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- 2025-12-23 02:34:31
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- 2 ADC drugs being discussed for reimb after Enhertu
- by Eo, Yun-Ho Feb 23, 2024 05:49am
- Trodelvy and Padcev are now being considered for follow-up discussions in the Economic Evaluation Committee. The two next-generation ADC drugs following ‘Enhertu’ draw attention as they are currently being considered reimbursement listing in South Korea. Gilead Science Korea’s Trodelvy (Sacituzumab govitecan), used to treat triple-negative breast cancer (TNBC), and Astellas Pharma Korea’s Padcev (enfortumab vedotin), used to treat bladder cancer, have cleared the Cancer Disease Review Committee of the Health Insurance Review and Assessment Service (HIRA). The drugs are now being considered for follow-up discussions in the Economic Evaluation Committee. The two drugs are known as antibody-drug conjugates (ADCs) and have demonstrated improved benefits compared to existing therapies in clinical trials. However, determining their domestic prices is challenging due to their high pricing. ‘Enhertu (trastuzumab deruxtecan)’ set a precedent as ADC drugs. In May of last year, Enhertu cleared the review by the Cancer Diseases Review Committee, and within eight months, it passed the Drug Reimbursement Evaluation Committee (DREC). Currently, Enhertu has entered the negotiations for drug pricing. The clearance of Enhertu by DREC may indicate positive outcomes for Trodelvy and Padcev. Considering Enhertu’s limited flexibility in price range during cost-effectiveness evaluation, DREC's approval of Enhertu this round suggests government proposed an ICER value in the mid-to-late range of 50 million won. Trodelvy and Padcev may have a higher chance of positive outcomes. Of course, the course of listing may depend on the results of their clinical evaluation and values. It will be interesting to see the outcomes for two ADC drugs awaiting review from the DREC this year after clearing the Cancer Disease Review Committee. Trodelvy is the first Trop-2 targeting ADC. It is comprised of monoclonal antibody that binds Trop-2, an antigen expressed on cell surfaces, and a TOP1 inhibitor payload ‘SN-38’ that destroys cancer cells. Trodelvy, a second-line or later therapy for patients with metastatic triple-negative breast cancer, is the only approved treatment, excluding cytotoxic chemotherapy, by the Ministry of Food and Drug Safety (MFDS) for use in the entire patient population regardless of genetic mutations or biomarkers. The National Comprehensive Cancer Network (NCCN) guidelines classify Trodelvy as Category 1 for second-line or later therapy in adult patients with metastatic triple-negative breast cancer. Padcev has a Category 1 priority recommendation in the NCCN guidelines. Padcev is a novel treatment option for urothelial cancer patients who have disease progression or relapsed following cancer immunotherapy and platinum-containing chemotherapy and are not eligible for previous standard-of-care treatment options. In March of last year, Padcev was approved in Korea as a monotherapy for patients with locally advanced or metastatic urothelial cancer who had previous experience with platinum-containing chemotherapy or PD-1 or PD-L1 inhibitors.
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- Yuhan ‘confirms the safety and efficacy of its allergy drug
- by Son, Hyung-Min Feb 22, 2024 05:49am
- Yuhan Corp announced on Tuesday that the results of the Phase 1a clinical trial of its allergy drug candidate YH35324 were published in the SCI-ranked International Journal of Immunopharmacology. YH35324 is a novel anti-immunoglobulin E (Anti-IgE) class Fc fusion protein drug. Its main mechanism of action improves allergy symptoms by reducing the level of free IgE in the blood. The Phase 1a clinical trial was the first time YH35324 was administered to humans (First-In-Human (FIH)). The study was conducted from September 2021 to January 2023 in allergy medicine departments of 4 Korean university hospitals and included a total of 68 patients. The study was conducted in two parts: Part A evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single dose of YH35324 in a stepwise dose escalation manner compared to placebo or omalizumab 300 mg. Part B evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single dose of YH35324 or