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- 2025-12-24 17:53:09
- Policy
- Will Rovelito by Handok & Sanofi succeed?
- by Lee, Tak-Sun Apr 07, 2020 06:44am
- Handok & Sanofi-aventis Korea are jointly developing a combination of Irbesartan & Amlodipine, which is antihypertensive drug and are expecting synergy effect between the two companies. Previously, Sanofi-aventis Korea co-developed Rovelito (Irbesartan-Atorvastatin calcium trihydrate), a new combination drug for hypertension/ hyperlipidemia with Hanmi Pharm. Because it was successful in the market through joint promotions, interest is also gathered in this joint development with Handok. In a business report reported to the DART of the Financial Supervisory Service on the 30th of last month, Handok signed a license agreement with Sanofi-aventis Korea for the domestic development, manufacture and licensing of antihypertensive combination drug on October 18 last year. The contract ends on October 17, 2029. The antihypertensive combination drug made by both companies is Aprovasc & CoAprovel. Prior to this, the substance of the combination was revealed through clinical approval from the MFDS on March 4th. It is a combination drug of ARB-based Irbesartan and CCB-based Amlodipine besylate by Sanofi, and a phase II clinical trial will be conducted to confirm efficacy and safety from a total of 440 people this month to March 2021. To date, several ARB-CCB combinations are available, but Irbesartan-Amlodipine combinations are not available. Therefore, it is expected that there will be a prescription merit due to product rarity. In addition, synergies can be doubled if joint marketing is continued between the two companies. Sanofi-aventis Korea has already demonstrated its power through joint marketing of Rovelito with Hanmi Pharm. Rovelito was also a combination drug developed jointly between the two companies. In 2012, the two companies agreed to jointly develop a new drug that combines Irbesartan and Atorvastatin, and acquired an item license in November 2013 under the name 'Rovelito'. Last year's outpatient prescription amount (Source: UBIST) for Rovelito was ₩20.1 billion, and Rovelito pushed out Yuhan's Duo Well (₩18.1 billion/Telmisartan-Rosuvastatin) and Daewoong Pharmaceutical Olostar (₩12 billion /Olmesartan medoxomil/Rosuvastatin) and holds the No. 1 position in the ARB-statin market. In the industry, Rovelito is said to be desirable as a combination of foreign pharmaceutical companies and domestic pharmaceutical companies. Therefore, it is paying attention to whether joint development of Sanofi and Handok will succeed. However, in the case of Rovelito, it was the first product among ARB-statin preparations, so the competition was not severe. The combination of ARB and Amlodipine (including 3 drugs) is not expected to be an easy challenge to the Sanofi-Handok, as there are more than 1,000 licensed products and market competition is fierce.
- Policy
- Samjin’s generic for Forxiga was first approved
- by Lee, Tak-Sun Apr 07, 2020 06:39am
- AstraZeneca’s ForxigaSamjin's SGLT-2 diabetes treatment drug 'Forxiga' was first approved. Unlike Forxiga, it is a product without solvates. Through this, it is expected to avoid the solvate patent and weigh the release around April 2023 when the material patent ends. On the 2nd, the Ministry of Food and Drug Safety approved Samjin Pharmaceutical's Dapazin 10mg (Dapagliflozin), a treatment for diabetes. Dapagliflozin is a key component of AstraZeneca's Forxiga used in type II diabetes treatments. Forxiga is the first SGLT-2 inhibitor that has a mechanism to enhance blood sugar by inhibiting reuptake of glucose from the kidneys and promoting the release of glucose through the urine. In particular, this drug is an insulin-independent mechanism of action and can be used in combination with existing oral blood sugar enhancers because it is not significantly affected by dysfunction of beta cells and insulin resistance. Based on these advantages, the sales performance has been increasing significantly in recent years. Last year's outpatient prescription amounted to ₩31.1 billion, an increase of 13.3% over the previous year. Because it was sold explosively, generic companies for Forxiga also started developing products. However, it is not easy to launch the market early because patents is valid. Accordingly, pharmaceutical companies succeeded in challenging the subsequent patents, except for the material patents, which ended on April 7, 2023. When PMS expired on November 25 of last year, pharmaceutical companies applied for approval the next day. The number of applications for permits reached 16 cases. Of these, Samjin Pharmaceutical was the first to obtain an item license. Unlike Forxiga, Samjin Pharm's licensed product is free of solvates. The original Forxiga has a solvate propanediol hydrate attached to dapagliflozin. It is a strategy of late-breaking drugs to avoid subsequent patents by different solvates. Accordingly, it is expected that the Forxiga solvate-modified drug will be available after April 7, 2023, when the patent for the substance ends.
