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- 2026-04-16 11:26:58
- Policy
- Forsteo reduced pricing effective from Aug. 25
- by Kim, Jung-Ju Aug 25, 2020 06:10am
- As the South Korean court ruled against Lilly Korea’s litigation claiming unfair pricing reduction on its osteoporosis treatment Forsteo (teriparatide), the government would execute the order as planned initially. The insured pricing reduction would be enforced on Aug. 25, but it could be suspended again if the company decides to take the case to the High Court. Which means the pricing change may not be applied in the healthcare institutes depending on the court registration schedule. On Aug. 20, Ministry of Health and Welfare (MOHW) announced the pricing reduction on Forsteo would be authorized according to the original plan, as the Seoul Administrative Court has recently dismissed Lilly’s litigation. MOHW applies ‘half-price drug’ regulation, or 53.55 percent of the original pricing, when a first generic is listed. But the health authority applies weighted pricing of 70 percent on the first-in-class drug for a year from the point of the first generic listing. And the weighted pricing is maintained until there are more than four companies supplying the same-substance drug, regardless of passing the one year point. Due to the government’s decision to authorize pricing reduction on Forsteo, the company filed a lawsuit against MOHW to revoke the maximum price adjustment. The Ministry was planning to bring down the pricing of Forsteo by 30 percent from 326,353 won a pen to 228,451 won. The decision was made as Daewon Pharmaceutical’s biosimilar Terosa was categorized as a same substance drug. The multinational company, however, argued the two medications are not the same. Nevertheless, the Administrative Court ruled in favor of MOHW’s decision. According to the court’s ruling, MOHW stated the authorized pricing reduction, initially planned from last March, would lower the drug’s pricing by 30 percent from Aug. 25. Unless the company takes another legal action before the regulation is enforced, the respective healthcare institutes would have to sell medication by the lowered pricing from Aug. 25. But if the company, again, request to halt the pricing reduction as it brings the case to the High Court for an appeal, the drug’s pricing in healthcare institutes may remain unchanged.
- Policy
- Democratic Party submits 5 bills to curb spiking COVID-19
- by Lee, Jeong-Hwan Aug 24, 2020 06:19am
- The ruling party readies for a full-on quarantine measures by introducing a series of bills to curb COVID-19 resurging in South Korea centering a far-right church in Seoul metropolitan area. On Aug. 20 and 21, the Democratic Party submitted five bills to the National Assembly (NA) to strengthen the existing regulations to contain the rapid spread of the novel virus. The bills would clarify standards of imprisonment or fine, in case of disrupting a COVID-19 epidemiological investigation or violating the ban on assembly like protesting at the Gwanghwamun Plaza, and seek indemnification for the damae of an individual willfully spreading the infection. The five bills on preventing resurgence of COVID-19 outbreak were registered on the NA Bill Information System website as of Aug. 23 that reinforce restriction against misconduct affecting the virus infection like the 8/15 Gwanghwamun Protest or relevant participants. The ruling Democratic Party is highlighting the close relationship between the United Future Party and the controversial Sarang Jeil Church’s pastor, Jun Kwang-hoon, as they introduced the bills. Ultimately, the new spike of COVID-19 cases has broken out right in the middle of political strife between the ruling and the opposition parties. First, the Democratic Party Lawmaker Jung Chung-rae proposed a revision bill in ‘Framework Act on the Management of Disasters and Safety,’ and reprimanded Sarang Jeil Church’s Rev. Jun and the followers being the catalyst to the major outbreak of COVID-19 in Seoul. Regarding the current law stipulating the restricted or prohibited use of a facility or site to prevent a severe disaster threatening the public safety and the submission of private information of related event participants, Lawmaker Jung pointed out the existing law, lacking a clear punishment for violators, is impractical. Therefore, the lawmaker submitted a bill to levy penalty on an individual disobeying the restricted or banned use of high-risk facility or site, mandated evacuation, or requested provision of personal information. Other lawmakers from the party—Kim Sung-joo (a ruling party adviser to NA Health and Welfare Committee), Lee Wonwook, Oh Young-hwan and Jeon Yonggi—have also introduced bills to amend ‘Infectious Disease Control and Prevention Act.’ (From left) Democratic Party Lawmaker Jung Chung-rae, Kim Sung-joo, Lee Wonwook, Oh Young-hwan and Jeon Yonggi. Lawmaker Kim Sung-joo’s bill stipulates a tightened penalty on a violator of the infectious disease control measures, and a regulation to claim damage compensation. The revision bill would legally allow the government or regional government body to claim damage compensation in case an infectious disease spreads or the risk of outbreak grows due to a third-party’s intentional conduct or major fault. Also the amended law would levy a severe penalty on a certain group or a leader or member of an organization refusing or disrupting the epidemiological investigation, or intentionally omitting or covering facts to impede relevant investigation. Moreover, the high-level penalty would be imposed on an individual intentionally refusing to be quarantined or hospitalized, or leaving the quarantined site and infecting others. Lawmaker Lee Wonwook criticized the existing law as it only imposes comparatively light criminal penalty on an infected patient refusing to receive in-patient treatment or hospitalization and treatment. In particular, the lawmaker rebuked the absence of penalty regulation on an individual that not only refuses the treatment, but also actively infects other individuals recklessly, and difficulties the law enforcements face when acquiring the location of an individual accused of committing the said misconduct. Accordingly, Lawmaker Lee’s bill would newly add penalty clauses for an individual infecting other people, and stipulate three years or less of imprisonment and arrest without warrant during an emergency. Meanwhile, Lawmaker Oh Young-hwan’s bill tightened the penalty on temporary prohibition order on gatherings like a protest. The existing law stipulates the Minister of Health and Welfare to prohibit protest to calm the spreading of infectious disease, and levies fine of less than 3 million won for violating the order. But the lawmaker argues such weak penalty has allowed the 8/15 Protest to boost the COVID-19 outbreak. Lawmaker Oh’s bill would make the penalty significantly stringent by tightening the current penalty of a fine less than 3 million won to five years or less of imprisonment or 50 million or less of fine. Lawmaker Jeon Yonggi also aims to reinforce the penalty when violating the restriction on an assembly like protesting. Referring to the ‘Assembly and Demonstration Act,’ his bill would elevate the penalty to imprisoning and warranting exemplary damages on an infected individual violating the health authority’s restriction on gathering. The NA plans to review and deliberate the submitted bills during the September provisional session.
- Company
- Celltrion begins to develop oral Remsima following SC type
- by Kim, Jin-Gu Aug 24, 2020 06:19am
- Celltrion starts developing oral 'Remsima'. Celltrion announced on the 20th that it has signed a joint research agreement with British biotechnology company Intract Pharma. Remicade, Remsima's original drug, is a drug administered by intravenous injection.. Celltrion has already developed and commercialized Remsima SC, the first in the world, with an improved administration method in the form of SC. It is expected to become the world's first oral infliximab drug if Celltrion succeeds in development. According to Celltrion, Intract Pharma was separated from University College London in 2015. It has its own oral formulation technology that efficiently delivers protein drugs to the intestine. It has conducted joint research with various global pharmaceutical companies such as Abbvie, Janssen, and Merck. Intract Pharma is exempted from non-clinical and phase I clinical trial for oral Infliximab from the UK Medicines and Healthcare products Regulatory Agency(MHRA), and is clinically targeting inflammatory bowel disease (IBD) patients in earnest from the second half of next year, and will launch in phase IIa clinical trial. Under this contract, Celltrion will supply clinical raw materials to Intract Pharma, and Intract Pharma will develop and verify the oral Infliximab product. Celltrion has secured the right to generic exclusivity upon completion of phase II clinical trials. In addition, it has agreed to allow part of the sales to be returned as royalties even when the license is out. In addition, Celltrion will exclusively supply Infliximab for the production of commercial substances even when Intract Pharma or another pharmaceutical company that has transferred the technology successfully commercializes the product. A Celltrion official emphasized, "We started developing oral Infliximab products with high efficacy, safety and ease of use, and we will proceed with preparations for development from the clinical design stage without any problems through close cooperation."
