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- 2026-04-18 02:23:25
- Opinion
- [FOCUS]Government sophistication to generic regulations
- by Chon, Seung-Hyun Nov 25, 2019 06:21am
- A few years ago, a multinational pharmaceuticals announced “high quality” by launching generics in the domestic market. It is the aspiration to show good quality generics based on strict production management, product monitoring and quality assurance system that have long been recognized in the global market. At the time, the head of the licensing review department of the Ministry of Food and Drug Safety, who got the news, rejected that "the quality of generic products is meaningless." Generics must pass strict standards from drug substances to finished product manufacturing facilities. In addition, a conformity test should be made in a bioequivalence study demonstrating that the generics are equivalent to the rate and concentration of original drug absorption. "Generic products that have passed all government-set standards and have been approved for sale should be regarded as equal in quality.“ The MFDS is trying to tighten restrictions on generics after last year's issue of Valsartan impurity. The MFDS announced the legislative draft of the “Revision of Partial Rules on the Safety of Pharmaceuticals,” etc. on the 18th. It contains a significant tightening of the licensing requirements for all fair commissioned manufacturing generics. It means that the GMP evaluation data, standards and test method data, which have been exempted from the consigned generic permit screening data, must be submitted. It is noteworthy that MFDS referred to “high quality generics” as the background for strengthening generic regulations. According to the Regulatory Impact Analysis Report of the revised regulations, the MFDS said that they will secure the trust of the people providing 'high quality' medicines and improving the soundness of drug distribution through the quality improvement of generics for each clause that strengthens the regulation of generics. The intention is to supply high-quality generics by strengthening generic regulations. It also means that there is differences in quality between generic products. This is contrary to the conventional view that "quality is equal if it passes the strict licensing process." It seems possible that even with the MFDS, there may be some low quality generics. It is also ambiguous to see how the strengthening of permit standards is related to quality improvement. Submission of GMP assessment data by authorized generic means re-release of data that has already been verified by the MFDS. GMP assessment data need not be submitted when consigning a product that is identical to a previously approved generic. However, one year after the proclamation of amendment, the authorized generics will also be required to produce three manufacturing units (batch) and submit relevant GMP data for approval. The submission of GMP evaluation data by authorized generics disappeared just five years ago. The MFDS implemented ‘the GMP Compliance Certification System’ in 2014, which permits Pharmaceutical production that all factories producing pharmaceuticals requires passing the standards set by the MFDS every three years. At this time, regulations for mandatory production of licensed drugs were relaxed. It was made possible for the establishment within the validity period of the conformity assessment to replace the data on the evaluation of the GMP implementation with the conformity assessment. They have already laid the foundation for strengthening quality management by introducing the ‘Certificate of GMP Compliance of a Manufacturer', and in the situation where the approved facility has determined the suitability of licensed drugs, it is decided that it is redundant regulation to receive the GMP evaluation data of the authorized generics again. The same applies to co-bioequivalence regulations currently underway. On April 15, the MFDS announced a partial revision of the “Regulations on the Authorization, Declaration, and Review of Pharmaceuticals,” which includes tightening regulations on co-bioequivalence regulations. According to the amendment, regulations will be tightened so that up to three authorized generic manufacturers are allowed to one original manufacturer one year after the notification. This means that up to four generics will be granted for each bioequivalence test. After three years, consiged bioequivalence is completely banned. Four years after the notification, only one generic may be approved in one bioequivalence study. As a result, after four years, the same product from the same manufacturing facility must be tested for bioequivalence separately. I don't know what it is related to run separate bioequivalence tests on the same product with ‘high quality generics’. Goal of the MFDS is clear that it tightens regulations of generics. Because of the serious difficulty of generics, the intention is to reduce the number of generics in the market by raising licensing barriers. It is clear that the overflow of generic manufacturing contractors is the cause of generic upheaval. It is also clear that generic upheavals were triggered by changes in government permit regulations. Wouldn't it be better to admit that the government's policies encouraged generic upheaval and try to persuade the reasons for changing the policy stance? Rather, the cause of “quality improvement,” which is not related to the regulations, can lead to confusion in the industrial field. This leads to distrust in government policy. Of course, the government may adjust the regulatory intensity in response to changing market conditions. However, companies need to be able to believe and follow only by providing a clear justification and justification for the new policy. If the government produces a policy without justification and changes the policy stance, in the turn of a hand, credibility falls.