omalizumab in patients with elevated serum total IgE levels (>700 IU/mL). Results demonstrated that YH35324 was well tolerated and safe at all doses, and was pharmacokinetically dose proportional. Also, YH35324 demonstrated more potent and sustained IgE inhibitory activity compared to placebo or omalizumab on serum-free IgE, a key pharmacodynamic biomarker. The notable factor was that Part B results demonstrated an excellent safety profile and more potent and sustained serum-free IgE inhibition compared to existing therapies, even in patients with elevated serum total IgE levels (>700 IU/mL). Part A top-line results from the Phase Ia study were previously presented at the 2023 European Academy of Allergy and Clinical Immunology (EAACI) Annual Congress last year. The top-line results of Part B top-line will be presented as a poster at the American Academy of Allergy, Asthma and Immunology (AAAAI) 2024 Annual Meeting this year. Dr. Hae-Sim Park, Professor of Allergy at Ajou University Hospital, who was the corresponding author for the paper, said, “YH35324 is an anti-IgE trap (Fc fusion protein). Not only was this trial the first successfully completed multicenter trial by Korean multicenter researchers, but it also showed encouraging results. We look forward to YH35324 being developed as a new treatment for patients with allergic diseases worldwide." Yeol-Hong Kim, R&D President of Yuhan Corp, said, “We are currently conducting a Phase 1b trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of YH35324 in repeated doses in healthy individuals with atopic dermatitis or patients with mild allergies, and will soon begin evaluating YH35324 in patients with moderate-to-severe atopic dermatitis.” Yuhan Corp licensed in the technology for YH35324 from GI Innovation in July 2020. The candidate substance is currently being researched and developed in collaboration with the two companies. Its global rights outside of Japan are held by Yuhan Corp, and GI Innovation transferred the Japanese sales rights for the drug to Maruho, a leading Japanese dermatology company, in October 2023.
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- Samsung Bioepis starts Global P1T for Keytruda biosimilar
- by Kim, Jin-Gu Feb 22, 2024 05:49am
- Samsung Bioepis announced today that it has initiated a global Phase I clinical trial for a biosimilar of Keytruda (pembrolizumab), the world's No. 1 selling drug. The product, which is being developed under the name SB27, is the 11th biosimilar in Samsung Bioepis' pipeline. Samsung Bioepis has recruited 135 volunteer patients with NSCLC in 4 countries, including South Korea, for the Phase I study, which will compare the pharmacokinetics, efficacy, and safety of SB27 to the original drug. Keytruda is MSD's immuno-oncology drug. After confirming the drug’s effect in multiple solid tumors, MSD has been expanding its indication to various solid tumors, including melanoma, non-small cell lung cancer, breast cancer, and gastric cancer. The drug topped the global market last year. According to MSD, Keytruda generated USD 25 billion (KRW 33.1 trillion) in sales last year, up 19% from USD 20 billion (KRW 26.7 trillion) it had posted in 2022. In Korea, Keytruda continued to lead overall sales, posting KRW 398.7 billion in sales last year. This is the 4th consecutive year that Keytruda has held the lead in the domestic pharmaceutical market, after first taking the lead in 2020 with sales of KRW155.7 billion. Il-Sun Hong, the Product Evaluation Team lead at Samsung Bioepis, said, “Based on the global clinical trial operation know-how we have accumulated so far, we will do our best to complete clinical trials promptly so that we can provide patients with more treatment options as soon as possible.” With the development of the Keytruda biosimilar, Samsung Bioepis has now expanded its biosimilar pipeline to 11 products. Currently, the company is selling 7 biosimilars in the global market and has completed clinical trials on 3 products. The 7 types currently on the market are ▲SB4(Enbrel biosimilar) ▲SB2(Remicade biosimilar) ▲SB5(Humira biosimilar) ▲SB3(Herceptin biosimilar) ▲SB8(Avastin biosimilar) ▲SB11(Lucentis biosimilar), and ▲SB12(Soliris biosimilar). The 3 others that have completed clinical trials and are awaiting commercialization are ▲SB15(Eylea biosimilar) ▲SB16(Prolia biosimilar), and ▲SB17(Stelara biosimilar).
