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- 2026-04-15 15:34:46
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- 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.
- Policy
- Pfizer vaccine can be administered over the age of 16 years
- by Lee, Tak-Sun Mar 03, 2021 06:23am
- The Central Pharmaceutical Affairs Review Committee, an expert advisory body for the MFDS, recommended the approval of Pfizer's COVID-19 vaccine. They gathered opinions that it is possible to administer them even over the age of 16. The MFDS explained the results by announcing the results of the Central Pharmaceutical Affairs Review Committee meeting held on the 25th. This Central Pharmaceutical Affairs Review Committee meeting is held with 19 external experts including 13 standing members of the Biopharmaceutical Subcommittee, which is a specialized subcommittee for deliberation on the safety and effectiveness of vaccines, 5 verification advisory members, and 1 expert recommended by the Korea Medical Association and the MFDS. Eight members, including the general review team, clinical review team, and quality review team of COVID-19 Crisis Response Support Division, attended the vaccine review team. They gathered opinions that item approval is possible when synthesizing the consultation results of the COVID-19 vaccine safety and effectiveness verification advisory group. In particular, based on the preventive effect confirmed in the results of clinical trials involving 16 years of age or older, it was concluded that it is reasonable to approve it for subjects 16 years of age or older like the efficacy and effect. Considering that the immune response of adolescents over 16 years of age is not different from that of adults, and considering the availability of adult clinical trial data, it was found that 'effectiveness and safety in adolescents aged 16 to 17 were extrapolated from the data of adults' in Korea as in the United States. The safety advisory result was an acceptable level for the safety profile, such as adverse events that occurred in clinical trials, but it was an opinion that close monitoring after administration was necessary for people with a history of hypersensitivity, including anaphylaxis. It was recommended that the reported abnormal cases be clearly reflected in the package insert. Based on this opinion, the MFDS announced that it plans to hold a final inspection committee by combining the efficacy and effect, indications and dose, and recommendations to determine whether or not to finalize the approval. The approval is expected to be decided next week.
- 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.
- Policy
- Will Kymriah be approved?
- by Lee, Tak-Sun Mar 02, 2021 06:25am
- The market approval of Kymriah by Novartis, a commercially available CAR-T (chimeric antigen receptor-T cell) treatment in the domestic market, is imminent. Kymriah is the first CAR-T treatment approved by the US FDA, and it applied for approval in Korea earlier last year. According to the industry on the 1st, Kymriah recently completed the safety and efficacy review by the MFDS, and is about to get item approval. It can be said that a new drug is almost finished after the safety and efficacy review is normally completed. Moreover, Kymriah applied for approval in Korea early last year, and it is a drug that has been reviewed for a long time. By the US FDA, Kymriah was approved as a treatment for refractory or recurrent or acute lymphocytic leukemia (ALL) on August 30, 2017. It is the first CAR-T treatment. CAR-T is a type of cell therapy, and refers to a technology in which T cells extracted from cancer patients are re-injected into patients by expressing specific chimeric antigen receptor (CAR) in cancer cells by using a virus vector. It is in the spotlight as a next-generation anticancer agent in that it selects and kills only cancer cells while minimizing damage to normal cells. The productivity is low and the cost is high. However, the market size is expected to grow to more than $10 billion with good efficacy. Accordingly, ventures such as AbClon and GCCell are conducting commercial development in Korea. Kymriah's listed price is $475,000 (about ₩534.8 million), and in Japan, approved in March 2019, it was listed at ¥33.49 million (about ₩354.41 million). Domestic insurance authorities will be concerned as it is very expensive.
- 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.
