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- 2026-03-14 16:18:04
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- Sam Chun Dang Pharm’s biosimilar equivalent to Eylea
- by Nho, Byung Chul Mar 28, 2023 05:56am
- On the 27th, Sam Chun Dang Pharm announced that it had received the final result report for its Phase III trial for SCD411 (Eylea biosimilar). The results are from a global phase III clinical trial that had been conducted on 576 patients at 132 hospitals in 14 countries from September 2020 to September 2022. Through the global Phase III trial, the company demonstrated the equivalence of SCD411 to the original Eylea in terms of efficacy (primary endpoint & secondary endpoint), safety, tolerance, effectiveness, and immunogenicity. The primary outcome measure, change from baseline in BCVA (best corrected visual acuity) measured from baseline to Week 8, fell within the equivalence limit interval set by the US FDA (Food and Drug Administration), EMA (European Medicines Agency), and Japan’s PDMA (Pharmaceuticals and Medical Devices Agency) compared to the original. UF FDA set the equivalence limit interval as a confidence interval of 90% with a treatment difference with the original between -3.0 to 3.0 characters, Europe’s EMA and Japan’s PMDA as a confidence interval of 95%, and a difference between -3.8 to 3.8 characters. The results of the primary outcome measure analysis showed that the differences in effect were between -1.6 to 0.9 characters under the US standards, and between -1.8 to 1.1 characters under the European and Japanese standards. Based on the results, Sam Chun Dang Pharm plans to apply for marketing approval of SCD411 in major countries such as the United States, Europe, and Japan and will supply and market the products through its partners as soon as it receives authorization.
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- Erleada's reimb and lower coinsurance rate raise issue
- by Eo, Yun-Ho Mar 28, 2023 05:56am
- Most latecomer drugs are priced at a lower level than first-comer. This is an essential element in Korea's reimbursement listing system. However, a rare occasion occurred where patients are complaining over the lower price set for a latecomer drug. The drugs that arose as an issue were Janssen Korea’s prostate cancer treatment ‘Erleada (apalutamide),’ and Astellas Korea’s ‘Xtandi (enzalutamide)’ which was listed for reimbursement before Erleada. The situation goes as follows. The price difference (list price) between the two drugs is not large. However, the problem lies in the listing registration system the two drug companies selected and the patient's coinsurance. In August of last year, reimbursement for Xtandi was extended through a selective reimbursement system. Xtandi was first listed in 2014 as a treatment for metastatic castration-resistant prostate cancer (mCRPC). The selective reimbursement system is a system for listed drugs that authorities determine is urgent to expand coverage. To rapidly extend the scope of reimbursement for such drugs, the authorities waive the economic feasibility evaluation process but differentiate the copayment rate for the drug. Xtandi met the purpose of the system for the 'metastatic hormone-sensitive prostate cancer (mHSPC)' indication, which was why Astellas chose to receive reimbursement through the system. However, the situation was different for Erleada. As a newly listed new drug, Erleada did not have the option to choose selective reimbursement, therefore, it had to undergo the essential reimbursement processes, including the pharmacoeconomic evaluation process. This was why the time to the listing of the two drugs differed significantly. The two drugs passed review by the Cancer Disease Review Committee of the Health Insurance Review and Assessment Service in February last year, but Erleada is only being listed for reimbursement starting next month. Applying selective reimbursement to new drugs has remained a long-cherished desire in the industry. The different reimbursement tracks taken by the two companies led to the difference in the amount paid by patients as coinsurance. Xtandi’s coinsurance rate under the selective reimbursement system is 30%, whereas the rate is a mere 5% for Erleada which is applied essential reimbursement and special calculation of exemptions. If so, it would seem that existing patients can opt to use the cheaper Erleada, but it is impossible for patients taking Xtandi to switch to Erleada under the current reimbursement standards. In other words, dissatisfaction is arising among patients as existing patients could not benefit from the use of a cheaper drug option that became available. However, no one is to blame for the situation. Aside from the company's strategy, Astellas quickly offered a reimbursed treatment option in mHSPC through the selective benefit system. Janssen also has no fault. The prevailing view had been that it would be difficult for anticancer drugs with the mHSPC indication to be listed for reimbursement in Korea. This was why the news that Janssen completed final negotiations and successfully receive reimbursement after receiving pharmacoeconomic evaluations was received with surprise in the industry. Also, a solution does exist. The gap caused by the difference in coinsurance rates can be resolved if Xtandi also receives pharmacoeconomic evaluations and switches to an essential reimbursement like Erleada. However, it is unclear whether such a decision can be made quickly due to the nature of multinational pharmaceutical companies. A pricing official in the industry said, “Although it is uncommon, we should not overlook the fact that this can happen again in the future. Institutional improvement is needed to resolve the out-of-pocket burden that occurs with the entry of latecomers for selective benefit-applied items.”
