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- 2026-05-21 02:27:45
- Policy
- Dupixent, reimbursement in next January upon settlement
- by Lee, Hye-Kyung Nov 20, 2019 06:33am
- Treatment for severe atopic dermatitis, Dupixent are under drug price negociations. NHIS(National Health Insurance Services) recently released this fact on its website. NHIS concluded pre-negotiation with Sanofia aventis before entering into drug price negotiations. Drug negotiations will last up to 60 days. If the drug price negotiations between the NHIS and pharmaceutical companies proceed smoothly, the reimbursement is expected to be secured in next January. Dupixent passed the HIRA's Pharmaceutical Evaluation Committee on October 11th. After negotiating a drug price agreement with the HIRA, it is necessary to put a name on the final list of reimbursement after deliberation by the MOHW Insurance Policy Review Committee. Dupixent will follow the RSA process as a treatment for serious diseases through ‘the detailed evaluation criteria of new drugs’ in August. Once the price negotiations are concluded, they will be the first beneficiaries of the expansion of RSA. The existing RSA system was only applicable to drugs for cancer and rare patients. However, due to its high price, Dupixent was also a target of RSA in that there were some broken cases when there is too much finance.
- Policy
- All prescription drugs to hand in bioequivalence test result
- by Lee, Tak-Sun Nov 20, 2019 06:33am
- Subject for bioequivalence test is to expand out to all prescription drugs. Also, drug specification with test criteria and procedure would be required, as well as Good Manufacturing Practice (GMP) evaluation result from external contract manufacturing companies. Korean Ministry of Food and Drug Safety (MFDS) announced on Nov. 18 its plan to enact partially revised ‘Regulation on Pharmaceutical Safety’, as a follow-up to the excessive commercialization of generics and last year’s valsartan incident with carcinogen contamination. The ministry is to accept public opinion on the matter until Jan. 20, 2020. For Korean pharmaceutical industry that bases most of business off of generic products, the revised regulation is the most detrimental level of regulation to hinder the industry. Some of regulations were previously alleviated on a moderate level, but they are now tightened back again. ◆ Bioequivalence test for all prescription drugs: First, all prescription drugs are to be gradually obligated to hand in bioequivalence test data. Currently only prescribed tablet, capsule, suppository and other specific drugs designated to provide bioequivalence test result were required to submit the material. About 60 percent of prescription drugs are included in the said subject group. But from now on, the applicable drug regimen types would expand out to all kinds. The administration method types required to provide bioequivalence test material would expand on oral in 2020, aseptic techniques including injection in 2021, and all the other types in 2022. Based on its cost-benefit analysis, MFDS projects affected pharmaceutical companies would spend about 164.4 billion won according to the revised regulation. The analysis estimated a single case of bioequivalence test would cost about 220 million won. ◆ Specification submission exemption removed: All prescription drugs would be obligated to hand in specification material. Specification, containing pharmaceutical test procedures and acceptance criteria for new drug, is to provide information on the drug’s manufacturing and test methodology and criteria for quality control, which also includes evidence and test performance data. Except for biopharmaceuticals, currently a drug listed on an official compendium, such as Korean Pharmacopoeia, was exempted from the material submission. Some officially recognized compendium include Korean Pharmacopoeia, Korean Herbal Pharmacopoeia, Good Manufacturing Practice criteria, and other official compendium or pharmacopoeia acknowledged by Minister of Food and Drug Safety (i.e. U.S. Pharmacopeia, Japanese Pharmacopoeia, British Pharmacopoeia, European Pharmacopoeia, German Pharmacopoeia, and French Pharmacopoeia). However, there would be no exception from now on. As of 2017, 51 percent of prescription drugs applying for approval were listed on the official compendium. MFDS suspects additional cost would be spent on evaluation service fee, as companies would already have documented specification related materials. The industry is expected to spend about 3.2 billion won, due to the revised regulation. ◆ CMOs to hand in GMP evaluation results: Besides the bioequivalence test, MFDS is also requiring contract manufacturing organizations (CMOs) to submit GMP status report and evaluation results. At the moment, the submission is exempted for drugs wholly manufactured in contracted manufacturer. GMP status report and evaluation result should include manufacturing plant floor plan, plant facility and environment management information, GMP-dedicated organization chart and related documentation rules, product specification related to applicant item, record of product and quality control, and copy of validation result. MFDS analyzed that annually 738 items are manufactured by CMOs. The ministry deduced the average number based on approved CMO products from 2012 to 2017, assuming items sharing joint bioequivalence test result are entirely manufactured in external facility. The health authority estimated the revised regulation would have companies to spend about total of 3.7 billion won. MFDS also clarified no additional documentation on GMP evaluation is required other than the materials filed by the client company, but explained additional cost would be probably spent on human resources and evaluation service fee.
