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- 2025-12-24 11:05:22
- Policy
- Lyrica CR generics begin development...PMS expires next July
- by Lee, Tak-Sun Aug 20, 2021 05:56am
- Development for generics of Pfizer’s pain reliever ‘Lyrica CR,’ whose post-market surveillance (PMS) period expires in July next year, has begun. Unlike Lyrica, which is taken twice a day, Lyrica CR is a once-daily formulation and is used for peripheral neuropathic pain in adults. With more than 80 pharmaceutical companies participating in the development of Lyrica generic, attention is focused on whether such avid interest will be shown for Lyrica CR as well. On the 17th, the Ministry of Food and Drug Safety approved the bioequivalence study protocol for Dasan Pharmaceutical’s DSP2102. The study will assess the bioequivalence of Dasan Pharmaceutical’s ‘DSP2102’ and Pfizer Pharmaceuticals Korea’s ‘Lyrica CR 300mg’ on 34 healthy adult participants. Dasan’s study will be the first to compare a drug with Lyrica CR. The PMS period for Lyrica CR, which was approved in July 2018, will expire in July next year. The move to conduct bioequivalence tests for the development of generics has begun as approval for generics is possible upon expiry of the PMS period. Lyrica is a leading product in the domestic pain reliever market. Lyrica sold 52.9 billion won according to IQVIA last year. However, Lyrica CR’s performance is not as significant as Lyrica’s as it has been released relatively recently, has a limited indication, and has viable competitors. In the same period, Lyrica CR only made 700 million won in sales. However, when considering that around 80 generic companies entered the market after Lyrica’s substance patent expired in 2012, the possibility remains that latecomers in the field will show an interest in the more convenient, less frequently taken Lyrica CR. However, with market competitors already existing in the market and new regulations in place for development, the number of companies jumping in to develop Lyrika CR generics is expected to be less than that for Lyrica. Six other companies including Yuhan Corp. own once-daily drugs containing the same ingredient as Lyrica CR. The products entered the market only a few months after the original, and the companies have been enjoying the first-mover advantage. Also, due to the restriction limiting each consigner to share its bioequivalence tests with only three consignees, the burden of companies needing to develop generic drugs themselves will have an effect in reducing the number of products seeking market entry. The use of Lyrica CR is limited compared to Lyrica, as it can only be used to treat peripheral neuropathic pain in adults. On the other hand, Lyrica is additionally indicated for epilepsy (as adjunctive therapy for partial-onset seizures with or without secondary generalization) and fibromyalgia.
- Policy
- The current health insurance premium increase rate is 2.91%
- by Lee, Hye-Kyung Aug 20, 2021 05:56am
- Health authorities have refuted allegations that health insurance premiums have been raised for the success of health insurance policies. The MOHW and the NHIS recently released a statement by the Korea Enterprises Federation (KEF) explaining that "reorganization, including a cap on health insurance premiums, is a reasonable and fair result of social consensus." The KEF said in a report that Japan and Taiwan, which have similar systems to Korea, have a higher upper limit on domestic health insurance premiums than other countries, with a gap of about 24 times and 12 times, respectively. The NHIS explained, "Health insurance is based on the principle of social solidarity, a social insurance system in which subscribers premiums, and anyone, regardless of income level, receives medical benefits as needed." The NHIS explained, "In Korea, as a single national health insurance, the insurance upper limit is institutionalized as income redistribution and social solidarity are emphasized, and the insurance upper limit is the result of social consensus that reflects the history of the national system and people's perception." In France, the health insurance premium rate reaches 13% (full copayment of patient), but the higher the wage level due to the lack of an upper limit, the greater the user's health insurance premium. The upper limit of insurance premiums is part of a reform of the health insurance premium system, and discussions have begun to cope with the heavy burden on low-income local subscribers. "It is based on years of social discussion and the agreement between the ruling and opposition parties to increase the equity of insurance premiums," the NHIS said. "It is planned to reorganize the imposition system of Step 1 in July 2018 and revise the effect of Step 1 in July 2022. In the process of promoting Moon Jae-In Care, the health insurance premium rate is 2.91%, which is lower than the average of 3.20% over the past decade (2007-2016), and the NHIS said, "As of 2021, the health insurance premium rate is 6.86%, France (13%), Germany (14.6%), and Japan (9.21-10.0%)." The NHIS said, "The health insurance premium rate for next year has not been determined, and it will be decided through social consensus after sufficient discussion by the Health Insurance Policy Committee, which includes all members, suppliers, and public interest members."