- Company
- Pfizer Korea dividend KRW 12.48M, net profit KRW 119.5B
- by Chon, Seung-Hyun Mar 27, 2023 05:56am
- Despite posting record-breaking performance last year, Pfizer Korea’s dividend was set at only KRW 12.48 million. The company adhered to its dividend policy of ’20% preferred stock’ regardless of its performance. According to the Financial Supervisory Service (FSS), Pfizer Korea set its dividend payout for the last year as KRW 12.48 million. With the decision, the company’s dividend payout has now remained the same at 12.48 million for five consecutive years. # i1 The dividend was calculated at the same level as before even though Pfizer Korea’s performance improved significantly due to sales of COVID-19 drugs last year. Pfizer Korea’s sales increased 90.4 YoY from KRW 1.694 trillion to KRW 3.225 trillion last year. Its operating profit more than doubled from the previous year to reach KRW 120.1 billion. Sales of its COVID-19 vaccines and treatments raised the company’s sales performance. Its sales had risen over fourfold in two years from KRW 391.9 billion in 2020, and profitability also improved significantly from its operating loss of KRW 7.2 billion in 2020. The company’s net profit also increased 24.0% YoY to reach KRW 119.5 billion. In general, companies pay out dividends to shareholders proportionate to their increase in net profit. However, Pfizer’s dividend remained the same at KRW 12.48 million as in the previous year, and its dividend payout ratio was a mere 0.01%. Pfizer Korea calculated its dividend by applying a 20% dividend rate to its preferred stock capital. Pfizer Korea’s total capital is KRW 922.92 million. Among them, the common stock capital (172,104 shares) is KRW 860.52 million, and the preferred stock capital (12,480 shares) is KRW 62.4 million. Therefore, with a 20% preferred stock, the dividend was set at 20% of the KRW 62.40 million, at KRW 12.48 million. Pfizer Korea’s largest shareholder is Pfizer’s Dutch subsidiary, 'PF OFG South Korea 1 B.V,’ which owns 99.99% of the shares. Therefore, PF OFG South Korea 1 B.V., which owns all of the company’s preferred stock, will be receiving a dividend of KRW 12.8 million. Pfizer Korea had paid dividends of KRW 12.48 million based on the same standard of '20% preferred stock' for all but two occasions over the past 20 years since 2003. In 2017, its dividends were set at KRW 79.79 billion, which was higher than its net profit. At that time, the dividend rate was set at 660% of the face value of KRW 5,000 for both its common stocks (2,455,520 shares) and preferred stocks (12,480 shares), increasing dividends. In 2008, the dividend was set at KRW 190 billion. Even though the company recorded a deficit of KRW 600 million at the time, the high dividend was determined based on a dividend rate of 3045% compared to face value. Over the past 20 years, these two were the only occasions the company set high dividends, and it upheld its small dividend policy of KRW 12.48 million during the rest of the period.
