- LOGIN
- MemberShip
- 2025-12-24 13:21:11
- Policy
- Chong Kun Dang’s capsuled low-dose Xarelto generic approved
- by Lee, Tak-Sun Apr 14, 2020 06:11am
- Xarelto tablet 2.5mgChong Kun Dang’s generic version of Bayer’s anticoagulant Xarelto (rivaroxaban) tablet was approved as a first capsule form in Korea. The 2.5 mg low-dose capsule would be able to evade Hanmi Pharmaceutical and SK Chemical’s preferential sales rights on their generic products with the change in administration form. On Apr. 9, Ministry of Food and Drug Safety (MFDS) has reported its clearance on ChongKunDang Rivaroxaban Capsule 2.5 mg. The generic the same pharmaceutical substance rivaroxaban as Bayer’s Xarelto tablet, but it is in capsule form. Chong Kun Dang’s generic is the first capsule out of the 22 generics approved with the same substance in Korea. The Korean company has its reason why it changed the form. SK Chemicals and Hanmi Pharmaceutical have already challenged the patent and respectively received the first approvals on their SK Rivaroxaban tablet 2.5 mg and Riroxban tablet 2.5 mg, along with the preferential sales rights. SK Chemicals and Hanmi Pharmaceutical have challenged Xarelto’s pharmaceutical substance patent (expected to expire on Nov. 13, 2024) with low-dose form (2.5 mg) and won the generic market exclusive sales right (preferential sales right) for rivaroxaban. The preferential sales right’s sales ban on other generics would last from Oct. 4, 2021, when Xarelto’s first-to-file (FTF) patent on the product and the use expires, to July 3, 2022. Accordingly, generics sharing a same type of form and active ingredient with Hanmi Pharmaceutical and SK Chemicals’ generic would be ruled out from market release during the sales ban period. But Chong Kun Dang’s capsule can avoid the sales ban with a different form of capsule. Ultimately, the three Korean companies would be able to launch their generics all at the same time. Besides Bayer with the original, Hanmi Pharmaceutical, SK Chemicals, Chong Kun Dang and Hanlim Pharm had their 2.5 mg low-dose rivaroxabans approved. Currently, Hanlim Pharm is in process of patent challenge. But its generic would be banned from the sales during the preferential sales rights period. A study has confirmed 2.5 mg rivaroxaban, combined with Aspirin, reduces the risk of heart attack, ischemic stroke or cardiovascular death in patients either with coronary artery disease (CAD) or peripheral artery disease (PAD) relatively more than the Aspirin monotherapy. Based on the findings, foreign academic societies recommend using Xarelto 2.5 mg plus Aspirin in patients with high-risk chronic CAD. The demand for 2.5 mg dose is exists, but other follow-on drug makers, except for those with preferential sales rights, would be able to launch their products after Nov. 14, 2024, when the original’s patent expires. UBIST reported the mega blockbuster drug Xarelto has made 46.2 billion won last year in outpatient prescription, which is why the industry is keeping their close eye on if Chong Kun Dang would get to successfully launch the capsule-form rivaroxaban dodging the preferential sales ban.
