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- 2026-03-14 21:27:04
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- 80 companies participated in the K-Cab patent dispute
- by Kim, Jin-Gu Jan 12, 2023 04:30am
- The patent dispute over HK Innoen's gastroesophageal reflux disease treatment K-Cab has expanded to the largest scale ever. A total of 80 companies challenged HK inno.N. According to the pharmaceutical industry on the 10th, a total of 80 companies have challenged K-Cab crystalline patents by the 9th. On December 24 last year, SCD filed a passive judgment on the scope of rights in the K-Cab crystalline patent for the first time. By the 9th, 80 companies challenged the same patent. These 80 companies qualified for the "first trial request," one of the generic for exclusivity requirements, by filing the same trial within 14 days of the SCD's filing of the trial. It is the largest ever based on a single item. Previously, there were large-scale patent challenges in the pharmaceutical industry, but there were 40 to 50 participating companies. However, Chong Kun-dang and Daewoong Pharmaceutical, which were active in challenging pharmaceutical bio patents, did not enter the dispute. This is because Chong Kun Dang jointly sells HK inno.N and K-Cab. Analysts say that Daewoong Pharmaceutical is selling Fexuclu, a competitive drug of K-Cab. During this period, 247 documents were filed with the Patent Tribunal. The figure adds to all the cases in which a generic company filed a judgment for the purpose of more than two claims. K-Cab is protected by a total of two patents. It is a substance patent that expires in August 2031, and a crystalline patent that expires in March 2036. Among them, the patents requested by generic companies are crystalline patents. If generic companies succeed in avoiding crystalline patents, they will be eligible to release late-stage drugs after the expiration of the substance patent in 2031. Although there is a long time left until the expiration of material patents, the reason why generic companies are interested in patent challenges is that K-Cab is performing very high in the prescription market. According to UBIST, a pharmaceutical market research firm, K-Cab surpassed 100 billion won in prescriptions in 2021, the third year of its launch. Last year, it booked a total of 92.2 billion won in the third quarter, surpassing 100 billion won for the second consecutive year. K-Cab is the flagship product of HK inno.N. It is a P-CAB-based gastroesophageal reflux disease treatment, and continues to grow with advantages such as that it is more effective than existing PPI-based products and can be taken regardless of before and after meals.
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- Dupixent to be reviewed by DREC for reimb after 2 years
- by Eo, Yun-Ho Jan 12, 2023 04:29am
- The atopic dermatitis treatment ‘Dupixent’ has taken a step forward in extending reimbursement to children and adolescents. According to industry sources, the low-dose formulation (200mg) of Sanofi-Aventis Korea’s Dupixent (dupilumab) will be deliberated by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee today on the 12th. This progress has been made 2 years after the company applied for the reimbursement extension in April 2021. It first took 7 months for expert opinion inquiries to begin on extending reimbursement of Dupixent to pediatric and adolescent patients, and the reimbursement standards for the indication were set in May last year. Being a high-priced new drug, the drug, which had difficulty being approved for reimbursement the first time, is having difficulty extending reimbursement as well. Although the specific indications may differ, the difference in speed of progress is evident when compared to other JAK inhibitors that applied for reimbursement extensions in atopic dermatitis, such as Lilly Korea’s ‘Olumiant (baricitinib),’ Abbvie Korea’s ‘RInvoq (upadacitinib)’ etc. The price of JAK inhibitors is also relatively lower than that of Dupixent, and the two drugs were both listed for reimbursement in May last year. Therefore, whether Dupixent will be able to pass DREC review and be extended reimbursement remains the focus of attention. However, the remaining journey will not be so easy for Dupixent. Being an RSA (Risk Sharing Agreement) drug as well as the addition of the separate 200mg dose, the drug will have to pass HIRA’s cost-effectiveness review process and complete drug pricing negotiations with the National Health Insurance Service. Meanwhile, the 300mg dose of Dupxient is currently reimbursed for adult patients aged 18 years or older with chronic severe atopic dermatitis who have had the condition for over 3 years and satisfy all three of the following criteria: ▲ who are unable to control their symptoms after receiving topical treatment for over 4 weeks, and ▲ unable to use systemic immunotherapies due to side effects or saw no response (50% or more decrease in EASI, EASI 50) after receiving treatment with systemic immunotherapies, and ▲ had an EASI score of 23 or higher before administering Dupixent.