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- Pfizer’s Zavicefta, sole CRE antibiotic in KOR, gets reimb
- by Son, Hyung-Min Feb 22, 2024 05:49am
- From the left, Professor Lee Dong-gun, Professor Yoon Young-kyung, and Pfizer Korea Medical Lead Choi Heeyeon. A new antibiotic has been added to the insurance reimbursement listing a year after Zerbaxa. Zavicefta, developed by Pfizer, is the only antibiotic that can be used to treat carbapenem-resistant Enterobacteriaceae (CRE). Experts have stressed the use of this drug only when necessary because there is a growing number of patients with antibiotic resistance. Pfizer Korea hosted a press conference at JW Marriot Seoul on the 21st to commemorate the reimbursement coverage of the new antibiotic drug, Zavicefta. Zavicefta is a combination of ‘ceftazidime,’ a third-generation cephalosporins-class antibiotic, and ‘avibactam,’ used to maintain microbial clearance. Zavicefta is the only antibiotic that can treat CRE infections in Korea. It can be used for treating patients with Gram-negative infections, including CRE. Starting on February 1st, Zavicefta has been covered by reimbursement for the treatment of gram-negative infections such as carbapenem-resistant Enterobacteriaceae, according to the Ministry of Health and Welfare (MOHW) announcement. Zavicefta is covered by reimbursement under one of the following conditions: ▲Complicated intra-abdominal infections, ▲Complicated urinary tract infections, ▲Pneumonia contracted within the hospital that is unresponsive to antibiotic treatment or when there is proof of multi-drug resistant P. aeruginosa or carbapenem-resistant Enterobacteriaceae. Zabicefta demonstrated non-inferiority compared to standard therapy in phase 3 clinical trials enrolling patients with various infections. In the RECLAIM study enrolling patients with complicated intra-abdominal infection, the clinical cure rate of the Zabicefta treatment group was 82.5%, similar to the 84.9% of the meropenem treatment group. In the RECAPTURE study enrolling patients with complicated urinary infections, the clinical cure rate of the Zabicefta was 90.3%, showing non-inferiority to the 90.4% of doripenem. Furthermore, Real World Data (RWD) has demonstrated the effectiveness of Zavicefta. In a clinical study involving patients with CRE infections and immune suppression, Zabicefta showed a clinical cure rate of 64.4% in patients with complicated intra-abdominal infection, 88.3% in patients with complicated urinary tract infections such as pyelonephritis, and 68.4% in patients with pneumonia contracted within the hospital such as ventilator-related pneumonia. Based on these results, the 2022 Infectious Diseases Society of America (IDSA) guidelines recommended Zavicefta as a preferred treatment option for CRE or complicated urinary tract infections, including difficult-to-treat pyelonephritis-related Enterobacteriaceae. Due to the growing number of CRE patients, the need to manage patients with antibiotic resistance is urgent Experts have raised concerns about the prevalence of multi-drug resistant infections and the growing number of resistant patients, emphasizing the need to secure adequate treatment options. New treatments are necessary when a patient develops antibiotic resistance, but there is concern that patients may eventually run out of treatment options. “It has been nine years since Zavicefta was developed. Upon reviewing patient cases, the rate of resistance stands at 10%,” Professor Yoon Young-kyung from the Department of Infectious Diseases at Korea University Anam Hospital stated. “In light of the growing number of antibiotic-resistant patients, it is recommended that Zavicefta should be used for patients with absolute needs to prolong its effectiveness,” Yoon emphasized. CRE infections that show resistance to carbapenem-class antibiotics are becoming prevalent globally. The number of CRE patients, 5,717 in 2017, doubled to 11,954 in 2018. Subsequently, it surpassed 23,000 in 2021 and recorded 30,546 in 2022, according to the Korea Disease Control and Prevention Agency (KDCA). “Medications used to treat infectious diseases are different from those used to treat conditions like diabetes or hypertension, where treatment begins after diagnosis, minimizing misuse. However, with antibiotics, there's a concern for misuse. Therefore, healthcare professionals and academia need to collaborate in exploring ways to use antibiotics appropriately,” Professor Lee Dong-gun of the Department of Infectious Diseases at Seoul St. Mary's Hospital said.
