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- 2026-03-17 23:19:10
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- Shingles vaccine market overwhelmed by COVID-19… drops 60%
- by An, Kyung-Jin Aug 27, 2021 05:59am
- The domestic market for shingles is shrinking at a fast pace. With vaccinations for COVID-19 ongoing in earnest from earlier this year and the new ‘Delta variant’ intensifying the resurgence of COVID-19 cases, sales of the two shingles vaccines have dropped together. According to the pharmaceutical research institution IQVIA on the 26th, the shingles vaccine market in Q2 this year was ₩9.2 billion, a 59.1% YOY decrease from the ₩22.6 billion in the same period of the previous year. Sales had decreased 53.0% compared to the ₩19.6 billion in Q2 2019. Cumulative sales in 1H of this year have also decreased 42.2% from the previous year to record ₩20.1 billion. The shingles vaccine market in Korea consists of two products – MSD’s ‘Zostavax’ and SK Bioscience’s ‘SKYZoster.’ Its market had grown rapidly with the introduction of ‘SKYZoster’ in 2017 that broke the monopoly held by ‘Zostavax.' The local vaccine ‘SKYZoster’ had gradually increased its influence in the market, to rise and record ₩27.9 billion in Q4 2019. However, this shingles vaccine market that was once on a roll, is riding a rollercoaster of ups and downs after the COVID-19 pandemic. In Q1 last year, when COVID-19 started to spread, the market sales had halved to ₩12.2 billion. In Q2 of the same year, the market showed some signs of recovery, recording ₩22.6 billion, but then started falling again to ₩20.3 billion in Q3 and ₩17.3. billion in Q4. Entering this year, the drop became steeper, to record the lowest-ever sales since the two-drug competition structure was established in the market. The industry pointed out that the shingles vaccine market and other vaccine markets are more vulnerable to external factors such as pandemics, etc. than the chronic disease treatment market. Such vaccines are used to prevent a disease rather than be used in emergencies, therefore, the spreading reluctance to visit medical institutions naturally leads to a reduced vaccination rate. Full-scale inoculations with COVID-19 vaccines developed by multinational pharmaceutical companies including Pfizer and BioNTech, AstraZeneca, and Janssen have started earlier this year and have affected the decrease in the number of people receiving other vaccines. According to the Korea Disease Control and Prevention Agency, as of midnight on the 25th, a total of 26,701,704 people have received their first dose of a COVID-19 vaccine. This is around 52.0% of the total population in Korea. With the social atmosphere prioritizing COVID-19 vaccinations, Most of the vaccine market for adults, including the one for the shingles vaccine, is experiencing a slump. The two types of shingles vaccines -‘Zostavax’ and ‘SKYZoster’ – have shown a similar trend in their distribution of quarterly sales since last year. ‘Zostavax’ sold ₩5.4 billion in Q2 last year, which is a 57.9% YOY decrease from the same period of the previous year. This is also a 17.0% drop from the previous quarter, during which ‘Zostavax’ sold ₩6.5 billion. This year's cumulative sales in 1H were ₩11.9 billion, a 40.8% decrease from the previous year. Starting this year, MSD’s ‘Zostavzx’ has been marketed and sold by HK Inno.N in Korea. SKYZoster’s sales dropped 60.8% YOY to record ₩3.8 billion in Q2 this year. This is the lowest ever performance shown for the product other than in Q4 of 2017, immediately after its release. Cumulative sales of the first half of this year were ₩8.2 billion, a 44.2% decrease from the previous year. Not only in sales but SKYZoster’s market influence, which had skyrocketed ever since its release, has also decreased due to the pandemic. Based on cumulative sales of 1H, SKYZoster’s share in the market has decreased 1.4%p YOY from 42.2% to 40.8%. SK Bioscience expected sales of SKYZoster to recover in 2H with the increase of people who completed COVID-19 vaccinations and the start of the flu vaccination season.’ Also, another competitor is soon to be introduced to the domestic shingles vaccine market, forewarning more changes to come. Earlier this year, GSK has applied for the marketing authorization of its shingles vaccine, ‘Shingrix,’ to the Ministry of Food and Drug Safety. ‘Shingrix’ has been approved and is being sold in major countries around the world since 2017, when it was first approved by the U.S. Food and Drug Administration. Due to its high demand, the vaccine has been met with shortages in stock abroad. If sold in Korea, GSK’s ‘Shingrix’ in Korea may intensify competition and become a game-changer in the market.
