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- 2026-04-16 04:58:38
- Policy
- 'Abortion' within 14 weeks of pregnancy is allowed
- by Lee, Tak-Sun Oct 12, 2020 06:13am
- As the government allowed abortions in early pregnancy in accordance with the Constitutional Court's ruling against the constitution of abortion, it also decided to permit spontaneous abortion inducing medicines. Accordingly, it is noteworthy whether 'Mifegyne', which is widely used overseas, will be officially introduced in Korea. The government announced on the 7th that it will improve the crime of abortion according to the order of the Constitutional Court through an advance notice of revisions to the Criminal Code, the Mother and Child Health Law, and the Pharmaceutical Affairs Law. This revision of the law creates a safe operating environment, prevents unwanted pregnancies, and reduces abortions within the legally permitted range, while providing social and institutional conditions. It explains that the focus was on the protection of the right to life of the fetus and the right to self-determination of women. The procedure for collecting opinions on the amendment will continue until December 31 of this year. In particular, through the revision of the Pharmaceutical Affairs Law, it is planned to allow the use of abortion suggestive phrases or designs for drugs permitted by the Criminal Act and the Maternal and Child Health Law. The MFDS is planning to take necessary measures preemptively, such as establishing a system for safe use of the drug and preventing illegal use. The policy is to apply for spontaneous abortion inducing medicines license and, if necessary, advance consultation for the application for permission is also promoted. There is no officially licensed spontaneous abortion inducing medicines in Korea so far. Overseas, the abortion pill called 'Mifegyne' is widely used to induce natural abortion. It is based on steroidal antiprogesterone that can be used within 50 days of pregnancy or up to 8 weeks. Mifegyne is used in 75 countries, and women and civic groups have strongly requested domestic introduction. Through the revision of the Criminal Law, the government decided to set the allowable period for determining pregnancy maintenance and childbirth for pregnant women to be 'within 24 weeks of pregnancy', and then divide it into 14 weeks and 24 weeks of pregnancy to differentially regulate the requirements. The current Maternal and Child Health Act allows abortion within 24 weeks of pregnancy only if there is a certain reason, but the amendment fully reflects the purpose of the decision of the Constitutional Court. An abortion can be decided according to the decision of the pregnant woman herself without certain reasons or counseling within 14 weeks of pregnancy. In addition, an abortion is allowed if there are reasons under the existing Maternal and Child Health Act and social and economic reasons specified in the Constitutional Court decision within 15 to 24 weeks of pregnancy. For safe abortion, it is limited to those that are performed by doctors as in the current practice, and abortions can be performed using medically recognized methods. Through the revision of the Maternal and Child Health Act, it was decided to expand the options by specifying treatment methods. In order to ensure access to medical information on induced abortion and to prevent repeated induced abortion, the written consent of the doctor has been established with the obligation to explain the procedure, sequelae, and compliance before and after the procedure. Rejection of induced abortion treatment according to the doctor's personal belief can be admitted. If the doctor refuses to request a procedure, he or she should immediately inform a pregnancy/birth counseling institution that provides information on whether to maintain pregnancy. The government announced on the 7th that it will do its best to complete the revision of the law within this year by promptly submitting the government legislation to the National Assembly through a legislative notice, review of the Legislative Office, and a cabinet meeting.
