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- 2026-04-16 01:49:55
- Policy
- Kang-rip Kim emphasized COVID-19 tx & vaccine development
- by Lee, Tak-Sun Nov 10, 2020 06:05am
- Kim Kang-rip, head of the MFDS, is greeting Kang-rip Kim (54 yrs old), the new head of the MFDS, emphasized, "We must concentrate our regulatory competencies as much as possible for the development of COVID-19 treatment and vaccine." At the inauguration ceremony held at the headquarters of the MFDS in Osong, Chungbuk on the evening of the 2nd, he said that he is at the forefront of critical work to overcome the era of COVID-19. He said, "First of all, we must mobilize our regulatory capabilities to develop COVID-19 treatments and vaccines that are safe for the public. We will develop new technologies and create a regulatory environment that can effectively respond to future medical demand through rational regulation. It is also important.” At the same time, he proposed four goals that centered on the life and safety of the people. The first goal is professional safety management. He said, "The MFDS will respect expertise as a top priority, and we will cultivate professional manpower, improve the workforce management system, and improve the working environment so that we can grow this area." The second is the strengthening of international competitiveness, he said that he will create a policy environment with comparative advantage by referring to countries with advanced regulations, and that he will foster a harmonious international model that promotes the technology industry based on safety and quality management. It will strengthen cooperation in international cooperation. Director Kang-rip Kim (right) is greeting the staff Third, he emphasized open organization and collaboration. It is to create a work environment based on internal and external communication, strive to communicate with major policy customers and other ministries, and work together to achieve results. Lastly, he emphasized that he will prepare international food regulations and respond proactively to innovative medical care in the future, saying that he will pursue future values based on strong safety. He said, "The MFDS is at the forefront of important tasks that determine the future of Korea in the context of COVID-19. I have a duty to present a path to save health, safety and economy together, not only to respond to COVID-19, but also to biohealth growth." He said, "I always believe in our ability to overcome the COVID-19 era and look forward to our ability." As a member of the MFDS, he pledged to work together with fierce thoughts. Lastly, he said, "I spent exactly 30 years and a few days in the Welfare Department, responsible for the happiness of the people, and worked in a culture that cares for people. I hope that leadership that can maximize the total happiness of each and every organization is established as a desirable leadership." The inauguration ceremony was held in the meeting room space in consideration of a non-face-to-face distance, similar to the retirement ceremony of Director Lee Eui-kyung in the morning, and only senior officials attended. He graduated from Yonsei University and was appointed as the 6th head of the MFDS on the 1st. At the MOHW, he worked as the head of the Insurance and Reimbursement Division, the Head of the Policy Team for the Disabled, the Head of the Medical Policy Team, the Head of the Health and Medical Policy Division, the Head of the Health Industry Policy Bureau, the Social Service Policy Officer, the Pension Policy Officer, and vice minister.
- Company
- Covered drugs decreased due to generic drug price system
- by Chon, Seung-Hyun Nov 09, 2020 06:18am
- Number of drugs on the monthly list of health insurance benefits (unit: number, source: the HIRA) The soaring number of medicines covered by health insurance showed a sharp decline. As the number of new generic licenses decreased due to the implementation of the new drug price system, the number of covered drugs decreased in 11 months. According to the HIRA on the 8th, as of November 1, the total number of drugs on the health insurance benefit list was 25,830, down 697 from the previous month's 26, 527. It was only 11 months since December last year that the number of covered drugs has decreased from the previous month. Health insurance-covered drugs have increased for 10 consecutive months from December of last year to October of this year. During this period, the number of covered drugs increased by 3,265 from 23,262 to 26,527. From the end of 2018, the number of covered drugs started to soar. From November 2018 to last month, except for No. 1, there was an increase every month. In November 2018, the number increased from 20,689 to 26,527 in two years. As the number of newly listed drugs decreased, the total number of covered drugs also decreased. From January to August, the total number of drugs registered for new benefits was 3,632. This means that an average of 454 items per month are newly listed on the health insurance benefit list. The previous drug price system was applied to the reimbursed list in May, but 836 items were listed in August. However, the number of new listings has declined sharply from September. In September, the number of newly-listed drugs was 122, a decrease of more than 700 from the previous month, and in October and November, it was only 108 and 60, respectively. The number of drugs listed for new benefits per month (Unit: number, Source: the MOHW) This is a change that emerged from the implementation of the new drug price system. According to the reorganized drug price system, which took effect in July, generic products can maintain the 53.55% upper limit compared to the original drug before the expiration of the patent only when both the direct conduct of the bioequivalence test and the use of the registered drug substance are satisfied. A stepped drug price system has also been introduced, in which the upper limit is lowered as the registration