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- The effect of government regulation
- by Chon, Seung-Hyun Jan 11, 2023 05:59am
- More than 7,000 Rx drugs have withdrawn from the market over the past 3 years, the report showed. It is analyzed that this is due to the fact that the item license renewal system, which regularly checks the safety and efficacy of drugs, has been established and a series of market withdrawals due to continuous clinical re-evaluation. Some point out that the government's pressure to re-evaluate generic drug prices also encouraged the market to withdraw. According to the Ministry of Food and Drug Safety on the 11th, a total of 2,167 cases were withdrawn from the market last year, including the withdrawal and cancellation of Rx drugs. The number of Rx drugs permits was 93.8% higher than 1118. This means that there were about twice as many professional drugs in which market withdrawals entered the market as new markets last year. The number of withdrawals and cancellations of Rx drug licenses surged 68.1% from 1,600 in 2019 to 2,690 in 2020. In 2021, 2,595 Rx drugs were withdrawn, and more than 2,000 Rx drugs disappeared for the third consecutive year until last year. A total of 7452 Rx drugs have been withdrawn from the market over the past three years due to the withdrawal and cancellation of permits. A total of 3,796 Rx drugs returned permits over the three years from 2017 to 2019, with the number of products withdrawn from the market doubling over the next 3 years. It is analyzed that the number of products disappearing from the market has increased due to the combination of government regulatory movements such as drug item license renewal, clinical re-evaluation, and price of generic re-evaluation. It is pointed out that the withdrawal of expired drugs from the market has increased due to the establishment of the item license renewal system. The key to the drug item renewal system, which was based on the revision of the Pharmaceutical Affairs Act in 2012, is that drugs approved by health authorities must be re-certified every five years to maintain their licenses. Existing drugs on the market have been verified for safety and efficiency once every 16-20 years through a procedure called reevaluation. However, the renewal system was introduced because it was deemed necessary to operate a reasonable evaluation system according to rapid scientific development. Drugs licensed from January 1, 2013 are maintained only after submitting data related to safety and efficacy every five years and being judged suitable by the Ministry of Food and Drug Safety. If a drug whose item license expires does not submit data for renewal, the license will be canceled. An industry official explained, "After the implementation of the item license renewal system, even if there are no safety and efficiency problems, the practice of withdrawing products with low sales volume from the market has been established." The government's continuous revaluation policy is also cited as a factor that accelerates the product cleanup phenomenon. In the case of clinical re-evaluation, which rechecks efficacy and safety, it often leads to the withdrawal of the drug from the market. For example, in the case of Choline alfoscerate, a brain function improvement drug, more than half of the licensed products left with the start of clinical re-evaluation. In June 2020, the Ministry of Food and Drug Safety requested the submission of clinical trial data for Choline, and 57 pharmaceutical companies were approved for re-evaluation clinical plans. Initially, the Ministry of Food and Drug Safety ordered a total of 134 companies to re-evaluate Choline's clinical trials, but less than half of 57 companies were approved for re-evaluation clinical trial plans. This means that 77 companies gave up the re-evaluation of Choline and chose to withdraw from the market. Recently, some diagnose that the withdrawal from the Rx drug market has increased due to the re-evaluation of generic drug prices. In June 2020, the Ministry of Health and Welfare announced a plan to reevaluate the upper limit of drugs that maintain the previous drug price if Generic, which does not meet the highest price requirements, submits BA test and registered raw material drug data by February 2023. The re-evaluation of the generic drug price is a policy to apply the new drug price system, which took effect