- Policy
- Dupixent targeting atopic dermatitis was launched
- by Lee, Tak-Sun Oct 08, 2020 06:25am
- Dupixent Since the first biological drug Dupixent targeting atopic dermatitis was launched in Korea, other foreign-funded pharmaceutical companies are also developing new drugs. There are four clinical trials approved in Korea this year. On the 6th, the MFDS approved the phase III clinical trial protocol of Lebrikizumab. It is evaluated for efficacy and safety in patients with moderate to severe atopic dermatitis in this clinical trial. The multinational clinical trial will involve 400 patients around the world, and 55 people will be recruited in Korea. Lebrikizumab is a candidate material for the treatment of atopic dermatitis, which Lilly acquired earlier this year through the acquisition of biotechnology company Dermira. Originally developed by Roche as a treatment for asthma, Dermira took over and changed its use as a treatment for atopic dermatitis and commercialized it. In December of last year, the Food and Drug Administration (FDA) designated the drug for expedited screening. Currently, Sanofi's Dupixent (Dupilumab) is the only biological agent that can be used by patients with moderate or severe atopic dermatitis. Prior to this, in June, Pfizer’s Abrocitinib was approved for a domestic phase III clinical trial. This is a clinical trial to evaluate the efficacy and safety compared to Dupilumab in adult patients receiving background topical therapy for moderate to severe atopic dermatitis. Commercially, Abrocitinib seems to be ahead of Lebrikizumab. Pfizer aims to approve Abrocitinib in the US within the year. In May, Pfizer’s Crisaborole was approved for a phase III clinical trial in Korea, an ointment for atopic dermatitis. Crisaborole was approved by the U.S. FDA in 2016, but has not yet obtained official approval in Korea. In this clinical trial, Pfizer will verify the efficacy and safety of 2% of Crisaborole ointment in Asian pediatric and adult subjects (2 years of age or older) with mild to moderate atopic dermatitis. Nemolizumab developed by Chugai in Japan is also undergoing phase III clinical trial in Korea. It was approved for phase III clinical trial in June, and Galderma is known to have marketing and development rights excluding Japan and Taiwan. In this clinical trial, the efficacy and safety of Nemolizumab will be evaluated in patients with moderate to severe atopic dermatitis. The last four new drug candidates approved for phase III clinical trial are all biologics like Dupixent . It was approved in Korea in 2018 and can be used for atopic dermatitis and asthma. In the case of atopic dermatitis, it is used for the treatment of moderate to severe atopic dermatitis, for which topical treatments are not adequately controlled or these treatments are not recommended. Atopic dermatitis is a disease whose exact pathogenesis is not yet known. There are about 950,000 patients in Korea, and it is increasing every year. Mainly non-steroidal topical treatments are used, but they only help relieve symptoms. Even long-term treatment is not likely to be cured. Accordingly, Medical staff are hoping for Dupixent. Dupixent was listed in this year, and sales in the first half of IQVIA recorded ₩8.5 billion, and it is clear that it will exceed ₩10 billion per year, which is the standard for domestic drug blockbusters.
- InterView
- Pfizer in the center of autoimmune disease treatment scene
- by Eo, Yun-Ho Oct 08, 2020 06:24am
- I&I Business Unit Lead Kim Hee-yeon Shifting the paradigm in autoimmune disease, tumor necrosis factor (TNF)-α inhibitors have taken root as major treatment option not only for rheumatoid arthritis, but also for other various areas including ankylsoing spondylitis, psoriasis, and psoriatic arthritis. Regardless, there are still patients struggling with unmet needs as they fail to control the diseases with TNF-α inhibitors. As a result of many pharmaceutical companies jumping into developing alternatives of TNF-α inhibitors, other options like Janus kinase (JAK) inhibitor and interleukin (IL) inhibitors have emerged. Considering the change in treatment scene, Pfizer is a key player in the autoimmune disease area. The company owns a conventional TNF-α inhibitor Enbrel (etanercept), but also it launched a first-in-class JAK inhibitor Xeljanz (tofacitinib). The company is also in process of seeking approval on the Xeljanz follow-up drug ‘abrocitinib.’ Daily Pharm interviewed Pfizer Korea’s Inflammation & Immunology (I&I) Business Unit Lead Kim Hee-yeon on the trend in autoimmune disease drug and marketing strategies. -Please tell us about your experience in the industry. Currently, I am leading the I&I unit in Pfizer Korea. From 2001 when I joined Pfizer Korea, I have acquired a wide variety of drug marketing and sales experiences in internal medicine, pain, respiratory and I&I areas. While managing numerous drugs’ commercial strategies, I was in charge of launching Caduet (amlodipine), Eliquis (apixaban) and Viviant (bazedoxifene) in South Korea, and also leading the off-patent marketing strategy for Lyrica (pregabalin) in seven countries as a regional marketing director in Pfizer Asia. -The I&I unit consists of two key products. What are the respective strengths of those