- Policy
- Controversy concludes about COVID-19 & Safety of HTN drugs
- by Lee, in-bok Apr 13, 2020 06:13am
- It is expected that clinical studies will begin in Korea to determine the association between COVID-19 and angiotensin converting enzyme (ACE) -based hypertensive drugs. It is a willingness to uncover whether it can be a threat to domestic hypertensive patients in terms of controversial issues worldwide. #It was confirmed that the public-private council agreed on the plan to promote such clinical research through a recent discussion. A representative participating in the public-private council pointed out that many studies pointed to the need for research on the fact that COVID-19 is spreading controversy over the risk of hypertensive drugs worldwide. and discussions are being made on the specific direction of implementation. Indeed, controversy continues in the academia about angiotensin receptor blockers (ARBs) and angiotensin converting enzyme inhibitors (ACEIs), which have a mechanism to regulate COVID-19 as it spreads ACE2 as a receptor. In response to this, major medical institutions such as the World Congress of Cardiology, the American Heart Association, and the European Society of Cardiology have said that patients should not stop or change hypertensive drugs such as ARB or ACEI, but there is no clear clinical evidence. In the end, in this controversy, the government and the medical community have rolled up their arms to relieve the anxiety of domestic hypertensive patients. Accordingly, this study is expected to be conducted in cooperation with the government and the medical community in line with the purpose of the public-private council. When the medical societies gather and form researchers, a kind of government service that provides the necessary funds and data for the government is influential. The problem is the patient data needed for these studies. This is because the data of patients who are prescribed ARB and ACEI in Korea along with COVID-19 confirmed information is essential. In response, medical associations are requesting that regulations such as personal information be loosened temporarily so that they can use the HIRA’s data, but it has been found that no conclusion has been reached. A representative from the council said that since it is not easy to control COVID-19 confirmed patients, The HIRA’s data is essential for related research. Along with this, it is expected that research on the development of a plasma treatment that has been successfully performed at Severance Hospital will also begin. This is because both the government and the medical community are now sympathetic to the need and have begun discussing it. Plasma recovery and separation technology for patients in recovery phase are still difficult. Although there were many opinions regarding the treatment of plasma, the officials of the council said that the government and the medical community decided to start research and development together because the first priority is therapeutics. Specific tasks will be announced through the Central Clinical Committee after the assignment has been made toward the KCDC.
- Policy
- President Moon “Expediting COVID-19 treatment approval”
- by Lee, Jeong-Hwan Apr 13, 2020 06:13am
- Amid COVID-19 pandemic, President Moon Jae-in of South Korea has expressed his expectation for Korean-made treatment and vaccine to save the humanity. President Moon personally emphasized the government support for the COVID-19 treatment vaccine through R&D investment and expedited approval process. At a meeting convened on Apr. 9 for the COVID-19 treatment and vaccine developing industry-academy-research-hospital collaboration, President Moon urged “Korea and the whole world are desperately waiting for the treatment and vaccine. They are the critical goals we have to achieve to overcome the pandemic completely.” The President Moon’s comment was interpreted as his commitment to bring together the government and corporate capacity on treatment and vaccine R&D as Korean infectious disease test kit and control model have been highlighted by the world amid the pandemic. At the meeting, the Korean president personally mentioned of Institut Pasteur Korea accelerating the treatment development via pharmaceutical substance rediscovery, and other cases of Korean biopharmaceutical companies concentrating on promptly developing treatment based on plasma, antibody and anti-inflammatory. President Moon said, “I have heard the inspiring news that Korea is at an exceptional level in developing COVID-19 treatment. Although the country is comparatively inexperienced in developing pharmaceuticals and lacks in resource aid compared to other developed countries, Korea has endeavored in developing related technology through the struggle we had during the MERS outbreak in 2015.” President Moon stressed, “As we have become an example of infectious disease control, hopefully we could also lead in treatment and vaccine development to give the people courage and confidence and become the hope to our economy,” and “scientists, research institutes, companies, hospitals and the government should work together to promptly develop safe and effective treatment and vaccine.” “More than anything, this could be our opportunity to not only upgrade the infectious disease control capacity, but also to enhance treatment technology,” and “while we put the people’s safety first, fast-track clinical trial review procedure would be implemented,” the President added. President Moon mentioned the government’s plans including opening biosafety laboratory to the public, providing necessary resources like convalescent plasma or patient’s sample, investing 210 billion won on COVID-19 vaccine development, reflecting treatment development cost and R&D investment funding on contingency budget, and establishing novel virus research laboratory. Regarding international collaboration he said, “The G20 have agreed to share related data and cooperate together to develop treatment. Korea would also actively participate in international cooperation led by the World Health Organization (WHO) and the UN.” President Moon emphasized, “The biggest goal of the humanity at the moment is developing treatment and vaccine,” and “The Korean government would do its best to support all of you to solely focus on R&D. And that is our role in saving the lives in all around the world.” And he encouraged the participants of the meeting by noting that “Korea’s mature sense of community is now a global example and standard of containing COVID-19,” and “With each and every one of you here being our driving force, Korea would be able to leap forward in treatment and vaccine development, and also contribute in the global community.”
