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- 2026-03-18 15:06:10
- Company
- Pantogar's Sales cut in half
- by Mar 08, 2021 06:19am
- OTC hair loss treatment by Merz, Pantogar, was delayed in import, and sales were cut in half. According to the pharmaceutical industry on the 4th, import of Pantogar has been temporarily suspended from the middle of last year due to changes in overseas manufacturing sites. It was sold out as Pantogar's domestic distribution was stopped. Pantogar is out of stock at major online pharmaceutical shopping malls. This caused Pantogar's sales to plummet. According to the pharmaceutical market research firm IQVIA, Pantogar sales decreased 53.8% from about ₩1.3 billion in 2019 to ₩600 million last year. Pantogar's competitors include DongKook's Pansidil and Hyundai's Minoxyl. Pansidil beat Pantogar with number one in sales. An official from Huhpharma, who is in charge of distribution of Pantogar in Korea, said, "We cannot import due to the change of the factory last year, but The stock remains until May. It will be normalized within the year."
- Company
- Hepatitis C treatment Vosevi was refocused
- by Eo, Yun-Ho Mar 05, 2021 06:26am
- Gilead is aiming to enter the market for hepatitis C treatment Vosevi, which has failed to designate an orphan drug in Korea. According to related industries, Gilead Science Korea is in the process of marketing approval of the three-drug combination Vosevi (Sofosbuvir + Velpatasvir + Voxilaprevir) along with the hepatitis C combination drug Epclusa (Sofosbuvir / Velpatasvir). Vosevi's designation as an orphan drug was canceled because it did not meet the criteria for orphan drug designation in 2018. This drug, like AbbVie's Maviret (Glecaprevir + Pibrentasvir), relieved the discomfort of using Ribavirin in combination with a pangenic hepatitis C treatment, or the duration of treatment. Indications for this drug include therapy with NS5A inhibitors, treatment with genotypes 1-6 or Sofosbuvir without NS5A, and treatment of adult hepatitis C patients with type 1a and 3 treatment experience. In the POLARIS-1 and POLARIS-4 studies, Vosevi achieved a primary endpoint in 340 out of 353 chronic hepatitis C patients with treatment experience (SVR12 96%). Gilead, through Sovaldi (Sofosbuvir), first established the concept of'cure' in the area of hepatitis C. However, the introduction of pangenetic therapeutics in Korea was relatively delayed. As the number of hepatitis C patients is decreasing and Maviret's sales are high, it is unknown how the entry of Gilead's generics will affect the market. The World Health Organization's (WHO) latest treatment guidelines for hepatitis C recommend pangenetic treatments such as Maviret that do not require additional testing.
- Company
- Sales of Tagrisso tripled in four years
- by An, Kyung-Jin Mar 05, 2021 06:25am
- The market for targeted anticancer drugs for EGFR, which is prescribed to patients with non-small cell lung cancer with specific mutation findings, set a record for sales last year. The benefit of Tagrisso, a third-generation drug that is effective in the treatment of resistance to existing drugs, has been listed. According to IQVIA on the 2nd, the domestic epithelial growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) market in Korea was ₩152 billion, up 15.0% from the previous year. Compared to ₩57.6 billion in 2016, the sales volume increased 2.6 times over the past four years. 'Four types of EGFR-TKI, including Iressa (Gefitinib), Tarceva (Erlotinib HCl), Giotrif (Afatinib), and Tagrisso (Osimertinib), formed a domestic market worth ₩57.6 billion in 2016. In 2017, the growth slowed down to ₩55.4 billion, but after nearly doubling to ₩104.3 billion in 2018, it is a new record for 3 consecutive years. The third-generation drug Tagrisso (Osimertinib) was listed, driving the expansion of the EGFR-TKI market. EGFR-TKI is a targeted anticancer drug prescribed for patients with metastatic non-small cell lung cancer (NSCLC) with EGFR mutation. EGFR mutations occur between exons 18 and 21. It is a very common genetically modified cancer observed in 30% to 40% of non-small cell lung cancer, which accounts for 80% to 85% of lung cancer, and is known to have a higher incidence rate in Asians than in Westerners. This means that there is a lot of demand for prescriptions in Asia including Korea. Tagrisso's sales were ₩106.5 billion in the domestic market last year. It increased 34.5% compared to the previous year, setting a record high. The market share of'Tagrisso' based on last year's cumulative sales reached 70.1%. It maintains an overwhelming market gap with Iressa, the second-largest