products? Enbrel, launched in South Korea in 2003, has over 16 years of a long history. As a first TNF-α inhibitor in the treatment area, it has been evaluated to have changed the paradigm of rheumatoid arthritis treatment. More than anything, the drug was able to maintain the market leadership with even a specific patient group dedicated to it as it is a TNF-α inhibitor without anti-drug antibodies (ADAs). And its trustworthy safety profile is its one of best strengths. Xeljanz has also proposed a new treatment paradigm in rheumatoid arthritis. A first JAK inhibitor used in rheumatoid arthritis, Xeljanz was listed for reimbursement in 2017 as a first-line therapy after it was released in South Korea in 2014. -The two drugs have an overlapping indication, which could put them in competition. As a business unit, what are the marketing strategies like? Rather than competitors, the two drugs are actually in mutually beneficial relationship. Except for the rheumatoid arthritis, Enbrel and Xeljanz do not share other common indications. Enbrel is indicated to treat patients with ankylsoing spondylitis, and it has been concentrating on the juvenile idiopathic arthritis (juvenile polyarthritis, extended oligoarthritis, psoriatic arthritis, and enthesitis) with healthcare reimbursement expanded last year. Especially, the patients and healthcare providers were exhilarated about the access to the treatment as the juvenile idiopathic arthritis market had highly unmet medical needs. On the contrary, Xeljanz is focused on rheumatoid arthritis and ulcerative colitis treatment area. Xeljanz may have more overlapping indications with Enbrel in the future as the drug is also constantly expanding its indication, but currently they are not competing against each other. -In terms of South Korean healthcare provider, there seems to be a barrier to prescribe JAK inhibitor. Because of that, it seems questionable if the drug would be able to expand its share in rheumatoid arthritis market. I agree. South Korea still tends to prefer conventional therapy. Despite the accumulating evidences highly recommending early treatment, the country’s healthcare providers seem to linger on using the conventional treatment. There could be many factors, but the patients’ stress on getting injections could be one of them. However, an oral JAK inhibitor like Xeljanz would be able to play a positive role in creating a new rheumatoid arthritis treatment environment. And it would also play a significant role in creating an encouraging environment for healthcare providers to assertively proceed with the treatment. -JAK inhibitor market competition is getting heated up. More competitors are emerging and generics are getting closer to challenge the original as it is a small molecule drug. Within the rheumatoid and digestive system disease treatment areas, Xeljanz would continue to expand its indication to provide as much medical benefit as possible to patients with inflammation and immune diseases. In fact, Xeljanz has the most number of indications for a JAK inhibitor, including rheumatoid arthritis, ulcerative colitis and psoriatic arthritis. Xeljanz is a top drug leading the JAK development program Pfizer is heavily engaged with. The company has already accumulated a vast amount of data on efficacy and safety of the drug tested with various groups of patients. The real world data (RWD) based on a wide array of patient groups is consolidating the healthcare providers’ trust in Xeljanz. As different JAK inhibitors have unique molecule structure, collecting such long-term safety data would also be very unique to Xeljanz. -What is the value of administration convenience in terms of autoimmune disease? Because autoimmune disease require a life-long management, consistent use of the needed drug is essential. Particularly, the company has been seeking for means to provide convenient treatment option to the patients as South Korean patients tend to shun injection and get scared of injections easier than patients in other countries. While Xeljanz has been embodying administration convenience itself, Enbrel—initially launched with pre-filled syringe—introduced a pen type called “MyClic” for patients to conveniently self-inject the treatment. The company also distributes an ambient package to store the injection at a room temperature and a E-base tool to keep 90-degree angle when self-injecting with minimum pain free of charge. -As a Business Unit Lead, what were the difficulties experienced when communicating with stakeholders like healthcare providers or government officials? Pfizer is putting much effort into developing and providing innovative pharmaceuticals in areas with highly unmet medical needs for the patients. Pfizer Korea is also endeavoring to introduce these innovative drugs to the Korean market, and to provide treatment benefits to the patients. However, new drugs like first-in-class drugs are facing a number of limitations when pursuing approval and reimbursement. It is gratifying when cooperating with various stakeholders like healthcare providers and government officials to resolve these limitations, but I also contemplate a lot on how to enhance access to innovative pharmaceuticals even faster for those patients fighting against their diseases in pain.