- Policy
- 161 items, subject to monitoring for Price-Volume agreement
- by Lee, Hye-Kyung Apr 13, 2020 06:12am
- AstraZeneca Korea's Tagrisso 40mg/80 mg (Osimatinib Mesylate) were added to the monitoring target for the price-volume agreement negotiation system in the second quarter of this year. Celgine's Pomalyst (Pomalidomide) 1·2·3·4 mg, Roche Korea's Tecentriq (Atezolizumab), and Jansen Korea's Sylvant (Siltuximab) 100·400 mg are also subject to monitoring. The NHIS recently released on the homepage the Drugs to be used in the second quarter of 2020- the price-volume agreement negotiation system is a method in which the risk of health insurance finance is shared by the NHIS and pharmaceutical companies. From April to June of this year, the monitoring target for the second quarter was 161 items in 92 drug groups. Ibsen Korea's Cabometyx (Cabozantinib) 20·40·60mg, Amgen Korea's Kyprolis (Carfilzomib) 30·60mg, and MSD Korea's Keytruda (Pembrolizumab) are also subject to monitoring. Type A(Ka) of the price-volume agreement negotiation system is when the amount of claims in the same product group with the estimated amount of claims agreed by the NHIS, price negotiations, negotiations on the adjustment of the price increase, negotiations to expand the scope of use, etc. has increased by more than 30%. Type B(Na) In the case of the same product group that has been negotiated by Type A(Ka) or has not been negotiated and has been four years since the date of initial listing, applies when the previous type A(Ka) is increased by more than 60% or more than 10% & 5 billion won more than the previous year's bill every year from the day following the end date of the analysis target period. On the other hand, drugs with an annual billing amount of less than ₩1.5 billion, drugs with lower upper limit than the arithmetic average of the generics, low-cost drugs, and shortage prevention drugs are excluded from the subject of the price-volume agreement negotiation system.
- Policy
- Salt-altering drugs for Pristiq ER got generic exclusivity
- by Lee, Tak-Sun Apr 13, 2020 06:12am
- PfizerPfizer's first generic drug for anti-depressant drug Pristiq ER (Desvenlafaxine) was also approved as generic exclusivity. Accordingly, four generics of Whan In, Myungin, Nexpharm Korea, Hallim, will be able to monopolize in the same ingredient formulation market until January 8, next year. On the 8th, the MFDS approved Whan In’s Defaxine SR 50·100mg, Myungin’s Esven SR 50· 100mg, Hallim’s Prenexa 50·100mg', Nexpharm Korea’s Desvera SR 50·100mg for generic exclusivity. Therefore, drugs with the same ingredients are prohibited from being sold from April 9, 2020 to January 8, 2021. Four items were monopolized for a certain period in the generic market, excluding the original items. Four items applied for the first permission among generic drugs on February 6, and in June of last year, the trial for patent evasion (confirmation of passive scope of rights) was judged and the claims were cited. These items are expected to be released to the market in July after going through the insurance benefit process.