- Policy
- Surprise order by MFDS for all substance impurity risk test
- by Lee, Tak-Sun Nov 25, 2019 06:21am
- The Korean pharmaceutical industry is shook up as Ministry of Food and Drug Safety ordered companies to conduct tests on impurity contamination in all synthetic active pharmaceutical agents. Other foreign health authorities like European Medicines Agency (EMA) has released a new templates of carcinogen risk evaluation and confirmatory testing for pharmaceutical manufacturers fill in. But the Korean regulator caught Korean pharmaceutical companies by surprise. At the moment, unprepared companies are in a hurry to find a testing lab. After the decision has been made to ban sales on 13 nizatidine products found with cancer-causing compound N-Nitrosodimethylamine (NDMA), MFDS ordered Korean pharmaceutical company on Nov. 22 to conduct an impurity risk test on all of their active ingredients to reinforce drug substance safety control. Accordingly, active pharmaceutical ingredient manufacturing and importing companies, and complete product manufacturing and importing companies are to evaluate and test for impurity risk in active ingredients. The risk evaluation result should be reported to MFDS by May 2020, and complete test result by May 2021. Impurity risk evaluation comprehensively analyzes and evaluates possible risk of impurity contamination in active agents based on effect of substance manufacturing procedure, self-decomposition and complete product storage conditions. The tests should follow test procedure verified by a Korean Good Manufacturing Practice (GMP) certified manufacturer, MFDS designated quality test institute, or city and provincial-managed environment research lab, according to test methodology officially disclosed by either Korean or international regulators. And also companies with at least three product serial numbers in the market are required to take the tests. MFDS stated Korean whole drug manufacturer may substitute required test result with data from active agent manufacturing and importing companies, but the ministry pressured that the ultimate liability would be on the companies. The pharmaceutical industry clearly seemed perplexed with the news. A mid-sized pharmaceutical company frustrated with the government order and complained, “The ministry unilaterally released the news on the media without a proper notice. So we are at a loss. They say there is an impurity risk evaluation program, but we are not sure if it could actually test all active ingredients.” Many also complain about overall cost and required time for the test are unknown. A top pharmaceutical company insider commented, “If the required materials can be substitute with active ingredient manufacturer’s data, then more than a half of products are off the hook. But for smaller-scale substance manufacturing companies may not have evaluation material, so probably complete product manufacturing companies would have to take the bullet”. But testing for agents with risk of impurity contamination definitely puts a strain on the industry. MFDS has reportedly disseminated an official notice demanding companies to hand in nizatidine product test results by next year. “Apparently, there are only a handful of laboratories able to test drug substances. As many pharmaceutical companies would rush to get the test done, our company is also promptly looking for a testing facility”, an executive from a mid-sized company explained. Companies are concerned that testing price skyrocket from a normal rate of one million won per a case to few millions per a case. “Regulators in EU and Switzerland have recently decided to reinforce safety management by requiring companies to submit impurity risk evaluation and test results of synthetic drug agents. MFDS plans to continue tightening regulation for active pharmaceutical ingredient safety control”, said MFDS official.
- Company
- The third JAK1 inhibitor,↑competition in Korea
- by Eo, Yun-Ho Nov 24, 2019 09:58pm
- It is the third rheumatoid arthritis drugs that is expectecd to enter domestic market. According to the industry, Abbie recently filed an application for permission to use 'Upadacitinib' for JAK inhibitors. Given the approval from the FDA in US on the 16th of last month, it is rapidly knocking on the Korean market. Abbie demonstrated the efficacy and safety of 'Upadacitinib' in various patient groups through a SELECT clinical program comprising approximately 4,400 patients with rheumatoid arthritis and a total of five phase III clinical studies. In the SELECT-EARLY study of patients with no experience with MTX, 52% of the Ufadacytinib-treated group achieved ACR50 at 121th week and showed a significant improvement over 28% of the MTX-treated control group. In the SELECT-MONOTHERAPY study, which compared the administration of 'Upadacitinib' alone with MTX treatment in patients with insufficient MTX treatment, such as the approved indication, 68% of the Upadacitinib-treated group achieved ACR20 at 141th week . 41% of the improvement was proved. On the other hand, Xeljanz (Tofacitinib) and Olumiant (Baricitinib)) are approved in Korea. Olumiant, once daily, has a mechanism to block JAK1 and JAK2, and drugs such as Xeljanz, Upadacitinib, and Filgotinib, which block twice daily, block JAK1.