- Policy
- The bioequivalence test of Lixiana's generic has begun
- by Lee, Tak-Sun Oct 08, 2020 06:23am
- The development of a generic for Lixiana (Edoxaban, Daiichi Sankyo Korea), which was released as the latest among new oral anticoagulants (NOAC), has begun. Lixiana was approved six years later than the country's first NOAC drug, Xarelto (Rivaroxaban, Bayer Korea), but it is currently recording the highest sales performance in the market. With the expiration of PMS in August of next year, bioequivalence testing for generic commercialization began. On the 29th of last month, the MFDS approved the bioequivalence test plan for 'SIL1107' of Sinil. SIL1107 is same as generic for Lixiana. Lixiana will end PMS on August 24 next year. After the end of the PMS, it is possible to apply for permission for generics. Sinil is expected to submit an application for permission for generic drugs based on the results of the bioequivalence test. All of the domestically released NOAC drugs will be released. In the case of Xarelto, PMS expired in April 2015, and currently 22 generics for Xarelto have received permission. In addition, PMS of Pradaxa (Dadabigatran, Boehringer Ingelheim Korea) expired in February 2017, and 10 generics received permission. Eliquis (Apixaban, BMS Korea Pharmaceutical) expired in November 2017, and 50 generics received permission. From May of last year, the drugs was launched on the market. It is analyzed that the market release of generics for Pradaxa will continue in July of next year, and the release of generics for Xarelto will continue in October. However, in the case of Lixiana, the material patent will be terminated only in November 2026, so it is necessary to wait another 6 years for generics to be released. In the current market, Lixiana ranks first among NOACs. Looking at the outpatient prescriptions for the first quarter based on UBIST, Lixiana recorded ₩15.8 billion, Xarelto and Eliquis, ₩11.2 billion and Pradaxa, ₩3.8 billion. Generics for Eliquis, launched last year, recorded a total of ₩1.4 billion in outpatient prescriptions from 14 companies. The domestic generics that are operating mainly in clinics have limitations because NOAC has grown mainly in general hospitals. Therefore, the influence of the original drug is expected to be great even if generics for Pradaxa and Xarelto are released next year.
- Company
- Roche Diagnosis provides COVID-19 customized diagnostic test
- by Oct 08, 2020 06:23am
- Roche Diagnostics Korea, which celebrates its 30th anniversary, has promised to provide rapid diagnostic tests in the pendemic. On the 6th, Roche Diagnostics Korea held an online press conference to commemorate the 30th anniversary of its founding, highlighting the value of diagnosis and the role of Roche Group in the situation of COVID-19. At this meeting, Hyung-ju Kim, head of Roche Diagnostics Korea, said that it has quickly provided the most suitable diagnostic method according to the progression of COVID-19." Hyung-ju Kim, head of headquarters, presenting at the press conference for the 30th anniversary of Roche Diagnosis Korea In February, when COVID-19 began to spread in Korea, the company first supplied nucleic acid extraction reagents, the core of the kit, to Korea in order to receive the Emergency Use Authorization (EUA) for a diagnostic kit that can screen patients with COVID-19. In addition, in preparation for the spread of COVID-19 around the world, it was the first to receive EUA approval from the US Food and Drug Administration (FDA) on March 12. In May, Roche Diagnostic's new antibody test 'Elecsys', which measures COVID-19 antibody in the blood and helps to identify the immune response, was additionally approved in the United States. At a time when the number of COVID-19 confirmed patients around the world increased rapidly, on-site test kits were released that can be diagnosed quickly. Most recently, in preparation for twindemic, where two viruses are simultaneously prevalent due to influenza (influenza), it has provided a field test that can simultaneously detect the flu virus and COVID-19. Currently, a screening for the COVID-19-flu simultaneous diagnosis kit is underway in Korea. Director Kim said that Roche Diagnosis is a standardized large-capacity PCR test system for the detection of flu and COVID-19 to help patients with respiratory infection symptoms receive accurate treatment. Also he added that the test system supports patients with respiratory infection symptoms so that they can receive accurate treatment, speed and medical access have been improved since nucleic acid extraction and testing can be performed in one system. He added, "In the future, we will make great efforts to quickly respond to the COVID-19 situation." In addition, Korea's rapid response system was supported, and it was selected as an exemplary case for quarantine in the world. Kwon Gye-cheol, chairman of the Korean Society for Diagnostic Laboratory Medicine, said, "We were able to actively respond from the early days of the outbreak of COVID-19 while maintaining close cooperation with the Roche Diagnosis and other related institutes, and successfully establish a quarantine model." Also he added that we hope that Roche Diagnosis and the academic community can continue joint research to respond to infectious diseases.”