in July 2020, to the original generic. Each time one requirement is not met, the upper limit is lowered by 15%. Pharmaceutical companies should choose strategies to accept drug price cuts for consignment generics or avoid drug price cuts through additional investments. Requirements for the use of registered raw materials can be met through the replacement of raw materials and medicines. Pharmaceutical companies are in a situation where they have to choose between accepting drug price cuts or maintaining drug prices through conducting BA tests. Accordingly, pharmaceutical companies are actively conducting BA tests on licensed generics. The goal is to avoid lowering drug prices through permission to change the drug price by making generics through pharmaceutical research, conducting BA tests, and obtaining equivalent results. At this time, if the permission is changed while converting consignment manufacturing to its own manufacturing, the company is using a strategy that meets the requirements for 'BA test implementation'. For pharmaceutical companies, if additional investment is burdensome, they have no choice but to accept a reduction in drug prices. It is known that many generics often choose to withdraw from the market rather than accept drug price cuts. Some analysts say that reckless entry into generics, which did not take into account marketability before the government tightened regulations on generics, may have led to a withdrawal from the market after stricter regulations. In 2018, 175 items containing Valsartan, a hypertension treatment, were banned from selling due to the detection of excess impurities. At that time, the Ministry of Health and Welfare and the Ministry of Food and Drug Safety set up a "consultative body for improving the generic drug system" and began to come up with measures to curb the generics crisis. As the government hinted at the government's move to tighten regulations, pharmaceutical companies moved to install generic products in advance, temporarily increasing generic permits. The number of Rx permits reached 1,562 in 2018, which surged to 4,195 and 2,616 in 2019 and 2020, respectively. 374 of the Rx licensed in 2019 returned their permits. In other words, it withdrew from the market less than three years after it was approved by the government's move to tighten regulations. There are also more products that disappear from the market due to unexpected variables such as impurities. The Ministry of Food and Drug Safety decided in September 2019 to ban the sale of all products containing Ranitidine, citing excessive detection of NDMA, a carcinogenic substance.
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- Rx Drugs permits have fallen by 73% in 3 years
- by Chon, Seung-Hyun Jan 10, 2023 05:35am
- Stair-type drug price systems and joint development regulations have dampened the entry power of generics Last year, the number of Rx drug permits decreased significantly. The number of market entries has been reduced by more than 70% compared to three years ago. Analysts say that the government's all-around regulatory pressure, such as the reorganization of the drug price system and regulations on joint development, has greatly reduced its entry into the generic market. According to the Ministry of Food and Drug Safety on the 9th, a total of 1,118 Rx drugs were approved last year. It decreased by 30.1% in a year from 1,600 in 2021. Last year, the number of Rx drug permits was less than half of the 2616 two years ago. Compared to 4,195 in 2019, it decreased by 73.3%. The number of Rx drug permits has decreased by 3077 compared to three years ago. The number of Rx drug permits averaged 130 per month to 1,562 in 2018, but more than doubled to 4,195 per month in 2019. In May 2019, 584 professional drugs were approved for a month. However, since 2020, the number of Rx drug permits has gradually decreased and seems to have regained the previous year's level. From October 2018 to July 2020, more than 100 Rx drugs were poured out every month, and in August 2020, Rx drug permits fell to less than 100 in 23 months. Last year, there were only four Rx drug licenses per month. It is analyzed that the number of generic permits, which account for the largest proportion of Rx drugs, has decreased. The reorganization of the drug price system is cited as a major factor in the decrease in the number of generic permits. The key to