- Policy
- Tagrisso and Eliquis pricing lowered 4% through PVA
- by Kim, Jung-Ju Aug 24, 2020 06:18am
- The insured pricing of AstroZeneca Korea’s Tagrisso tablet (osimertinib mesylate) and Bristol-Myers Squibb’s (BMS) Eliquis tablet (apixaban) would be lowered by approximately 4 percent from next month due to pricing-volume agreement (PVA). According to the pharmaceutical industry sources, South Korea’s Ministry of Health and Welfare (MOHW) is in process of revising the ‘List of Reimbursed Drugs and Upper Limit Pricing.’ The finalized version would come in effect from Sept. 1. Under the Type ‘Ga (가)’ PVA, National Health Insurance Service (NHIS) and pharmaceutical companies negotiated over lowering the pricing of AstraZeneca’s Tagrisso and Celgene’s Pomalyst each in different doses. The Type Ga is applied to a new drug listed through pricing negotiation that marked over 30 percent surge in claimed reimbursement against the projected amount of the claim. The item’s claimed amount is calculated from the claims made under the same supplier, administration method, active ingredient and form of the item. The reimbursed pricing would reduced by 4.2 percent on 40 mg and 80 mg Tagrisso tablets from 121,686 won to 116,563 won, and from 227,312 won to 217,782 won, respectively. The pricing on Celgene’s Pomalyst would be brought down from 377,979 won to 367,774 won (2.7 percent) in 1 mg tablet, from 377,829 won to 368,633 won (2.4 percent) in 2 mg, from 382,629 won to 373,215 won (2.5 percent) in 3 mg, and from 386,537 won to 376,364 won (2.6 percent) in 4 mg. The pricing on three items would also fall under the Type Na (나) PVA. The case applies to an item that has been listed for over four years, without pricing adjustment by Type Ga PVA, but its total amount of claim exceeded by 30 percent from the amount projected at the point of listing. For such items, NHIS negotiates with the supplier depending if the claimed amount has surpassed 60 percent more than the previous year’s amount, or the increased amount has surpassed over 10 percent and adds up to over 5 billion won. The new pricing on Lilly Korea’s Trulicity 1.5 mg, effective from next month, would be brought down by 0.2 percent from 34,289 won to 34,213 won. Also the pricing on BMS’ Eliquis 2.5 mg tablet and 5 mg tablet would be lowered by 4.5 percent from 1,185 won to 1,132 won. Meanwhile, some drugs’ reimbursed pricing is lowered even further after the PVA negotiation, as relevant company voluntarily reduce the pricing. Lilly Korea’s Trulicity 1.5 mg/ 0.5 ml (dulaglutide) single-dose pen would be priced at 32,129 won from next month, dropping from the existing pricing at 34,213 won. On the contrary, some companies request a raise in the upper limit pricing of an item, and the government accepts the new pricing after a negotiation. Saehan Industry’s Techne DMSA kit Injection (dimrcaptosuccinic acid) was the case. The item was approved with radioactive medicine dimrcaptosuccinic acid (99mTc) dispensed in an injection. Although the item was not designated as an essential drug, other foreign supplier raised the cost and disrupted the supply in Korea. The foreign company’s decision ultimately made the product an orphan drug with an irreplaceable option and no further prospective production plan. The company underwent a new pricing negotiation with NHIS and agreed to raise the pricing by 62.6 percent. Effective from next month, the injection in two doses—1.4 mg and 1.2 mg—would be priced at 20,700 won, brought up from the current price at 12,728 won.
- Company
- United promotes phase III tx for COVID-19 in the Philippines
- by Aug 24, 2020 06:18am
- Korea United Pharmaceutical (CEO Kang Deok-young) is starting to develop a cure for COVID-19. It is Drug Repositioning of the company's Incrementally Modified Drug 'UI030'. United said on the 19th, "UI030 has confirmed the antiviral effect of up to 30 times compared to Ciclesonide in cell experiments." According to the company, UI030 is a combination of Desonide & Formoterol, an Incrementally Modified Drug developed by United for six years as an asthma treatment. AstraZeneca's treatment for asthma and chronic obstructive pulmonary disease 'Symbicort' is a salt-modifying product. It is characterized by a low risk of systemic side effects as it is an inhaled formulation that allows patients to easily administer drugs directly. Recently, in a cell experiment on human lung cells (Calu-3 cells) at the Biosafety Center, Korea University, the possibility of treating COVID-19 was discovered. UI030 confirmed the antiviral activity of 5 to 30 times that of Ciclesonide. Ciclesonide was previously found to be twice as effective as Remdesivir in an antiviral test conducted by Institut Pasteur Korea. United expects that UI030 can simultaneously exhibit antiviral and immunomodulatory effects, which are the mechanisms of treatment for COVID-19. The company is preparing application documents for approval of the phase III clinical trial protocol for the development of UI030's COVID-19 treatment. In Korea, phase I clinical trial is conducted with Asthma as an indication. When the clinical trial in the Philippines is successfully completed, it is seeking to obtain a domestic new drug license based on this. The target time for permitting is in the first half of next year.