- Policy
- 17 new drugs including Verzenio got to expand coverage
- by Kim, Jung-Ju Oct 08, 2020 06:23am
- Apparently, total 13 new drugs have been listed for healthcare reimbursement this year. Total four already-listed drugs had their reimbursement expanded with the coverage enhancement policy. The record demonstrates the social consensus has flexibly expanded healthcare coverage even on expensive drug for a limited patient size. Daily Pharm surveyed new drugs and already-listed new drugs that the South Korean healthcare authority granted new reimbursement or expansion with extended indication or administration standard. The statistics found total 17 drugs have received the new benefit. When including various doses listed together, the total number of drug items with the new benefit doubles. Based on the date of reimbursement provision, a chronic constipation drug Rucalo was newly listed, and Rafinlar plus Meqsel combination therapy for patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation expanded the reimbursement standard for the combination. Locally advanced NSCLC treatment Imfinzi and chronic lymphocytic leukemia treatment Venclexta were applied with reimbursement as of Apr. 1. An acute lymphocytic leukemia treatment Blincyto also expanded the coverage on the same day. The South Korean health authority listed a new drug for hemophilia Hemlibra as of May 1, when a new drug for juvenile-onset hypophosphatasia Strensiq, a severe psoriasis treatment Skyrizi and a breast cancer treatment Verzenio were also newly listed on June 1. On the same day, the reimbursement standard on breast cancer therapy Ibrance was revised to expand its coverage. A severe asthma treatment Xolair and a multiple sclerosis treatment Mavenclad were newly listed on July 1 and on Aug. 1, respectively. A NSCLC treatment Tecentriq’s reimbursement was expanded on Aug. 1 as well. In-vitro fertility-aiding Rekovelle and cytomegalovirus treatment Prevymis won reimbursement as of Sept. 1. And a Parkinson’s disease treatment Ongentis and a metastatic Merkel cell carcinoma treatment Bavencio have been listed from this month. The expanded coverage on the said drugs would provide yearly healthcare reimbursement benefit of approximately 144.81 billion won to 243,707 patients in South Korea. One of the treatments on the list would treat patients in Korea as many as 110,000, but some would only benefit 10 or even less patients. A few years ago, the ‘evidence-based’ drug pricing and evaluation hindered listing expensive drugs targeted for a small number of patients. But this year’s listing for pharmaceutical reimbursement shows the National Health Insurance benefit priority order has become more flexible for those drugs that can create social consensus.
- Company
- MSD on final stretch with Keytruda coverage expansion
- by Eo, Yun-Ho Oct 07, 2020 06:09am
- MSD Korea made the last move for the Keytruda coverage expansion. Now it is back to the government’s turn to make the decision. Related industry sources confirmed, MSD has submitted the final financial expense sharing plan to Health Insurance Review and Assessment Service (HIRA) after revising the detailed strategies regarding the reimbursement expansion of immunotherapy Keytruda (pembrolizumab) in treating patients with non-small cell lung cancer (NSCLC) as a first-line therapy. Accordingly, the Cancer Deliberation Committee would be able to revisit the matter on Oct. 14 at earliest. The next session would be Keytruda’s eighth Cancer Deliberation Committee review. If the upcoming session does not include Keytruda in the agenda, the reimbursement expansion talks would be delayed by more than a month. The Cancer Deliberation Committee deferred Keytruda’s reimbursement expansion once again on Aug. 26, claiming the expense sharing plan was insufficient. HIRA then relayed the financial plan discussed among the committee to MSD in early September and demanded a revised version. The health insurance authority actually took the version positively as it was flexible on the conflicted clause of ‘the pharmaceutical company to pay for the initial three-cycle administration cost.’ As the MSD’s global headquarters was unconvinced of the clause, the company certainly seemed like it won a wiggle room in expanding the coverage. However, the government proposed MSD to resubmit a financial plan including a new clause equivalent to the initial clause. The company immediately started revising the plan, and sent in the latest version right before the Chuseok holiday. It seems like the company has a similar clause that could replace the clause of ‘initial three-cycle administration cost payment.’ If the Cancer Committee refuses the new financial plan, Keytruda’s attempt to expand coverage would be technically over. MSD official noted regarding the issue that “The company has presented a new version of Keytruda expense sharing plan to receive reimbursement as a first-line therapy treating NSCLC, prior to the eighth Cancer Deliberation Committee session. The revised version has thoroughly reflected the recommendations made by the committee in August, and increased the company’s part of the expense sharing as a final stretch.”