the revised drug price system, which took effect in July 2020, is to maintain the upper limit of 53.55% of the original drug before the expiration of the current patent only when generic products meet both the direct BA test and the use of the registered raw drugs. The reorganized drug price system includes a stepped drug price system in which the upper limit decreases as the salary registration period is delayed. If more than 20 generics are listed in the specific ingredient market, the upper limit of newly listed items will be up to 85% of the existing lowest price. Analysts say that the permission for the entire process of manufacturing consignment generics has decreased significantly due to the structure in which drug prices fall significantly if pharmaceutical companies do not develop generics themselves and conduct BA tests. Since more than 20 generics have already entered most markets with high marketability, late generics will inevitably lose their motivation to enter new markets as drug prices fall significantly due to the application of the step-type drug price system. Some say that regulations on the joint development of drugs, which took effect in July last year, have promoted the decline in generic permits. The revised Pharmaceutical Affairs Act, passed at the plenary session of the National Assembly in May last year, calls for limiting the number of improved new drugs and generics that can be approved as a clinical trials. If all manufacturing processes are manufactured the same way with the same prescription and manufacturing method at the same manufacturing plant as the pharmaceutical company's drug that directly conducted the BA test, the use of BA data is limited to three times. This means that only four generics can be approved for one BA test. Clinical trial data can also be agreed to only three items other than drugs from direct-performing pharmaceutical companies. In the past, dozens of pharmaceutical companies often received consignment generic licenses with the same data if certain pharmaceutical companies were approved for generics through BA tests, but joint development regulations have made it impossible to "unlimited generic replication." Critics point out that the government provided the cause of the surge in Rx permits in 2019 and 2020. The government's move to tighten regulations on generics has led to a surge in generics permits. In 2018, 175 items containing valsartan, a hypertension treatment, were banned from selling due to the detection of excess impurities. At that time, the Ministry of Health and Welfare and the Ministry of Food and Drug Safety set up a "consultative body for improving the generic drug system" and began to come up with measures to curb the generic crisis. As the government's move to tighten regulations showed, pharmaceutical companies moved to install generic products in advance, temporarily increasing generic permits. The number of generic permits surged due to the government's move to tighten regulations and returned to the previous level after the system was reorganized.
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- HIV drug Pifeltro may be prescribed at hub hospitals in Kore
- by Eo, Yun-Ho Jan 10, 2023 05:35am
- ‘Pifeltro,’ a single-ingredient drug used for HIV, can be prescribed at general hospitals in Korea. According to industry sources, MSD Korea’s HIV treatment Pifeltro (dovavirine) passed the Drug committees of tertiary hospitals such as the Seoul National University Hospital and Sinchon Severance Hospital as well as local hub hospitals (national and public hospitals) that are in charge of HIV treatment in Korea, including the Kyungpook National University Hospital, National Medical Center, Pusan National University Hospital, Soonchunhyang University Hospital, Ulsan University Hospital, Chonnam National University Hospital, and Hanyang University Hospital. MSD’s fixed-dose combination drug ‘Delstrigo (dovavirine, lamivudine, tenofovir disoproxil) also contains the main active ingredient in Pifeltro, dovavirine. Both Delstrigo and Pifeltro were listed for reimbursement in October 2021. The final listed price was set at KRW 7,975 per tablet for Pifeltro, and KRW 19,491 per tablet for Delstrigo. Delstrigo is already being prescribed at major medical institutions in Korea. Both drugs are indicated for the treatment of HIV-1 infection in patients without prior antiretroviral therapy (ART) treatment history in Korea. The efficacy of the drugs was identified through the DRIVE-AHEAD trial, in which Delstrigo demonstrated noninferiority to efavirenz·emtricitabine·tenofovir(EFV/FTC/TDF). In the trial, the proportion of patients who sustained viral suppression through 48 weeks (viral suppression of HIV-1 RNA