item. Tagrisso received marketing approval from the MFDS in May 2016 for local advanced or metastatic non-small cell lung cancer patients with EGFR-T790M mutation confirmed after administration of EGFR-TKI in May 2016. It is used as a secondary treatment for patients with non-small cell lung cancer who developed resistance after administration of the existing 1st and 2nd generation EGFR-TKI such as Iressa, Tarceva, and Giotrif. Tagrisso's sales surged as it was reimbursed as a second-line treatment in December 2017. Tagrisso sales, which started at ₩2.3 billion in the first year and ₩10.3 billion in 2017, jumped 5.8 times in a year to ₩59.4 billion in 2018. Since then, it has maintained a steep growth rate of more than 30%. In December 2018, a first-line therapy indication was added in Korea, but the expansion of benefits has been pending for more than two years. Sales of EGFR-TKI were sluggish excluding Tagrisso. Iressa's sales last year were ₩19.6 billion, down 30.7% from the previous year. Iressa's market share, which occupied 51.1% in 2016, fell 38.2%p in 4 years to 12.9%. Last year, Roche Tarceva's sales fell 10.9% year-on-year to ₩7.3 billion. Compared to ₩17.3 billion in 2016, the scale of sales has halved in four years. Boehringer Ingelheim's Giotrif's sales last year were ₩18.6 billion, up 12.2% from the previous year. Sales are increasing from ₩8.6 billion in 2016 to ₩10.9 billion in 2017 and ₩13.6 billion in 2018. However, the market share decreased by 2.7 percentage points from 14.9% in 2016 to 12.2% in 2020. Even though it was a second-generation drug, it did not overcome the resistance that occurred after the first-generation EGFR-TKI treatment and did not secure differentiation. The industry observes that there will be a big change in the EGFR-TKI market this year. Pfizer's Vizimpro, a second-generation drug, was listed at the end of last year, and it became possible to prescribe a general hospital. In February of last year, Vizimpro received item approval from the MFDS as a primary treatment for'local advanced or metastatic non-small cell lung cancer with EGFR exon 19 defect or exon 21 L858R substitution mutation. Tagrisso's rival drug, Yuhan's Leclaza, can also be prescribed within the year. Leclaza, a third-generation drug, was approved by the MFDS in January as a treatment for patients with EGFR T790M mutation-positive local progressive or metastatic non-small cell lung cancer who had previously been treated with EGFR-TKI.
- Company
- Roche has applied for insurance benefits of Polivy
- by Eo, Yun-Ho Mar 04, 2021 06:10am
- According to related industries, Roche Korea has submitted an application for Polivy (Polatuzumab), an antibody-drug conjugate (ADC) that is used in combination with conventional BR therapy (Bendamustine+Rituximab) for the treatment of Diffuse Large B-Cell Lymphoma and DLBCL. DLBCL, which accounts for the highest proportion of Non-Hodgkin lymphomas, is an aggressive lymphoma that requires immediate treatment due to its rapid disease progression. More than half of the patients have a good response rate to the extent of reaching remission, but 30-40% of patients do not respond to the standard therapy R-CHOP or experience recurrence after the first treatment. Relapsed/refractory DLBCL has not been an effective treatment option so far, although most patients experience recurrence within 2 years and the survival period is only 6 months. Polivy is the first ADC drug that targets CD79b, and has a mechanism to induce apoptosis by binding to CD79b expressed in B cells. Polivy was validated in a phase 1b/2 clinical study that confirmed the clinical efficacy and safety of Polivy combination therapy in 80 patients with relapsed/refractory DLBCL who were unable to receive hematopoietic stem cell transplantation and had more than one treatment experience. It was designated as an orphan drug in Korea in October of last year. As a result of the study, Polivy combination therapy group had higher complete remission rate (CR, Complete Response) and overall survival (OS, Overall Survival) longer than BR therapy (Bendamustine+Rituximab) group. Professor Ko Young-il, hematology and oncology at Seoul National University Hospital, said, "DLBCL patients who are difficult to transplant hematopoietic stem cells have a poor prognosis, and if they recur after hematopoietic stem cell transplantation, the survival period is only about 6 months. "Polivy has been clinically proven to be useful and is a recommended treatment option in international guidelines. It is significant in that it presents a new alternative to the previously limited relapsed/refractory DLBCL treatment," he added.