- Company
- Patent dispute for Promac, eventually to Supreme Court
- by Kim, Jin-Gu Aug 24, 2020 06:18am
- PromacThe patent dispute over the anti-ulcer drug, Promac (Polaprezinc) was finally concluded in the Supreme Court. According to the pharmaceutical industry on the 19th, SK Chemical, which holds a formulation patent for Promac, recently filed an appeal to the Supreme Court against Hana Pharm and Korea Prime. Earlier, on the 17th of last month, SK Chemical received a ruling against the plaintiff in a patent invalidation trial cancellation lawsuit by the Patent Court (second trial). Promac is a gastric mucosa protective agent used to improve gastric ulcers, acute gastritis, and chronic gastritis, and Polaprezinc, the active ingredient, was developed by Zeria in Japan. SK chemicals improved its marketability by developing the existing product in the form of granules into tablets in 2013. The patent held by SK Chemicals is also about converting granules into tablets. Several domestic companies have challenged this formulation patent. Hana Pharm in April 2018 and Korea Prime in November of the same year filed a request for a trial to confirm the passive scope of rights. Generic companies won in the first trial. In March 2019, a trial decision was made for Korea Prime and Hana Pharm in July of the same year. The Intellectual Property Trial and Appeal Board judged that similar formulations developed by generic companies do not infringe the patent. SK Chemical appealed to the Patent Court. However, the second trial was ended as the Patent Court sided with the generics company following the first trial. SK Chemicals is aiming for a dramatic reversal in the Supreme Court with this appeal decision. Promac is one of SK Chemical's flagship products, and according to UBIST, a drug market research institute, Promac's outpatient prescription last year amounted to ₩11.1 billion. The prescription performance was ₩6.3 billion in the first half of this year. Promac is facing tough challenges from generics regardless of SK Chemical's appeal. Korea Prime's first-trial victory received a exclusivity for generic product and launched the first generic, Prezinc at the end of last year. Prezinc produced ₩51 million in prescription results in the first half of this year. The exclusivity period ends on the 30th of this month. In addition to Prime Korea, Hana Pharm, Pharvis, Pharmedix, Hutecs, Kukje, Medix Pharm, REYON, Samsung Pharm, Wooridul, Daewoo, Medica Korea, Dong-gu Bio, Daewoong Bio, Jin Yang, Binex, Ilhwa, Dongkook Pharm, Guju Pharm, Ahngook, Daehan New Pharm, Intro Bio Pharma, Hanpoong Pharm, Mothers Pharm, Kolmar Korea, Korea Global Pharm, Jungwoo, Eden Pharma, Nexpharm, Firrson, etc. are trying to launch a generic for Promac.