- Company
- SGLT-2 combo Qtern awaits release in Korea
- by Eo, Yun-Ho Mar 27, 2023 05:56am
- With reimbursement extensions to combination therapies that use SGLT-2 inhibitors imminent, the combination drug ‘Qtern’ is rapidly landing at general hospitals in Korea. According to industry sources, AstraZeneca’s DPP-4i+SGLT-2i Qtern (saxagliptin+dapagliflozin) which is being solely distributed by Ildong Pharmaceutical in Korea, has passed the drug committee (DC) reviews in tertiary hospitals such as Seoul National University Hospital, Seoul St. Mary’s Hospital, Seoul Asan Medical Center, Sinchon Severance Hospital, and other general hospitals including Gangwon National University Hospital, Korea Anam University Hospital, Nowon Eulji Medical Center, Ewha Womans University Medical Center, Inje University Ilsan Paik Hospital, Chonnam National University Hospital, Jeju National University Hospital, Chungnam National University Hospital, and Hanyang University Guri Hospital. Although the drug had been approved in March 2017, it was not released in Korea due to the non-resolution of the reimbursement issue for antidiabetic combination therapies in Korea. However, However, Qtern may finally be released in line with the progress made regarding the government’s discussions on antidiabetic combination drugs and the reimbursement standards being expanded for antidiabetic combination therapies from next month (April). Qtern is currently undergoing reimbursement listing in Korea. Other DPP-4+SGLT-2 combination drugs that are approved in Korea include Boehringer Ingelheim’s ‘Esglito (linagliptin+empagliflozin)’ and MSD’s ‘Stegluzan (sitagliptin+ertogliflozin).’ These drugs are also awaiting the revitalization of the combination market that will come with the resolution of the reimbursement issue. Generic versions of antidiabetic combos are also awaiting entry into the market. The post-marketing surveillance period for DPP-4i+SGLT-2i combos is soon to expire, until which application for generic drugs is blocked. Meanwhile, in a Phase III trial that studied adding dapagliflozin or placebo to the saxagliptin+metformin two-drug combination therapy for 52 weeks, results showed that patients that used the three-drug combination showed an improvement in terms of lowering blood sugar level and achieving glycosylated hemoglobin (HbA1c) target level over the two-drug combination therapy. No hypoglycemia side effects were additionally observed in the study.
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- Discussion of reimbursement for Vyndamax is running in place
- by Eo, Yun-Ho Mar 24, 2023 05:48am
- It seems that discussions on registration of transthyretin (TTR) amyloid cardiomyopathy drug 'Vindamax' for insurance benefits are at a standstill again. As a result of the coverage, Pfizer Korea's ATTR-CM (ATTR amyloidosis with cardiomyopathy) treatment Vyndamax, (Tafamidis 61mg) passed the HIRA last year, but the schedule for presentation to the Pharmaceutical Reimbursement Evaluation Committee has not yet been set. there is. In fact, it is judged that the discussion has ceased. The passage of the standard subcommittee itself was the result of only the fourth challenge, but it disproves that the gap between the government and pharmaceutical companies remains. Vyndamax failed to designate an essential drug in its first reimbursement challenge in early 2021. Afterward, an economic evaluation was conducted in the first half of the same year and a second challenge was reached through a Risk Sharing Agreement, but the results were the same. And in April of last year, it failed to exceed the standard subcommittee again, but in the second half of last year, it barely made a step forward. However, it is judged that there were still difficulties in finding a point of agreement in terms of financial sharing. It remains to be seen whether Vyndamax will be able to supplement the data again and continue discussions on salary listing. Meanwhile, Vyndamax is virtually the only ATTR-CM treatment option. ATTR-CM has been regarded as a disease with poor treatment results because it is misdiagnosed as simple heart failure or has no treatment, even though it is fatal enough that the survival period is only 2 to 3.5 years if not treated appropriately. In this situation, Vyndamax is a drug that has been shown to reduce the occurrence of cardiovascular events in CM patients through the phase 3 ATTR-ACT study and to improve the 6-minute walking test. In the ATTR-ACT study, 441 patients have randomized to Tafamidis 80 mg, Tafamidis 20 mg, and placebo in a 2:1:2 ratio. The main secondary endpoints of the study were the change in the 6-minute walk test from baseline to 30 months, the Kansas City Cardiomyopathy Questionnaire-Overall Summary, and the KCCQ-OS score, where higher scores mean better health. As a result of the study, the Tafamidis-administered group showed a statistically significantly lower risk of all-cause death and cardiovascular-related hospitalization compared to the placebo-treated group.
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- 5th time the charm for Tagrisso’s reimbursement extension?