- Company
- Boycott against Japan makes no impact on drug sector
- by Kim, Jin-Gu Nov 20, 2019 06:33am
- Although this year’s deficit generated from trade with Japan is expected to hit the lowest point, the pharmaceutical sector has not been affected on a notable level. For last six years, Japanese drug import volume skyrocketed by around 57 percent. The import volume easily overwhelmed the Korean export volume, resulting in inevitable heavy deficit. In general, Korean boycott movement against Japanese goods, started spreading since June, seems not to have affected Japanese drug as much. According to Ministry of Trade, Industry and Energy (MOTIE) and Korea Customs Service (KCS) on Nov. 18, South Korea’s total trade deficit with Japan from January to October this year was USD 16.37 billion, which has gone down by 20.6 percent than same time last year at 20.61 billion dollars. As far as total deficit made from January to October goes, this year’s deficit has been the least ever since 2003 with 15.57 billion dollars. If the trend continues until the end of the year, Korea’s total deficit with Japan would be under 20 billion dollars for the first time in 16 years. It would be about the half of highest volume marked in 2010 at 36.12 billion dollars. However, the pharmaceutical sector seems to be an exception to the trend. Until last October, Korea marked trade deficit with Japanese pharmaceutical products of 132.3 million dollars. Deficit from January to October has hit the lowest figure since three years ago in 2016 (deficit of 120.63 million dollars). But considering average deficit in five years from 2014 to 2018 (accumulated from January to October) was around 95.71 million dollars, this year’s improvement on deficit is hardly remarkable. In the same time, Korea’s export volume to Japan has surged by 51.6 percent from 127.69 million dollars to 197.83 million dollars, but the import volume also surged by 56.6 percent from 185 million dollars to 330.13 million dollars. The increase in import rose over the increase in export, generating the total net deficit as a result. Jan. to Oct. drug trade trend by year (unit: USD 1,000). Red shows this year’s trade volume. Figure improved the most since last 3 years (2017-2019) but still deficit reached higher than before. Even when the boycott movement took off July, the changes of pharmaceutical import and export volume by month did not leave a notable change in trend. As for July, Korea made a deficit of 22.19 million dollars. The country exported 23.97 million dollars of pharmaceutical products and imported 46.16 million dollar-worth of goods. July had the heaviest deficit of the year. The deficit was lowered to 5.56 million dollars in August, but it is getting larger again after generating 10.11 million dollars and 14.57 million dollars of deficit in September and October, respectively. Analyzing last three years of monthly trade deficit, the boycott movement did not make a clear mark on the graph. The result is quite contrasting from major consumer goods, such as automobile, apparel, alcohol beverages and electronics that got struck by the boycott against Japanese goods. Drug trade volume trend by month in last 3 years (unit: USD 1,000) Red shows trade volume in July-Oct. after boycott, but no special tendency found
- Policy
- Consigned items duty to produce on the rise, Overregulation
- by Lee, Tak-Sun Nov 20, 2019 06:33am
- As the MFDA foretells the resurgence of mandatory production of three batches of consignment items as a solution to the problem of generic stagnation, the pharmaceutical industry is pushing for excessive regulation. It is dissatisfied that consignment production is bound to be stopped if mandatory production of consignment items is obligated while abolishing consignment. The MFDA included these details when it announced legislation on the revision of some of the rules on safety of medicines and others. In addition, it is necessary to submit data on the evaluation of the GMP implementation status in the future manufacturing process. The GMP implementation assessment data also includes validation data to verify the uniformity of the product. Validation data is pre-checked through three batch productions. In other words, a drug produced at another plant will have to produce three batches of data from the plant when approved. Depending on the manufacturing facilities, as many as 100,000 tablets are produced per batch. When placed three times, 300,000 tablets are made. Pharmaceutical companies will not lose money if they sell 300,000 tablets produced for permits. In addition, submission of GMP data will also lengthen the license period. This is a big burden for the consignment company. Of course, trustees can benefit