- Policy
- FDA requests removal of all Ranitidines from the market
- by Lee, Tak-Sun Apr 06, 2020 06:27am
- Ranitidine products collected for recovery As the Food and Drug Administration (FDA) decides to withdraw all products containing Ranitidine on the 1st, domestic pharmaceutical companies seeking to resume sales are embarrassed Until recently, some Ranitidine products were on sale in the US market, so it was expected that if the stability data were submitted in Korea, it would be possible to resume sales sufficiently. However, the FDA also hopes that if a pharmaceutical company demonstrates safety and stability through scientific data, it may consider resuming sales. The FDA said on the 1st that it had requested the manufacturer to collect all of the Ranitidine drugs to withdraw immediately from the market. The FDA has requested voluntary recalls for some lot numbers of Ranitidine. However, in this announcement, it was explained that Ranitidine have increased in carcinogenic substance NDMA (N-nitrosodimethylamine) over time in a general storage environment and recovered in full quantity. This action is similar to the action taken by the MFDS on September 26 of last year. In response to this, an official from the Food and Drug Administration said that there were criticisms that the domestic measures were excessive but the FDA's decision made Korea's preemptive measures reasonable. However, the situation was uncomfortable for companies that were aiming to resume sales of ranitidine formulations. An official from the related company said that the company had been conducting sales resumption through verification that NDMA was not generated even over time, but the FDA's decision will make the MFDS to resume sales more conservatively. Companies that had high sales of Ranitidine formulations expected it would be possible to resume sales. In particular, the U.S. FDA said that the risk of NDMA is not high in Ranitidine formulations, some companies voluntarily recovered it and sold it in the market. Therefore, the prospect was high that the MFDS would allow sales to resume. However, it was analyzed that a more thorough verification was inevitable for the resumption of sales of Ranitidine due to FDA's decision to withdraw. The MFDS has adhered to the principle that, in order to resume sales, manufacturers must prove that NDMA is not produced in the product for a long time. However, the stability period was not specified, and the industry complained of inconvenience. However, some officials from the MFDS have often said that the cause of NDMA production of Ranitidine preparations is a structural problem, and the longer the storage period, the greater the risk, making it difficult to make a decision to resume sales. Nevertheless, manufacturers watched the overseas situation and thought it would be a resumption of sales. Earlier, an official from the company said that the EMA is expected to produce results as soon as possible after the US FDA. and added that if the action of an advanced institution is to expel Ranitidine, it is inevitable to review the sales resumption strategy. On the other hand, there is a response that it is too early to discuss the complete withdrawal because the FDA said that, like the Ministry of Food and Drug Safety, it will allow sales to resume if related companies prove it with scientific data. The FDA responds to this action if the company shows that, through scientific data, their Ranitidine products are stable and that NDMA levels do not increase to an unsafe level over time, the FDA will release the Ranitidine products to the US market. The FDA also added that it did not withdraw its application for commercial approval of Ranitidine. The MFDS also said that there has been no change in relation to the resumption of sales. The MFDS said that no pharmaceutical companies have submitted data regarding the resumption of sales to date.