- Company
- K-made anticancer drugs Leclaza, Rolontis show sales growth
- by Chon, Seung-Hyun Feb 22, 2024 05:49am
- New anticancer drugs developed by Korean pharmaceutical companies are showing a steady growth path in the market. Yuhan’s Leclaza, a lung cancer treatment, surpassed 20 billion won in annual sales, becoming the first domestically developed anticancer drug to achieve this. Hanmi’s Rolontis, a treatment for neutropenia, reached 10 billion won in sales just two years after its launch. Last year, Leclaza generated 22.6 billion won in sales, showing a 40.3% year-over-year (YoY) growth, according to a drug market research company IQVIA on the 21st. Leclaza is the 31st domestically developed new drug approved in Korea for treating non-small cell lung cancer (NSCLC) in January 2021. Leclaza entered the prescription market after its reimbursement listing in July 2021. The following year after its launch, Leclaza’s sales surpassed 10 billion won, reaching 16.1 billion won. Last year, Leclaza surpassed 20 billion won in sales. Qauterly Leclaza sales trend (Unit: 1 million won, Source: IQVIA). Leclaza was the first domestically developed anticancer drug to surpass annual sales of 10 billion won and later achieved sales of over 20 billion won. Domestically developed new anticancer drugs receiving approval before Leclaza are Il-Yang Pharm's Supect, Dong-A Pharm's Milican, Chong Kun Dang's Camtobell, Samsung Pharm’s Riavax, and Hanmi Pharm's Olita. None of these drugs have exceeded annual sales of 10 billion won. The expanded reimbursement of Leclaza as a first-line treatment will likely drive rapid market growth. Initially, Leclaza was approved as a second-line treatment for locally advanced or metastatic NSCLC that had developed acquired resistance due to a specific genetic mutation (T790M) following the administration of first or second-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKI). Then, Leclaza has received approval for use as a first-line treatment. Last June, the Ministry of Food and Drug Safety (MFDS) approved the application for approval of changes for expanding the use of Yuhan’s Leclaza to a ‘first-line treatment of NSCLC.’ Yuhan submitted an application to the Ministry of Health and Welfare (MOHW) for Leclaza’s reimbursement as a first-line treatment. The MOHW approved Leclaza’s reimbursement expansion to include its use as a first-line treatment last month. Starting this year, Leclaza became available for health insurance reimbursement as a ‘first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with specific genetic mutations.’ The MOHW has estimated that granting reimbursement of Leclaza as a first-line treatment option will require an additional budget of 88.1 billion won. Numerically, there is potential for Leclaza’s sales to surpass 1 trillion won next year. However, competition is expected to increase due to expanded reimbursement of Tagrisso, a similar drug in the same class. Hanmi’s Rolontis generated 11.4 billion won in sales last year, expanding three times compared to its 2022 sales of 3.2 billion won. Rolantis became the second domestically developed new anticancer drug, after Leclaza, to exceed annual sales of 10 billion won. Quarterly Rolontis sales trend (Unit: 1 million won, Source: IQVIA). Rolontis is administered to cancer patients who have undergone myelosuppressive chemotherapy as a treatment of neutropenia or as a preventative measure. Rolontis belongs to a granulocyte colony-stimulating factor (G-CSF) class, which stimulates granulocytes to enhance neutrophil production. It shows a mechanism of action similar to Amgen’s blockbuster drug, Neulasta. After it generated its first sales in Q1 of 2022, Rolontis showed a steady growth in sales. It surpassed 2 billion won in sales last Q1; later, it surpassed 3 billion won in the previous Q4. After its launch, Rolontis generated a cumulative sales of 14.6 billion won. Rolontis is a domestically developed new drug that also received approval from the U.S. Food and Drug Administration (FDA). In 2012, Hanmi Pharm made a technology transport of Rolontis to Spectrum. In September 2021, it won FDA approval under the U.S. product name of Rolvedon. Initially, Rolvedon secured FDA approval after Spectrum Pharmaceutical acquired Rolvedon’s technology transport. Following the approval, Assertio Holdings, a pharmaceutical company specializing in the central nervous system, pain, and inflammation, acquired Spectrum in April last year.