- Company
- Samsung Bioepis enters phase 1 of Stelara
- by Lee, Seok-Jun Mar 04, 2021 06:10am
- Samsung Bioepis has begun phase 1 clinical trial of the 10th biosimilar pipeline SB17. SB17 is a biosimilar for Stelara (Ustekinumab). Samsung Bioepis launched Phase 1 in February to confirm the pharmacokinetics, safety, and immunogenicity of SB17 for 201 healthy volunteers in France. Stelara is a treatment for autoimmune diseases such as psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis sold by Johnson & Johnson in the United States. The volume of global sales in 2020 is about ₩8.4 trillion. Samsung Bioepis was founded in 2012, and has developed three types of autoimmune diseases (SB2: biosimilar for Remicade, SB4: biosimilar for Enbrel, SB5: biosimilar for Humira) and two anticancer drugs (SB3: biosimilar for Herceptin & SB8: biosimilar for Avastin). It is also developing treatments for eye diseases (SB11: biosimilar for Lucentis, SB15: biosimilar for Eylea), blood diseases (SB12: biosimilar for Soliris), and skeletal diseases (SB16: biosimilar for Prolia).
- Company
- Generic approvals soar again despite new stepped pricing
- by Chon, Seung-Hyun Mar 03, 2021 06:24am
- Despite being seemingly suppressed by the revised drug pricing system, the number of approved generic is soaring again. Hundreds of Atozet and Januvia generics have entered the market and recorded the highest number generic approvals since May last year. In the second half of last year, the pharmaceutical companies had a vacant gap in new approval as they have already had their generics approved before the pricing system revision. However, the companies seem to jump into the generic approval competition, whenever a large generic market opens up, to take the advantageous pricing. According to the Ministry of Food and Drug Safety (MFDS) on Mar. 2, 319 prescription generics have been authorized last month. Compared to 102 generics approved in January, the number almost tripled. The number of approved generic is surging compared to 50 items cleared from last June through December. It has been nine months, since last May, the number of newly approved generics surpassed 300 in a month. Monthly generic approval number (Unit: Item) Source: Ministry of Food and Drug Safety Many of the newly approved generics are following originals like cholesterol-lowering Atozet and anti-diabetic Januvia. Apparently, 89 pharmaceutical companies received the South Korean health authority approval on total 256 items combining atorvastatin and ezetimibe. The original combination drug is Atozet sold by MSD and Chong Kun Dang. A group of generic makers all applied for approval after Jan. 11, when the original’s post-marketing surveillance period ended. And 44 of sitagliptin generic versions of MSD’s original anti-diabetic Januvia were approved as well. The number of generic approvals started rising rapidly from early 2019, and it slowed down in the latter half of last year. Total 5,488 generics, or with monthly average of 323 items, were authorized from January through May 2019. In a span of year in 2018, total 1,110 generics were approved with monthly average of 93 items. The approval rate has tripled in just a year. The government’s sign of tightening the generic regulation has eventually instigated the surge in generic approval. Implemented from last July, the drug pricing system was revised to sustain the 53.55 percent of the original pricing before patent expiration for generics that individually conducted a bioequivalence test and use drug master file (DMF) submitted active ingredient. Moreover, MFDS’ approach on regulatory changes in generic approval also encouraged the generic makers to rush for the approval. The ministry warned of strengthening the regulation on joint bioequivalence test regulation by partially revising the Regulation on Pharmaceuticals Approval, Notification and Review in April 2019, which restricts the number of a manufacturer conducting a joint bioequivalence test. Although the joint bioequivalence test regulation restriction never got passed due to the opposition by Regulatory Reform Committee at Government Policy Coordination Office, the application for generic approval soared immediately after the ministry disclosed the plan to restrict the bioequivalence test early last year. However, the soaring number of generic approval application bounced back down after the revised drug pricing system was implemented. The generic approval number, tallied up to be 427 as of last May, plunged to 73 in June. For seven months, from July through December last year, 73, 51, 45, 43, 58 and 69 generics were approved, respectively, with monthly average of 58 shrinking down to 18 percent of the previous 18-month average. The products that applied for the National Health Insurance (NHI) reimbursement before last May would receive the previous pricing benefits. Technically, the generics that applied for the reimbursement from following June would be applied with the new lower pricing. And it explains why the number of new generic approval applications dropped drastically from June. The recent surge in new generic approvals was led by the generic fully manufactured by consignment contract. 