- Policy
- P-CABs, compete for indication expansion
- by Lee, Tak-Sun Apr 10, 2020 06:29am
- The only P-CAB gastric disease treatment drug currently on the market Potassium-Competitive Acid Blocker (P-CAB) drugs, which are called next-generation gastric acid inhibitors, are spurring to expand indications. Currently, the only drug released in Korea is K-Cab by HK inno.N (Tegoprazan). As Vocinti (Vonoprazan by Takeda) is getting permission and is planning to release, Daewoong Pharmaceutical's Fexuprazan has also applied for permission, so the competition between products will soon become fierce. Accordingly, there is competition for development to expand the use of products in the market. Daewoong’s Fexuprazan (Development name: DWP14012) was approved by the Ministry of Food and Drug Safety on the 1st of the Phase III clinical trial protocol to evaluate the efficacy and safety in patients with acute or chronic gastritis. The clinical trial will be conducted at Hanyang University Hospital by October of next year for a total of 327 patients. Fexuprazan is a P-CAB (Potassium-Competitive Acid Blocker) formulation with a mechanism that reversibly blocks the proton pump that secretes gastric acid from the stomach wall and it is a series of drugs such as K-Cab by HK inno.N and Vocinti by Takeda. Daewoong Pharmaceutical has completed phase III clinical trials for 260 patients with erosive GERD and has applied for approval for items to the MFDS earlier this year. However, the clinical trials of Fexuprazan continue. This is because there are limitations only in indications of erosive GERD when faced with competitors in the market. Daewoong is currently conducting Phase III clinical trials to study Fexuprazan for treatment of ▲non-erosive GERD ▲maintenance therapy for patients with cure of erosive GERD ▲ treatment for acute or chronic gastritis. Currently on the market, K-Cab is approved as an antibiotic combination therapy for ▲Antibiotic combination therapy for the elimination of Helicobacter pylori in patients with peptic ulcer and/or chronic atrophic gastritis ▲treatment of erosive gastroesophageal reflux disease ▲ treatment of non-erosive gastroesophageal reflux disease ▲treatment of gastric ulcer In addition, Takeda’s Vocinti was approved for ▲the prevention of recurrence of gastric ulcer or duodenal ulcer when administering nonsteroidal anti-inflammatory drugs (NSAIDs)▲gastric ulcer ▲erosive GERD and maintenance therapy. When comparing the three P-CABs, it has indications for the treatment of erosive gastroesophageal reflux disease and has its own characteristics of use. K-cab has non-erosive GERD indication, and Vocinti has indications that other products do not have the purpose of preventing recurrence of gastric ulcer or duodenal ulcer when administering nonsteroidal anti-inflammatory drugs (NSAIDs). Daewoong Pharm's indications for patients with acute gastritis who are undergoing Phase III clinical trials do not apply to the other two drugs. However, K-Cab and Vocinti are also continuing clinical trials to expand indications. In the case of K-Cab, the treatment of erosive GERD has been confirmed through an endoscope and is currently undergoing phase III clinical trials for maintenance therapy of patients. Although clinical trials in progress have not been confirmed in Korea, Vocinti is said to have been rejected for the treatment of duodenal ulcer in the first application. It is an analysis that if Vocinti completes the reimbursement procedure and launches in earnest, it can be developed in Korea. K-Cab received a positive evaluation that it was able to outweigh the PPI-based treatments, which were established in the existing gastric acid secretion inhibitor market, with an outpatient prescription of ₩26.4 billion last year. Accordingly, attention is also focused on the market strategy of the remaining two P-CABs being prepared for release.
- Policy
- The first generics for Pristiq ER were approved
- by Lee, Tak-Sun Apr 10, 2020 06:28am
- PfizerThe generic drugs that avoided the patent of Pristiq ER obtained the item permission. They are expected to be competitive as first generics in the market. The Ministry of Food and Drug Safety approved the approval of four items of Desvenlafaxine, generic for Pristiq ER on the 7th. The generics are Defaxine SR 50·100mg by Whan In, Desven SR 50·100mg by Myungin, Prenexa SR 100mg by Hanlim, Desvela SR 50·100mg by Nexpharm. They have different salts from the original drug Pristiq ER (Desvenlafaxine succinate), and they changed to succinic acid salts rather than benzoate to avoid product licensing and patents. The four companies received a affirmed decision in June last year at a trial to confirm the passive scope of rights to evade patents. It has overcome the salt patent (expected to expire on October 7, 2022) as a salt change drug. And on the 5th of February, when Pristiq ER's PMS expired, they immediately applied for permission on the 6th. As long as it meets the requirements, Patent evasion is also confirmed without Pfizer appealing. Therefore, it is expected to release the product to the market in July after the reimbursement procedure. Pristiq ER is considered as the next-generation antidepressants because they have a low risk of drug interactions and less adverse reactions such as weight loss and decreased sexual function. According to UBIST last year, the outpatient prescription amount is ₩3.1 billion.