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- K-CAB and Fexuclue, new P-CAB drugs, expand globally
- by Kim, Jin-Gu Feb 21, 2024 05:45am
- HK inno.N’s K-CAB (Left) and Daewoong Pharmaceutical’s Fexuclue (Right). New P-CAB class drugs, K-CAB (tegoprazan) and Fexuclue (fexuprazan), for treating gastroesophageal reflux disease are competing for global entries. HK inno.N’s K-CAB has entered 35 countries globally through technology exports or finished product exports. Within a year of its launch, Daewoong Pharmaceutical’s Fexuclue has been introduced to 24 countries, including Korea. Both companies are aiming to reach 1 trillion in sales. K-CAB has expanded to 35 countries globally, and the company “Aims to achieve 1 trillion won in global sales” HK inno.N announced on the 20th that K-CAB has recently received product approval from the Agencia Nacional de Medicamentos (ANAMED) in Chile. In Peru, the drug will be marketed under the name ‘Ki-CAB.’ Ki-CAB received approval for four indications: ▲Treatment of erosive gastroesophageal reflux disease, ▲Treatment of non-erosive gastroesophageal reflux disease, ▲Treatment of gastric ulcer, and ▲Antibiotic combination therapy for the eradication of Helicobacter pylori in patients with peptic ulcer or chronic atrophic gastritis. K-CAB has launched or is awaiting launch after receiving product approval in nine countries, including Korea. In Asia, K-CAB is sold in China, Mongolia, the Philippines, Indonesia, and Singapore. In Latin America, it is available in Mexico and Peru. Furthermore, K-CAB will be available in Chile as it has obtained product approval. The company seems particularly focused on expanding into the Latin American market. In 2018, HK inno.N signed a contract for finished product exports with Laboratorios Carnot and 17 Latin American countries. Furthermore, the company launched products in Mexico and Peru in May and October. In December 2022, the company exported K-CAB technology to Brazil, the largest pharmaceutical market in Latin America. HK inno.N said they expect drug approvals in various Latin American countries this year. The company’s strategy is to expedite entering the Latin American pharmaceutical market, valued at 72 trillion won. Besides Latin America, K-CAB has entered 35 countries around the world, including the United States and China, through technology exports or finished product exports. HK inno.N aims to accelerate its global entry and enter 100 countries by 2028. Through this, the company aims to achieve its goal of 1 trillion sales. Dal Won Kwak, CEO of HK inno.N, said, “As we await approval in various Latina American countries this year, K-CAB’s global entry is expected to accelerate.” K-CAB has expanded to 35 countries and Fexuclue has entered 24 countries within a year of its launch. Within a year of its launch, Fexuclue has entered 24 countries, with the “Goal of reaching 100 countries by 2027” Fexuclue is also rapidly expanding its global presence. Just one year after its launch, the drug has already reached 24 countries outside of Korea. Fexuclue was officially launched in the Philippines in August last year, marking its first overseas launch. Furthermore, Fexuclue is also set to launch in Mexico, Ecuador, and Chile, where it has received product approvals. Daewoong has applied for product approvals in 13 countries including China, Saudi Arabia, Morocco, Malaysia, Singapore, Costa Rica, and Panama. Last December, Daewoong agreed on exports with India’s number one pharmaceutical company, Sun Pharma. The countries that agreed on Fexuclue export deals now include India, the United Arab Emirates, Bahrain, Kuwait, Oman, and Qatar, bringing the total to six countries. Daewoong is planning to apply for product approval in 30 counties by next year. Also, the company aims to expand its entry into 100 counties world-wide by 2027. The global sales target is set at 1 trillion won, which is the same as K-CAB’s. “Fexuclue achieved noticeable accomplishments, including entering the world’s fourth antiulcer drug market, India,” Daewoong Pharmaceutical Vice President Park Sung-soo said. “We aim to expedite Fexuclue approval in all countries and launch in Mexico this year. Our objective is to expand to 100 countries by 2027.”
- Company
- Sanofi Korea CEO Kyungeun Bae promoted to head 3 countries
- by Eo, Yun-Ho Feb 21, 2024 05:45am
- Sanofi-Aventis Korea’s Country Manager, Kyungeun Bae(53) is continuing on her prosperous career path. Dailypharm’s coverage found that Bae (Sanofi Korea Country Lead) was recently appointed as the general manager to lead subsidiaries including Korea, New Zealand, and Australia of the Sanofi Group. This is the first time a Korean has been appointed to head a foreign subsidiary of a global pharmaceutical company. In addition, Sanofi is unifying its management system. With the exception of Sanofi Pasteur, which is in charge of the vaccines business and has been operating independently, the other businesses will be integrated, the reorganization for which will be made under Bae's leadership. Bae is also the longest-serving CEO of a multinational company in Korea. Appointed CEO of Genzyme Korea in 2010, Bae has led Sanofi-Aventis Korea and the Sanofi Integrated Management Committee (then Sanofi-Aventis, Sanofi Pasteur, Genzyme, and Merial) for more than a decade, since 2013. Regarded as one of the representative female CEOs of a multinational company, Bae has spent most of her career experience at Novartis, after which she joined Genzyme and led the integration process that led to Genzyme's full acquisition by Sanofi in 2019.