83 percent, or 84 out of 102 generics approved in last January were manufactured with consignment contract. Also 85 percent, or 319 out of 375 generics approved in last month were the same. From last October through December, only 26 percent, 38 percent and 70 percent of the prescription generics were respectively manufactured by consignment contract. Ratio of generics manufactured by consignment contract among monthly generic approval number (Unit: percent) Source: Ministry of Food and Drug Safety As for Atozet generic makers, only nine out of 89 companies are directly manufacturing the drug. The majority of the generics would not be able to obtain high drug pricing without the individually conducted bioequivalence test, but they still joined the generic market. In fact, entering the existing generic market late became meaningless with the reformed pricing system. Due to the stepped pricing system, entering the market late would mean significantly low pricing. The industry predicts the temporary exponential surge in generic approval would repeat in the future whenever a large new generic market opens up like Atozet’s. Hundreds of Atozet generics were released due to huge marketability. A pharmaceutical market research firm UBIST reported Atozet’s prescription volume last year reached 74.7 billion won making a year-on-year growth of 13.5 percent. In two years from 2018, the volume rapidly surged by 60.6 percent from 45.4 billion won. A pharmaceutical company associate commented, “Not many generic makers would join the already saturated market with the new stepped pricing system. When a largely profitable original has its patent expire, a lot of generic makers would continue to try to launch their products at once to get the best pricing.”
- Company
- Spravato Nasal Spray can be prescribed at general hospitals
- by Eo, Yun-Ho Mar 03, 2021 06:23am
- Janssen's new depression drug Spravato can be prescribed at general hospitals. According to related industries, in addition to Big5 such as SMC and SNUH, Kyunghee University Hospital, Kyungpook National University Hospital, Pusan Paik Hospital, Chung-Ang University Hospital, Jeju National University Hospital, and Haeundae Paik Hospital have passed DC of Spravato (Esketamine), which is used as a combination therapy with oral antidepressants. Spravato, approved in Korea in June last year, is the first Nasal Spray in the field of treatment-resistant depression and the first in 30 years in the field of major depressive disorders. Spravato (Esketamine) improves symptoms of depression by regulating the activity of glutamic acid receptors called NMDA receptors in the brain, thereby restoring synaptic connections and increasing neurotrophic signaling. Spravato also added indications for a major depressive disorder with suicidal thoughts at the end of last year. Baek Jong-woo, a professor of mental health medicine at Kyunghee University Hospital, said, “In a serious situation with the highest suicide rate among OECD countries, we are excited to receive approval for a new and rapid treatment method for major depressive disorders with suicidal thoughts and behaviors. In the future, medical treatment will be applied through insurance coverage, etc. " "We look forward to having the system in place quickly so that people in real crisis in the field can use it when they need it." Spravato's indications for suicidal depression were based on the results of the ASPIRE I study and the ASPIRE II study, a global phase 3 clinical trial. In both ASPIRE I and ASPIRE II studies, Spravato was used in combination with conventional standard therapy (including oral antidepressants and hospitalization) as a primary efficacy defined as reduction of depressive symptoms within 24 hours after first dose on the Montgomery-Asberg Depression Rating Scale (MADRS). The endpoints were met. The efficacy in treatment-resistant depression, the first approved indication, was demonstrated in a phase 3 clinical trial consisting of short-term and long-term trials in more than 1,700 adult patients. the efficacy of Spravato in a short- and long-term phase 3 clinical trial conducted on 1,700 patients with treatment-resistant depression. Short-term clinical trial TRD (Treatment-Resistant Depression) 3002 divided 223 patients with treatment-resistant depression aged 18 to 65 years of age, and administered either Spravato and oral antidepressant group or placebo and oral antidepressant group. The results showed that the effect of improving treatment-resistant depression was excellent in the Spravato group compared to the placebo group. Particularly, the Montgomery-Asberg Depression Rating Scale (MADRS) score was significantly lowered (19.8 points vs. 15.8 points). In the long-term trial, the recurrence probability in the Spravato group was also 51% lower than that of the placebo group.
