto is recommended as a standard treatment in domestic and foreign heart failure treatment guidelines, but it was difficult to use it initially in Korea as a limited standard. Professor Kang said, "Inpatients have not been able to use Entresto in the first round, but clinical studies have supported the importance of using drugs that can reduce mortality at the time of hospitalization," adding, "Now domestic inpatients are expected to use Entresto to significantly reduce re-entry and mortality." Entresto has also expanded its use in patients with a heart rate of more than 40% to less than normal (about 60%), which has been in unmet demand. Reduced hardness of ejection rate and some conservative patients can be treated with Entresto. Throughout this, Entresto has become the drug with the widest range of chronic heart failure indications in Korea. Entresto showed the greatest clinical effect in patients with a heart rate of 60% or less. Professor Cho Hyun-jae said, "When looking at the left ventricular ejection rate according to the quintile, it showed a consistent positive effect from less than 25% to less than 60%," adding, "9.6% of patients who preserved the ejection rate were progressing heart failure a year later. There have been many studies so far, but Entresto is expected to benefit from proving its effectiveness for the first time." Professor Cho then said, "Recently, SGLT-2 inhibitors have also shown some effects in preserving the ejection rate," adding, "Entresto and SGLT-2 inhibitors play different roles in three axes of heart failure treatment. Therefore, since the two drugs are not in a substitute relationship, but in a complementary relationship, standard treatment will move toward using Entresto and SGLT-2 together in the future, he added. Entresto surpassed 30 billion won in outpatient prescriptions within five years of its launch. Last year, prescriptions amounted to 32.3 billion won, up 37.3% from the previous year.
- Company
- Four types of PE exemption drugs listed in one month…
- by Eo, Yun-Ho Mar 28, 2022 06:10am
- Coverage expansions of new drugs continue to be reported. In fact, four new drugs were successfully listed last month. According to industry sources, starting with Astellas’ ‘Xospata (gilteritinib)’ in March, Novartis’s ‘Kymirah (tisagenlecleucel),’ Roche’s ‘Rozlytrek (entrectinib),’ Bayer’s ‘Vitrakvi (larotrectinib)’ were listed as new drugs under the pharmacoevaluation exemption track. Despite the difficulties faced during discussions, all the drugs were successfully listed in the end. ◆'Xospata’ resolves the unmet needs in leukemia Xospata is the first treatment approved for FLT3mut+ relapsed/refractory Acute Myeloid Leukemia (AML). The drug, which was approved in March 2020, passed the Health and Insurance Review Service’s Drug Reimbursement Evaluation Committee on the 9th last year, and then started negotiations with the National Health Insurance Service in October of the same year, Although the parties were unable to reach an agreement within the set negotiation period (60 days) and extended the period once more to reach an agreement. Xospata was approved early this month. As a newly introduced treatment option, the public’s interest in on Xostapa’s reimbursement. In fact, the Korea Organization for Patient Group had delivered the opinion on the accelerated reimbursement of new drugs including Xostapa at a roundtable meeting with the MOHW’s Department of Pharmaceutical Benefits. ◆ GOV and company promptly works for the reimbursement of ' Kymriah' The reimbursement of the ultra-high-priced one-shot CAR-T therapy Kymriah has been successfully achieved with the efforts of the government, pharmaceutical company, and the patient. This drug started its reimbursement listing process with the MFDS approval through the approval-reimbursement evaluation linkage system in March last year. Although the agenda was listed for review by the Cancer Disease Deliberation Committee six months later, it was deferred at the time. As soon as the deferral was disclosed by the press, the Korean Alliance of Patient Organization issued a statement criticizing the government and the company. KAPO had previously criticized the delay in deliberations of the agenda by the Cancer Disease Deliberation Committee. As a result, Kymriah passed CDDC in the October of the same year. This was also the first day HIRA had disclosed the CDDC deliberation results. Also, Kymriah passed the review of the first Drug Reimbursement Review and Assessment Service meeting in 2022. And after extending negotiations once, the company succeeded in completing its negotiations and is set to be listed in April. Of course, this is a frustrating period of wait for the patients who long for reimbursement. However, considering the time usually consumed in the registration process for innovative new drugs in Korea, Kymriah’s reimbursement was quick. ◆'Rozlytrek' and 'Vitrakvi’ pave the road for tumor-agnostic drugs Rozlytrek and Vitrakvi had also overcome many obstacles. The two drugs passed the HIRA DREC review but their listing were deferred in the final stages, with the drug pricing negotiations being extended. As these drugs can be applied to many solid cancers that have specific genetic mutations, the authorities had difficulty applying one specific evaluation system and are judged that it will take a while for discussions to be made between the government and the pharmaceutical company. Rozlytrek and Vitrakvi are indicated for the treatment of patients that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic, or where surgical resection is likely to result in severe morbidity and have progressed following treatment or have no satisfactory alternative therapy. In other words, the drugs can be used in most tumors with identified NTRK gene fusions. However still, conservative restrictions remain for the use of the drugs. The use of the two drugs was limited to cancer types mentioned in the NCCN guidelines.