- Policy
- NHIS, HIRA and NECA on joint reevaluation for listed drugs
- by Lee, Hye-Kyung Nov 24, 2019 09:58pm
- Drug Reimbursement Evaluation Committee (DREC) affiliated under Health Insurance Review and Assessment Service (HIRA) is to conduct reevaluation on already-listed high-cost drug items. When forming the seventh DREC, HIRA also established a ‘Post-marketing Drug Evaluation Subcommittee’ to be in charge of selecting insurance listed drug items or classes that need reevaluation. Initially, the subcommittee was to consist of four DREC members, two government officials and two experts, but HIRA finalized on three government officials, one clinical expert, two consumer and patient group representatives, and one external expert from DREC human resource pool. As a result, a chief of Pharmaceutical Management Department at HIRA Park Young-mi, a chief of Health Benefit Strategy Office at National Health Insurance Service (NHIS) Park Jong Heon, and a chief of Economic Evaluation Research Office at National Evidence-based Healthcare Collaborating Agency (NECA) Shin Sang Jin are to represent government bodies. The three government agencies have been running various researches related to post-management of already-listed drug items since last year. Professor Lee Dae-ho at Seoul Asan Medical Center, as recommended by Korean Academy of Medical Sciences, president of Korea Health Personnel Licensing Examination Institute Lee Yoon-seong and an executive director of Korea Alliance of Patients Organization Lee Eun-young, as recommended by consumer and patient groups, are selected to serve as members of the subcommittee. At the latest annual audit by National Assembly Health and Welfare Committee, HIRA answered Lawmaker Kim Myung-yeon’s question on ‘monitoring reimbursement feasibility of drugs with significant financial impact on National Health Insurance’, and stated “HIRA plans to have DREC to deliberate and compile a list of reevaluation subject items, and conduct reimbursement feasibility reevaluation on them”. After the Ministry of Health and Welfare (MOHW) unveiled the first National Health Insurance Comprehensive Plan, HIRA has been compiling reimbursement feasibility monitoring plan for drugs granted with the insurance reimbursement. “The subcommittee would consider clinical efficacy, financial impact, and external reimbursement listing reference of the reimbursed items. HIRA would consult with other government agencies and report reevaluation plan for more efficient management of National Health Insurance expenditure in the future”, HIRA official commented.
- Company
- Big5 hospitals adds Glead’s new HIV option Biktarvy
- by Eo, Yun-Ho Nov 24, 2019 09:58pm
- Glead’s new HIV combination drug, Biktarvy is landing its code on tertiary hospital’s prescription list. According to pharmaceutical industry source, Biktarvy has been passed by drug committee (DC) at the Big Five tertiary hospitals in Korea, including Seoul National University Hospital, Samsung Seoul Medical Center, Severance Hospital and others, after the drug passed the insurance listing in July. The main active agent of Biktarvy, bictegravir has been evaluated as a powerful second generation integrase inhibitor that displays a high resistance barrier lowering the risk of developing resistance. Tenofovir alafenamide is also a nucleoside reverse transcriptase inhibitor (NRTI) backbone that shows improved safety profile of tenofovir disoproxil fumarate (TDF). Biktarvy does not require HLA-B*5701 genetic screening and it is able to start treatment fast as it does not have restriction on patients’ viral load or CD4 count. The treatment regimen is an orally taken once-daily tablet, and a patient can take the tablet regardless of food intake. Biktarvy has high barrier to resistance, and it enhanced patient’s administration convenience presenting the smallest size of tablet among three-drug combination drug on HIV infection. Gilead confirmed Biktarvy’s safety and efficacy in four of Phase 3 clinical studies --Study 1489, Study 1490, Study 1844, and Study 1878-- on adult patients with HIV infection who had or not had antiretroviral treatment,. Professor Kim Yeon-Sook of virology department at Chungnam University Hospital explained, “The median age of HIV-infected patients who received antiretroviral treatment has reached 48. HIV infection accelerates development of renal, cardiovascular system, hepatic, bone, neurological and cancer diseases, as the therapy puts pressure on certain aging process.” “While the overall population’s number of death by cardiovascular disease has been going down, the number of death by cardiovascular disease in patients with HIV infection has gone up from seven percent to 13 percent. To reduce the risk of cardiovascular disease in HIV-infected patient, blood pressure and lipid managements are needed,” the professor added. In Study 1844 that compared 563 adult patients with HIV-1, who have undergone antiretroviral therapy for at least three months, the participants in respective arms were treated with ABC, DTG, 3TC and Biktarvy. The result found only 1 percent of 282 patients who switched to Biktarvy had virological failure at 48 weeks. The treatment arm demonstrated noninferior efficacy compared to ABC, DTG and 3TC arms (n=281), as the 94 percent of Biktarvy arm maintained virologic suppression. In both Study 1844 and Study 1878 of 48-week Phase 3 clinical trials, Biktarvy demonstrated no case of emergent drug resistance.