- by Jung, Sae-Im Mar 24, 2023 05:48am
- After five attempts, the EGFR mutation-positive non-small cell lung cancer (NSCLC) treatment ‘Tagrisso (osimertinib)’ finally crossed the first hurdle to receiving reimbursement as a first-line treatment. Although other procedures such as deliberation by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee remain, the fact that it had overcome the highest barrier to reimbursement, the Cancer Disease Deliberation Committee review, 4 years after its indication was expanded to the first line, is regarded an achievement. HIRA’s CDDC held its second 2023 Reimbursement Standard Deliberation Meeting for Anticancer Drugs on the 22nd and established reimbursement standards for Tagrisso. The CDDC determined it was appropriate to set reimbursement standards for Tagrisso as a ‘first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations.’ With the decision, the drug was able to pass the first gateway for third-generation EGFR-targeted anti-cancer therapies to receive reimbursement as a first-line treatment. ◆Passes CDDC review after 5 attempts...sees fruition 4 years after indication expansion Tagrisso is a third-generation targeted anticancer therapy that targets the EGFR mutation. It inhibits both the EGFR mutation and T790M mutation that are represented by L858R and Exon 19 deletions. As the drug has a high blood-brain barrier (BBB) permeability than first and second-generation EGFR-targeted therapies, Tagrisso has shown a superior effect in patients with brain metastasis. Tagrisso, which added its first-line indication in December 2018 in Korea, attempted to extend its reimbursement to the indication in 2019. However, the drug was unable to receive reimbursement as a first-line treatment for over 4 years. AstraZeneca had attempted reimbursement for Tagrisso at the CDDC level 4 times since 2019 and failed every attempt. When Tagrisso’s reimbursement to the first line first emerged as an agenda in the second half of 2018, the government had been in favor of extending reimbursement. However, the favorable stance faltered with the release of the Asian subgroup analysis results from a global Phase III trial in 2019. The FLAURA trial assessed the efficacy and safety of Tagrisso in the first line, and the Asian subgroup analysis results of this global trial had risen as a barrier to its reimbursement as its hazard ratio (HR) was 0.995. An HR of 0.995 indicates that the difference between Tagrisso and the control group is 0.005, which could be interpreted as the difference being insignificantly small. After such results were disclosed, the CDDC in October 2019 decided to defer its decision until the full data from the Phase 3 FLAURA trial was released. The company made its second attempt, submitting the overall OS data of FLAURA in 2020. However, due to the rapid spread of COVID-19, the CDDC meeting that was set for February of the year had been pushed back and canceled several times and finally held at the end of April. The reimbursement standards for the drug had not been set then either. Although AstraZeneca expressed their will to accept most of the cost-sharing plan proposed by the government in consideration of the Asian subgroup data, the reimbursement fell through due to strong opposition from committee members that raised the issue of the drug’s clinical efficacy. In September of the same year, the company made its third attempt powered by results from the FLAURA China study that confirmed improved OS in Asians. The FLAURA China trial data analyzed a cohort of 136 Chinese patients that included 19 Chinese patients from the global FLAURA trial as well as 117 patients from a trial that had been separately conducted. Results showed that the median PFS of the Tagrisso group was 17.8 months, which was comparable to the results from the global study. Median OS in the Tagrisso group was 33.1 months, 7.4 months longer than the 25.7 months in the control group. This is a higher OS improvement than the 6.8 months identified in the global trial. The third reimbursement extension discussions for Tagrisso were made in April 2021. The third attempt also resulted in failure. At the time, CDDC members concluded that the OS value from the FLAURA China trial lacked statistical significance. After the third attempt failed, patient groups rose to the occasion. After Tagrisso's failure to receive reimbursement in April, 1,713 lung cancer patients and their families sent a joint statement to the government imploring the government to extend Tagrisso’s reimbursement to the first line as in many major countries. Academic societies also criticized how only Tagrisso is not being reimbursed as first-line treatment in Korea. 3 months after its third setback, AstraZeneca applied for the 4th time to extend reimbursement. This time, the company adopted a strategy of narrowing part of its reimbursement standards. The company excluded Exon 21 mutation from the 'EGFR exon 19 deletion or exon 21 (L858R) mutation NSCLC’ it had been indicated for. The company narrowed the criteria to 'first-line treatment for patients with EGFR exon 19 deletion and brain metastases' and reapplied for reimbursement. The plan was to increase the clinical value of the drug by excluding the patient group that showed a relatively small difference in efficacy from the control group. However, Tagrisso’s reimbursement extension was rejected at the CDDC meeting that was held in November 2021. Real-world study on first-line Tagrisso use in Japan. OS results according to gene mutation status (Data: ESMO) This reluctant sentiment on Tagrisso’s reimbursement extension was reversed at the end of last year with the release of large-scale real-world data on Tagrisso’s use in the first line in Asia and Europe. Analysis of real-world data on 660 Japanese patients confirmed a longer progression-free survival period (20.0 months) and an overall survival period of more than 3 years (40.9 