- Company
- Celltrion wins lawsuit over Mabthera patent
- by Kim, Jin-Gu Mar 02, 2021 06:25am
- Truxima Celltrion finally won the patent dispute over Mabthera (Rituximab). Celltrion has been able to completely overcome the patent risk of Mabthera biosimilar Truxima by confirming the victory in the lawsuit that lasted more than five years. On the morning of the 25th, the Supreme Court ruled in an appeal for invalidation of patent registration filed by Biogen. It also took the side of Celltrion. It is Mabthera's use patent. This article is about how to treat hematologic malignancies associated with a high number of circulating tumor cells by administering chimeric anti-CD20 monoclonal antibody. Including this, Biogen holds five patents of Mabthera. However, the remaining 4 patents were all invalidated according to Celltrion's patent challenge, which was developed from the end of 2015. Through this ruling, Celltrion succeeded in invalidating the last patent. Celltrion has completely eliminated Truxima's patent risk. If the final judgment was on the side of Biogen, it was highly likely that Biogen would file a claim for damages arising from patent infringement. In particular, Celltrion Truxima's domestic and overseas sales were significant, so it was a heavy burden on Celltrion when it lost. Truxima, along with Remsima and Herzuma, is one of Celltrion's flagship products. In Korea, it was launched in 2017. According to Celltrion, it recorded a market share of 19.8% as of the fourth quarter in the US market last year. It recorded a market share of 38% as of the third quarter in the European market.
- Policy
- Celltrion abandoned clinical trials of CT-P59
- by Lee, Jeong-Hwan Mar 02, 2021 06:25am
- It was found that Celltrion gave up the clinical trial of CT-P59, a prophylactic antibody treatment to respond to COVID-19. Celltrion decided to suspend the project selection agreement in less than a month after it was selected for the government support project in December of last year. Celltrion cited the difficulty of developing vaccines from global pharmaceutical companies and recruiting patients for clinical trials as a reason for giving up clinical trials. On the 25th, Jeon Bong-min (Independent Representative) made the announcement through the 'COVID-19 treatment/vaccine development project, abandonment of the 2nd selection project agreement in 2020' submitted by the MOHW. In August and November of last year, the government provided a total of ₩31.7 billion for the development of Celltrion antibody treatments. Antibody therapy, which was the first task, has been in use since the 17th with the approval of the MFDS on February 5 this year. In mid-December, less than a month after the second selection project, Celltrion submitted a waiver to the Korea Drug Development Fund. Celltrion cited the difficulty of developing vaccines for global pharmaceutical companies and recruiting participants in clinical trials as reasons for giving up. Jeon Bong-min said, "The government is trying to develop a domestic treatment for COVID-19 with a budget of several hundred billion won, but the treatment for urgently ill patients is not being developed." He said, "The government will have to come up with a more systematic support plan in preparation for the re-proliferation of COVID-19 that there may be more."
- Policy
- KDCA on cost-effectiveness of expanding HPV vaccination
- by Lee, Tak-Sun Mar 02, 2021 06:25am
- HPV vaccine ‘Gardasil 9’ The government is apparently conducting a study on the cost-effectiveness of expanding the human papillomavirus (HPV) vaccination subject and vaccine types. The outcome of the research could affect the pharmaceutical industry. On Feb. 24, the Korea Disease Control and Prevention Agency (KDCA) official answered Democratic Party Lawmaker Choi Hye-young asking about the agency’s clear stance on the expansion of HPV vaccination subject, as a part of the low birthrate and aging society responding master plan, and said a relevant research is ongoing at the moment. KDCA official elaborated, “The Fourth Low Birthrate and Aging Society Responding Master Plan states the government would review the effectiveness of expanding the HPV vaccination subject from female adolescents alone to both female and male adolescents and switching the quality vaccine targeting two to four types of HPV to nine types. Based on the result of the consignment research in progress, the government agency would consider expanding the vaccination subject.” The ongoing research, running from May last year to coming May, would decide the prioritized order of the national vaccination subject and related mid to long-term plan. And another follow-up research, running from last January to December next year, would analyze the cost-effectiveness in expanding the national HPV vaccination. The KDCA official said, “The government would comprehensively evaluate the result of the policy research regarding the unique quality of the disease, the vaccine’s preventive efficacy against the disease and cost-effectiveness to decide the prioritized order of the vaccination from a public healthcare perspective.” Currently, HPV vaccines like Gardasil and Cervarix are supplied in South Korea. The government’s decision to expand the vaccination subject and vaccine type could positively affect the relevant companies.