- Policy
- Background of reimbursement standards enhancement of Avodart
- by Lee, Hye-Kyung Nov 24, 2019 09:57pm
- Starting this month, the 5α-reductase inhibitors (5ARI), reimburesement standards of Pinagren tablets 5mg (Finasteride) and Avodart 0.5mg (Dutasteride), which are used to treat prostate enlargement and hair loss, will be strengthened. The Ministry of Health and Welfare has decided to reimbursement benefits when it is administered to 'positive prostate hyperplasia' among the permission of Pinagren and Avodart if both conditions are met. The conditions are as follows: ▲ more than 8 points of IPSS (International Prostate Symptom Score) ▲ Prostate size more than 30ml by ultrasound test or, if the rectal balance test showed moderate or more benign prostatic hyperplasia or serum seroprostate-specific antigen (PSA) levels exceeded 1.4ng/ml. In this regard, the Health Insurance Review and Assessment Service released a question and answer on the establishment of 5ARI reimbursement standards on the 5th and explained the background of strengthening the reimbursement standards of the two drugs. HIRA concluded that there is room to interfere with the correct interpretation of serum PSA level when serum PSA levels were decreased and used for early diagnosis of prostate cancer through taking 5ARI in the process of reviewing textbooks, clinical guidelines, and related opinions from the Korean Academy of Societies. The clinical literature also showed an increased probability of detecting high-risk prostate cancer in the 5ARI-treated patients, and HIRA said it has established a 5ARI reimbursement standards in consultation with relevant societies and associations to encourage the safe use of 5ARI. In addition, HIRA expected that problems such as decreased serum PSA levels and early diagnosis of prostate cancer related to 5ARI administration would be the same when administered for the purpose of treating male hair loss. HIRA explained that it is desirable to consult in a medical association or society considering that these male hair loss medicines are non reimbursement. The new reimbursement criterion 'must meet both conditions' means the condition at the start of 5ARI administration to benign prostatic hyperplasia. This condition was set in consideration of the clinical guidelines for benign prostatic hyperplasia published by a large group of experts (EAU, AUA, NICE, and Korean Urology Association). Excluded country guidelines suggest that the target of 5ARI administration are patients with a prostate size of 30-40ml or more. The related society suggested that 'more than 25-30 g of large prostate size' could be defined as 'more than moderate benign prostatic hyperplasia' There was also a description of the reimbursement condition that, during the administration of Pinagren and Avodart with both of the conditions, the PSA test should be performed at least once every 12 months to evaluate and record the value. HIRA said, "Because benign prostatic hyperplasia is common in men over 40 years old, When diagnosed with benign prostatic hyperplasia at this age, the experts’ opionion that regular assessment of the patient's condition through PSA testing is essential for early diagnosis of prostate cancer was reflected. However, the purpose of 5ARI treatment is to reduce prostate size and lower urinary tract symptom. Decreased serum PSA levels do not serve the purpose of treating benign prostatic hyperplasia, and sustained administration of 5ARI is possible even if PSA levels decrease during 5ARI administration. HIRA said, “In order to respect the autonomy of medical care, the inspection was made as a recommendation, not as a mandatory recommendation.” Patients who were diagnosed with benign prostatic hyperplasia prior to the establishment of the reimbursement standard and who received 5ARI may continue to receive the reimbursement even if they do not meet the two conditions. In the guidelines related to benign prostatic hyperplasia, Pinagren and Avodart are classified as 5ARI without classification according to the ingredients, and the same contents are mentioned. Both ingredients are considered reimbursement if they meet the conditions at the beginning of the administration under the reimbursement standard and alternative administration is possible.