- Policy
- AbbVie does not enforce Kaletra’s patent right
- by Lee, Tak-Sun Apr 09, 2020 09:43pm
- AbbVie's HIV-1 treatment AbbVie’s Kaletra (Lopinavir/Ritonavir), which is used in the clinical field as a treatment for COVID-19, has abandoned patent rights, but there is no news of generic development in Korea This is because the market size of AIDS treatment (HIV-1), which is the main indication of Kaletra, is not large in Korea and is already occupied by other new drugs, which is disadvantageous in terms of marketability. However, it is known that some pharmaceutical companies are looking at overseas markets and promoting the development of products for export. According to the industry on the 8th, there are three domestic registered patents for Kaletra, which will expire on August 23, 2024 and February 21, 2026, respectively. AbbVie said it would abandon Kaletra's international patent rights on the 23rd of last month. The company explains that it is a humanitarian measure that allows generic drugs to enhance patient access. In this regard, it is known that AbbVie does not enforce Kaletra’s patent rights in Korea. However, since then, there has been no news of generic development in Korea. In order to obtain a license for a generic item, it is necessary to undergo a bioequivalence test to prove its equivalence with the original, but no test has been approved so far. The industry also expects no pharmaceutical companies to develop generic for Kaletra for the domestic market. Because there is no marketability. This is because the domestic COVID-19 infection situation may improve, and marketability cannot be guaranteed even if a generic drug is made. Domestic AIDS treatment marketing manager said that the domestic AIDS treatment market was not as big as ₩40 billion, and even the original pharmaceutical companies with new drugs such as Gilead, GSK, and AbbVie were in control. He also said that even if a new drug patent for AIDS treatment expires, it is difficult to have generic drugs in Korea. Last year, the domestic sales of Kaletra based on IQVIA were ₩2.4 billion. It is an analysis that it is difficult to expect a big hit in the domestic market. Moreover, the AIDS treatment market has a high preference for originals, so generics have limited market share. However, it is expected that there will be demand overseas. Currently, there are more than 1 million COVID-19 confirmed patients worldwide, and there is a high possibility that the epidemic will continue for a while. As a result, it is known that some domestic pharmaceutical companies with overseas distribution networks are pursuing the approval of Kaletra’s generic for export. The item license for export is judged only through the document screening process, so it can be obtained in a week. However, it must be examined separately in the country of import, which may exceed 1 year until actual export. It has been reported that raw materials are already being supplied in countries such as India. An industry official said that some companies are importing raw materials from overseas to make preparations, and they are aimed at overseas markets rather than domestic markets.
- Policy
- Can generic listing negotiation prevent reckless listing?