- Company
- Keytruda leads mkt for 4 consecutive years
- by Chon, Seung-Hyun Feb 21, 2024 05:45am
- The immuno-oncology drug Keytruda has taken the lead in the domestic market for the 4th consecutive year. Its quarterly sales exceeded KRW 100 billion for the first time in the domestic market after being expanded reimbursement to the first line. The gap with the runner-up had more than doubled, reinforcing Keytruda’s leadership in the market. According to the market research institution IQVIA on the 21st, MSD’s Keytruda topped the list of drugs sold in Korea last year with sales of KRW 398.7 billion. The drug had continued to show high growth, rising 66.4% from the previous year. This is the fourth consecutive year that Keytruda has kept the lead, having first topped the list in 2020 with sales of KRW 155.7 billion. Released in 2015, Keytruda is an immune checkpoint inhibitor that inhibits PD-1 (programmed death 1) proteins expressed at the surface of activated T cells, thereby inhibiting its binding to PD-L1 and activating the immune system to treat cancer. Currently, Keytruda is indicated to treat▲Lung cancer, ▲head and neck cancer, ▲ Hodgkin lymphoma, ▲urothelial carcinoma (bladder cancer), ▲esophageal cancer, ▲ melanoma, ▲renal cell cancer (kidney cancer), ▲endometrial cancer, ▲stomach cancer, ▲small intestine cancer, ▲ovarian cancer, ▲pancreatic cancer, ▲biliary tract cancer, ▲colorectal cancer ▲triple negative breast cancer, and ▲cervical cancer. It is indicated for the largest number of cancer types among cancer immunotherapies approved in Korea. The drug is currently reimbursed for 7 indications in 4 types of cancer - non-small cell lung cancer, melanoma, urothelial carcinoma, and Hodgkin's lymphoma. Keytruda is also reimbursed for first-line use in melanoma and NSCLC. In the early years of its release, in 2016 and 2017, its sales had only been KRW 100 billion and KRW 12.2 billion. However, its sales started to surge with reimbursement approval. After being reimbursed as a second-line treatment for non-small-cell lung cancer in August 2017, its sales soared over fivefold to KRW 70.3 billion in 2018 and then exceeded KRW 100 billion by 2019. In 2020, the drug outsold the then-lead Lipitor and rose to the lead. Keytruda’s sales grew 28.5% and 19.7% year-on-year in 2021 and 2022, respectively, and the growth rate accelerated further last year with its reimbursement expansion. In March 2022, Keytruda’s reimbursement was extended to cover its use as a first-line treatment for non-small cell lung cancer. Keytruda's sales then increased 33.4% from KRW 40.4 billion in Q1 2022 to KRW 53.9 billion in Q2 2022. In Q3 and Q4, the drug’s sales rose to reach KRW 67.2 billion and KRW 78 billion, respectively Keytruda’s sales exceeded KRW 80 billion and KRW 90 billion in Q1 and Q2 last year, respectively, then exceeded KRW 100 billion in Q3. In Q4 its sales reached KRW 108.9 billion, renewing its record for the 6th consecutive quarter since Q3 2022. Despite a 25.6% reduction in its price ceiling that was applied in March 2022 with the reimbursement expansion, Keytruda’s Q4 sales increased 99.3% compared to Q4 2021, before the reimbursement expansion. As such, Keytruda has again solidified its market lead, with its sales more than double what was posted by the runner-up in the market, Prolia. New drugs from multinational pharmaceutical companies have also shown strong sales last year. Amgen's Prolia ranked second overall with sales of KRW 151.1 billion last year, up 30.6% from the previous year. Its sales increased 64.0% in 2 years from KRW 92.1 billion in 2021. Prolia, which was released in November 2016 in Korea, is a biological osteoporosis treatment that targets the RANKL protein essential for the formation, activation, and survival of osteoclasts that destroy the bone. Its sales started to rise after it was applied reimbursement as a second-line treatment in 2017. After additionally being approved for reimbursement for first-line use in April 2019, Prolia’s sales rose explosively. In 2022, Prolia’s sales exceeded KRW 100 billion for the first time in 6 years and continued strong growth last year as well. Sales of Sanofi’s atopic dermatitis treatment Dupixent rose 36.1% YoY to record ₩143.2 billion last year. Dupixent is the first targeted biologic for the treatment of moderate-to-severe atopic dermatitis that is not well controlled with prescription topical therapies or who cannot use topical therapies. Sales of Dupixent, which was approved in March 2018, increased rapidly after it was approved for reimbursement for severe atopic dermatitis in January 2020. After posting sales of KRW 77.2 billion in 2021, its sales grew 85.4% in 2 years. Sales of Ono Pharmaceutical’s cancer immunotherapy Opdivo increased 18.7% YoY to record ₩130.4 billion this year. Sales of Opdivo, which was approved in 2015, grew greatly after being listed for reimbursement in 201 It exceeded annual sales of KRW 100 billion for the first time in 2022 with sales of KRW 109.9 billion, and sales grew even further last year. Its sales had grown 85.4% over the 2 years. Also, other new drugs from multinational pharmaceutical companies, such as Lipitor, Perjeta, Tagrisso, and Gardasil, surpassed the KRW 100 billion mark in sales last year. Among drugs developed by domestic companies, HK Inno.N’s K-Cab and Hanmi Pharmaceutical's Rosuzet topped the list with sales in the KRW 100 billion range.