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- Braftovi can be prescribed at tertiary hospitals
- by Eo, Yun-Ho Jan 10, 2023 05:34am
- The new colorectal cancer drug Braftovi has settled in tertiary hospitals. According to related industries, Ono's BRAF-inhibitory ELECTRIC CANCER (colorectal cancer) treatment Braftovi passed the Drug Commission (DC) of Korea University Anam Hospital, including Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, and Asan Medical Center. Braftovi is still a non-reimbursed drug. It was approved in August 2021 and passed the Cancer Disease Review Committee in January of the following year. It quickly passed the HIRA Cancer Disease Deliberation Committee, the highest level in anticancer drug benefits, but failed to present the agenda of the Drug Benefit Evaluation Committee. If it succeeds in registering this year, it is expected to lead to actual prescriptions quickly. Braftovi can be used as a combination therapy with Erbitux of Merck Korea for adult patients with direct bowel cancer with previous treatment experience and confirmed BRAF V600E mutation. Braftovi combination therapy confirmed efficiency through a three-phase clinical BEACON CRC study in patients with unstoppable progressive or recurrent direct bowel cancer with BRAF V600E mutation after primary or secondary treatment. Braftovi -Cetuximab combination therapy showed statistically significant elongation (HR 0.60, p=0.0003) in OS compared to the control Irinotecan-Cetuximab-based combination therapy. The median OS value was 8.4 months in the Braftovi group and 5.4 months in the control group. In ORR according to BICR, Braftovi-Cetuximab combination therapy was 20%, showing statistically significant improvement compared to 2% of the control group. The median PFS value was 4.2 months for Braftovi-Cetuximab combination therapy and 1.5 months for the control group. In this study, there was no unexpected toxicity of Braftovi-Cetuximab combination therapy. In Korea, BRAF V600E gene mutation is positive in 4.7% of patients with direct bowel cancer. It is known that if there is a BRAF V600E mutation, the prognosis is worse than that of patients who do not. There were no approved drugs based on efficacy and effectiveness in direct bowel cancer with BRAF gene mutation, so a new treatment option was needed.
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- Obesity drug Saxenda’s sales surge with expanded indication
- by Moon, sung-ho Jan 10, 2023 05:33am
- Saxenda (liraglutide) has been recording dominant sales in the growing obesity treatment market in Korea. Therefore, the drug is expected to monopolize the obesity treatment market until other new obesity treatments such as ‘Wegovy (semaglutide, Novo Nordisk)’ and ‘Mounjaro (tirzepatide, Lilly)’ are released in Korea. #According to the market investigation institution IQVIA on the 25th, Novo Nordisk’s Saxenda showed a surge in quarterly prescription sales recently. More specifically, Saxenda’s sales recorded KRW 10.4 billion in Q1 last year, then increased to KRW 15.4 billion in Q2, then recorded a quarterly best record of KRW 16.6 in Q3 last year. In other words, the company succeeded in bringing in more than KRW 40 billion in only three quarters last year. Compared to the same three quarters of the previous year, the drug recorded a 70% growth in its sales and solidified its lead in the domestic obesity treatment market. Sales of its competitor Qsymia((phentermine / topiramate ER) have been pushed back by Saxenda's rapid growth, and the sales gap between the two drugs seems to be rather widening despite Qsymia’s sales increase. Alvogen Korea’s Qsymia recorded prescription sales of KRW 8.2 billion in Q3 last year, which is over twice the difference in quarterly sales compared to Saxenda. Qsymia is currently sold by Chong Kun Dang in Korea. Then why has Saxenda been able to enjoy such rapid growth in sales? The medical and pharmaceutical industry pointed to how the drug’s indication was expanded to treat children and adolescents this year. In December 2021, the indication