from additional production. However, most pharmaceutical companies are expected to suffer damage in the midst of active consignment production. In addition, the MFDA's stance is to phase out the allowance for joint and consigned living. The MFDA announced in a regulation notice that, starting from next June, the number of items allowed for joint and entrusted livelihood will be limited to three companies, and not allowed from June 2023. In addition, the MFDA is in a position to lower drug prices for consignment and joint livestock products. In the meantime, if consigned drugs are reinstated to become mandatory to produce three batches, the counterfeiting transaction between pharmaceutical companies will be markedly reduced. The provision of mandatory production data for three batches of consignment manufacturing items disappeared following the introduction of the 2014 GMP Conformity Decision. The revival will bring back regulation in almost five years An official in the pharmaceutical industry said, "In the event of last year's Valsartan, there was an opinion that we would revive the production of three batches of consignment items without leaving the co-provisioning regulations." The MFDA announced the revision of the rules on safety, such as the drugs, as well as mandating the production of three batches of consigned drugs, and expanding the subjects for submitting biotest data to all specialty drugs, and eliminating the exemptions for submitting the law. In addition, it will revise the report on overseas safety measures related to the suspension or withdrawal within from 15 days to 3 days, and the burden on pharmaceutical companies is expected to increase further.
- Policy
- Annual sales↑to ₩6.5 billion by generic exclusivity
- by Lee, Tak-Sun Nov 20, 2019 06:32am
- Myung-jin Chung, director of KHIDI, is announcing the results of the impact assessment on the patent linkage According to a survey result, the drug costs in 2018 were reduced by up to ₩4.8 billion due to generic drug exclusivity. Sales of generic pharmaceutical companies increased by up to ₩6.5 billion while the original company's drug costs were reduced by ₩11.3 billion. Myung-jin Chung, general manager of KHIDI, announced the results of the four-year impact assessment of the Patent linkage at the '2019 Drug Licensing Patent Linked System Policy Forum' held at the Four Points Hotel, Seoul Guro on the 19th. The impact assessment of the patent linkage began in 2016 under the applicable Act and was the fourth time this year. The study period was from April to October of this year, and the study was conducted on drugs that received prohibition of sale or generic exclusivity from January 2018 to December 2018, and their disposal were terminated (expiration of the period, expiration of effect, etc.). During this period, there were 29 items in generic exclusivity, and the targeted brand listed drugs were 5 items. The representative generic exclusivity drugs include 10 generic products of the osteoarthritis named “Layla” and 14 generic products of the hepatitis B named “Viread”. As a result, early entry effect of late drug market was 1.3 ~ 4.6 months. Early entry effect was based on 9 months from the date of notification to the original company following the application for the permission of generic exclusivity. If the original company asks for a prohibition of sale under the patent linkage system, it will not be able to enter the market for 9 months. The sales of generic companies, which acquired the generic exclusivity, increased from ₩5.696 billion to ₩6.473 billion. On the other hand, targeted pharmaceutical companies with the original listed drugs declined from a minimum of ₩9.9 billion to sales of ₩11.3 billion. In the case of Viread, pharmaceutical companies with listed drugs declined from ₩6.2 billion to ₩7.6 billion. On the other hand, Generics sales increase from ₩3.4 billion to ₩4.2 billion. As a result, the drug costs have been reduced from ₩4.53 billion to ₩4.76 billion. The indirect effect of generic exclusivity items is an increase in the research development costs and employment. According to the research results, the R & D expenditure increased from minimum of ₩180 million to maximum of ₩360 million. Employment also increased from a minimum of 19 people to a maximum of 38 people. Myung-Jin Chung said, "Prior to the 4th year after the implementation of the system, the approval of generic exclusivity has had a positive effect on the domestic pharmaceutical industry and health policy." He added. “Unlike concerns when introducing the system, original companies don't apply the prohibition of sale much. Activation of the genetic exclusivity has led to a rise in sales of domestic pharmaceutical companies.