- Company
- 3 MSD vaccines to raise supply price at least by 15%
- by Mar 03, 2021 06:23am
- Product image of Gardasil 9 and RotaTeq Three vaccines by MSD Korea—Gardasil, Gardasil 9 and RotaTeq—would raise their supply price from April. A pharmaceutical industry source told on Feb. 27 that MSD Korea has decided to raise the price of human papillomavirus (HPV) vaccines Gardasil and Gardasil 9 and a rotavirus vaccine RotaTeq. The new price would be implemented from coming Apr. 1. The prices would be increased by 15 percent for Gardasil and Gardasil 9, and 17 percent for RotaTeq. Accordingly, Gardasil 9 would be supplied at an approximate price of 120,000 won (VAT excluded). Gardasil would be priced at just below 100,000 won and RotaTeq at 50,000 won. But for the bidding wholesale, the price increase would be postponed during the contract period. MSD Korea is to soon inform of the price change to hospitals. The two HPV vaccines have been maintaining the same price for a long time. So was RotaTeq. Regardless of a competitor Rotarix by GSK raising the price, RotaTeq kept its price. Due to increase in the supply price, the consumer’s inoculation fee would also inevitably rise as well. About the reason for the price increase, the company official explained “We have tried our best to maintain the launching price, but the price increase was unavoidable because of the constantly surging production cost.” Meanwhile, IQVIA reported Gardasil and Gardasil 9 have generated 200 million won and 42.5 billion won last year, respectively. RotaTeq made 11.7 billion won during the same time.
- Company
- Boryung and Kwangdong overcome MM drug Pomalyst patent
- by Kim, Jin-Gu Mar 02, 2021 06:26am
- A product image of Pomalyst Boryung Pharmaceutical and Kwangdong Pharmaceutical have successfully evaded the composition patent on Celgene’s multiple myeloma treatment Pomalyst (Pomalidomide). Overcoming the biggest barrier to receive the preferential sales approval, the two South Korean companies can now release the generics early in January 2024, immediately after the original’s product patent expires. The industry predicts the two companies assertively strengthening the oncology pipeline would be able to even further expand their anticancer treatment line-up with the patent evasion. On Mar. 1, a pharmaceutical industry source told the Intellectual Property Trial and Appeal Board has approved of Boryung Pharmaceutical and Kwangdong Pharmaceutical requesting for a negative confirmation of the patent confirmation against Celenge. On July 31 last year, Boryung Pharmaceutical filed a patent challenge case to evade Pomalyst’s composition patent. Also, Kwangdong Pharmaceutical followed suit on Aug. 12. As Kwangdong Pharmaceutical filed the case within 14 days of Boryung Pharmaceutical’s case, Kwangdong Pharmaceutical would qualify to win the preferential sales rights as well. Ultimately, the seven-month patent dispute concluded with the board ruling in favor of those generic makers. Pomalyst can only protect the product patent expiring in January 2024, as the two South Korean companies have successfully evaded the composition patent expiring in July 2030. The post-marketing surveillance (PMS) period for Pomalyst is to end in June 2023, and the two companies are to release their generics after January 2024 when the original’s product patent expires. The two companies can now consolidate their anticancer pipeline with the latest patent challenge. A pharmaceutical market research firm IQVIA reported Pomalyst has generated 13.8 billion won last year. The growth has been steep compared against 8.4 billion won made in 2019. Boryung Pharmaceutical and Kwangdong Pharmaceutical have been approaching the oncology business assertively for last few years. Among the South Korean pharmaceutical companies, Boryung Pharmaceutical continues to top the