period is delayed. In fact, the government's policy to strengthen generic regulations has led to a surge in new generic licenses by pharmaceutical companies for about two years. In this year, a total of 1,631 generics were licensed until last May. On average, 326 generics per month received new licenses. However, after a sharp decline to 73 cases in June, 70 cases in July and 50 cases in August showed a marked decline. According to the MOHW, the previous drug price system will be applied to products applied for the list in May. Generics, which have been approved since June and applied for the registration, are said to receive low drug prices by applying the new drug price system. This is the background of the sharp decline in the number of new generic licenses from June. The MFDS' attempts to strengthen licensing regulations have contributed to the licensing of a bunch of generics. In recent years, with the recommendation of the Regulatory Reform Committee of the Office for Government Policy Coordination, the strengthening of regulations on the joint bioequivalence test was unsuccessful, but applications for generic licenses increased sharply shortly after the plan to strengthen the biometrics regulation was disclosed earlier last year. In the industry, it is also evaluated that as a result of the intensive approval of generics for pharmaceutical companies in the government's regulatory reinforcement movement, the areas for further entry into the market have significantly decreased. This means that most of the generics that pharmaceutical companies can sell were licensed before the tightening of regulations. From December 2018 to May this year, a total of 5,611 generics were newly entered. On average, 312 generics were released per month.
- Company
- Generics for Lyrica, expanded by 60% in 3 years
- by Kim, Jin-Gu Nov 09, 2020 06:18am
- Lyrica The market for Pregabalin, a pain treatment drug for peripheral neuropathy, has expanded rapidly over the past three years. The amount of outpatient prescriptions from ₩19.8 billion in the third quarter of 2017 increased 61% to ₩32 billion in three years. It is an analysis that the growth of generics after the expiration of the patent has greatly contributed to the market expansion. Pfizer tried to defend generics by releasing new low-dose products and sustained-release formulations, but sales of the original 'Lyrica' are not as good as expected. According to the drug market research institute UBIST on the 4th, the market size of Pregabalin in the third quarter of this year reached 32 billion. It increased by 9% from ₩29.4 billion in the third quarter of last year. It is rapidly expanding since the third quarter of 2017. It is confirmed that it is 61% larger than 3 years ago, compared to ₩19.8 billion in the third quarter of 2017. In particular, the prescription performance of generics increased significantly during this period. Pregabalin's prescription performance increased more than 10 times from ₩1.5 billion in the third quarter of 2017 to ₩15.2 billion in the third quarter of this year. On the other hand, Lyrica decreased 9% from ₩18.3 billion to ₩16.7 billion over the same period. Looking at the quarterly results for the past three years, it appears that prescription performance has been stagnant with approximately ₩16 billion to ₩17 billion. Quarterly prescription performance of Lyrica and generics (Pregabalin) (Unit: ₩100 million, Source: UBIST) Lyrica's patent expiration is the reason why this generic market has expanded rapidly since three years ago. The core of this patent was the indication (application patent). A patent dispute between the original company and the generic company continued over whether generic products could be used for 'treatment of peripheral and central neuropathic pain in adults'. In the dispute that reached the Supreme Court, Pfizer finally won. Generic companies have been releasing products one after another since Lyrica's PMS expired in 2011, but they were unable to achieve satisfactory results due to failure to secure indications. Then, in August 2017, the use patent expired. The prescription performance of generics has grown rapidly from this period. generics for Lyrica, which had produced ₩1 billion in prescriptions until the third quarter of 2017, jumped to ₩4 billion in the fourth quarter of that year. The share of generics in the entire Pregabalin market has also increased from less than 10% to 20%. From 2018, the prescription performance of generics has increased sharply. The generic share in the Pregabalin market exceeded 30% in the second quarter of 2018 and 40% in the third quarter of 2019. In the third quarter of this year, the market share increased to 48%. It is expected that this trend will overtake the original prescription amount as early as in the fourth quarter of this year. By product, HK inno.N's Kabalin’s sales amounted to ₩3 billion, Daewoong Bio's Lyribear amounted to ₩1.2 billion, Hanmi's Prebalin, and Gabaneuro amounted to ₩700 million, and Samjin's Neurocover-PG amounted to ₩600 million. The market's explosive growth didn’t reduce the popularity of generics for Lyrica. Domestic companies have obtained generic licenses until recently, three years after patent expiration. This year 17 pharmaceutical companies have received new approvals for 41 products. This accounts for 12% of the 338 generics. Quarterly share of Lyrica & generics (unit: ₩100 million, data:UBIST) Pfizer, the original company, came up with various strategies to prepare for competition with generic companies after Lyrica’s patent expiration. In February 2018, it was granted a low-dose product, and in July 2018, it was granted a sustained-release formulation in line with the patent expiration. However, it is observed that such a strategy is not very good yet. Only in the fourth quarter of last year, sustained-release formulation achieved only ₩100 million. In the third quarter of this year, only ₩160 million worth of prescriptions were prescribed.