- Company
- Localization of Korean pharmaceuticals in Vietnam is pouring
- by Nho, Byung Chul Nov 22, 2019 06:32am
- Recently, listed pharmaceutical companies are stepping up their efforts to localize Vietnam, which has been spotlighted as a Pharmerging market. Pharmaceutical companies investing in Vietnam include Chong Kun Dang (local branch), JW Pharmaceuticals(acquired Euvipharm), Korea United Pharm. Inc. (local plant), Ctcbio (joint plant),Shin Poong Pharm. Co.,LTD.,(Shin Poong Daewoo Vietnam Pharma), Seoheung Capsules (plant / corporation). The Vietnamese market is attracting attention because of: ▲ High growth potential due to population increase ▲ Generic consumption increase ▲ Specialty drug market expansion due to the aging / chronic diseases increase ▲ High investment refund due to continuous regulatory reform and FOL reduction Can be mentioned. As of 2018, the Vietnamese pharmaceutical market is estimated at ₩7 trillion, of which imports amount to ₩3.30trillion. Other than this, ₩3,6 trillion is the local production scale. Pharmaceutical spending per person is ₩71,000 per year, and it is gradually increasing. Exports are still weak at around ₩ 120billion. By product, the ETC market is about three times larger than OTC and occupies about 75% of the total market. The major importers of pharmaceuticals are European countries such as France (11.4%), Germany (11%), Switzerland (6.7%), Italy (6.7%), UK (4.8%) and Spain (2.8%). India and Korea are representative among Asian countries In particular, Vietnam's pharmaceutical market has high growth potential, It should not be overlooked where the entry of foreign companies is very difficult. The Vietnamese government considers the distribution of medicines to be directly related to national health and national security, and sets high barriers to entry into the Vietnamese pharmaceutical market for foreign companies. In particular, foreigners are not allowed to distribute or sell medicines in Vietnam For foreign companies to distribute and sell medicines in Vietnam, it is possible only through local agents and distributors Drug categorization of bidding for supply of drugs for public health facilities The bidding policy for the supply of medicines for public medical facilities is also worth noting. Vietnam bids on threeparts about generics, originals, and oriental pharmaceuticals in the public health sector. In the case of fiercely competitive generic drugs, bidding companies are divided into 5 groups, and since 1st and 2nd groups have high standards, it is difficult for Vietnamese companies to participate, so foreign pharmaceutical companies belonging to 1st and 2nd groups are advantageous for bidding competition. .Recently, Vietnamese pharmaceutical companies are increasing their investment in technology development to prepare for the increase in imported drugs .The Vietnam market competition is expected to increase due to Vietnam's imports of medicines from the entry into force of the CPTPP and the EU-Vietnam FTA .The removal of the foreign equity cap by local pharmaceutical companies valued a good thing .Vietnam's largest pharmaceutical company DHG (DHG Pharmaceutical Company) officially announced on its website in July 2018 that it will eliminate the foreign ownership limit (FOL) and allow up to 100% .Trapaco also said it plans to eliminate the foreign ownership limit, and Domesco (DMC), the third-largest pharmaceutical company, already owns more than 50% of Chile's Abbott (US Abbott subsidiary) .One of the reasons why Vietnam's major pharmaceutical companies remove foreign ownership limit is to increase R & D investment through foreign investment and gain an edge in the fierce market competition .Vietnam's No .1 pharmaceutical market leader is DHG, with sales of ₩210 billion as of 2017 .The head office is located in Can Tho, South Vietnam .Along with domestic sales, the company exports products to 13 countries including Ukraine, Romania, Myanmar, Russia, Mongolia, Cambodia, Laos and Singapore .In addition to over-the-counter drugs, the company also produces health functional food and attracted ₩120 billion in investment from Taisho Group, Japan's top five pharmaceutical company, in April 2019 .It is also partnering with Vinamilk, Vietnam's largest dairy company, to expand health functional food .Trapaco, the No .2 company, has sales of ₩100 billion and is building a portfolio of all areas including professional, general and health functional food .Another unique feature is having three production plants that meet GMP standards Daewoong Pharmaceuticals is participating in management through equity investment, and it is believed that it is cooperating in various fields, including local production, distribution, sales, business, and bidding .Recently, Vietnam's major companies are actively investing in the retail pharmaceutical distribution market .As a result, Vietnamese pharmacies are gradually transforming into modern distribution channels .In April 2018, Vietnam's No.1 Vin Group announced its entry into the pharmaceutical industry, and in November of the same year, it launched the retail pharmacy brand 'VinFa' in Hanoi and established VinFa Drug Research and Production Center in Bac Ninh province in northern Vietnam .. Vietnam's leading electronics retailers, Mobile World and FPT Retail, also entered the pharmaceutical market through a stake acquisition. Mobile World acquired a 40% stake in Phuc An Khang, a local pharmacy chain, and FPT Retail also acquired Long Chau pharmacy chain and established FPT Long Chau Pharmaceutical JSC (FPT Pharma). Pharmacity, one of Vietnam's leading drugstores, expands its distribution network to major Vietnamese cities such as Ho Chi Minh City, Binh Duong, Can Tho and Hanoi, increasing the number of stores to 196 in June 2019, making it one of the largest pharmacy chain stores in Vietnam. Pharma City plans to increase the number of stores across Vietnam to over 1000 by 2021. Meanwhile, the number of Vietnamese pharmacies is about 57,000, most of them in small families, and the proportion of modern retail channels is only 1.5% of the total.