- Welcoming preemptive measures to protect generic exclusivity
- by Lee, Tak-Sun Aug 21, 2020 06:27am
- #Most of the pharmaceutical industry is welcoming the plan to improve the generic for exclusivity items contained in the amendment to the Pharmaceutical Affairs Act on the 20th. It is a "preemptive measure" for the method of restricting the patentee's deletion of patents from the patent list after the generic has received generic exclusivity. However, other than the industry, some argue that it is an 'excessive measure' to block cases where patent invalidation is confirmed and it is removed from the patent list. On the 20th, the MFDS announced a legislative amendment to the Pharmaceutical Affairs Act to operate the drug patent linkage system more reasonably. Particularly noteworthy in the amendment is the method to prevent the deletion of a patent from the patent list after the generic exclusivity was acquired. The patent right registered in the patent list can be deleted if the registered person requests it, but if there are drugs that have been granted the generic exclusivity by challenging the relevant patent, they are limited to maintain the effect of the generic exclusivity. In response, the MFDS said, "According to the current laws and regulations, it is difficult to prohibit the sale of the same drug (with the same active ingredient as the registered drug) to maintain the effect if there is no registered drug for generic exclusivity." If a patent for a listed drug is deleted from the patent list, the drug can enter the market even though the generic exclusivity is granted. This is in accordance with Article 50-9, Paragraph 1 of the Pharmaceutical Affairs Act. However, there have been no such cases since the enforcement of the generic exclusivity system. Instead, the MFDS explained that there are cases that are likely to be problematic. An official from the MFDS said this plan was prepared to preemptively respond to the protection of the generic exclusivity drugs. Officials in the pharmaceutical industry also generally positively answered that domestic pharmaceutical companies welcome this preemptive plan. An official from a pharmaceutical company said that they welcomed the company's rights to generic exclusivity in the generic market through a patent challenge. However, the pharmaceutical industry was concerned about the case where the patentee arbitrarily deleted the list of patent rights. Other officials in the industry pointed out that if a patentee deletes a patent from the patent list in a situation where a patent is challenged to obtain the right copyright, generic companies' efforts will be in vain. The pharmaceutical industry explains that there are many cases of deletion of patent lists, and the pharmaceutical industry explains that it needs to be supplemented.. There are rather different opinions outside the pharmaceutical industry. It is whether it is necessary to maintain even the patent deleted from the patent list due to the determination of the invalidity of the patent. In the event that the patent is invalidated, even if there is a generic exclusivity drug, other generics should freely obtain the approval and put it on the market. A person in the legal profession said, “The Ministry of Food and Drug Safety had shown a position that it was inevitable until ex officio deletion due to the confirmation of patent invalidation. It seems that the opinions of the pharmaceutical industry were more accepted.”
- Company
- Drug industry back on full alert as COVID-19 cases resurge
- by Aug 21, 2020 06:26am
- The pharmaceutical industry is on full alert again as the confirmed cases of novel coronavirus infection (COVID-19) is resurging rapidly around Seoul metropolitan area. Some companies have already reinitiated emergency working system with employees working in shifts or from home. The South Korean government has recently decided to toughen the social distancing measures in Seoul and Gyeonggi Province to level two. The threat of massive surge in confirmed COVID-19 cases is imminent after more than 200 cases have been confirmed in a single day. Daily confirmed case of COVID-19 reported in last seven days (Source: KCDC) The pharmaceutical industry is now in a heightened alert mode. But because many companies have implemented flexible working conditions during the first surge of COVID-19, the companies were able to take the necessary actions quickly. Centering heavily affected regions, the pharmaceutical companies are ordering the employees to work from home. Most of multinational companies order employees to work in shifts Multinational pharmaceutical companies are taking actions fast. Even before the government raised the social distancing level, most of the multinational companies have been rotating working hour shifts. The employees have been coming to the office every other day or working from home two to three days a week. But with the resurging of confirmed cases, the companies are reiterating the need of the strict measures. Due to the government’s tightened infection control measures in Seoul metropolitan area and a confirmed case reported from Seoul LS Yongsan Tower, Janssen has closed down the office until the end of the week and disinfected the area for the safety of employees. In particular, the employees working at the LS Yongsan Tower are all working from home until the end of the week. GSK Korea, also headquartering in the same building, is recommending the employees to work from home. And a biweekly schedule was given to those who have to come into the office. Lilly had their in-office employees to work from home from Aug. 18 to 19, and they are rotating their office hours from Aug. 20. Their sales people are only allowed to visit designated hospitals. Following the government’s order, Bayer has decided to work from home twice a week until the end of August, while Sanofi, Novartis, MSD and Takeda Pharmaceuticals are working from home every other day from Aug. 18. Companies like Roche, Bristol-Myers Squibb (BMS), Astellas and Pfizer have already been rotating office hour shifts or voluntarily working from home, and they plan to maintain the existing system. An associate from a multinational company commented, “The company would closely follow the reports of confirmed cases and update the working guideline accordingly to put the employees’ safety first.” Large Korean companies to work from home again Korean pharmaceutical companies have ended the order of working from home and returned to their regular working system as the social distancing has ended in last May. But with the resurge, the companies are bringing back the social distancing working system. First, Yuhan has ordered all employees to work from home, and the same order was give to in-office employees at the GC Pharma headquarters. JW Pharmaceutical is rotating two-shift to work from home. The company seems to have different shift systems in each department. Daewoong Pharmaceutical has asked employees to voluntarily work from home but to refrain from convening an in-person meeting or gathering. Dong-A ST has banned employees to come to office in regions with level-two social distancing order and refrained them from visiting hospitals. Boryung Pharmaceutical and Chong Kun Dang are still reviewing the working system as they closely watch the emergency status. An associate commented, “From various perspectives, the company is reviewing the period, type and subject of the shift in working system,” and “A guideline would be set as the situation is worsening.’ Moreover, off-line symposium and workshops, initially planned as the spread of COVID-19 seemed contained, are to be canceled. Korea United Pharm had scheduled an employee workshop from Aug. 21 to 22, but now the company is considering on cancelling it. Even if the event carries on, it would only convene less than 50 people. The workshop venue is located in Gwangju, Gyeonggi Province, where an event with over 50 people is banned. Korea United Pharm official said, “There is a possibility of canceling the event. But if not, the company would strictly follow the infection control regulations.”