- Policy
- The first generic for Afinitor & Betmiga will be released
- by Lee, Tak-Sun Apr 06, 2020 06:26am
- Afinitor by NovartisGuangdong Pharmaceutical is licensed for the first generic version of the breast cancer treatment drug Afinitor (Everolimus, Novartis) and is expected to launch this year. In addition, Hanmi Pharm and Chong Kun Dang also received the first generic approval of the overactive bladder treatment drug 'Betmiga' (Mirabegron, Astellas). These products are also expected to be released this year. This is because they all solved the patent problem. The Ministry of Food and Drug Safety (MFDS) approved the product of Everolimus, Erinito 5mg, for breast cancer treatment by Guangdong Pharmaceutical on March 31. This drug is imported from the Chilean pharmaceutical company 'Synthon Chile Ltda.' Earlier, in March of last year, Guangdong Pharmaceuticals was also permitted to receive Erinito 10mg, which has a different dose. The original drug for breast cancer treatment Everolimus is Novartis' Afinitor. Afinitor is a blockbuster drug that raised sales of ₩20.4 billion based on IQVIA last year. It is used not only for breast cancer but also for various cancer diseases such as pancreatic, gastrointestinal tract, neuroendocrine tumor of lung origin, kidney cancer. Guangdong Pharmaceutical has long filed a patent lawsuit with Novartis, a patent holder, to enter Afinitor's first generic market. However, on Jan. 28, Guangdong Pharmaceutical won the patent invalidation trial for the treatment of cancer. In addition to winning the patent lawsuit, Guangdong also obtained generic exclusivity. As a result, Erinito 5mg was recognized for its monopoly in the generic market by December 31st. During this period, no other generic drug can be released. Guangdong Pharmaceutical has a high proportion of OTC businesses such as Ssangwhatang and Vita500, but has recently strengthened its anti-cancer drug business. It is the first time that the generic for Afinitor has obtained an exclusive right by the end of this year, so it is noteworthy whether Guangdong will compete with the original and achieve meaningful results. Meanwhile, on the same day, the first generic version of the sensitization bladder treatment drug 'Betmiga' was also approved. The generics are Chong Kun Dang's ChongKunDang Mirabegron SR 50mg and Hanmi Pharm's Mirabeg SR 50mg. Betmiga is also an ultra-large blockbuster that posted sales of ₩54.6 billion based on IQVIA last year. Many domestic generics have filed an omnidirectional patent lawsuit to enter the market early. As a result, they succeeded in avoiding all other patents (agents) except the material patent that ended on May 3rd. Accordingly, Chong Kun Dang and Hanmi are expected to launch a generic item in July after undergoing a three-month reimbursed procedure. Since Chong Kun Dang and Hanmi are exerting influence in the clinic market through a large-scale sales network, high sales are expected. However, as Astellas is trusted in the urology department, it is unlikely that Hanmi and Chong Kun Dang will be able to take their original share for a short period of time.
- Policy
- Will Hanmi and Chong Kun Dang's generic exclusivity effect?
- by Lee, Tak-Sun Apr 03, 2020 06:35am
- It is noteworthy whether Hanmi Pharm or Chong Kun Dang among the domestic pharmaceutical companies will be able to achieve the performance in the market while acquiring generic exclusivity, which is the most outstanding pharmaceutical company. In particular, attention has been focused on Hanmi and Chong Kun Dang in that there are no successful cases among the products that have obtained a generic drug exclusivity introduced in 2012. Mirabeg SR 50mg Chongkundang Mirabegron SR Tab 50mg On the 1st, the Ministry of Food and Drug Safety designated Hanmi Pharm's 'Mirabeg SR 50mg' and Chong Kun Dang's 'Chongkundang Mirabegron SR Tab 50mg' as generic drug exclusivity. Accordingly, the two products obtained the right to monopolize in the generic market for 9 months from May 4 to February 3 of next year, when the material patent of the original product expires. This is because generic drugs cannot be put on the market during this period. In addition to the two drugs, it was found that there were no products to receive additional generic exclusivity. The Ministry of Food and Drug Safety explained that there are only two products that have obtained a right to generic exclusivity in the Mirabegron, which is used as an overactive bladder treatment. Of course, there were many other pharmaceutical companies that participated in product development and patent litigation aimed at generic exclusivity in addition to Hanmi and Chong Kun Dang. However, it was reported that most of the bioequivalence tests did not prove the equivalence with the original. An official from the related company said that the original product, Betmiga, is a sustained-release preparation in which the drug is slowly released from the body, so that the generic drugs with the same ingredients were found to have difficulty in equivalence. In addition, he said that there are no pharmaceutical companies applying for permission immediately after PMS ends, except Hanmi and Chong Kun Dang. Betmiga's PMS expired on