- Policy
- IMD of Januvia approved, launching scheduled for Sep 2023
- by Lee, Tak-Sun Nov 22, 2019 06:32am
- The salt-modifying drug of Janivia (Sitagliptin Phosphate Hydrate, MSD Korea), which has a high share in the diabetes treatment market as a DPP-4 inhibitor was approved for the first time. This is Januritin alpha 100mg in Daewon pharmaceuticals. MFDS approved the marketing of Januritin alpha on the 19th as drug requiring the safety/efficacy review data submission. Januvia is a big drug with an outpatient prescription of ₩43.3 billion last year. In addition, Janumet, which combines Sitagliptin phosphate hydrate and Metformin hydrochloride, was the best out of diabetic medicine last year, with ₩ 69.4 billion in outpatient prescription sales. Of course, domestic latecomers are highly interested in entering the market. As a result of the development of late-release drugs, 149 cases of Sitagliptin drugs in domestic pharmaceutical companies were approved. The patent challenge also eliminated the patent for salts and hydrates in Januvia. At this time, 55 items that succeeded in patent challenge and first applied for permission obtained exclusivity for generics from Sep 2 2023 until June 1 2024, when the substance patent was terminated 'Januritin tablet 100mg', generic for Januvia and 'Januricombi', generic for Janumet in Daewon Pharmaceutical were also approved in Aug 2015, but did not obtain exclusivity for generics. However, with the initial approval of IMD, the company laid the foundation to enter the market even during the ban on exclusivity of generics. Januritin alpha in Daewon Pharmaceuticals is the first component of Sitagliptin hydrochloride in Korea. It is IMD(incrementally modified drug) synthesized from Januvia phosphate to hydrochloride. As long as there is no same ingredient, it is expected to be available for sale after Sept 2 2023, when the Zanubia material patent is terminated. Existing licensed products are 'Sitagliptin hydrochloride monohydrate with the same ingredients as Januvia or Sitagliptin hydrochloride '' without hydrates. A total of 55 items were approved for Sitagliptin hydrochloride. Attempts have been made to avoid material patents in Januvia. But in last September, patent tribunal dismissed the claim of a domestic pharmaceutical company. Domestic pharmaceutical companies tried to neutralize about 1 year extension to the substance patent as a salt-modified or hydrate-modified drug, but patent tribunal did not accept it. In last January, the Supreme Court ruled that the salt-changing drug also falls within the scope of the extended patent for substance. If the material patent challenge was successful, the launch of the late drug could be after July 5 2022. Currently, however, the patent is blocked, so the late-release drug of Januvia will have to wait another four years. It is the woe of a late comer.