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- Korea Pharma has signed a contract to supply Accrufer
- by Aug 27, 2021 05:59am
- Korea Pharma announced on Monday that it has signed an exclusive contract with Shield Theapeutics to supply the anaemic drug Accrufer in Korea. Anemia is very common in patients with inflammatory bowel disease (IBD) and chronic kidney disease (CKD). Poor treatment of anemia increases the morbidity and morbidity of cardiovascular disease. According to Korea Pharma, existing oral anemia treatments have severe side effects such as gastrointestinal disorders and constipation. Since intravenous iron tablets require visiting hospitals once to three times a week, it takes time and is economically burdensome. Accrufer is an ideal alternative because it does not cause side effects such as gastrointestinal disorders and constipation, and absorbs as much iron as the body needs. Accrufer is a formulation that can replace the main used iron in the AEGIS-H2H study published in March 2019. Accrufer is expected to reduce the economic burden of intravenous iron preparations and improve patient conformity. Accrufer is approved by the FDA and EMA and is sold in Europe and the United States. It is the only oral anemia treatment in Korea that has been recognized for its excellent efficacy and safety with FDA approval. "Korea Pharma is a successful pharmaceutical company with outstanding performance in product development and commercial success," CEO Greg Madison said. "Iron deficiency is a global problem, and through this agreement, more iron deficiency patients in Korea will be able to use Accrufer in the near future," he said. Park Eun-hee, CEO of Korea Pharma, expects that the company will be able to provide iron deficiency treatment to Korea through Accrufer. Korea Pharma signed the world's first one-liter PEG bowel cleansing Plenvu exclusive contract with Norgine in December 2018, and this time it has expanded to IBD and CKD through Accrufer exclusive contract.
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- Who will head Novartis Korea after Joshi Venugopal?
- by Eo, Yun-Ho Aug 26, 2021 05:58am
- The president of Novartis Korea is expected to change soon. According to industry sources, Joshi Venugopal, who had led Novartis Korea since September 2018, has completed his term at the end of last month and made a promotional transfer to become the Global Head of New Products at Novartis headquarters. Novartis Korea’s Chief Finance Officer, Kim Skafte Mortensen, has been running the company as the acting head since Joshi Venugopal’s resignation. Novartis is currently seeking a new head for its Korean subsidiary that will officially be appointed in coming October. Regarding the new appointment, some industry officials are cautiously mentioning internal rumors of a Korean national being appointed. Although Novartis has been operating its oncology and pharmaceutical division independently as a separate division, with reimbursement discussions for the CAR-T therapy ‘Kymriah (tisagenlecleucel)’ and SMA treatment ‘Zolgensma’ in progress, who will be appointed the new head is attracting much attention. Since its establishment in 1997 and the first president Frans Hompe, the company had mostly appointed foreign heads to lead the Korean subsidiary, including Jean-Luc Scalabre in 1998, Peter Maag in 2003, Andrin Oswald in 2006, Peter Jager in 2008, Brian Gladsen in 2014, and most recently, Joshi Venugopal. The only Korean national that had been appointed until now was Hak-sun Moon in 2015.