- Company
- Samsung Bioepis will directly sell 3 of its biosimilars
- by Nho, Byung Chul Feb 20, 2024 06:00am
- (From the left) Samsung Bioepis’s Etoloce (Enbrel biosimilar), Remaloce (Remicade biosimilar), and Adalloce (Humira biosimilar) Samsung Bioepis is expected to strengthen its sales and marketing force and network and switch to direct domestic sales of its 3 self-developed biosimilars. According to industry sources, Samsung Bioepis will directly sell 3 of its biosimilars for autoimmune diseases (TNF-alpha inhibitors) in the domestic market from next month (March). The products Samsung Bioepis will directly sell in Korea include Etoloce (Enbrel biosimilar), Remaloce (Remicade biosimilar), and Adalloce (Humira biosimilar), which were previously sold by Yuhan Corp. In October 2017, Samsung Bioepis switched its distributor for its Etoloce and Remaloce from MSD to Yuhan Corp. Afterward, in March 2021, the companies added a marketing and partnership agreement for Adalloce to establish a sales cooperation system. The two companies have been expanding the prescription of biosimilars in the KRW 200 billion domestic TNF-alpha inhibitor market and contributing to saving Korea’s national health insurance through drug price reductions. With the termination of the marketing and partnership agreement with Yuhan Corp, Samsung Bioepis plans to directly market the 3 products from March without extending the agreement or entering into additional partnerships. To this end, Samsung Bioepis has reportedly established its own sales organization and recruited professional personnel for distribution. In this regard, an industry insider said, "Samsung Bioepis currently has established a sales headquarters in Korea with 20 people, and will soon begin to provide guidance on the company’s direct sales plan to healthcare providers in Korea.” However, Samsung Bioepis refrained from commenting on the plan, explaining “While it is true that the marketing partnership has ended, we are not at a stage to comment on specific plans related to the transition to direct sales.” In addition to its autoimmune disease drugs, Samsung Bioepis is currently selling 2 anti-cancer drugs through Boryung and 1 eye disease drug through Samil Pharm. On the 1st, the company announced the signing of its sales agreement with Samil Pharmaceutical for its follow-up product (SB15, Eylea biosimilar). Another industry insider noted, "Unlike biosimilars, the specialty drugs that Samsung Bioepis is selling gin partnership with Boryung and Samil have high barriers to entry, so it is unlikely that Samsung Bioepis will expand direct sales to cancer and eye disease drugs in the future."
- Company
- Generic Pazeo sales 24%↑ after patent dispute win
- by Kim, Jin-Gu Feb 20, 2024 06:00am
- Last year, generic products in the market for eye drops with the active ingredient olopatadine, used to treat allergic conjunctivitis, posted a 24% year-over-year (YoY) increase in prescription sales. It is the most significant sales expansion since 2019. The pharmaceutical industry anticipates a substantial expansion in prescription sales of generic olopatadine. In Q3 of last year, generic companies scored a win in a six-year-long patent dispute for ‘Pazeo 0.7% Eye Drops’. This means that they no longer have the burden of potential infringement of patent and compensation payments. The prescription of olopatadine eye drops tends to increase in the second and third quarters when outdoor activities are more prevalent. Therefore, generic companies aim to market a ‘0.7% highly concentrated product’ that no longer has patent risks. Prescription sales of olopatadine eye drops increased from 57.6 bil to 71.1 bil. Major generics rose 20%↑ According to UBIST, a pharmaceutical market research agency, on the 19th, the market size of outpatient prescription treatments of allergic conjunctivitis (eye drops) containing the active ingredient olopatadine was 71.1 billion won. The market has expanded rapidly over five years, with an approximately 14% yearly growth: 39.4 billion won in 2019, 43.6 billion won in 2020, 50 billion won in 2021, and 57.6 billion won in 2022. Last year, sales increased by 23% YoY, showing a steep growth. It is speculated that generics, which constitute 86% of the market, performed well, contributing to this growth. Original vs. Generics prescription sales of eye drops containing active ingredient olopatadine (Unit: 100 million won, Source: Ubist). Net prescription sales of generic olopatadine increased from 49.4 billion won in 2022 to 61.3 won last year, showing a 24% growth over a year. The sales of the major generic products increased