- Policy
- MOHW “COVID-19 vaccine-treatment approval early next year”
- by Lee, Jeong-Hwan Nov 09, 2020 06:18am
- Minister Park Neung-hoo of Health and Welfare stated the South Korean government is anticipating a temporary use approval of COVID-19 vaccine in March next year and treatment early year. However, the minister said the vaccine would most likely to be an imported product by a multinational pharmaceutical company, and Korean-made treatment would receive approval for an urgent use, instead of a complete approval, on products that completed Phase 2 clinical trial. On Nov. 4, Minister Park answered with the said detail to Democratic Party Lawmaker Heo Jongsik at the National Assembly Health and Welfare Committee’s general meeting to review 2021 budget plan for Ministry of Health and Welfare (MOHW) Lawmaker Heo questioned the minister of the estimated timeline of COVID-19 vaccine and treatment approval. Minster Park predicted the vaccine developed by a multinational company would be approved by March next year at latest. The minister also anticipates the government to grant an urgent use approval on COVID-19 treatment developed by a South Korean company with a condition to conduct Phase 3 trial. Minister Park elaborated, “The government would likely to get an access to the vaccine by a global company first. The vaccine is expected to be approved and accessible in South Korea by March next year. Two of Korean-made treatments are to conduct Phase 2 study until the end of this year. The two drugs would have outstanding Phase 3 trial to conduct, which could take a significantly long time.” The Health and Welfare Minister elaborated, “The developers of the two treatments could request for the temporary use approval, if they can properly prove the efficacy in a Phase 2 trial. While the Phase 3 trial is in process, the treatments with completed Phase 2 trial result could be temporarily approved. However, the biggest challenge is insufficient number of clinical patients. Most of the Korean-made treatments are targeting mild case of the infectious disease. In early next year, we expect a drug approved for urgent use with completed Phase 2 trial would be accessible.”
- Company
- Rx performance is poor due to spin-off of Organon
- by Kim, Jin-Gu Nov 09, 2020 06:17am
- MSD Korea's spin-off of Organon has come for three months. However, sales of most Organon items, such as Singulair, Vitorin, and Cozaar, are sluggish in the domestic outpatient prescription market. In contrast, Sales of Januvia by MSD increased by nearly 10%. According to UBIST on the 4th, MSD's outpatient prescriptions in the third quarter of 2020 were ₩107.7 billion. Compared to ₩105.3 billion in the third quarter of last year, it increased by 2%. What is interesting is the change in prescription amount by item that MSD and Organon decided to share. The amount of prescriptions for major items in MSD increased, while the amount of prescriptions for items of Organon mostly decreased. First of all, Januvia prodcuts in MSD, increased prescriptions in the third quarter of this year compared to the third quarter of last year. MSD has a DPP-4 inhibitor-based diabetes treatment Januvia, Metformin combination drug Janumet, and Janumet XR. Januvia's prescription amount for the third quarter was ₩12.1 billion, a 5% increase from ₩11.5 billion a year earlier. During the same period, Janumet increased by 10% (₩11.8 billion → ₩20.6 billion and Janumet XR by 13% (₩11.5 billion → ₩13 billion). The total prescription amount for Januvia products increased 9% from ₩41.9 billion to ₩45.7 billion. The annual prescription amount for the three items was ₩168.2 billion last year, and this year's surpassed ₩170 billion is the most likely. Other products except Januvia will be transferred to Organon after spin-off. Among the products passed to Organon, Atozet is the only one with increased prescription performance. Changes