- Company
- Sanofi Launches 3rd Generation Antihistamine Alllegra
- by Nho, Byung Chul Mar 28, 2022 06:10am
- Sanofi Korea announced on the 23rd that it released Allegra 120mg, an allergic rhinitis treatment with 3rd generation antihistamine ingredients, in February. Most 3rd generation antihistamines are Rx drugs, which can only be taken after prescription at clinics, but Allegra can be purchased without prescription at pharmacies with permission from OTC for a dose of 120mg. Fexofenadine, the actvie ingredient of Alllegra, is a third-generation antihistamine component. Antihistamines are classified from 1st to 3rd generations according to the development order, and have gradually improved in terms of effects and side effects as generations evolve. The newly launched Alllegra is a next-generation ingredient that improves/complementes the advantages and disadvantages of first- and second-generation antihistamines, and it is a third-generation antihistamine allergy drug that is effective quickly, reduces sleepiness, and lasts 24 hours. Allegra is 10 tablets per pack, and one tablet (120 mg) can be taken once a day with sufficient water before meals. It is expected to improve the quality of life of busy modern people such as drivers, office workers, and students who usually suffer from allergic rhinitis, as the effect is rapidly expressed within 60 minutes on average and the effect lasts for 24 hours. In addition, there is no interaction through hepatic metabolism, so patients taking other drugs can also take them according to the advice of medical experts. Allergic rhinitis, classified as a chronic disease, is mainly caused by allergic antigens such as house dust, mold, cockroaches, and pollen, or by rapid temperature changes, air pollution, and pet hair, and is classified as the most common disease type worldwide. Symptoms of allergic rhinitis are similar to colds, such as stuffy nose, clear runny nose, sneezing, and itchy eyes and nose. Advertising for the new Alllegra will be on-air through TV and digital platforms from March. Under the theme of house dust, pet fur, change of seasons, and air pollution, the advertisement plans to actively promote allergic rhinitis and improve the quality of life through Allegra, a third-generation antihistamine drug, even in various daily situations.
- Company
- Antengene’s first new drug Xpovio lands in hospitals
- by Eo, Yun-Ho Mar 25, 2022 05:48am
- ‘Xpovio, the first drug introduced by the Chinese pharma company Antengene, has landed in general hospitals. According to industry sources, the company’s anticancer drug Xpovio (Selinexor) has passed the review of drug committees (DCs) at 4 of the Big 5 tertiary hospitals - Samsung Medical Center (SMC), Seoul National University Hospital (SNUH), Seoul St.Mary’s hospital, Seoul Asan Medical Center (AMC) – and has been added for prescriptions through an emergency DC at the Severance Hospital. Xpovio, which had been designated as an orphan drug and then approved in August last year, is a drug with a new mechanism of action that selectively inhibits the nuclear export protein XPO1. The drug was approved for two indications: ▲ for use in combination with dexamethasone for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least 4 prior therapies and whose disease is refractory to at least 2 proteasome inhibitors (PI), at least two immunomodulatory medicinal products (IMiD), and an anti-CD38 monoclonal antibody (mAb); and ▲ as a monotherapy for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL) who have received at least two prior lines of treatment. XPO1 inhibitors are expected to be used to improve outcomes of various diseases in combination with other regimens (drugs) in the future. The National Comprehensive Cancer Network (NCCN) guidelines currently recommend 5 treatment regimens including Xpovio. Most multiple myeloma recurs and is refractory to treatment, and diffuse large B-cell lymphoma that has failed systemic treatment also has less chance of being cured or achieving long-term progression-free survival every time the disease progresses after treatments. As a result, a dire need has existed for a more safe and effective treatment method in relapsed and/or refractory multiple myeloma and relapsed/refractory diffuse large B-cell lymphoma. However, experts expect that it will take some more time for the drug to be listed for reimbursement. Xpovio had undergone review by HIRA’s Cancer Disease Deliberation Committee in January but had failed to set reimbursement standards. The reason for the failure is known to be that the company wasn’t able to satisfy ‘the number of A7 country released’ requirement. Therefore, the company needs to wait for the drug’s results in other countries to attempt reimbursement in Korea. Meanwhile, the drug’s efficacy was demonstrated through two Phase II trials – the STORM and SANDAL trials. In the STORM study, Xpovio achieved an objective response rate (ORR) of 26% and a clinical benefit rate (CRB) of 39.9% in combination with dexamethasone in patients with relapsed and/or refractory multiple myeloma who have received at least 4 prior therapies In the SADAL study that was conducted on patients with relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL) who have received at least two prior lines of treatment, Xpovio as monotherapy had achieved an ORR of 28.3% and a CR of 11.8%.