- Company
- When will the Zyprexa lawsuit for damages be concluded?
- by Kim, Jin-Gu Oct 07, 2020 06:09am
- ZyprexaInterest is focused on whether the lawsuit for Zyprexa (Olanzapine) could be completed within this year. The range of compensation for patent infringement is determined according to the decision of the Supreme Court. If the Supreme Court sided with the original company Lilly Korea, it would be an obstacle to the early release of generics by domestic companies. ◆ Fourth year pending in Supreme Court According to the pharmaceutical industry and legal circles on the 7th, the lawsuit for damages between Lilly Korea and Hanmi filed in the Supreme Court on October 31, 2016 has been in progress on the 1438th day. Myungin’s damage claim, also 944 days have passed since it was filed on March 9, 2018. It seems that the proceedings of the lawsuit have been slow since the conclusion has not been reached for the fourth year, but the legal dispute is still going on very fiercely. Even if it is limited to the Hanmi case, there are more than 30 data submitted by the plaintiff and the defendant. Even just before this Chuseok holiday, the two sides are in a tight confrontation, submitting reference materials and answers. The Supreme Court also appears to be cautious about the decision. The opinions of interest groups and civic groups were received to understand the impact of the judgment. Opinions were submitted by the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, the KRPIA, and the Pharmaceutical Association for a Healthy Society. ◆ Generic release after overcoming patents, Supreme Court's ruling overturned by 'patent infringement' The lawsuit is very complicated. The initiation was a request for a patent invalidation trial. In 2008, a trial was filed stating that Zyprexa's patent was invalid. The first and second trials interpreted the patent as invalid. Based on this ruling, Hanmi and Myungin launched generics called 'Olanza' and 'Neurozapine' in 2011. The situation got complicated as the Supreme Court overturned the ruling. Hanmi and Myungin overcame their patents and then infringed suddenly their patents. After the Supreme Court ruling, Lilly fought back. Each filed a lawsuit for damages against Hanmi and Myungin. In both cases, it was ruled to compensate the patentee for damages. Hanmi and Myungin accepted the judgment. The profits from selling generics were paid to Lilly as damages. ◆Mixed judgment by the second trial court Usually, a lawsuit for damages due to patent infringement is concluded in this way. However, Lilly Korea, not the patent holder (Lilly's headquarters), filed a lawsuit. Lilly Korea said that the drug price of Zyprexa was lowered with the release of generics, so the two companies should be compensated for the damages. In the first trial, Lilly Korea won. The court ruled in favor of some of the plaintiffs. However, the judgment was changed at the second trial. The two courts made different judgments on the case with the same contents, different from the defendant, Hanmi and Myungin. The second trial court on Hanmi did not accept Lilly Korea's claim. The Seoul High Court interpreted that Hanmi had no 'illegal intentions' because the subject of the drug price cut was the MOHW. On the other hand, the second trial court related to Myungin sided with Lilly Korea. The Patent Court judged that Myungin launched a generic by infringing the patent, knowing well that the drug price of Zyprexa would be lowered, causing damage to Lilly Korea. Accordingly, Lilly Korea and Myungin, who lost in the two cases, each filed appeals. It was October 2016. Four years later, the Supreme Court is struggling with this. ◆When Lilly wins,'strategy for early release of generics after overcoming patents' virtually lost The Supreme Court's ruling is expected to have a considerable impact on the domestic pharmaceutical industry. If the Supreme Court decides on the side of Lilly Korea, the strategy of 'early release of generics after overcoming patents' is expected to lose power. This is because the burden of generic companies for patent challenges becomes very large. In the event that a generic company is finally judged for infringement of a patent, it must compensate for damages from drug price cuts in addition to the sales revenue of the generic. There is a possibility that astronomical compensation will be charged depending on the sales volume of the original drug and the period of early generic release. It is pointed out that the generics are released only after the patent dispute is completely ended, and at this time,'early release' becomes impossible. This is because if the original company attempts a 'delay strategy' that leads the patent dispute to the Supreme Court, the release of the generic is delayed and the patent may expire while a dispute is in progress depending on circumstances. ◆Does the Supreme Court to conclude this year? As a result, the attention of the pharmaceutical industry and the legal profession is drawn to the Supreme Court, but it is likely that it is difficult to predict what kind of judgment the Supreme Court will make for the time being. One legal official said, “Unlike the first and second trials, the Supreme Court does not make public arguments except in special cases. Most of the schedule and progress of the hearing are kept secret. For this reason, it is difficult for the parties to know when the final judgment will be made.” Another legal official was rumored that the sentence was imminent last year, but in the end, the two sides are still in a firm position, and officials expect that the sentence will be postponed again to next year as the Supreme Court struggles. An official from a pharmaceutical industry said that the cost of the lawsuit itself is ₩1.5 billion for Hanmi and ₩27 million for Myungin, which is not a heavy burden on the company. However, as the Supreme Court decision will determine the direction of the early generic release strategy in the future, it is expected that there will be little impact.