- Company
- Teva-Handok turns around and readies CNS for next year
- by Eo, Yun-Ho Nov 22, 2019 06:32am
- Teva-Handok is shooting for business expansion as it scores a turnaround. One of the most prominent multinational pharmaceutical companies, Israel-based Teva was the talk of the year 2013 in Korean pharmaceutical industry when it entered into a joint venture with a Korean pharmaceutical company, Handok. But, Teva-Handok’s performance was unexpectedly underwhelming, and for a while it has been operating in the red. Among all the other factors, Teva took a risk of operating new drug-centered portfolio, despite the new launch in the market takes time. In fact, 70 to 75 percent of Teva-Handok’s sales were from original items, and by 2018, it turned around as it planned with surge of sales in major new drugs, such as Parkin’s disease treatment Azilect, an opioid agonist for breakthrough pain in cancer Fentora, prolonged neutropenia treatment Lonquex, and severe asthma treatment Cinqair. ◆Teva-Handok’s successful turnaround: Teva-Handok, based on the successful turnaround, is currently operating four business sectors consisting of central nervous system (CNS), anticancer, primary care and respiratory. Above all, CNS disease treatments have been the star of the company leveraging Teva-Handok’s notable growth. Besides multiple sclerosis treatment Copaxone and Parkinson’s disease treatment Azilect, narcolepsy treatment Nuvigil launched September last year propelled the company’s expansion. Nuvigil, a new comer in the Korean narcolepsy treatment market after 15 years, is made of armodafinil, an R-enantiomer of modafinil. It shares same administration with modafinil, but armodafinil’s effect lasts longer. As narcolepsy’s major symptom is excessive daytime sleepiness, prolonged duration of effect could be a deciding factor for patients, who need to be active during the day. Launched in September last year, Nuvigil landed code-in deals at major tertiary hospitals and heightened expectation for next year’s sales growth. ◆ Future plan to reinforce CNS pipelines: Teva-Handok’s CNS portfolio build up plan for next year is to maintain the existing product’s stabilized position in respective markets, and also to rapidly grow new drugs after their launch in Korea next year. The new emerging stars are Huntington’s disease and tardive dyskinesia treatment deutetrabenazine (Austedo, trade name in the U.S.), and new migraine preventive drug, fremanezumab (Ajovy, trade name in the U.S. and EU). Duetetrabenazine, developed by Teva, is a new treatment option approved by the U.S. Food and Drug Administration (FDA) for chorea in Huntington’s disease patients or antipsychotic-induced tardive dyskinesia patients, who did not have a proper treatment option to date. Teva-Handok is currently busy preparing for duetetrabenazine’s release in Korea as Korean Ministry of Food and Drug Safety (MFDS) designated the medicine as an orphan drug for chorea in Huntington’s disease in last May. Fremanezumab is a new migraine-prevention medicine in recently emerging anti-CGRP class. Within the same class, the new medicine is the only option to provide quarterly or monthly choice of administration. So the company is expected to emphasize the administration convenience when promoting the follow-on drug in migraine treatment market for adults in Korea. “Teva-Handok’s mission is to provide as much benefit as possible to many more patients. Instead of strategically segregating new drug and generic lineup, the company stuck to a pipeline portfolio building to target patient’s unmet needs, and also steadily generated expected level of performance. And next year, in particular, the company’s distinctive pipeline in CNS sector would generate even more remarkable results”, the company official stated.
- Policy
- NHIS collected 440 million won for valsartan indemnity
- by Lee, Hye-Kyung Nov 21, 2019 11:40pm
- Only 21.5 percent of pharmaceutical companies have paid the charged indemnity on valsartan damage. Report on ‘Valsartan related Indemnity Claim and Collection Status’ provided by National Health Insurance Service (NHIS) to Democratic Party Lawmaker Nam In-Soon stated the government agency has charged 69 pharmaceutical companies 2.03 billion won as indemnity for additional National Health Insurance expenditure made. However, only 26 out of 69 of them, or 21.5 percent, have paid 436 million won to the government. NHIS announced it spent about 2.03 billion won the agency was not liable for, due to the drug exchange order on already dispensed valsartan medicines last year. The amount consists of 964 million won for diagnosing 109,967 patients, and 1.07 billion won for dispensing other option of treatment to 133,947 patients. Accordingly, the agency charged indemnity for the additional expenditure against 69 pharmaceutical companies on Sept. 25. The first payment deadline was on Oct. 10, but the initial collection rate reached about 4.8 percent. After the second deadline on Oct. 31, total of 26 pharmaceutical companies paid 21.5 percent of the charged indemnity. “Based on external legal consulting, pharmaceutical manufacturers had a fault in safety of manufactured products. On the grounds of product defect as stated in the Product Liability Act, the government claiming for damages was confirmed legitimate. The agency is considering on filing a litigation case worth 1.59 billion won against 43 companies for the unpaid indemnity payment”, NHIS official explained. Meanwhile, pharmaceutical companies with the unpaid due are reportedly considering on taking a joint legal action or litigation to prove absence of legal liability, when NHIS files for damage suit.