- Policy
- Seven companies are supplying flu vaccines this year
- by Lee, Tak-Sun Aug 20, 2021 05:55am
- SK Bioscience will focus on COVID vaccine after consulting with the KDCA. The market share of the GC Pharma is likely to increase. Two imported vaccines including Sanofi and GSK Flu vaccines, which will be distributed and sold in Korea this year, are nine items from seven companies, down three from the previous year. SK Bioscience, which had the highest sales performance of flu vaccines last year, will not supply them this year due to the production of COVID-19 vaccine, and Dong-A ST and LG Chem have also been excluded from the market. According to the MFDS on the 17th, domestic manufacturers that distribute flu vaccines this year are Boryung Bio (2 items), Boryung, GC Pharma (2 items), Il Yang (2 items), and the importers are Sanofi Pasteur and GlaxoSmithKline. Compared to last year, SK Bioscience, Dong-A ST, and LG Chem were excluded. SK Bioscience has been unable to distribute flu vaccines in Korea this year due to the production of COVID vaccine. SK Bioscience is commissioning and producing AZ and Novavax vaccine and is also developing its own products. A company official said, "The existing production line of the flu vaccine at Andong plant is producing COVID vaccines, in consultation with the KDCA, we decided not to supply flu vaccines this year." SK Bioscience recorded the highest performance in Korea last year, with production of only 4-valent flu vaccine worth ₩164.7 billion. As SK Bioscience is out this year, only two companies that produce raw material to finished products in Korea will remain: GC Pharma and Il Yang. The share of GC Pharma, which recorded the second highest production performance of ₩82.9 billion after SK Bioscience last year, is expected to increase significantly. In the case of Dong-A ST, the company received the original amount from Sanofi and manufactured and supplied the finished product, but due to the expiration of the contract, Vaxiflu Tetra Injection Solution Prefilled Syringe was revoked in January. LG Chem, which receives products from GC Pharma, is not selling flu vaccines this year. Like last year, Sanofi Pasteur and Glaxosmithkline distribute imported vaccines. However, Sanofi Pasteur participates in NIP for children and pregnant women under the age of 13. It is explained that the mandatory vaccination for national procurement aged 65 or older was not available because it was difficult to meet the supply schedule suggested by the KDCA. It is known that importers such as GSK do not actively participate due to the same low cost of the national mandatory vaccination project as last year. The MFDS predicts that about 28.8 million flu vaccines will be distributed this year. Among them, 14.6 million people were involved in the NIP project. Last year, National lot releases for 29 million people were distributed. As of the 13th, the national lot release for 3.66 million people was received.
- Policy
- Hanmi's Suvast 2.5mg has been approved
- by Lee, Tak-Sun Aug 19, 2021 06:03am
- There was no Rosuvastatin 2.5 mg available.Hanmi has started to create a new market by pushing for the approval of combination drug. The MFDS approved Hanmi's Suvast 2.5mg on the 17th. It is Rosuvastatin 2.5mg, which is not released in Korea. It is used in primary hypercholesterol and complex hyperlipidemia. Ministry of Health, Labour and Welfare of Japan recommends Rosuvastatin 2.5mg to Asians with smaller body types. According to indications of Suvast 2.5 mg, the recommended initial dose is 2.5 mg or 5 mg because of increased systemic exposure to Asian patients. Previously, if Rosuvastatin 5mg was used for initial dose, the drug choice that can be used with 2.5mg was increased. Hanmi is known to be planning to market Rosuvastatin 2.5mg strategically. Hanmi is also pushing for the approval of combination drug containing Ezetimibe. It is said that in April, it applied to the MFDS for approval of Rosuzet 10/2.5 mg (Rosuvastatin 2.5mg / Ezetimibe 10mg). Rosuzet posted ₩99.1 billion in outpatient prescription sales last year alone. It is expected to focus on Suvast 2.5mg, and drugs containing Rosuvastatin 2.5mg in Korea. As a result, it is expected that it will emphasize that the amount of Rosuvastatin 2.5mg is more suitable for Koreans with its initial dose. Hanmi conducted phase 3 of Ezetimibe/Rosuvastatin 10-2.5 mg dose group (N=68), this drug (Rosuvastatin 2.5 mg) dose group (N=67), Ezetimibe 10 mg dose group (N=70), and Rosuvastatin 5 mg dose group (N=70) for 8 weeks in 275 patients with primary hypercholesterol. In the primary validation, the LDL-C change rate (%) in this drug (Rosuvastatin 2.5 mg) administration group decreased statistically significantly compared to the Ezetimibe 10 mg administration group, and the average LDL-C change rate (%) in Ezetimibe / Rosuvastatin 10/2.5 mg administration group decreased by 2.5 mg. Through clinical trials, the complex has already been announced
- Policy
- PPIs benefit from ranitidine’s market removal
- by Lee, Jeong-Hwan Aug 19, 2021 06:03am