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- GSK will supply Fluarix Tetra through Kwang Dong
- by Aug 26, 2021 05:58am
- GSK has signed a contract with Kwang Dong, which has disrupted discussions between SK Bioscience and Fluarix Tetra. GSK announced on the 24th that it has advertised and signed a joint sales contract with the flu vaccine Fluarix Tetra as a new partner. Initially, GSK discussed co-sale of Fluarix Tetra with SK Bioscience, which decided not to produce the flu vaccine "SKY Cellflu" this year. It seemed that the contract in the form of SK Bioscience sales marketing and receiving inquiries from hospitals and clinics in the consumer counseling office was almost finalized, but it was not contracted. GSK signed a contract with Kwang Dong. Kwang Dong decided to supply only a small amount of Fluarix Tetra to some hospitals, but it also decided to take charge of all the supplies SK Bioscience was planning to take. Kwang Dong will be responsible for the sale of Fluarix Tetra in all areas, including internal medicine, family medicine, orthopedic surgery, pediatrics and gynecology. GSK is expected to strengthen its expertise in distribution of influenza vaccines through the signing of this partnership. Yoon Je-young, brand manager of GSK's vaccine marketing department, said, "I think this contract will serve as an opportunity for Fluarix Tetra to be supplied and distributed more appropriately to the market."
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- MSD’s Keytruda becomes the 'symbol' of cancer immunotherapy
- by Eo, Yun-Ho Aug 25, 2021 05:57am
- Pic. of Keytruda “Reinforcing the body’s immunity to attack cancer cells” By some, the idea was regarded improbable. Not many were convinced that immunotherapy would rise to the position it is in now. Even without reference to the famous story of how the former US president Jimmy Carter cured melanoma with immunotherapy, cancer immunotherapy has become an important pillar in the management of cancer disease nowadays. Among the many drugs introduced, MSD’s (Merck in the US) ‘Keytruda (pembrolizumab)’ has risen to become the symbol of ‘cancer immunotherapy.’ The drug, which was first approved in March 2015 as a treatment for melanoma, is currently approved for 18 indications in 14 cancer types in Korea. One thing to note is that Keytruda is yet far from reaching its turning point. ◆A neglected substance becomes an all-around anticancer drug Keytruda’s history goes all the way back to 2003. Keytruda was developed as a humanized antibody by Organon, a Dutch pharmaceutical Company. In 2007, Organon was acquired by Schering Plough, and the substance was approved for clinical trials by the FDA in December 2012. In 2014, only 3 years after trial approval, the company submitted a New Drug Application to the FDA and received approval as a treatment for melanoma in September of the same year. This was how Keytruda’s journey began. One interesting aspect to note is that MSD was not a prominent player in the field of oncology. The company, whose key areas focused on chronic disease, women’s disease, and vaccines, realized the potential of Keytruda and established a business division for the single drug. MSD’s insight and drive in making the decision to invest in a substance that was neglected by the initial developer is also one key strength of the company to note. After the initial melanoma indication, Keytruda was approved as a second-line treatment for non-small cell lung cancer in 2016, an area in fierce competition. Then, the drug became the first among cancer immunotherapies to receive approval as a first-line treatment for Stage 4 metastatic NSCLC. Afterward, by adding the combination therapy option to its treatment regiment, the drug’s indication was expanded from patients with high PD-L1 expression to all patients to position itself as the standard treatment option for all patients with metastatic NSCLC. Also, Keytruda transformed the concept of cancer treatment by becoming the first to be approved for ‘tumor agnostic' use in all cancer types based on specific genetic features regardless of the initial cancer site. In Korea, the drug was approved as a second-line treatment for 7 types of microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, and more recently, as a first-line treatment for metastatic MSI-H/dMMR colorectal cancer. Keytruda ◆MSD Reaps rewards for its foresight… No.1 in sales in both Korea and the global market