for Saxenda had been expanded to treat adolescents aged 12 to 18 with obesity in Korea with a body weight above 60 kg and an initial BMI corresponding to ≥30 kg/m2 for adults. Novo Nordisk had implemented active sales and marketing activities, such as opening a 'Saxenda portal' exclusively for doctors and launching a digital weight management application to support weight control for patients who have been prescribed Saxenda. A PM that requested anonymity, said, “In the case of Saxenda, its indication expansion to adolescents was the key driver of its sales growth. The number of obesity patients has surged with the COVID-19 pandemic, and the timely indication expansion to pediatric and adolescent patients brought a synergistic effect.” Also, the industry saw that the lowered price and MFDS’s ‘warning’ in addition to the COVID-19 pandemic was behind the rise in sales of Saxenda in local clinics. Since last year, the MFDS has been strengthening control over antipsychotics that contain ▲ phentermine, ▲ phendimetrazine, ▲diethylpropion, and ▲mazindol to address concerns over the misuse and abuse of drugs. A doctor from an internal clinical in Seoul who requested anonymity said, “The obesity treatment market is one representative non-reimbursed treatment market. Its average price had been up to KRW 150,000 at the highest, but its price has now fallen to the KRW 70,000-80,000 range in some areas. In the case of Qsymia, no dumping sales of the product are being made yet as the drug is still new to the market.” “Qsymia costs KRW 4,000 per tablet, therefore, a 30-day prescription of the drug will cost KRW 120,000. Saxenda’s lowered price has therefore led to the increase in sales as well.” Professor Hee-Jin Hwang of the International St. Mary’s Hospital (Department of Family Medicine) who also serves as an executive member of the Korean Society for the Study of Obesity, said, “The MFDS had issued a warning disposition to some doctors in the course of reinforcing management of antipsychotic drugs. As some obesity treatments contain controlled substances, this would inevitably affect the prescription behavior of doctors.”
- Company
- Mylotarg can be prescribed at general hospitals
- by Eo, Yun-Ho Jan 09, 2023 06:11am
- Mylotarg, a new drug for acute myelogenous leukemia, can be prescribed at general hospitals. According to related industries, Mylotarg, Pfizer's Acute myeloid leukemia (AML) treatment, passed the Drug Commission (DC) of medical institutions such as Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, and Sinchon Severance Hospital. Mylotarg can be used in the primary treatment of adult AML patients who are CD33 positive, and newly diagnosed with Antibody-Drug Conjugate (ADC). Mylotarg has not yet been applied to insurance benefits. The drug was introduced to the HIRA in May last year, but it was judged that the benefit standard was not set. Mylotarg, approved in Korea in December 2021, is an ADC composed of CD33 target monoclonal antibodies and a cytotoxic drug Calicheamicin, which acts on cells expressing CD33 antigens that appear in 90% of all AML patients. This blocks cancer cell growth and induces apoptosis. The Mylotarg permit was based on a clinical study conducted on 271 newly diagnosed AML patients with no treatment experience before the age 50 to 70. The clinical trial was ALFA-0701 clinical trial, which was conducted with open-label, random assignment, and multi-organ phase 3. The existing chemotherapy, Downorubicin or Citarabin combination therapy, Mylotarg, Daunorubicin, and Cytarabine combination therapy were compared and evaluated. As a result, the Mylotarg+Daunorubicin+Cytarabine combination group showed an effect of extending about 7.8 months compared to 9.5 months of the Event-free survival median value of 17.3 months. The risk of induction failure, recurrence, or death was reduced by about 44%. The median value of Relapse-free survival was 28.0 months in the Mylotarg+Daunorubicin+Cytarabine bottle administration group and 11.4 months in the Daunorubicin+Cytarabine combination administration group, showing a significant difference of about 16.6 months. In the case of the median value of Overall survival, there was no statistically significant difference between the Mylotarg+Daunorubicin+Cytarabine combination administration group for 27.5 months and the Daunorubicin+Cytarabine combination administration group for 21.8 months.