- MFDS notice regarding ban on ranitidine drugs With proton pump inhibitors (PPI) enjoying reflective interest in sales from the market removal of ranitidine, which was banned due to detection of the potentially carcinogenic substance NDMA(N-Nitrosodimethylamine), criticism is rising that national health insurance finances are being unnecessarily wasted. The point is that PPIs cost on average twice to three times more than tidine-class H2 receptor blockers, and the increased use of the PPIs not only increases NHI expenditures but also increases the financial burden borne by the patients. On the 17th, the pharmaceutical industry was been busy analyzing the changes in the peptic ulcer treatment market brought on by the banned sales of ranitidine drugs after the rise of its NDMA impurity issue in 2019. After ranitidine was removed from the market due to the detection of NDMA impurities, a significant amount of prescriptions have moved from H2 receptor blockers to PPIs. Annual prescription sales from 2018 to 2020 also show that prescription sales of PPIs have increased from ₩454.9 billion in 2018 to ₩523.4 billion in 2019, and ₩633.5 billion last year. On the other hand, prescription of H2 receptor blockers decreased from ₩346.5 billion in 2018 to ₩296 billion in 2019 when NDMA impurities were detected and relevant products were banned from the market, then fell to ₩132.5 billion last year, to be reduced to 1/3 in just 3 years. Numbers show that the size of the peptic ulcer prescription market has rather grown compared to 2018 due to an increase in PPI prescriptions despite the removal of the ranitidine ingredient. The growth of the prescription market was influenced by the increased use of PPIs that cost on average twice to three time more than H2 receptor blockers. More specifically, H2 blockers cost ₩276 to ₩360 a day at an average of ₩314/day, whereas PPIs cost from ₩527 to ₩1,300 at an average of ₩314/day. Due to this, some have criticized that replacing ranitidine prescriptions with the high-priced PPIs that are of a different class when other lower-priced H2 blockers in the same class as ranitidine with no NDMA detected are available increases waste of NHI finances. Their position is that changing prescriptions to higher-priced drugs not only increases NHI expenditures but also increases the financial burden borne by patients in the long term. To resolve the issue, industry experts had suggested that the authorities should provide same-class drug prescription recommendations in the event inevitable recalls and substitution of drugs arise due to safety issues as in the NDMA case, Industry experts believe efforts such as introducing pop-up windows in the DUR system that show same-class drug recommendations when HCPs select and prescribe drugs should be made to prevent an unnecessary increase in NHI expenditures. An official from a domestic pharmaceutical company said, “I am positive about the government’s decision to promptly recall and discontinue sales of the potentially harmful ranitidine substance, but it is unfortunate that there were no specific guidelines on its replacement and that it caused an increase in NHI expenditures. It is a waste of NHI finances as well as an increased financial burden on the patients to substitute ranitidine to high-priced PPIs when there are other, lower-priced drugs available in the same class with the same indications.” He continued, “The replacement process for hazardous drugs should be further improved and advanced using the DUR system, etc. It is the doctor’s responsibility to select or switch drugs due to their lack of effect in the treatment process, however, the use of same-class low-priced drugs should be prioritized for substitutions due to external factors."
- Policy
- It plans to expand its supply of Moderna vaccines in Aug/Sep
- by Kim, Jung-Ju Aug 19, 2021 06:02am
- It plans to expand its supply of Moderna vaccines in August and September. Samsung Biologics' distribution in Korea is still pending. A government delegation to the U.S. announced the results after visiting Moderna The government received an apology from Moderna for the disruption in the domestic supply of COVID vaccines and announced that it will receive more domestic supplies this month and next month and move up the supply schedule early next month. However, the government avoided giving a definite answer as there are many obstacles such as contracts between companies regarding supplying models or products that Samsung Biologics is consigned to Korea first. At the COVID-19 Central Disaster and Safety Counters Headquarters, video conference held today (the 17th), the delegation consisting of Kang Do-tae, the second vice minister, and Ryu Geun-hyuk, the presidential secretary for social policy, reported last week's visit to the U.S. Moderna headquarters, and the company's recent discussion on vaccine supply disruption and supply stabilization. According to the MOHW and Central Disaster and Safety Counters Headquaters, during the visit, Moderna apologized for the government and people's difficulties caused by sudden supply disruptions, and explained that the manufacturing laboratory problems at cooperative manufacturers are now being resolved and gradually released in July. The government asked the company to provide supplies that could not be supplied from August to early September, and to inform the schedule by this week, and Moderna said it would do its best to supply supplies and notify the government of its supply plan. In particular, the government has not received a clear answer on how it can supply production volume of Samsung Biologics, which is consigned to produce Moderna vaccines, to South Korea. In an answer to a regular briefing question, Vice Minister Kang Do-tae said, "It is desirable that domestic consignment production supplies are supplied to Korea in terms of securing safety in the supply of vaccines and streamlining the distribution process. He added, "There is a need for continuous consultation on the contractual relationship between Samsung Biologics and Modena, and the interrelationship between companies and domestic administrative procedures" According to the government, there will be no significant disruption to the age-specific vaccination plan and achievement of the target.