The company reaped rewards from its aggressive investment. Keytruda recorded No.1 in global sales in 2020, earning $14.38 billion (₩16.8 trillion as of August 18th, 2021). The same went for Korea as well. According to IQVIA, Keytruda recorded ₩155.7 billion in the domestic pharmaceutical market in 2020 to rank first among all pharmaceuticals in sales and has maintained the lead in the first half of this year. In the early years of its release, in 2016 and 2017, Keytruda sold around ₩10 billion’s worth; however, its sales hit ₩70 billion in 2018. The upsurge was driven by its reimbursement approval as second-line treatment for NSCLC in August 2017. As previously mentioned, much potential remains for Keytruda. MSD is conducting more than 1,400 global clinical trials focusing on Keytruda. Korea’s contribution is also quite significant in the area. Around 120 of the global anticancer therapy trials being led by MSD are being conducted in Korea and consist of around 88% of all trials conducted by MSD Korea. Based on the number of participating patients, Korea has ranked 1st among Asia-Pacific countries and 4th in global. ◆The remaining challenge...a rough ride to reimbursement extension However, obstacles do exist in Keytruda’s winning strides as well. Reimbursement is an issue as the insurance benefit is only approved for two indications, as second-line treatment for melanoma and lung cancer. The drug was not able to extend its scope of reimbursement since September 2017. In MSD’s discussions with the health authorities to reimburse Keytruda as second-line treatment for lung cancer, its competitor, the ‘all-comer’ drug ‘Opdivo (nivolumab),’ took away a partial win by strategically narrowing its scope of reimbursement, however, Opdivo also had not seen much progress in expanding its reimbursement ever since. The discussion for Keytruda’s reimbursement as first-line treatment in NSCLC has been ongoing for around 4 years now. It took 9 attempts for the agenda to pass the Health Insurance Review and Assessment Service’s Cancer Disease Review Committee (CDRC) meeting, however, the committee still requested further revisions to be made to the cost-sharing plan. With the burden of re-revisions in mind, MSD is waiting for the agenda to be put up for deliberation by the Drug Reimbursement Evaluation Committee. With the negotiations for contract renewal of the Risk-sharing Agreement (RSA) also overlapping, Keytruda is now at its highest inflection point since its entry into the Korean market. Due to its versatility, expanding the scope of reimbursement for Keytruda may indeed result in the creation of a budget-gobbling monster. In every field, the industry always moves faster than the system. Whether Keytruda will be able to continue making progress in the sea of unprecedented, advanced new drugs that are being introduced remains to be seen.
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- Keytruda monopolizes the domestic pharmaceutical market
- by Chon, Seung-Hyun Aug 24, 2021 06:06am
- MSD's immuno-cancer drug Keytruda has taken the lead in the domestic pharmaceutical market for the sixth consecutive period since the first quarter of last year. New drugs recently released by domestic and foreign pharmaceutical companies such as Perjeta, Prolia, and K-CAB are growing. According to IQVIA, a pharmaceutical research firm on the 23rd, Keytruda recorded the highest sales of ₩93.3 billion in the first half of last year. It is up 29.% from the same period last year. Keytruda saw its sales rise 27.0% year-on-year to ₩44.1 billion in the first quarter, and continued its growth rate of 31.0% with sales of ₩49.2 billion in the second quarter. Keytruda has topped the list for the sixth consecutive quarter since its first quarterly sales of ₩34.7 billion in the first quarter of last year. Keytruda, which was released in Korea in 2015, is an immune checkpoint inhibitor that inhibits 'PD-1' protein on the surface of immune cell T cells to treat cancer through activation of immune cells. It is showing outstanding performance in more than 30 cancer species including lung, parietal, gastric, and cervical cancer. Keytruda's quarterly sales remained around ₩3 billion shortly after its release, but sales began to rise at a rapid pace since August 2017 when insurance benefits were applied as a secondary treatment for non-small cell lung cancer. Keytruda surpassed ₩10 billion in sales in the first quarter of 2018 and ₩30 billion in sales in the second quarter of 2019. In the first quarter of last year, Lipitor, which had never missed the lead in quarterly sales since the fourth quarter of 2015, was ranked No. 1 overall. In the second quarter, Keytruda had a sales gap of more than ₩10 billion with the second-largest Lippitor (₩38.3 billion). The gap with Avastin (₩30.2 billion) is close to ₩20 billion. Sales of new drugs recently released by domestic and foreign pharmaceutical companies such as Perjeta, Prolia, and K-CAB have risen sharply. Roche's Perjeta saw its first-half sales rise 29.6% year-on-year to ₩45 billion. Perjeta is a metastatic or localized HER2-positive breast cancer patient who has never received HER2 targeted chemotherapy or chemotherapy. It is a drug used in combination with Trastuzumab or Docetaxel. Perjeta is a primary treatment for HER2-positive metastatic or intemperable breast cancer patients who have never received anti-HER2 treatment in 2017, and sales also surged as Trastuzumab and combination therapy became the standard for preoperative supplementary therapy in May 2019. Perjeta ranked seventh overall in the second quarter, with sales rising 34.7% year-on-year to ₩23.6 billion. Amgen's Prolia ranked ninth overall, with sales rising 21.6% year-on-year to ₩42.4 billion in the first half. Prolia, which was released in Korea in November 2016, is a biomedicine osteoporosis treatment that targets protein RANKL, which is essential for the formation, activation and survival of bone-destroying skeletal cells. Prolia's sales have exploded since April 2019 as insurance benefits have been recognized in primary treatment therapy. Chong Kun Dang is jointly selling Prolia with Amzen. HK inno.N's new drug K-Cap, an anti-orgel drug, was the only one among the top 10 developed drugs in Korea, with sales rising 57.4% year-on-year to ₩41.7 billion in the first half. K-CAB, which was released in March 2019, is an anti- ulcer drug of the potassium competitive gastric acid secretion inhibitor (P-CAB) family of Tegoprazan. It is a new mechanism for inhibiting gastric acid secretion by competitively combining proton pumps and potassium ions located in the final stage of acid secretion in stomach wall cells. K-CAB secured an indication of gastrointestinal reflux disease as its first indication, and added gastrointestinal ulcer treatment adaptation in July of the same year, showing more sales growth. Sanofi's anti-thrombotic drug Plavix increased sales by 21.3% year-on-year to ₩46.8 billion in the first half of the year. Patent of Plavix expired in 2007 and more than 100 generics were released. It has been more than 10 years since the patent expired and is showing rather steep growth even though it competes with more than 100 generics.
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- Tylenol sales jump 140% due to the pandemic
- by Chon, Seung-Hyun Aug 24, 2021 06:05am
- Sales of the OTC antipyretic analgesic ‘Tylenol’ have soared. With the increased demand among people receiving the COVID-19 vaccinations, Tylenol sold ₩43.6 billion in the first half of this year, which is twice more than that sold in the whole term of last year. There has been criticism that the government’s recommendation to take Tylenol in the early phases of inoculation has promoted sales of specific brands. According to the pharmaceutical research institution IQVIA on the 23rd, sales of Tylenol Tab. and Tylenol 8 hours ER Tab. had sold 139.6% more year-on-year to record ₩43.6 billion in the first half of this year. Tylenol’s sales increased 167.9% YOY to record ₩33.6 billion, and sales of Tylenol 8 hours ER Tab. increased 77.0% YOY to record ₩10 billion. Tylenol and Tylenol 8 hours ER are both antipyretic analgesics containing the single-ingredient acetaminophen. Sales of both Tylenol and Tylenol 8 hours ER had surged in Q2 this year. Tylenol’s sales in Q1 increased 25.9% YOY to ₩8.1 billion, but expanded further in Q2 to increase 318.6% YOY to record ₩25.5 billion. Tylenol 8 hours ER sold ₩2.5 billion in Q1, which was a 27.9% decrease YOY to ₩2.5 billion, but sales of the product rebound in Q2 to rise 253.5% YOY and record ₩7.5 billion. Sales have increased with those receiving COVID-19 vaccinations buying Tylenol in advance to prepare for fevers or muscle aches. Inoculations started in Korea in late February, and with the number of people receiving vaccination increasing, demand for antipyretic analgesics has also surged. Also, there