- Policy
- Abbott accused of sponsoring academic society too often
- by Lee, Jeong-Hwan Oct 07, 2020 06:08am
- Global pharmaceutical and medical device company Abbott has been accused of providing questionable financial benefit to healthcare providers that exceeded the legal amount stipulated in the ‘Korean Sunshine Act.’ Apparently for a year, Abbott has sponsored Korean Society of Interventional Cardiology (KSIC) an approximate total of 250 million won for the participants in 12 overseas academic conferences and convened product presentations for their medical devices in grilled beef restaurants. On Oct. 5, Democratic Party Lawmaker Ko Young-in reprimanded, “Abbott has been providing suspicious amount of financial benefit for KSIC as if it were their private pot of money.” The Korean Sunshine Act, or “K-Sunshine Act,” was enforced to mandate pharmaceutical and medical device companies to report their expenditure for financial benefit provision, but Lawmaker Ko argued the law has been useless. The lawmaker pointed out the regulation was implemented three years ago, but the Ministry of Health and Welfare Committee (MOHW) has barely reviewed any of those reports. He claimed the ministry has sampled and reviewed only four pharmaceutical and medical device companies’ reports filed in 2018. Regarding the reports, Lawmaker Ko raised an issue regarding Abbott’s report on the financial benefit provision. The reports submitted to the lawmaker’s office found that Abbott has sponsored KSIC a total of 250 million won for the society’s participation in 12 overseas academic conferences from February 2018 to March 2019. Basically, Abbott has offered about 45 percent of all the overseas conferences the academic society participated during the same period of time, as its website posted schedules of total 29 overseas conferences. The sponsored amount varied from maximum 50 million won to 50,000 won per event, and the report did not specify how many members of the society have received the out-of-pocket expense for the conference. And the company also reportedly spent total of 227,290 won (16,235 per person) for food and beverage provision for 14 associates from a hospital on Mar. 28, 2018, from 6 p.m. to 9 p.m. Out of all expenditure reports submitted by Abbott, it was the only on product presentation for an individual healthcare institute. The lawmaker’s office checked the restaurant located in Busan City mainly serve grilled beef menu ranging from Bulgogi priced at 16,000 won to special beef cuts priced at 23,000 won per portion During the product presentation, the company briefed about their product ‘Architect,’ which is an immunoassay analyzer frequently used in hospitals since a decade ago. Lawmaker Ko pinpointed the product is too universally used already for a private product presentation. And considering the product is massive system equipment, the lawmaker was suspicious if the presentation was properly conducted in a restaurant setup. Moreover, Lawmaker Ko criticized MOHW for monitoring the expenditure reports from only four companies for last three years. According to MOHW’s survey on expenditure report monitoring on pharmaceutical and medical device industries, 73.8 percent of the pharmaceutical industry was complying, whereas only 24.1 percent of the medical device industry was complying. Ultimately, only 1,962 companies out of 6,206 companies (30 percent) have filed and achieved the reports. 188 companies, or 6.5 percent of the two industries, said they were not even filing the reports. The Pharmaceutical Affairs Act stipulates the companies to file and archieve expenditure report on provided financial benefit for five years, and they are to submit them when demanded by the Minister of Health and Welfare. The companies that have not filed or archived the report along with the ledger and evidential materials would be ordered to correct their practice and fined up to 2 million won. Lawmaker Ko stated, “MOHW would have to properly operate and toughen the report monitoring according to the K-Sunshine Act that aims to cut the illegal ties between pharmaceutical and medical device industries and healthcare providers and hospitals. The production cost of pharmaceuticals and medical devices would be raised and ultimately push up the National Health Insurance premium and medical service fee, if the healthcare providers and hospitals continue to receive excessive sponsorship from the companies for introducing new technology.” “As the industries used to provide rebate worth billions of wons, the current fine of 2 million won could be easily ignored by the responsible industries. The fine should be raised and the reports should be mandatorily submitted or reviewed every year, or even rather publicly opened like in the U.S. for the public to verify,” Lawmaker Ko added.