months) than those identified in the Phase III trial. With this data, the company put an end to Tagrisso’s efficacy controversy in Asia. AstraZeneca took on its 5th challenge with this new data and a plan to lower drug prices as supplements. The patient organizations’ petition requestion reimbursement extension also added support. The 'Petition regarding the request for first-line treatment of the lung cancer treatment Tagrisso’ that was uploaded to the e-People website in February was sent to the National Assembly Health and Welfare Committee for deliberation after receiving over 50,000 consents. As a result, after 5 attempts in the course of the past 4 years, Tagrisso finally made it through the first barrier to its reimbursement and passed the CDDC review. ◆Can it be reimbursed within the year? Depends on DREC progress Although it has passed the high barrier of CDDC review, many procedures still remain for its reimbursement extension. For anticancer drugs, CDDC review is only the first step of many. The agenda has to pass HIRA’s Drug Reimbursement Evaluation Committee (DREC), and then undergo pricing negotiation with the NHIS, then pass MOHW’s Health Insurance Policy Deliberation Committee (HIPDC) review to complete all the procedures required to extend benefits. Tagrisso is subject to the risk-sharing agreement (RSA) scheme and must pass the pharmacoeconomic evaluation. HIRA’s statuary evaluation period is set to 120 days or less, but it is common for HIRA to exceed the set deadline if the company is required to submit supplementary data. After completing discussions with HIRA and passing DREC review, the company has to conduct drug pricing negotiations with NHIS for up to 60 days. Within 30 days from the period, MOHW’s HIPCD will deliberate and then issue a notification on the new drug price and then list the drug for extended reimbursement. In other words, at maximum, Tagrisso’s reimbursement extension is set to be made by the end of this year. The decisive step in advancing or delaying this timing of Tagrisso's reimbursement is expected to depend on DREC’s stage, where the pharmacoeconomic evaluation takes place. If DREC requests supplementary data repeatedly, reimbursement listing may be delayed indefinitely. In fact, several anticancer drugs have not been deliberated for over a year at the DREC level after passing the CDDC review. In the case of MSD's Keytruda, which succeeded in extending reimbursement to the first-line treatment of NSCLC after 4 years, Keytruda’s reimbursement agenda was presented to DREC 6 months after passing the CDDC review in July 2021. Although the company showed a high willingness to negotiate the reimbursement of Keytruda, the process was only completed eight months after passing the CDDC review due to a delay in its schedule, such as an unsuccessful submission for the DREC review in November 2021. AstraZeneca plans to make the best efforts to extend Tagrisso's reimbursement within the year. The company said, "We welcome the CDDC’s decision and would like to express our thanks to the government and committee members for making efforts to enable this. We will continue to do our best to complete the procedures that remain and receive the reimbursement decision”
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- Neurofibromatosis Tx Koselugo makes progress for reimb
- by Eo, Yun-Ho Mar 23, 2023 04:45am
- Finally, reimbursement discussions for the new neurofibromatosis drug ‘Koselugo’ has made some progress. Results showed that AstraZeneca Korea’s new neurofibromatosis drug has passed the review by the Health Insurance Review and Assessment Service’s Drug Reimbursement Standard Subcommittee recently. Therefore, its reimbursement can now be deliberated by the Drug Reimbursement Evaluation Committee. After the drug received a non-reimbursement decision from DREC in March, the company worked promptly and prepared the supplementary data to restart listing discussions for the drug. As NF1 is a rare disease area with no available treatment option, whether Koselugao will be able to receive reimbursement approval this time remains to be seen. Until now, patients had to rely on symptomatic treatment for neurofibromatosis due to the lack of an appropriate treatment option. Neurofibromatosis is a rare disease, and 85% of the patients with neurofibromatosis have neurofibromatosis type 1 (NF1), which is caused by a mutation in the neurofibromin tumor suppressor gene located on chromosome 17. The incidence of NF1 is approximately 1 in 3,000. Its first symptom is café-au-lait spots 1 to 3 centimeters in diameter early in life. Since then, the patients experience Optic nerve gliomas (brain tumors) at age 6, and scoliosis around age 6-10. In adulthood, lisch nodules, or iris hamartomas, occur predominantly in patients with NF1. If possible, treatment includes surgical removal of affected sites or chemotherapy and radiation therapy. However, most recur even after surgery, and as the patient must undergo a major operation, its treatment puts an immense burden on both the medical staff and the patient. Recurrence is even more frequent among pediatric patients, which means the patients must live with painkillers and often suffer from speech and movement disorders even after receiving several operations. Meanwhile, Koselugo was jointly developed by AstraZeneca and MSD. The drug blocks the activation of MEK to inhibit the growth of cell lines. The Phase II SPRINT study that became the basis for Koselugo’s approval showed that Koselugo reduced tumor size by over 20% in 68% of the patients that received Koselugo, and achieved its primary endpoint of ORR. Also, 82% of the patients that showed a partial response had sustained responses lasting at least 12 months. In contrast to the non-treated patients, half of which experience disease progression 1.5 years after diagnosis, only 15% of patients using Koselugo showed disease progression at year 3.