has been criticism over the government’s contribution to the surge of sales. The government authorities have informed people receiving COVID-19 vaccinations that “it is good to take Tylenol when fevers or other side effects arise after vaccination.” Since then, the demand for Tylenol took a sudden leap and led to shortages in its stock. Due to the continued instability in the supply of Tylenol, the government belatedly set out to address the issue. In May, the Ministry of Food and Drug Safety had announced that around 60 single-ingredient acetaminophens products are being sold in the market, and guided citizens to purchase other products. In June, the Ministry of Food and Drug Safety, Korean Pharmacists’ association, Korea Pharmaceutical and Bio-Pharma Manufacturers Association, Korea Pharmaceuticals Distribution Association, and Tylenol’s manufacturer Johnson & Johnson had agreed to work together to stabilize the supply of acetaminophen. The Korea Pharmaceuticals Distribution Association had made emergency measures to promptly supply the acetaminophen that they received to all pharmacies nationwide. The MFDS also discussed measures with the Korea Pharmaceuticals Distribution Association and Johnson & Johnson Korea to expand the supply of Tylenol to pharmacies nationwide. However, other acetaminophen products did not enjoy such an increase in their sales. Sales of major acetaminophen agents in Korea have shown that sales of Samjin Pharm’s ‘Geborin’ fell 30.3% YOY to record ₩6.6 billion in the first half of this year. Geborin’s sales fell 6.9% YOY in Q1, then increased 8.3% YOY in Q2, and did not benefit from the increased number of COVID-19 vaccinations. Sales of Chong Kun Dang’s ‘Penzal Q’ and ‘Penzal 8 hours ER’ fell 7.2% YOY to record ₩2.2 billion in the first half of this year. In fact, acetaminophen’s position in the market had become unstable with the constant safety issues that were being raised recently. The MFDS has strengthened the safety measures for prolonged-release forms of acetaminophen-containing agents in 2018 to reduce risks from overdose such as liver damage etc. The authorities reduced the package units to less than the maximum daily dose and indicated the dosing interval (8 hours) in the product name. In 2011, the strength of each dosage unit of prescription acetaminophen products was restricted to 325mg due to the risk of liver damage and allergic reactions. In addition, an impurity concern arose last year. In July last year, the acetaminophen API manufactured and supplied by the Chinese API manufacturing company Anqiu Lu'an Pharmaceutical was found to be contaminated by 4-Chloroaniline. The Ministry of Food and Drug Safety announced that it had collected and inspected a total of 60 lot numbers from all manufactories and that the impurity in question was not detected. However, the sudden spread of the pandemic and the increase in vaccinations have brought an upsurge in sales of Tylenol. Sales of the 4 Tylenol series products including Tylenol Cold S and Women’s Tylenol have recorded ₩45.1 billion, increasing 122.2% compared to the previous year.
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- Ono Pharma Korea’s Braftovi has been approved in Korea
- by Aug 24, 2021 06:05am
- Ono Pharma Korea announced on the 23rd that it has been approved by the MFDS on the 19th by Braftovi (Encorafenib), a direct bowel cancer treatment. BRAF inhibitor Braftovi can be used as a combination therapy with Erbitux (Cetuximab) in adult patients with direct colon cancer with previous treatment experience and confirmed BRAF V600E mutation. In Korea, the positive BRAF V600E gene mutation is found in 4.7% of patients with direct bowel cancer. There were no approved drugs based on effectiveness in BRAF gene-variant bowel cancer, requiring a new treatment choice. This approval is based on the results of BEACON CRC study in patients with non-ablastic progressive or recurrent direct colon cancer showing BRAF V600E mutation after primary or secondary treatment. In the study, combined therapy of Braftovi-Cetuximab is a control group, and the overall survival period (OS) compared to Irinotecan (Iritecan)-Cetuximab based combination therapy showed statistically significant extensions (HR 0.60, p=0.0003). OS median was 8.4 months for Braftovi group and 5.4 months for control group.
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- Will the issue of GLT-2 inhibitors be resolved in 3 years?