- Policy
- Indication extensions filed by Abilify generics increase
- by Lee, Tak-Sun Aug 18, 2021 05:51am
- Otsuka After Yungjin Pharm finally succeeded in invalidating the use patent of Abilify (aripiprazole·Korea Otsuka Pharmaceutical) after 6 years of patent dispute, other generics products of Abilify are now seeking to extend its indications. The use patent that was in dispute had protected Abilify’s ‘bipolar disorder’ indication, due to which generic companies other than Yungjin Pharm were unable to include the indication in their Abilify generics. According to the Ministry of Food and Drug Safety on the 16th, applications containing the 'treatment of acute manic and mixed episodes related to bipolar disorder' indication are being continuously filed for Abilify generics. Bipolar disorder, commonly known as 'manic-depressive disorder,’ causes extreme mood swings that include a pattern of emotional highs (mania or hypomania) and lows (depression). Abilify is a representative central nervous system (CNS) drug that has many indications, including schizophrenia, bipolar disorder, major depressive disorder, irritability associated with autism, and Tourette syndrome, etc. However, Otsuka had registered use patents for each indication at the time of indication expansion, restricting the use of generics for such indications. As a result, most domestic companies with Abilify generics had released their product in the market with only 1 to 2 indications, such as schizophrenia and Tourette syndrome. On the other hand, Yungjin filed an invalidation suit on the use patent registered for Abilify’s bipolar disorder and received approval for the said indication. The patent suit continued for 5 years from March 2015 when the invalidation claim was first filed. In the first trial, the Intellectual Property Trial and Appeal Board turned down Yungjin’s claim and ruled in favor of Otsuka. However, in the second trial, the Patent Court of Korea overturned the first trial decision and rule in favor of Yungjin Pharm. Last April, the Supreme Court ruled the use patent invalid, ending the fierce dispute in Yungjin Pharm’s victory. For Yungjin, the trial could have ended in immense claims for damages from patent infringement. Moreover, when the Patent Trial and Appeal Board rejected the claim, reducing the possibility of patent invalidation, other generic companies had taken a step back, withdrawing their claims and deleting their indications. After twists and turns, Yungjin, the only company to continued the suit, succeeded in invalidating the use patent. The win came with less than a year left until patent expiry, as the patent was scheduled to expire on January 29 of next year. Yungjin’s win has affected indications filed by other generic companies as well. Daewoong Pharmaceuticals and Pharvis Korea had already received approval for the bipolar disorder indication for their generics. The companies’ products are produced by Yungjin Pharma under a CMO agreement. Other companies have also recently applied for approval of their generics that contain the bipolar disorder indication. As the patent had expired due to patent invalidation, and the number of generics with the bipolar disorder indication is expected to continue to increase in the future. Abilify is a blockbuster drug that posted 45.4 billion won in sales last year. Even after its substance patent expired and generics were introduced to the market, the drug maintained its high market share with its use patents. However, the continued patent challenges filed by generic companies are expected to continue to challenge Abilify's throne in the market.