December 30 of last year, and only Hanmi and Chong Kun Dang appear to have submitted the ANDA(Abbreviated New Drug Application) on December 31, the next day. This is the explanation that the first patent challenge, the patent lawsuit win, and the conditions for the first license application are satisfied, and the products of Hanmi and Chong Kun Dang have obtained generic exclusivity. Eleven companies, including Hanmi and Chong Kun Dang, participated in the patent challenge, and the nine companies did not appear to meet the requirements for the initial permit application. As a result, Hanmi and Chong Kun Dang, which are known to have the largest number of salespeople in Korea, gained exclusive rights to the generic market of Betmiga. Hanmi has approximately 1000 salespeople and Chong Kun Dang has approximately 900 salespeople, and both companies have a number of hospitals clients in Korea. Accordingly, it is expected that the market share can be increased as much as possible during the period of monopoly. Betmiga's outpatient prescription last year was ₩54.7 billion. Even if they take 20% of the share of the two pharmaceutical companies, they will be able to exceed the ₩10 billion market. Because Astellas' influence is so great, there are many prospects that even Hanmi and Chong Kun Dang will not be easily taken away. This was also seen in the case of Vesicare (Solifenacin), an irritable bladder treatment in 2017. Ahn-gook Pharm and Hanmi Pharm, which have salt-changing products, succeeded in avoiding patent expiration and came out 7 months and 3 months before generics, respectively, but were insufficient to threaten the original. Looking at the outpatient prescription amount (Source: UBIST) last year, Ahngook's A-Care was promoted to ₩3 billion and Hanmi’s Besigum amounted to ₩2.1 billion, but it was less than Vesicare’s ₩13.4 billion. Nonetheless, the two pharmaceutical companies are expecting 9 months of monopoly. An official of the related company said that although there is a patent appeal with the original company, it is expected to enforce the launch because it has obtained generic exclusivity and it is expected to monopolize the market once there is no representative generic drug itself. Meanwhile, so far, 328 generics have won generic exclusivity. However, no case has ever grown into a large-sized product that exceeds ₩10 billion annually. This is analyzed because there are many products from the same ingredient, and because of illegal marketing regulation, it is not able to exert the sales power of generic drugs as before.
- Policy
- Rumor: Chief Yang as new Pharmaceutical Benefits Director
- by Kim, Jung-Ju Apr 03, 2020 06:33am
- Apparently, a rumor is circulating about the new director of Pharmaceutical Benefits Division at Ministry of Health and Welfare (MOHW), who would lead the Moon Jae-in Care-initiated drug pricing system revision. According to pharmaceutical industry sources on Mar. 31, Chief Yang Yoon Seok of Smart Healthcare Regulation Revision Planning Team (Graduated from Department of Consumer Science and Child Development Family Studies at Seoul National University) is speculated as a new director of Pharmaceutical Benefits Division and take over the major tasks on MOHW’s pharmaceutical insurance benefit policies. Within the welfare sector of the ministry, Chief Yang used to serve at Aging Society Policy Division and Division of Basic Livelihood Security, and in the health sector, he served at Healthcare Policy Division and as a Chief of Primary Healthcare Improvement Team. In 2014, he participated in talks between the government and medical organization about remote medicine. Then after, he has served as an Administrator of Health and Welfare at the Cheong Wae Dae and a Director of National Pension Finance Division back in MOHW. Even a month after former Director of Pharmaceutical Benefits Division, Kwak Myeong-seop, was transferred in February, the position is still vacant and the division is proceeding with the pharmaceutical policies slowly, but steadily. Although Lee Seon-joo has been newly appointed as a Senior Deputy Director, she was temporarily transferred to COVID-19 response team. Concerns of overloaded work on two deputy directors of the division have been raised internally and externally, but the industry is patiently waiting for the MOHW’s regular personnel changes to be announced amid the outbreak. The government is committed to base the groundbreaking coverage enhancement initiative Moon Care to provide better accessibility on high-cost drugs and to manage listed drugs. Accordingly, the industry expects an official willing to firmly press on with the policy projects would be appointed. And considering all planned initiatives, MOHW has internally agreed on selecting a well-experienced director from other division as the next Director of Pharmaceutical Benefits Division. In other words, the ministry would not gamble on promoting an inexperienced official as the new director. MOHW would likely to finalize the new Director of Pharmaceutical Benefits Division and announce the successor this week at earliest. Meanwhile, former Director Kwak Myeong-seop was dispatched to the South Korea Consulate in Guangzhou, China.