- Company
- Ferinject for bloodless surgery, reimbursement started up
- by Nho, Byung Chul Nov 20, 2019 06:19am
- It is noted whether high dose iron injection, Ferinject may be included as insurance reimbursement for bloodless surgery (Minimal Transfusion). According to the industry, JW Pharmaceutical applied for a non-reimbursement item, Ferinject, to HIRA on the 18th. High-dose iron is effective as a transfusion replacement therapy for surgical patients who need to increase hemoglobin levels in a short time, and for mothers who have bleeding from childbirth. Introduced by Swiss company, Vifor in 2011, JW Pharmaceutical is currently generating sales of about ₩10 billion. This product is a 500mg high iron injection that can be replenished quickly by administering up to 1000mg of iron per day for 15 minutes. Conventional intravenous iron injections are difficult to administer high doses, so many visits are needed to the hospital. It took more than 40 minutes in a single dose, but Ferinject can be administered up to 5 times faster (in 3 to 5 minutes). Clinical data shows that Ferinject 500mg high-injection iron injection has the same effect as 2 packs of blood 420ml. In addition, it has been evaluated as a safe iron with reduced side effects and vascular pain compared to conventional intravenous iron injection. Ferinject is an effective iron deficiency treatment that can improve the side effects of oral iron containing products with high absorption rate and stability of 99%, and can be administered faster than the existing intravenous iron products. It elevates patient compliance and reduces overload of nurse and hospital work. It is also a safe, high-dose iron infusion that can be used for patients 14 years of age and older, demonstrating safety in pregnant women. Therefore, iron, which is lacking in blood with minimal blood transfusion to surgery patients or anemia patients, has recently emerged as a minimal transfusion treatment supplemented with iron injections, which will greatly contribute to improving the quality of life of patients. High-capacity iron injections are priced at ₩150,000 ~ 200,000 per 500mg of 1 ampule. The reimbursement price is expected to be around ₩70,000 ~ 90,000. The single daily dose is 1000 mg and the maximum maximum dose is 1000 mg or 20 mg / kg. It is contraindicated as follows. Patients with hypersensitivity to Ferinject or its components, patients with known significant hypersensitivity to other parenteral iron preparations, patients with anemia other than iron deficiency (microcytic anaemia), iron overdose or iron impairment. or patients with bacteraemia should be avoided. Adverse events (1% to 10%) are usually headache, dizziness, high blood pressure, nausea, injection site reactions, increased ALT, and hypophosphatemia.
- FDA and EMA warn patients taking high dose of Xeljanz
- by Nho, Byung Chul Nov 19, 2019 06:34am
- The European Medicines Agency (EMA) has decided to limit high dose prescription of a Janus kinase (JAK) inhibitor medicine, Xeljanz (tofacitinib citrate), following a similar move by the U.S. Food and Drug Administration (FDA), and now Korean Ministry of Food and Drug Safety (MFDS) is also expected to make a similar decision in response. On Nov. 15 (local time), EMA officially confirmed that the maintenance therapy taking 10mg twice daily should not be used in patients with ulcerative colitis who are at high risk of blood clots unless there is no suitable alternative treatment. Previously, EMA’s safety committee, also known as Pharmacovigilance Risk Assessment Committee (PRAC), issued a statement in last May and warned healthcare providers “must not prescribe” 10mg twice daily dose of Xeljanz to patients with high risk of pulmonary embolism (PE), who take combined hormonal contraceptives, are receiving hormone replacement therapy or undergoing major surgery. While 10mg is higher dose only recommended to patients with ulcerative colitis, PRAC has recommended patients with the condition and are at high risk of blood clots “must not” start with Xeljanz, but to choose another option. EMA then stated it would announce a revised guidance as soon as a review result is out. And on Nov. 15, the agency officially confirmed its restriction on the JAK inhibitor. On Nov. 15, EMA posted an official statement about Xeljanz on its website In last July, the U.S. FDA also amended one of Xeljanz’s indications as first-line treatment for patients with ulcerative colitis to second-line treatment of the condition. Negotiating with FDA, Pfizer cited the Xeljanz’s risks on its ‘black-box warning’ and revised indication for ulcerative colitis around the