market share. It owns line-ups like Genexol, Gemzar, Campto and Oxalitin. Genexol is a generic version of Bristol Myers Squibb’s (BMS) Taxol (Paclitaxel). Since 2017, Boryung Pharmaceutical has been selling Genexol developed by Samyang Biopharmaceuticals. Two years into the sales, Genexol’s sales volume exceeded that of the original from 2018. IQVIA reported Taxol made 9.5 billion won last year, when Genexol made 21.4 billion won. The South Korean company concentrated on propelling the oncology business last year by independently separating the sector. As a result, it licensed in the South Korean sales rights of Eli Lilly’s Gemzar (gemcitabine). Kwangdong Pharmaceutical is also actively growing their oncology business. The company’s star anticancer treatments are Revlimid (lenalidomide) generic Lenaldo, and Afinitor (everolimus) generic Erinito. Especially with the newest success in the patent challenge, Kwangdong Pharmaceutical gets to fully complete the multiple myeloma treatment line-ups. Lenaldo, released to the market since 2018, is used to treat multiple myeloma in first and second-line therapies. The Pomalyst generic that overcame the patent would be used as a third-line therapy for patients with multiple myeloma.
- Company
- Viatris Korea downsizing and offering ERP?
- by Mar 02, 2021 06:25am
- Pfizer Upjohn and Mylan recently merged and kicked off a new subsidiary Viatris, but now the company is busy downsizing. While planning to globally restructure and let go of maximum 9,000 employees, the multinational company’s massive change is to also affect the South Korean branch. A month after the official launch in last November, Viatris announced the organization restructuring plan. By 2024, the company would shut down and sell off maximum 15 plants to shave off production cost by at least USD 1 billion (approximately 1.1 trillion won). Due to the project, maximum 20 percent (about 9,000) of the total 45,000 employees would be affected. Viatris has already let go of employees at West Virginia, Ireland and Puerto Rico plants, and closed an injection manufacturing plant in Poland. Although the most of downsizing would take place in manufacturing plants, many of the redundant positions between Mylan and Pfizer Upjohn may be asked to leave. Viatris Korea is also to undergo the massive restructuring. An insider from Viatris Korea commented, “According to the headquarter’s plan, the Korean branch is also preparing to optimize organization structure and efficiently streamline the operation system to meet the prospective business goal.” A significant change may be avoided as Viatris Korea does not have manufacturing staffs and there was no Mylan branch in South Korea, but the company would likely to offer early retirement plan (ERP) program to the sales. The industry is already talking about the rumor that a certain level of positions would receive the ERP offer. Viatris Korea clarified, “The details cannot be disclosed at this point according to the internal policy,” but the industry is sharing detailed ERP conditions. The trend of ERP seems to be continuing on from last year, where a number of multinational pharmaceutical companies experienced the similar situation. Especially due to COVID-19, non-contact sales became the new normal, and the companies tried to downsize the organization claiming to achieve ‘better efficiency.’ However, Viatris insiders say even if the management offers the ERP, the staffs would not be forced to accept them. Viatris labor union associate said, “We are not too concerned of unfair ERP program, as the management has signed an agreement after the negotiation that prospective ERP program would not force any of the staff to leave against their will.” Previously, the management has negotiated and agreed to pay out incentive of 12 million won to every employee transferred to Viatris.