- Company
- SK Biopharm targets US sales of Xcopri
- by Kim, Jin-Gu Mar 25, 2022 05:48am
- SK Biopharm announced that it will double U.S. sales of Cenobamate (Xcopri) this year. Cho Jung-woo, CEO of SK Biopharm, presented this year's goal at an online press conference on the 24th. SK Biopharm generated 78.2 billion won in sales from Cenobamate in the U.S. last year. Sales have more than increased seven times compared to 10.6 billion won in 2020, the first year of its launch. SK Biopharm plans to double its sales to 160 billion won this year. New marketing plan has been drawn up this year. First of all, the government plans to double the annual number of prescriptions from 90,000 last year to about 90,000 this year. If the company focused on increasing the new prescription rate of doctors who mainly deal with CNS diseases until last year, it plans to expand marketing to target various doctors from this year. It plans to focus on raising awareness of SK Biopharm and Cenobamate in the epilepsy treatment market. It has set a goal to achieve No. 1 recognition of products and companies in the epilepsy treatment market within this year. CEO Cho Jung-woo said, "Cenobamate is growing into a top tier in the U.S. epilepsy treatment market. Considering that patents for major competitors will expire next year, it will be able to establish itself as the only new drug for epilepsy. We will expand face-to-face sales and marketing to double sales in the U.S.," adding, "In the U.S., quarantine guidelines have been eased until the stage of taking off masks." In the second half of this year, face-to-face activities are expected to recover to around 90%." He added, "We will improve awareness of diseases through TV advertisements and SNS marketing, and increase brand awareness of companies and products."
- Company
- Why Vemlidy's patent dispute took 3 years to win the 1st tri
- by Kim, Jin-Gu Mar 24, 2022 05:54am
- Generics, which challenged the patent of Gilead Science's hepatitis B treatment Vemlidy (Tenofovir Alafenamide HemiFumarate), won the first trial in about three years. According to the pharmaceutical industry on the 21st, Intellectual Property recently made a "claim establishment" trial on the passive scope of the Vemliddy salt patent filed by Dong-A ST, Daewoong Pharmaceutical, and Chong Kun Dang against Gilead. The patent expires in August 2032. Pharmaceutical companies that won the first trial have been qualified to release generic products after September, when Vemlidy's PMS period expires. Attention is drawn to this by the referee. Dong-A ST and others requested a trial in December 2018. It took more than three years for the decision to be reached. Generics usually apply for a "priority trial" at the same time when requesting a trial, so it is unusual for the decision to take three years. ◆The conclusion was reached 3 years after the request for trial The pharmaceutical industry explains that Vemlidy's remaining PMS expiration period had a decisive impact on the prolonged dispute. Vemlidy's PMS expires on September 12. As of December 2018, when generics requested a trial, Vemlidy's PMS expiration date was about three years and nine months away. However, Intellectual Property did not immediately look into the incident. This is due to Intellectual Property's regulations on preferential trials. Article 31 of the Administrative Rules of Intellectual Property's "Patent Trial Handling" stipulates that the claimant's application for a priority trial must be judged before other cases.This regulation stipulates that "the trial case for patent rights related to drugs whose expiration date of the retrial period is one year after the date of application for priority trial is excluded." When generics filed a patent trial in 2018, Vemlidy's PMS did not expire within a year, so it was excluded from the priority trial, and only recently, when the PMS expiration date was within a year. An official from the pharmaceutical industry explained, "With the implementation of the patent-approval linkage system, there have been more requests for patent trials by generics to accept generic for exclusivity, and I understand that Intellectual Property has set these regulations to prioritize." He said, "Under this regulation, hearings have not been conducted for a while since the request for a trial, but only recently have the Patent Tribunal begun to look into the case," adding, "The rest of the Vemlidy salt patents that have yet to be concluded are expected to come out soon." Vemliddy is another hepatitis B drug from Gilead, generic for Viread. The active ingredient is Tenofovir Disoproxil Fumarate, but Gilead has newly developed the drug in pro-drug form. This improved drug resistance and kidney toxicity side effects. Vemlidy is rapidly replacing existing Viread in the hepatitis B treatment market. According to IQVIA, pharmaceutical market research firm, Vemlidy's sales surged in four years from 500 million won in 2017 to 28 billion won last year, the first year of its launch. During the same period, Viread's sales fell nearly half from 129.3 billion won to 63.1 billion won.