- Company
- Next-gen flu drug Xofluza green lit in general hospitals
- by Eo, Yun-Ho Oct 06, 2020 06:25am
- The next generation influenza treatment ‘Xofluza (baloxavir)’ has been passed by major general hospitals for prescription. According to the related industry source, the Drug Committees at the ‘Big Five’ general hospitals like Seoul National University Hospital and Seoul St. Mary's Hospital green lit Xofluza, while the rest of the Big Five hospitals (Severance Hospital, Seoul Samsung Hospital and Seoul Asan Medical Center) are also processing the drug. Other major hospitals around the country, including Gangnam Severance Hospital, Gangdong Kyung Hee University Hospital, Chung-ang University Hospital, Korea University Anam Hospital, Seoul National University Bundang Hospital, Kangbuk Samsung Hospital, Kyung Hee University Hospital, and Bucheon St. Mary’s Hospital, have already landed the prescription code. The influenza treatment is still in process of seeking the health insurance coverage. When the drug is listed, the hospitals would be quick to prescribe them. The supplier Roche Korea has signed a co-marketing deal with Chong Kun Dang in last March to enter the market steady and fast. Endo-nuclease inhibiting Xofluza is a new influenza treatment, approved two decades after the launch of ‘Tamiflu (oseltamivir),’ that treats flu patients with a single dose (Tamiflu requires five-day administration). While an anti-virus can always develop tolerance, nothing but neuraminidase inhibitor is recommended for treating influenza patients at the moment. As for South Korea, the influenza immunization rate is highest in the world, but 2.26 million people have contracted influenza in 2018. And as the public interest on anti-virus drugs has been heightened amid COVID-19, the talks on listing Xofluza would likely to be processed timely. The approval on Xofluza in South Korea was based on outcomes of 'CAPSTONE-1 study' on acute influenza patient group from age 12 to 64 with no underlying disease, and 'CAPSTONE-2 study' on high-risk influenza patients aged 12 and up. The CAPSTONE-1 study with healthy adults and adolescents has found the median time to alleviation of symptoms was 26.5 hours shorter in the Xofluza-administered patient group, compared to the placebo group. Xofulza also demonstrated comparatively faster time of viral shedding. It took 24.0 hours for Xofluza to halve the patients found with the virus, which was significantly shorter than the placebo group (96.0 hours, about four days) and Tamiflu group (72.0 hours, about three days). During the CAPSTONE-2 study with high-risk influenza patient groups including senior and chronic disease patients, the high-risk patient group treated with Xofluza demonstrated median symptom alleviation time of 73.2 hours, which was about 29 hours shorter than placebo group (102.3 hours). In the same study, Xofluza halved the viral shedding in 48.0 hours, improved by approximately 50 percent than placebo (96.0 hours) and oseltamivir (96.0 hours). Professor Lee Jae-gab of Hallym University Medical Center Infectious Disease Department commented, “Besides the advantage of convenient one-dose oral administration, Xofluza is expected to be used for various indications as it has a different mechanism of action compared to other existing options”.