in prescription amount for each major product of MSD in the third quarter (Unit: ₩100 million, Source: UBIST) On the other hand, it is observed that prescription sales of most of the items passed to Organon have decreased. The main items passed from MSD to Organon are ▲Atozet ▲Singulair ▲Vytorin ▲Cozaar ▲Fosamax and ▲Proscar. Among them, the remaining prescriptions except Atozet appeared to be decreasing or stagnating. Singulair, a treatment for asthma and allergic rhinitis, is the item with the largest decline. It decreased by 30% from ₩8.5 billion in the third quarter of last year to ₩5.9 billion in the third quarter of this year. It is an analysis that the US Food and Drug Administration (FDA) was affected by attaching a black box warning to the Montelukast formulation earlier this year. The domestic COVID-19 situation also contributed to the reduction of prescriptions. In the case of asthma and allergic rhinitis, the proportion of pediatric and adolescent patients is larger than that of other diseases, and since COVID-19 outbreak, visits to hospitals by pediatric and adolescent patients have decreased significantly. MSD's hypertension treatment Cozaar is still stagnant in prescription performance. MSD has five items in series: Cozaar, Cozaar XQ, Cozaar Plus, Cozaar Plus F, and Cozaar Plus-Pro. The total prescription amount for the five items in the third quarter of this year was ₩12.9 billion, down 1% from ₩13 billion in the third quarter of last year. Of the five, Cozaar and Cozaar Plus-Pro prescriptions increased, while Cozaar XQ, Cozaar Plus, and Cozaar Plus F decreased. Fosamax also decreased the amount of prescription. MSD has the osteoporosis treatments Fosamax, Fosamax Plus, and Fosamax Plus D. The total prescription for the three items in the third quarter was ₩3.9 billion, down 4% from ₩4.1 billion in the third quarter of last year. The prescription amount of Vytorin (Ezetimibe/Simvastatin), a hyperlipidemia combination drug, decreased 16% from ₩6 billion in the third quarter of last year to ₩5.1 billion in the third quarter of this year. Changes in prescription amount for each major item of MSD in 3Q (Unit: ₩100 million, Source: UBIST) Atozet (Ezetimibe/Atorvastatin), another combination of MSD's hyperlipidemia, is almost the only one that goes to Organon, where prescriptions have increased. Atozet's prescription amount increased 16% from ₩17 billion in the third quarter of last year to ₩19.7 billionin the third quarter of this year. MSD announced a spin-off plan at the global headquarters level earlier this year. The name of the spin-off company was decided as Organon. Organon focuses on patent expired medicines, women's health products, and biosimilars. Existing MSD focuses on blockbuster treatments, vaccines, and hospital-supplied medicines such as Lynparza, Lenvima, Gardasil, Bridion, Zerbaxa, and Bravecto, including Keytruda, an immune anticancer drug. However, Januvia is a drug that has expired, but it was decided to remain in MSD. MSD Korea is also undergoing a spin-off procedure. Last month, MSD Executive Director Kim So-eun was selected as the new CEO of Organon Korea. MSD Korea, which has reached its new head, is planning to announce a list of employees who will move to Organon by setting guidelines in November. MSD announced the completion of the spin-off in February next year. However, MSD Korea's labor union recently decided to engage in labor disputes in earnest, and as the domestic COVID-19 situation prolongs, there is a possibility that the spin-off operation may be disrupted. Business division plan that MSD released in February of this year (material Merck conference call)
- Policy
- Antiviral Zovirax license transferred from GSK to Ilsung
- by Lee, Tak-Sun Nov 06, 2020 06:26am