by more than 20%. The sales of Sam Chun Dang’s ‘Oloten'·'Oloten Hi'·'Oloten Plus’ increased from 7.8 billion won in 2022 to 9.4 billion won last year, showing a 20% growth. The sales of Lite PharmTech’s ‘Lite Olon’ series Eye Drops increased from 4.3 billion won to 6.7 billion won, a 57% growth. The sales of Hanlim Pharm’s ‘Olo-Once'·'Olopanol'·'Olopower’ increased from 4.1 billion won to 5.9 billion won, a 44% growth. The sales of Dae Woo Pharmaceutical’s ‘Paradin’ series Eye Drops increased from 4.6 billion to 56 bilion won, a 44% growth. With the risk associated with patent trials reduced, generic companies will now aggressively market the ‘0.7% high concentration product’ The pharmaceutical industry anticipates that generic prescription sales will likely expand even more this year. This is because generic companies won against Novartis in a patent dispute for Pazeo Eye Drops, eliminating patent infringement risks. On August 31st of last year, the Supreme Court dismissed all Alcon’s appeals in the second trial against Hanmi Pharm. The patent dispute over Pazeo Eye Drops that lasted six years ended with generic companies’ victorious win. Novartis owns three original products containing the active ingredient olopatadine, differentiated by dosage: 0.1% Eye Drops named ‘Patanol,’ 0.2% Eye Drops named ‘Pataday,’ and 0.7% Eye Drops named ‘Pazeo.’ Photos of Pazeo. Novartis filed a separate patent for its 0.7% high concentration product. The patent dispute was related to Pazeo. Pazeo, a medication developed by Novartis in 2016, has a higher active ingredient concentration at 0.7%. Novartis filed two separate active ingredient patents for Pazeo, which will expire in 2032. Generic companies filed a patent invalidation trial against two patents. Based on their victory in the second trial, several companies have since launched generics of 0.7% eye drops. However, after Novartis appealed to the Supreme Court, generic companies did not market their products aggressively. The analysis suggests that generic companies were cautious about potential patent infringement and subsequent compensation payments if the Supreme Court ruled in favor of Novartis, leading to their passive marketing of the 0.7% product. There is a noticeable difference in prescription records between the original product and generic products, particularly in terms of concentration. In the case of the original product, prescription records are highest for the 0.7% high-concentration product. Based on last year's prescription sales, Patanol, the 0.1% product, and Pataday, the 0.2% product, each amounted to 1.7 billion and 2.4 billion won respectively, while Pazeo, 0.7% product, reached 5.6 billion won. More than half (57%) of the prescription sales for olopatadine original products comes from Pazeo. On the other hand, for generics, the prescription sales for the 0.7% product are at a minimal level. Taking the market-leading product series from Sam Chun Dang, the Oloten series, as an example, while Oloten, the 0.1% product, and Oloten Plus, 0.2% product, each amounted to 3.2 billion and 5.1 billion won, respectively, Oloten Hi, the 0.7% product, only reached 1.1 billion won. The proportion of the 0.7% product in the entire series is merely 12%. Prescription sales for major products containing the active ingredient olopatadine. The highest prescription volume for the original product is for 0.7% high concentration product. For generics, prescriptions are primarily for the 0.1% and 0.2% products. It was observed that Hanlim Pharm, which holds the third-largest share in the market, had a similar record of prescription pattern. Last year, the prescription sales for their 0.1% product, Olopanol, and 0.2% product, Olo-Once, were 2.8 billion won and 2.9 billion won, respectively, whereas the 0.7% product, Olopower, only amounted to 300 million won, constituting about 4% of the total. As a result, many companies have opted to launch products with concentrations of 0.1% and 0.2%, instead of the 0.7% product. However, last year’s Supreme Court ruling has greatly reduced risks involved in trials. As a result, generic companies are expected to begin marketing 0.7% high-concentration products aggressively. Sales performance during the second and third quarters will be crucial, as prescriptions are primarily made during the second and third quarters due to the high outdoor acitivities that exacerbate allergic conjunctivitis. A pharmaceutical company with a related product stated, “We have high expectations for the 0.7% product. Especially now that the trial risks have diminished, we anticipate aggressive sales this year.”