- Policy
- New drug reimbursement review costs KRW 39 million
- by Lee, Hye-Kyung Apr 02, 2020 06:26am
- Experts recommend the Korean government should review implementing service fee system for reimbursement review to enhance speed and efficiency of pharmaceutical reimbursement listing procedure, and to provide quality service through sufficient financial and human resources. While the Health Insurance Review and Assessment Service (HIRA) does not currently collect service fee for the insurance reimbursement listing procedure, a study claims the reimbursement review costs about 39 million won. According to the HIRA’s cosigned research on ‘Appropriate Service Fee for NHI Pharmaceutical Reimbursement Listing Procedure (Principle Investigator: Lee Sang-Hoon at Korea Productivity Center (KPC))’ on Apr. 1, government bodies of Australia, Canada, Switzerland, the U.K., Japan and many other countries are charging for the pharmaceutical listing service. Specifically for reviewing new drug, the service charge apparently goes up over 100 million won. In Korea, the pharmaceutical reimbursement listing is dealt by New Drug Listing Division under the Pharmaceutical Benefit Department at HIRA, and the subject for reimbursed pricing is selected by Drug Pricing Calculation Division. And other additional support is provided by the Pharmaceutical Management Division. The research team surveyed HIRA organization and human resource capacity to calculate the cost of reimbursement review and deduced that each case of review would cost 39 million won, based on the salary class (last three years) of 17 officials in Pharmaceutical Management Division, 28 officials in New Drug Listing Division, 21 officials in Drug Pricing Calculation Division and 32 officials in Pharmaceutical Benefit Standard Division. The researchers explained, “The implementation of service fee system could be justified through the principles of specialty (compensation for the service provided by a specialized individual), the principles of expense compensation (compensation for the cost of time and physical expense spent on an individual’s benefit) and the principles of beneficiary (compensation for the financial profit provided through administrative service).” As for the administration service fee systems in Korea, HIRA charges service fee for pharmaceutical distribution information and big data provision, which comes down to basic salary of fourth level government officials and five percent of general maintenance fee. Ministry of Food and Drug Safety’s (MFDS) pharmaceutical approval service fee has not been changed since 2008. But it would be raised before July 2020, followed by a raise in 2016 based on a cosigned research outcome. Although the 2016 research has assessed and suggested an adequate service fee, 60 percent of the suggested fee was reflected. The research team stated, “The deduced cost of a new drug review case in Korea is expensive at approximately 39 million won, however, it would be not be considered excessively high compared to other countries,” regardless, “the public may be resistant to the system implementation, so the service fee should be set under the prime cost, taking in account the generated public benefit.” At the initial phase of the system implementation, the researchers recommended the government to introduce the system by charging basic administration fee and gradually increasing the fee to avoid clash with pharmaceutical companies. The researchers also emphasized, “However, the possibility of gradual increase of service fee is very low and charging the basic administration fee only could become permanent. As the service fee gap between new drug and other drugs is significantly big that charging the basic fee could be as meaningless as not charging any fee at all.” The study concluded the government should prioritize assessing the actual cost based on the current operation system to accurately deduce appropriate service fee.
- Policy
- Marketing approval for major Ranitidines have been renewed
- by Lee, Tak-Sun Apr 02, 2020 06:26am
- The approval of Ranitidine formulations, such as Albis, Curan, and Zantac, which have been banned from the end of September last year due to the detection of carcinogenic substances NDMA, has been renewed. Accordingly, permits will remain in effect until March 31, 2025. It is noted whether sales can be resumed during this period. According to the Ministry of Food and Drug Safety, major items containing Ranitidine such as Albis (Daewoong), Curan (Ildong), and Zantac (GSK), whose expiration date was originally set until today (March 31, 2020), were successfully updated. As a result, the validity period for the next 5 years is granted and the permit is maintained until March 31, 2025. The renewal will continue the possibility of resuming sales. Some companies, such as Daewoong, are known to be preparing safety data for resuming sales. However, the MFDS believes that it is difficult to judge the safety for a long period of time because it is considered a problem with the structure of drugs because of concerns about carcinogenesis of Ranitidine. Therefore, there is much interest in the decision of the MFDS when the related companies apply for resumption of sales. This renewal is expected to pass if the company applied without returning the permit. When reviewing the existing renewal, whether or not to register for an overseas formulary is the key, The most important thing is whether or not to list in the foreign formularies, Ranitidine, which has passed the existing renewal review, is already listed in the foreign formularies. However, it is expected to act as a variable in the next update audit, as it plans to strengthen the renewal audit, such as mandatory regular reporting of safety information. If sales are not resumed within 5 years of validity, the marketing approval will likely be canceled.