- GSK’s Zovirax Tablet sold in the global market. Ilsung Pharmaceuticals is to take over the brand sales rights in South Korean market. Used for decades in South Korea as an antiviral drug against herpes simplex virus (HSV) and varicella zoster virus (VZV), Zovirax (acyclovir) has completed the local sales rights transfer from GlaxoSmithKline (GSK) to Ilsung Pharmaceuticals An acyclovir original, Zovirax, lost ‘GSK’ from its name as recently GSK voluntarily dropped the license on importing the finished pharmaceutical product in the cream and other forms. Instead, Ilsung Pharmaceuticals gained the sales rights in South Korea and renamed the product as ‘Ilsung Zovirax.’ On Nov. 5, GSK intentionally revoked the licenses over two finished products—‘Zovirax Intravenous Injection’ and ‘Zovirax Cream.’ The license on ‘Zovirax Ophthalmic Ointments’ was automatically canceled from last Oct. 1, when the license expired. Now, the multinational company has no license over any of Zovirax lineups in South Korea. However, ‘Zovirax Tablet’ is to maintain its well-known brand name with Ilsung Pharmaceuticals. The South Korean company has requested for license change to rename the product as ‘Ilsung Zovirax Tablet’ and completed the transfer procedure on last Oct. 7. Zovirax is a bestselling antiviral drug sold in South Korea since 1985 by Dong-A ST (formerly known as Dong-A Pharmaceutical). The drug is widely used for treating various viral infections, including first-time and recurrent genital herpes, HSV on skin and mucous membrane and even on shingles. Also the drug has treatment efficacy and benefit on a child over two years of age with chickenpox. However, the drug sales performance plummeted from 2018, when Dong-A ST stopped supplying the product due to contract expiration with GSK. According to IQVIA, the antiviral drug has generated 5.7 billion won in 2016, but the figure dropped to 40 million won last year. Ever since the contract termination with Dong-A ST, Zovirax could not find the right partner. Nevertheless, Ilsung Pharmaceuticals inked the license transfer deal with GSK and followed through with the process. In South Korean market only, there are 172 acyclovir items available. But the market is currently valued only at around 10 billion won, due to pricing reduction and intense competition between products. The industry experts assume Dong-A ST halted the sales after the contract expiration, because of the underwhelming performance. But as the brand has been maintaining its high reputation and credibility for a long time, the experts also predict the product may have another chance in the market again. Now, the market would have to wait and see how Ilsung Pharmaceuticals would resuscitate the Zovirax brand.
- Company
- Servier Korea has appointed Melanie Loresry as new CEO
- by Eo, Yun-Ho Nov 06, 2020 06:25am
- Melanie Loresry, CEO of Servier Korea Servier Korea appoints a new head. According to related industries, Servier Korea appointed Melanie Loresry (43) as new CEO, on the 1st of last month. Colette Rouches, who had previously led Servier Korea, moved to a Taiwanese subsidiary. This allowed Servier to continue the female CEO system. French CEO Melanie Loresry has been in the pharmaceutical industry for about 20 years and has accumulated various experiences in pharmaceutical companies such as AstraZeneca and Novartis through sales, marketing, and medical departments. At Servier, she joined the French headquarters in 2017 and has served as Deputy Operational Manager in southern European countries such as Spain, Greece, Italy and Portugal. Meanwhile, Servier is a French pharmaceutical company with expertise in the field of cardiovascular disease, and supplies high blood pressure treatment 'Acertil' and heart failure treatment 'Procoralan' in Korea. In 2018, Servier acquired Shire's anticancer drug division, which was merged with Takeda, and secured the pancreatic cancer treatment 'Onivyde'. Onivyde was approved in Korea in 2017, but has not yet been listed on the insurance reimbursement list.