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- Promoting the extension of the term of drug patents
- by Kim, Jin-Gu Mar 23, 2023 04:45am
- Previously, patentees could legally extend the duration of a patent unlimitedly, but the government's plan is to promote it up to 'up to 14 years'. According to the pharmaceutical industry on the 21st, the Korean Intellectual Property Office recently prepared an amendment to the Patent Act to reform the system for the duration of drug patent rights. The amendment is expected to be submitted to the National Assembly through legislative acts. In the current drug patent term extension system, there is no separate upper limit (cap). In addition to the essential patent period of 20 years, it extends the time taken for clinical trials and approval and approval of drugs. In other words, the duration of drug patents can be 21 years, 27 years, or 37 years in the '20+α' method. However, the United States and Europe set an upper limit on the additionally recognized period. This means that even if it took a total of 23 years for clinical trials, licensing, etc., only 14 years (USA) or 15 years (Europe) are recognized. On the other hand, Korea and Japan do not have a separate upper limit for this period. As a result, criticism has been constantly raised in the pharmaceutical industry that the patent holder's patent term is excessively long. As part of the evergreening strategy, the original company takes a strategy of registering a new patent and extending the total duration before the patent expiration date. It is criticism.
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- Forxiga's generics will be suspended until the 7th
- by Kim, Jin-Gu Mar 22, 2023 05:47am
- Manufacturing and sales of Dong-A ST's SGLT-2 inhibitor-type diabetes treatment Dapapro are expected to be suspended by early next month. According to the pharmaceutical industry on the 20th, the Seoul Central District Court recently cited AstraZeneca's request for an injunction to prohibit infringement of patent rights filed against Dong-A ST. As a result, Dong-A ST will not be able to manufacture and sell Dapapro until the 7th of next month, when Forxiga's patent expires. Dapapro is a follow-on drug to Forxiga. Among the SGLT-2 inhibitors of Dapagliflozin, the original diabetes treatment, it is currently the only one listed as reimbursement, except Forxiga. In November of last year, Dong-A ST succeeded in avoiding part of the duration of the material patent for Forsyga alone in the first trial by using a 'prodrug' strategy. With this decision, Dong-A ST obtained the right to release a follow-on drug before the patent expiration of Forxiga. In December, Forxiga released Dapapro, a follow-up drug, for reimbursement. It was five months before the expiration of the Forxiga patent. AstraZeneca appealed to the Patent Court immediately after the first trial. At the same time, it filed an application for a provisional injunction requesting a ban on infringement of Dong-A ST's patent rights, including the manufacture and sale of Dapapro, until the second trial verdict. The Seoul Central District Court cited AstraZeneca's application for a provisional injunction. An official from AstraZeneca Korea said, "We welcome the decision of the Seoul Central District Court. Substance patents for active ingredients must be respected for the development of the pharmaceutical industry in Korea." We will work hard to do so,” he said.