- Policy
- NHIS to act on growing number of administrative litigations
- by Lee, Hye-Kyung Apr 02, 2020 06:26am
- National Health Insurance Service (NHIS) is setting down administrative litigation response strategy to handle pharmaceutical companies’ taking legal action against drug pricing reduction. NHIS has recently started a cosigned research on ‘Drug Pricing Reduction Related Litigation Case Study and Response Plan.’ The research would be conducted for four months with the budget of 50 million won. From 2015 to 2019, total 24 cases of drug pricing reduction-associated litigations have been filed by pharmaceutical companies against the Korean government. Only three cases were filed every year from 2015 to 2017, but the number soared to 13 cases in 2018 and eight cases in 2019 since the start of a case regarding pricing reduction on single-use eye drop. In last year, most of those litigations were filed due to the 30 percent cut in maximum reimbursed price from the point of a first generic launch. NHIS official said, “As the number of administration litigations against drug pricing reductions has surged, the government agency requires in-depth analysis of precedent cases,” so “the aim of the research is to seek improvements in legal principles and administration for the pricing reduction litigations.” The cosigned research would consist of analysis on drug pricing reduction related litigation in last ten years (litigation type, cause, outcome, ruling and impact on health insurance), proposed legislative revision based on litigation analysis, and legal response against litigation through case analysis and practical persuasion strategy for pharmaceutical industry.
- Policy
- HIRA clears 4 out of 5 Spinraza reimbursement pre-approvals
- by Lee, Hye-Kyung Apr 02, 2020 06:26am
- Korean health authority has passed four out of five preliminary applications submitted last month to treat spinal muscular atropy (SMA) with reimbursed use of Spinraza. Even the one denied case would likely to be cleared, if the applicant submits additional evidential data of patient’s onset symptoms of SMA. In every four months, Spinraza users receiving reimbursement have to submit monitoring report prior to maintenance administration. And the health authority has approved all ten monitoring reports submitted. On Mar. 31, Health Insurance Review and Assessment Service (HIRA, President Kim Seung-taek) posted the results of pre-administration approval on four listed items—Spinraza, Soliris, ventricular assist device (VAD) and hematopoietic stem cell transplantation (HSCT)—Treatment Review and Assessment Committee deliberated in February. Spinraza’s reimbursed use standard stipulates patients are eligible for reimbursement when qualifying all conditions—positive genetic testing of a deletion or mutation in the survival motor neuron 1 (5q SMN-1) gene, onset of SMA symptoms from age three or less and not on permanent ventilator (more than 16 hours a day for over 21 consecutive days). The reimbursed use of the drug has to be assessed before the initial administration, after administering initial dosage (four doses) but before the fifth dose, and every maintenance dose then after based on clinical evaluation (development stage, motor function and respiratory function). Before the Spinraza review, the committee reviewed pre-administration applications on reimbursed use of Soliris (eculizumab). All three to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) were cleared, but one case of atypical hemolytic uremic syndrome (aHUS) treatment was denied. The rejected aHUS case was to treat 67-year-old patient, who visited an emergency room for nausea and vomiting and was hospitalized due to acute renal failure and observation of symptoms like thrombocytopenia, anemia and schistocyte but continued to have thrombotic microangiopathy (TMA) despite receiving steroid and therapeutic plasma exchange (TPE). Nevertheless, it was ultimately rejected, as the doctor’s record of the patient’s schistocyte and thrombocytopenia did not coincide with the TMA described in the reimbursement standard notice. Other details of the Treatment Review and Evaluation Committee’s deliberation can be found on HIRA website.