- by Kim, Jung-Ju Apr 09, 2020 06:26am
- Although some pharmaceutical companies are voicing their concerns over the generic reimbursement negotiation, to be enforced from the second half of the year, some are actually welcoming the new system with an anticipation of positive benefits. Along with the revised drug pricing system coming in effect around the same time, the generic negotiation is expected to eliminate ‘reckless’ competition among reimbursed drugs in same class. Pharmaceutical industry sources reported on Apr. 6 about the growing voices of the industry claiming the partially revised Regulation on National Health Insurance (NHI) Reimbursement Standard is needed for the amended stepped drug pricing system. The revised Regulation on NHI Reimbursement Standard aims to require drugs receiving automatically calculated reimbursed pricing to negotiate with the government and the insurer to sign an agreement before listing. The Korean government and insurer manage drug pricing with pricing and projected volume negotiation prior to the listing, and with price-volume agreement (PVA) negotiation after the listing. So far, the pre-listing obstacles have been mostly targeting new drug or high-cost drugs only, but soon the generics would have to undergo similar procedure to enhance reimbursement listing value and NHI expenditure efficiency. Reimbursement negotiation does not only regard drug pricing, but also regards supplier’s duty, patient accessibility and financial stability depending on the various pursuing items, which allows healthcare insurance to be utilize more directly to manage active pharmaceutical ingredient’s supply and quality and drug production and distribution. The negotiation for generics with National Health Insurance Service (NHIS) would be completed under 60 days like the new drug reimbursement procedure. The government is currently accepting the industry’s opinion while scheduling the amendments to take an effect from the second half of the year. Nevertheless, the industry has expressed their concerns of the government trying to burden the pharmaceutical companies with excessive liability through unnecessary administrative procedure. And some even complained of the government trying to reinforce pre-listing obstacles and keep pharmaceutical companies on a leash to lower drug pricing. However, contrasting voices have been raised, noticeably. They claim the newly revised stepped pricing system could motivate generics to recklessly apply for reimbursement to be more competitive in the market. Accordingly, other set of regulation to manage the generic pricing system is needed. A pharmaceutical company insider said, “Regardless of their sales plan, some generic products are aggressively applying for reimbursement after their approval. When the stepped pricing system comes in effect, generic makers with actual plan to release the product would unfairly receive pricing close to nothing.” The insider also noted the negotiation with the government and insurer would be able to resolve the loophole issues. Another pharmaceutical industry insider argued “When the reckless listing phenomenon gets more prevalent, pricing of some originals with extremely low marketability could be pressured to drop and they could suspend supplying for the Korean market and cause shortage. Ultimately it could negatively affect patient’s accessibility and treatment, so the government and NHIS should clearly address the subject on the agreement.” Moreover, another pharmaceutical company has mentioned of a reverse discrimination. The company insider said, “The government and the insurer impose duty and liability on original item and its company’s agreement, only because it is a first-in-class. But their competitors, the generic companies, are free of any liability. This is why the question of reverse discrimination has surfaced.” The company insider emphasized, “The government should be considerate of some companies complaining of generic reimbursement negotiation, but also some agreeing on the necessity of the system. Based on the industry’s reaction, hopefully the government and the insurer could reflect their opinions on the system”
- Policy
- GV1001 developed as a demetia drug, approved for COVID-19
- by Lee, Tak-Sun Apr 08, 2020 06:21am
- The Ministry of Food and Drug Safety approved a new drug candidate 'GV1001' by GemVax, which is being developed as a treatment for dementia, for the purpose of treating COVID-19 patients. The request for approval for the use of treatment was made by Kyungpook National University Chilgok Hospital. The MFDS approved the use of GV1001 (Tertomotide HCl), applied by Kyungpook National University Chilgok Hospital on the 3rd, for COVID-19 confirmed patients. Kyungpook National University Chilgok Hospital applied for two cases, and two patients received GV1001. GemVax, which is developing GV1001, said that GV1001 has applied for a patent related to COVID-19. GV1001 is a peptide derived from hTERT (Human Telomerase reverse transcriptase). The enzyme telomerase maintains the length of telomere located at the ends of chromosomes, and the treatment has anti-inflammation, anti-oxidation cellular protective effects, as well as anti-cancer effect. GemVax is currently conducting clinical trials to develop Alzheimer's treatments. GemVax explained that GV1001 proved through preclinical studies to prevent cytokine storms by regulating various inflammatory mediators such as cytokines against severe inflammation caused by COVID-19 infection. The approval for the use of treatment is a system that enables the use of clinical trial drugs for treatment purposes in order to provide treatment opportunities to patients with life-threatening diseases without other means of treatment. In other words, it is different from commercialization clinical trials for product approval for large-scale patients, or sponsor-investigator trials conducted by researchers to prove effectiveness or safety. Approval of use for treatment purposes requested by the hospital is permitted for individual patients, and at the time of application by the company, two or more persons are permitted. Therefore, there is not enough data to demonstrate the effectiveness or safety of the therapeutic use.