- by Eo, Yun-Ho Aug 23, 2021 10:28pm
- Attention is focusing on whether the issue of combined benefits of DPP-4 inhibitors and SGLT-2 inhibitors will finally be solved. According to academia, the HIRA will hold a meeting of experts on September and discuss the combined benefits of oral diabetes treatment DPP-4 inhibitors and SGLT-2 inhibitors. The issue, which has been almost three years, was put on full hold in 2018 when the government planned a "public notice of improvement of the benefits standard for each drug" to strengthen convenience at the medical sites and patient guarantee, but pointed out that there was insufficient evidence of validity of drugs without separate clinical research. It was the opinion of the medical community that the government should discuss expanding the combined benefits of diabetes drugs. Each drug in the same category has different indications, causing side effects such as confusion at the prescription site and cuts in insurance benefits. The same was true when the combined benefits between DPP-4 inhibitors and TZD-related drugs expanded in 2013. However, the results are different. The medical community, which has emphasized the importance of clinical experience and expert judgment rather than permission and financial impact, is also unusual. It started in 2013 when Yoon Gun-ho, a professor at Seoul St. Mary's Hospital who actively expressed his opinion to expand the benefit of diabetes drugs, became the chairman of the Korean Diabetes Association. He conveyed to the government that health insurance can be applied by affiliates as an expert's recommendation, and in August last year, the MFDS said it would "simplify" the registration method of diabetes drugs. It said that it was to reflect permits from the U.S. and Europe and the demands of the medical community and industry, but many in the industry believed that it was a cornerstone for preparing standards for combination therapy. As a result, pharmaceutical companies submitted simplified labels for the efficacy of diabetes treatments from November of the same year, and the MFDS approved Jardiance, Forxiga, Suglat, and Steglatro sequentially in the first half of this year. Companies with such drugs immediately submitted applications for expansion of combined benefits, but so far, the agenda has not been submitted to the Subcommittee. An industry official said, "We hope that this expert discussion will solve the unfulfilled demand of clinical sites. As we have accumulated experience in prescribing SGLT-2 inhibitors in Korea, we expect positive results."
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- Accumulated exports of K-Biosimilars reach ₩9Tril
- by Chon, Seung-Hyun Aug 23, 2021 05:55am
- Cumulative exports of biosimilars developed by Celltrion and Samsung Bioepis exceeded ₩9 trillion. Growth has slowed compared to the products’ first market entry, however, the products have been marking stable growth based on their solid pipeline. ◆Celltrion Healthcare exports ₩789.5billion in H1…cumulative sales exceed ₩6 trillion According to the Financial Supervisory Service on the 19th, Celltrion Healthcare’s exports reached ₩789.5 billion, a 1.6% increase from the ₩777.2 billion in the same period last year. Although growth was not as explosive as in the previous year, the company still recorded large-scale overseas exports. Celltrion Healthcare is an affiliate of Celltrion that has Celltrion Healthcare Holdings (share 24.3%) as its largest shareholder. Celltrion Healthcare sells antibody biosimilar products that it received from Celltrion to global distributors. In other words, Celltrion Healthcare’s sales refer to the export performance of biosimilars developed by Celltrion. Celltrion Healthcare is selling 4 biosimilar products including ‘Remsima,’ ‘Truxima,’ ‘Herzuma,’ and ‘Remsima SC’ in the global market. Remsima’s original is Janssen’s ‘Remicade.’ Remsima SC is a subcutaneous injection formulating of Remsima. Truxima and Herzuma are biosimilars of ‘MabThera’ and ‘Herceptin,’ respectively. By each product, Remsima sold the most in exports, recording ₩302.1 billion in H1 this year. Adding Remsima SC(₩35.1), the Remsima brand sold ₩337.3 billion in exports in H1 this year. Remsima is the first biosimilar product that was approved in 2012. It had annually recorded the highest export sales among all Celltrion’s biosimilars but was outrun by Truxima’s record of ₩786.8 billion last year. However, this year, sales of Remsima again surpassed that of Truxima and became the No.1 product in exports. Truxima’s export sales fell 25.3% YOY from ₩365.8 billion to ₩273.3 billion in H1 this year. The company explained that Truxima’s sales in Q1, which saw a 32.6% YOY decrease to mark ₩109.7 billion, was due to a temporary adjustment in the supply schedule of its products. Herzuma’s export sales in H1 this year were ₩102.3 billion, a 25.7% YOY increase. Herzuma’s share in the European market in Q1 was 15%, a slight decrease from the 19% it held in Q1 last year. However, in the Japanese market, its share exceeded that of its originator Herceptin, to record 50%. This was more than a twofold market expansion in a single year from the 25% share it held in Q1 last year. Celltrion Healthcare, which was listed on KOSDAQ in 2017, has been recording its export performance in its business report since 2014. Since 2014, Remsima and Remsima SC have recorded the most in exports with a cumulative record of ₩3.7123 trillion. Truxima, which started making export performance in 2017, marked ₩1.9925 trillion, and Herzuma’s cumulative exports amounted to ₩575.1 billion. On whole, Celltrion Healthcare’s cumulative exports from 2014 to H1 this year marked ₩6.3 trillion. ◆Samsung Bioepis makes ₩354.2 billion in H1… cumulative sales record ₩2.0889 trillion Samsung Bioepis’s operating profit last year was ₩145 billion, an 18.1% YOY increase from the same period of the previous year. Since it recorded its first profit in 2019 with ₩122.8 billion, its profit has grown even more in a single year. Samsung Bioepis recorded ₩187.5 billion in sales in Q2, which is a 22.7% YOY increase. The company had continued on a downward roll since Q3 of last year, when it recorded its all-time high with ₩236.9 billion, however, in only 2 quarters since then, the company has recovered its performance to a level similar to its pre-COVID-19 performance. The accumulated sales of Samsung Bioepis in the 1H of this year rose 5.5% compared to the same period of last year, to record ₩354.2 billion Most of its sales were generated from overseas sales of the company’s self-developed biosimilars. Samsung Bioepis had succeeded in commercializing 5 biosimilars of biopharmaceuticals – ‘Enbrel,’ ‘Remicade,’ ‘Herceptin,’ ‘Humira,’ and ‘Avastin.’ In the global market, the company has signed marketing partnership agreements with multinational pharmaceutical companies such as Biogen and Organon to sell its products. Biogen is in charge of the local distribution and sales of the three autoimmune treatments, ‘ Benepali,’ ‘Flixabi,’ and ‘Imraldi.’ Organon (formerly known as MSD) is selling the three products in countries other than the U.S., Korea, and China, as ‘Renflexis (Remicade biosimilar), ‘Brenzys (Enbrel biosimilar),’ ‘Hadlima (Humira biosimilar).’ Organon is also in charge of selling the two anticancer drugs - the Herceptin biosimilar ‘Ontruzant’ and Avastin biosimilar ‘Avincio’ – abroad. According to performance reports by Biogen and Organon, biosimilars of Samsung Bioepis had made $573 million (approximately ₩675 billion) in H1 this year. Sales made by Biogen rose 4.3% YOY to record $407 million (approximately ₩470 billion). Sales made with biosimilars through Organon were $166 million (approximately ₩195 billion). Although the drugs sold less in comparison to its performance in the European market, its growth of 43.4% YoY has been received positively due to its growth potential. Due to the preorders that were made in Q1, sales in Q2 had decreased, then rose sharply in the second half of the year with the technology fee (milestone payments) from signing biosimilar license agreements with Chinese companies such as S Bio and C-Bridge Capital in 2019 being reflected in the revenue. This year, sales have stabilized to record ₩166.7 billion in Q1 and ₩187.5 billion in Q2. Samsung Bioepis, which was established in 2012, had shown full growth since recording ₩147.5 billion in sales in 2016. Last year, sales increased over fivefold compared to four years ago. Since its launch in 2012, Samsung Bioepis has recorded a cumulative sales of ₩ 2.8895 trillion. Most of Samsung Bioepis' sales come from overseas sales of biosimilars or technology fees. Its domestic sales contributions are small compared to exports. In other words, Celltrion and Samsung Bioepis’ combined exports of biosimilars recorded over ₩ 9 trillion in total.