- Policy
- Moderna apologized to the gov for the disruption in supply
- by Kim, Jung-Ju Aug 18, 2021 05:51am
- Kang Do-tae, the second vice minister of welfare, and other delegations visited the U.S. headquarters for an interview. The government visited the U.S. headquarters of Moderna that supplies the vaccine worldwide to protest against the supply disruption and ask for quick measures. The delegation, composed of Kang Do-tae, the second Vice Minister of health and welfare, and Ryu Geun-hyuk, secretary to the President for Social Policy, received an official protest and apology from the U.S. headquarters of Moderna today. After the meeting, Vice Minister Kang said, "The government asked for a faster supply of COVID vaccines," adding, "Moderna expressed its apology and promised to do its best." However, the company failed to respond to the government's request to move it up as soon as possible, so it plans to hold additional consultations. Therefore, detailed information is expected to be released on the 16th when the team returns back. "Today's meeting was an opportunity for the government and Moderna to enhance mutual understanding," Kang said. "I asked them to move up the schedule as soon as possible. We will make an official announcement after further consultation with the company after returning to Korea. Moderna is experiencing disruptions in supply not only to Korea but also to the world due to production disruptions. Some of its supplies were already delayed once last month in Korea, and this time, the supply was reduced by less than half. As a result, the government has extended the interval between 1st and 2nd vaccinations of mRNA-based vaccines such as Moderna and Pfizer from 4 weeks to 6 weeks. The KDCA signed a contract on the 13th to purchase 30 million doses of Pfizer vaccine and 30 million optional doses to secure the vaccine early. The optional doses is the amount of volume that can be added according to the mutually agreed period and conditions, if necessary. Up to 60 million batches could be supplied. In addition, 300,000 Janssen vaccines, which the U.S. government decided to donate, will arrive at Incheon International Airport on the 15th.
- Policy
- Opdivo's RSA renewed… benefit extended for use with Yervoy
- by Lee, Hye-Kyung Aug 17, 2021 05:52am
- ‘Opidivo inj. (nivolumab),’ the first cancer immunotherapy approved in Korea has successfully extended its contract ahead termination of its risk-sharing agreement (RSA) term. In addition to Opdivo, the breast cancer treatment ‘Kisqali (ribosiclib) was also included in the list of drugs that completed negotiations with the National Health Insurance Service (NHIS) that was recently disclosed by NHIS. The RSA contract term for Opdivo, which was granted reimbursement through the RSA scheme since August 21st, 2017, was set to expire by August 20th this year. Before expiry, Ono Pharma Korea and Bristol-Myers Squibb Korea Pharmaceutical had applied to the NHIS to extend Opdivo's RSA contract and to expand reimbursement for its use in combination with ‘Yervoy(ipilimumab)’ in first-line kidney cancer. The combination of the PD-1 inhibitor Opdivo and CTLA-4 inhibitor Yervoy was approved as a first-line treatment for renal cell carcinoma (RCC) in August 2017. The indication passed NHIS’s Cancer Disease Deliberation Committee review in June last year. In April this year, 9 months after the CDRC review, the combination’s indication for the ‘treatment of patients with moderate- and high-risk, previously untreated advanced renal cell carcinoma (RCC), was recognized appropriate for reimbursement by HIRA’s Cancer Drugs Benefit Appraisal Committee. Since then, the company has been in pricing negotiations with the NHIS. However, in the first 60-day negotiation period, negotiations fell through with the NHIS and pharmaceutical companies being unable to reach an agreement. The two parties finally signed an agreement in the second negotiation that followed. Specifics of the RSA extension for Opdivo and use in combination with Yervoy will be disclosed after amendments to the notice are deliberated and passed by the Ministry of Health and Welfare’s Health Insurance Policy Deliberative Committee. In addition to Opdivo, the NHIS announced that it had also completed negotiations for Kisqali. Kisquali is approved in combination with an aromatase inhibitor in pre-, peri-, post-menopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer; or with fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy in postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.
- Policy
- SK Chemical will sell Zemplar
- by Lee, Tak-Sun Aug 17, 2021 05:52am
- The original Zemplar (Paricalcitol) will be sold by SK Chemical in Korea. It is imported and supplied by AbbVie Korea, and SK Chemical has been in charge of distribution, sales and marketing in Korea since July. SK Chemical is expected to compete fiercely with generic companies. According to industries on the 12th, SK Chemical has been distributing and selling AbbVie's Zemplar in Korea since July. Sales of Zemplar ampules, which had previously been distributed, were discontinued. Zemplar is used to treat and prevent secondary parathyroidism associated with chronic renal failure. It is especially used to treat complications in dialysis patients. Last year, IQVIA was sold at ₩7.9 billion, which is widely used in dialysis complications markets along with Kyowa Kirin Korea's Regpara. Last year, generic for Zemplar was launched for the first time in Korea. Boryung's Pacitol was granted permission on January 30 last year. Pacitol has been on sale since April of that year. As of last year's IQVIA, sales amounted to ₩1.3 billion. Since then, Huons' Hucitol has expanded its consignment production with permission. This change in Zemplar's domestic sales company is interpreted as a response to the generic's offensive. Its strategy is to win the competition with Generic through SK Chemical, which has a well-established distribution network in Korea. The reason why the ampule formulation was discontinued is because of the lower price due to the launch of generic products. Zemplar ampule formulation was twice as expensive as vial formulation, but since April, when generic items were released, both original and generic have become the same price. As a result, competition between original and generic companies is expected to intensify.