- Company
- Samsung Bioepis makes ₩847 billion expanding overseas
- by Chon, Seung-Hyun Mar 23, 2022 05:51am
- Samsung Bioepis made a new sales record last year. With the global expansion of its biosimilars well on track, the company had made over ₩800 billion last year. According to the Korea Financial Supervisory Service, Samsung Bioepis’s sales recorded ₩847 billion last year, a 9.0% increase from the previous year. This is the largest record ever since the company was established in 2012. Sales have increased 129.7% in just 3 years from ₩368.7 billion in 2018, and have been breaking its sales record ever since. Annual Sales of Samsung Bioepis (Unit: million won, Data: Financial Supervisory Service) After recording ₩765.9 billion in sales in 2019, the company’s growth rate had fallen to 1.5% the next year. The reduced growth has been due to the temporary market contraction that occurred in the early stages of the COVID-19 crisis. The company’s quarterly performance had then showed ups and downs with preorders from hospitals and wholesalers in Europe to secure a supply. However, the company’s recovered growth last year was driven by the increased sales of biosimilars in the US and Europe. Samsung Bioepis’ sales are mostly generated by overseas sales of biosimilars that were developed by the company. Samsung Bioepis had succeeded in commercializing biosimilars of 6 products - Enbrel, Remicade, Herceptin, Humira, Avastin, and Lucentis. All 6 products were approved in Europe, and 5 products less the Avastin biosimilar achieved marketing authorization in the US. The five biosimilars from the company had recorded $1,255,100,000 (approx. ₩1.5 trillion) in overseas sales last year. This is an 11% increase and a new record from the $1,125,800,000 it made in 2020. Samsung Bioepis’ biosimilar is sold abroad by its partners Biogen and Organon. Biogen sells the company’s biosimilars of Enbrel, Remicade, Humira for autoimmune diseases in Europe. Organon sells the mentioned products in countries other than Europe and Korea, and the Remicade biosimilar in the US. Organon is also in charge of overseas sales of Samsung’s two anticancer drugs, the biosimilars of Herceptin and Avastin. Last year, Biogen’s sales of Samsung Bioepis’ biosimilars recorded $831,100,000 (approx. ₩1 trillion), which was a 4% increase from the previous year. Organon’s sales of Bioepis’ products also increased 28% from the previous year to record $424,000,000 (approx. ₩500 billion). Also, the approval of the biosimilars abroad has added new milestones. In August last year, the company’s Lucentis biosimilar ‘Byooviz’ that it developed received marketing authorization from the European Commission (EC) and the U.S. Food and Drug Administration (FDA) a month later. Samsung Bioepis will be converted into a wholly-owned subsidiary of Samsung Biologics. At the time of its establishment, Samsung Bioepis was established as a joint venture between Samsung Biologics and Biogen. Samsung Bioepis was launched in February 2012 with a capital of ₩164.7 billion, and Biogen initially invested 15% of the capital, 24.7 billion won. With Biogen only partially participating in the paid-in capital increase, its share fell to 5.4% in 2017. In 2018, Biogen had exercised its call option over Samsung Epis and increased its shares to 50%. Previously, the company had signed a call option agreement under which the company may acquire ‘50% less 1 share’ of Bioepis’s stock by June 29th, 2018. And upon the date of expiry, Biogen decided to acquire the stocks. In June 2018, the company acquired 9,226,068 of the 19,567,921 shares of Bioepis that were owned by Samsung Biologics for $700 million (₩748.6 billion). In January, Samsung Biologics decided to acquire 10,341,852 shares (50% stake) of Samsung Bioepis that was owned by Biogen for ₩2.765 trillion. Samsung Biologics plans to pay the remaining amount of the acquisition price in installments over the next two years. After the acquisition, Samsung Biologics will own 100% of Samsung Bioepis’s shares.