- Company
- MSD Korea’s trade union protests against organon's spinoff
- by Nov 06, 2020 06:25am
- Picket hung in front of MSD Korea headquarters The MSD Korea’s trade union began disputes on the 3rd due to the breakdown of the second round of mediation by the National Labor Relations Commission on the 2nd. On the 3rd, the union hung a picket and banner on the MSD Korea office building in Seoul Square, urging against the spin-off of Organon and urged cooperation in signing a collective agreement. As the spin-off of organon began in earnest, some members of the union executives held a demonstration for the first time since its formation on the morning of the 4th. The union also conveyed its intention to refuse the management meeting for the division of Organon. Earlier, union members in the DV/PC department to be moved signed a unilateral move to Organon. An official from the MSD Korea union said, "The union continuously raised issues about meetings that were held without the individual consent of the employees, but the management had only held formal meetings." He said that the meeting to communicate only the progress without collecting opinions from workers was judged to be meaningless, so we notified the company of the refusal to attend through the “struggle for the rights” twice. On the morning of the 4th, some of the union executives held a demonstration in front of Seoul Square for the first time since its formation
- Company
- Menarini Korea labor union in pursuit of stable job security
- by An, Kyung-Jin Nov 06, 2020 06:25am
- On Nov. 4, Korea Democratic Pharmaceutical Union reported Menarini Korea has recently established a labor union and joined the Democratic Union as a new chapter. Sources confirm the company union has completed the union registration on Oct. 28 and started their official activities from then on. Menarini Korea is a multinational company that headquarters in Italy. Formerly known as Invida Korea, established in November 2005 for pharmaceutical sales, the company was renamed in February 2013 as Menarini Korea. Menarini Asia-Pacific wholly owns the subsidiary in South Korea. According to an audit report submitted early this year, Menarini Korea has 122 employees. As of Nov. 3, 51 employees, a half of the employees able to join the union, have signed up to be the members of the labor union. Chief Kim Tae-Woo of Menarini Korea Chapter of Korea Democratic Pharmaceutical Union stated, “Due to changes in the corporate management and business policy, the workload on employees has increased immensely and damaged their job security. The management has rashly expanded the employees’ work scope, and seriously toppled their balance between work and life. We saw the need of a labor union to advocate the employees’ voice.” The union is determined to reconsolidate the job security and help the company with sustainable development. Korea Democratic Pharmaceutical Union kicked off in December 2012 as a pharmaceutical industry-specific labor union. Currently, there are chapters in Takeda Pharmaceuticals Korea, BMS Korea Pharmaceutical, Ferring Pharmaceuticals Korea, Baxter, Zuellig Pharma Korea, Allergan Korea, Fresenius Kabi Korea, AbbVie Korea, Astellas Pharma Korea, Kolon Pharma, MSD Korea, Fresenius Medical Care Korea, Mundipharma Korea, Galderma Korea, Zuellig Pharma Solutions Service Korea, Lundbeck Korea, Zanovex Korea, and Medtronic Korea With the newest addition of Menarini Korea Chapter, now the Democratic Pharmaceutical Union has 19 active chapters.
- Company
- Eisai strengthened Pariet's sales, collaborated with Yuhan
- by Nov 06, 2020 06:25am
- Eisai strengthened the collaboration of Pariet (Rabeprazole) with a domestic company of PPI. The joint sales were expanded to Pariet 10·20mg following low-dose Pariet 5mg. According to the pharmaceutical industry on the 3rd, Yuhan recently signed a joint sale contract with Eisai for Pariet 10·20mg, and started supplying the product from this month. Yuhan will focus on hospitals and clinics, and co-promotions will be held by the two companies in general and university hospitals. Eisai signed a partnership with Yuhan earlier this year to sell low-dose Pariet 5mg. This is the first co-promotion with a domestic company. After that, the two companies expanded the contract to Pariet 10·20mg. Pariet is a representative PPI product developed by Eisai and launched in Korea in 2000. At that time, it was leading the PPI market with a high market share, but performance has slowed in recent years due to intensifying competition such as PPI formulations and generics. Based on UBIST, Pariet's outpatient prescriptions amounted to ₩6.3 billion in 2015, ₩8 billion in 2016, and ₩12.4 billion in 2017, showing a double-digit growth rate from the previous year. The stagnation of earnings began in 2018. In 2018, it reached ₩13 billion, an increase of only 5.2% from the previous year, and in 2019, it increased slightly to ₩13.3 billion. This year, the aftermath of COVID-19 was added. Until the third quarter, the cumulative prescription amount was ₩7.9 billion, down about 20% from the same period last year. Eisai, which had sold exclusively after ending the joint sales contract with Janssen in 2015, launched aggressive marketing to increase sales. After strengthening the Pariet lineup last year, it signed a co-promotion contract with Yuhan this year. Pariet 5mg introduced in Korea in September of last year. Pariet 5mg is the lowest dose among PPI and released in Korea. Low-dose Pariet is receiving a positive response from medical staff who prescribe long-term prescriptions. An official from Eisai said, "As Yuhan's strong sales power was added, it was determined that the synergy effect was clear." He also explained, "The marketing was not active due to COVID-19 incident right after the contract, but sales of Pariet will be expanded."