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- Reinforced drug regulations change generic drug approvals
- by Chon, Seung-Hyun Jan 09, 2023 06:10am
- The number of generic drugs approved per every bioequivalence test fell greatly. Affected by the reform made in Korea's drug pricing policy, the proportion of generic drugs approved per bioequivalence test dropped significantly. According to the Food & Drug Statistical Year Book published by the Ministry of Food and Drug Safety on the 6th, 648 items were approved after being recognized as bioequivalent to their alternative in 2021. This was a 58.8% decrease from the 1,573 approved in 2020. Compared to the 2,358 in 2019, this was a 72.5% decrease in 2 years. Drugs recognized as bioequivalent are products recognized as being equivalent to their original drug, and are mostly granted for newly approved generic drugs. No. of bioequivalent items (left) and No. of items approved per bioequivalence test (right) (Unit: items, Data: MFDS) The drastic reduction in the number of bioequivalent drugs in 2021 is considered to have been directly influenced by the reform of the drug pricing system. The main change that had been made with the reform of the drug pricing system that had been implemented in July 2020 was that only generic drugs that meet both requirements – those that directly perform bioequivalence tests and those that use registered APIs – are allowed to maintain a price level that is at 53.55% of the original drug price prior to patent expiry. The reformed system also contained a stepped drug pricing system that lowers the price ceiling of drugs by order of listing and reducing the price of those that are listed later. If 20 or more generic drugs are listed for a certain ingredient, the price ceiling set for the newly listed drugs afterward is set at 85% of the existing lowest price. As companies cannot receive a high drug price without directly performing bioequivalence tests, this reduced the companies’ attempts to receive approval for generic drugs after consigning the whole manufacturing process. Therefore, the number of generic drugs approved per bioequivalence tests has been reduced greatly. Among the 648 bioequivalent drug items approved in 2021, 75 performed a direct bioequivalence test. This roughly translates to 8.6 generics being approved for each test. In 2019 and 2020, the number has been 29 and 9.4 drugs per bioequivalent test each. The proportion of consigned generics among bioequivalent drug items reached 96.6% in 2019 but was reduced to 88.4% by 2021. By year, the number of bioequivalent drug items increased exceptionally in 2019 and 2020. The number, which had been 625 and 789, suddenly rose threefold in just a year to 2,358 in 2019. This explosive increase is analyzed to be caused by the government's move to tighten regulations on generic drugs. A total of 175 valsartan-containing hypertension drugs were suspended sales due to excess detection of impurities. At the time, the Ministry of Health and Welfare and the Ministry of Food and Drug Safety prepared measures to inhibit the flooding of generic drugs by organizing a ‘Consultative Body to Improve the Generic Drug System.’ In response to the government’s move to reinforce regulations, pharmaceutical companies have worked to receive approval for their generic drugs in advance, which greatly increased the number of generic approvals for a short period of time. In other words, the government’s work to reinforce regulations had caused an increase in generic approvals, and the level only returned to the previous level after the system reform. As the regulations for the approval of generics have also been strengthened, the proportion of approved consigned generics is expected to be further reduced. According to the amended Pharmaceutical Affairs Act, which took effect in July last year, the number of consigned generics that can be approved for each bioequivalence test has been limited to a maximum of three. Therefore, the proportion of consigned generics among generic approvals will not be able to exceed 75%.
- Company
- Sanofi consumer healthcare appoints Chung Kyung-hee as CEO
- by Eo, Yun-Ho Jan 09, 2023 06:10am
- Sanofi's Korean subsidiary Consumer Healthcare (Sanofi CHC) division announced on the 5th that it had appointed Chung Kyung-hee as its new CEO. Chung Kyung-hee, the new CEO, has been intensively building his capabilities in various global companies' marketing and digital fields over the past 26 years. From 2020 to May last year, he served as CEO of Pierre Fabre Dermocosmetics Korea, leading in-house cultural innovation to improve the group's overall performance and organizational efficiency. From 2015 to 2020, he led the successful sales growth of major brands such as Aveda, Clinique, and Lab series as a brand general at ELCA Korea. "Based on our past experience, we will do our best to bring out the potential and balanced growth of the CHC division," said new CEO Chung Kyung-hee.