- Company
- 10 years of the global launch of K-biosimilars
- by Chon, Seung-Hyun Mar 22, 2023 05:47am
- The cumulative exports of biosimilar products developed by Celltrion and Samsung Bioepis recorded 13 trillion won. Celltrion's Remsima is rapidly expanding its territory 10 years after entering the European market. Celltrion's biosimilars posted cumulative exports of 9 trillion won, and Samsung Bioepis' overseas sales of more than 4 trillion won. ◆Celltrion Health, accumulated exports of 9 trillion won by selling 4 similar types since 2013 According to the Financial Supervisory Service on the 22nd, Celltrion Healthcare's four biosimilars, Remsima, Remsima SC, Truxima, and Herzuma, posted a total of 1.71 trillion won in exports. It increased by 9.2% from the previous year and broke the record for the largest export. Celltrion Healthcare is an affiliate of Celltrion, and Celltrion Healthcare Holdings is the largest shareholder (24.3% stake). Celltrion Healthcare receives antibody biosimilar products from Celltrion and sells them to global distributors. Celltree Healthcare is selling four biosimilars in overseas markets: Remsima, Remsima SC, Truxima, and Herzuma. Remsima is a biosimilar product of Remicade. Remsima SC is a subcutaneous formulation of Remsima. Truxima and Herzuma are biosimilar products of anticancer drugs Mabthera and Herceptin, respectively. Last year, Remsima recorded the largest export of 859.3 billion won. It increased by 6.1% from 809.6 billion won in 2021 and produced the most exports since obtaining European permission in 2013. Despite intensifying competition in biosimilars, Remsima continues to increase exports as more than 100 countries obtained item approval last year. Remsima recorded exports of 145.3 billion won in 2013, and the cumulative amount of exports for 10 years until last year totaled 5,163.1 billion won. Remsima SC exported 236.9 billion won last year, more than double the previous year's 89.6 billion won. With only two products, Remsima and Remsima SC, the joint venture achieved 1.96 trillion won in exports last year. Remsima SC made its first export of 34.8 billion won in 2020 and recorded a cumulative export performance of 361.4 billion won over the past three years. Truxima showed exports of 436.5 billion won last year, down 4.9% from the previous year. It is the second consecutive year of decline since recording 786.8 billion won in 2020. It is analyzed that the growth rate has slowed somewhat as the competition for biosimilars intensified. Truxima posted its first export of 383.2 billion won in 2017 and achieved a total of 2.6148 trillion won in overseas sales over the six years until last year. Herzuma's export volume last year was 181.7 billion won, down 13.9% from the previous year. After posting overseas sales of 211 billion won in 2021, the growth trend has slowed down. Herzuma recorded a cumulative export performance of 865.6 billion won from 2017 to last year. Celltrion's four biosimilars jointly exported a total of 9.49 trillion won for 10 years from 2013 to last year. Samsung Bioepis is also breaking new records every year. Samsung Bioepis' operating profit was 231.5 billion won, up 20.1% from the previous year, and sales were 946.3 billion won, up 11.7% from the previous year. Both operating profit and sales are the highest since its launch in 2012. Sales increased by 21.7% in two years from 777.4 billion won in 2020, and operating profit increased by 59.6% during the same period. The operating profit to sales ratio last year was 24.5%, the highest ever. Starting with the Enbrel biosimilar in January 2016, Samsung Bioepis received approval for six and five biosimilars in Europe and the US, respectively. Biosimilars of five biosimilars of Samsung Bioepis, Enbrel, Remicade, Humira, Herceptin, and Lucentis, have been approved in Europe and the United States. In Europe, it has additionally obtained approval for the sale of Avastin biosimilars. Samsung Bioepis is selling five biosimilars in Europe and three biosimilars in the US. Samsung Bioepis started selling Enbrel and Remicade biosimilars in Europe in 2016. In 2018, it introduced biosimilars to Herceptin and Humira markets and started selling Avastin biosimilar AYBINTIO in Europe in 2021. In the US, among the five licensed products, Remicade biosimilar RENFLEXIS was launched in the US market in 2017, and Herceptin biosimilar Ontruzant was launched in the US in 2020. Last year, it started selling Lucentis biosimilar BYOOVIZ in the US. Established in 2012, Samsung Bioepis generated sales of 43.7 billion won for the first time in 2013. In 2016, when the biosimilar overseas targeting began in earnest, it recorded sales of 147.5 billion won, and has continued to grow every year since. Since its launch in 2012, Samsung Bioepis has recorded cumulative sales of 4,311.2 billion won. Most of Samsung Bioepis' sales come from overseas sales of biosimilars or royalties. Domestic sales volume is negligible. According to IQVIA, a pharmaceutical research institute, Samsung Bioepis' five biosimilars sold a total of 42.5 billion won last year. In other words, the biosimilars of Celltrion and Samsung Bioepis have exported more than 13 trillion won in total over the past 10 years.