- Policy
- Promote legislation to include the shingles vaccine in NIP
- by Lee, Jeong-Hwan Aug 21, 2020 06:26am
- A bill is being promoted to include the shingles vaccine, which is classified as a premium vaccine, in the National Immunization Program,(NIP). On the 19th, Yoo Sang-beom, a member of the United Future Party announced that it had proposed a bill with the same content. He explained that the onset of shingles markedly lowers the quality of life of the patient due to complications along with acute and chronic pain. In addition, he pointed out that the number of patients in Korea is increasing from about 660,000 as of 2015 to about 740,000 in 2019, which induces the burden of disease socially and economically. Currently, the KCDC is recommending vaccination of the shingles vaccine for the elderly aged 60 and over, but the inoculation rate is only 10% for those in their 50s or older at a cost of about ₩150,000 to ₩200,000. He said, "The shingles vaccination has great disease prevention effect and a great reduction in cost compared to the cost of an outbreak, so it is subject to national vaccination in the UK, Germany, Canada, and Australia, and Korea should also be included to reduce the burden of national medical expenses."
- Opinion
- [Reporter’s Note] Clinical trial info, do we have enough?
- by Lee, Tak-Sun Aug 21, 2020 06:26am
- South Korea’s Ministry of Food and Drug Safety (MFDS) has decided to provide wider scope of information regarding clinical trial approval process from October last year. And the ministry has been uploading elaborative details about the process on its official website. MFDS explained further disclosure of the information aims to expand treatment opportunity in rare disease patients and to protect to rights of clinical trial participants. Since then the website started publishing information necessary for participating in clinical trial, such as the name of participating institute, contact information and standards of participant selection and exemption. Basically, a patient or their guardian can use the provided information to directly contact the participating institute. The scope of disclosed information expanded, however, the speed of information update has gone down. Only a handful of clinical trials’ information is uploaded on the day of approval. Even worse, some information is posted days later. Such delay in information update is now hindering patients, guardians and investors interested in the company’s clinical trial from timely acquiring the information. The website is sluggish to upload the latest clinical trial information on the homepage, and the interested users have to dig through website to find the information. And even if the information is updated, the related companies usually limit the scope of disclosed information claiming confidentiality in the material. For example, the name of clinical drug substance is not properly disclosed or labeled with a tentatively given name. These confusing naming become useless information to patients or their guardians as they cannot be identified properly. In case the Korean government only shows a tentative name, the actual drug substance used can be found in the U.S. National Institutes of Health (NIH) official website, ClinicalTrials.gov. MFDS initially announced the scope of provided information would be on par with the NIH website. However, the Korean clinical trial website has too many omitted information. Especially, the information is exceptionally more limited for products developed by a Korean company. Surely, more specific clinical trial information is provided than before. But the current system is close to incomplete for the general public, participants and their guardians to confidently say the access to information has gotten better. If the information update delay is unavoidable, the website system should compartmentalize disclosed and undisclosed information to speed up the update. Also the standard of deciding undisclosed information should be clarified for the public. The current system is more likely to leave the people looking for interested information disappointed.