same time. With the FDA’s most stringent warning labeled, Xeljanz can now be prescribed to ulcerative colitis patients who took conventional therapy, but did not have a response with tumor necrosis factor (TNF) inhibitor. In a nutshell, Xeljanz in the U.S. has been removed from first-line treatment for ulcerative colitis and was pushed down to second-line, and also the drug has a formal restriction on prescription for patients at high risk of blood clot in Europe. Initially, Xeljanz was approved as a treatment for rheumatoid arthritis, psoriatic arthritis and ulcerative colitis. The approved dose for rheumatoid arthritis is 5mg twice daily, whereas for ulcerative colitis is 10mg twice daily for the first eight weeks and either maintain 10mg or decrease to 5mg twice daily depending on the treatment reaction. Xeljanz treatment for ulcerative colitis previously required starting dose of 10mg for the first eight weeks. But the interim analysis on post-marketing clinical trial studying Xeljanze in comparison to a TNF blocker, a same class as Humira and Remicade, significantly influenced the U.S. and the European health authorities’ decisions to amend approval and restrict prescription. The analysis apparently found concerning reporting of 19 cases of blood clots in the lung and 45 cases of death from all causes out of 3,884 patient-years of follow-up in patients who received Xeljanz, compared to three cases of blood clots in the lung and 25 cases of death out of 3,982 patient-years in patients who received TNF blockers. On the foreign health authorities’ decisions, MFDS and Pfizer Korea officials noted, “We are paying a close attention on the FDA and EMA’s decision and actions. The ministry and the company are in mutually cooperative talks to take an appropriate action considering the safety of Korean patients.” When EMA issued a temporary restriction on the drug in last May, Pfizer Korea disseminated a letter of safety warning and held seminars for healthcare providers in Korea. But the company has not yet made a decision on the news of the drug being pushed down to second-line treatment or prescription restriction on patients at high risk of blood clots. Meanwhile, Japanese Ministry of Health, Labor and Welfare in last August added venous thromboembolism (VTE) as a ‘serious adverse reaction’ on Xeljanz’s label, and recommended doctors to consider other options when prescribing a treatment to a patient at high risk of cardiovascular events.
- Company
- Power of Innovative Drugs, Keytruda & Spinraza Shake Market
- by Chon, Seung-Hyun Nov 19, 2019 06:34am
- New products, which are regarded as innovative new drugs in the domestic pharmaceutical market, are shaking the upper hand. Keytruda, an immunocancer drug, spearheaded Lipitor to the chin with a steep rise. Rare disorder treatment “Spinraza” presented a remarkable quarterly sales of ₩20 billion immediately after applying for health insurance reimbursement. According to IQVIA,the health information technology and clinical research on the 18th, Pfizer's Lipitor, medicine that lowers cholesterol in the blood, posted the highest sales of ₩36.3 billion in the third quarter. It rose 5.5% over the same period in the previous year. Lipitor, which was released in Korea in 1999, is still well despite the entry of more than 100 generic products after the patent expiration in 2009. Top 10 sales medications in third quaeters 2019 (Unit: KRW million, %, Source: IQVIA) Keytruda's propaganda was noticeable. Keytruda's the third-quarter sales grew 78.9% over the same period in the previous year to ₩33 billion ranking second after Lipitor. The company's quarterly sales gap with Lipitor is narrowed to ₩3.3 billion threatening its lead. Keytruda binds to the PD-1 receptor, blocking both immune-suppressing ligands, PD‑L1 and PD‑L2, from interacting with PD-1 to help restore T-cell response and immune response. When functioning properly, T cells are activated and can attack tumor cells. Since August 2017, insurance reimbursement has been applied as a secondary treatment for non-small cell lung cancer. Quarterly sales of Keytruda jumped from ₩4.9 billion in the fourth quarter of 2017 to ₩13.6 billion in the first quarter of 2018. Keytruda exceeded sales of ₩ 20billion in the fourth quarter of last year and has recorded sales of ₩30 billion since the second quarter of this year. Keytruda has booked a record-breaking ₩100 billion in sales in the third quarter of this year. It also attempt to get top position of Lipitor. The sales gap between Lipitor and Kitruda is ₩19 billion based on cumulative sales in third quarter Quarterly Sales Revenue by Quarter (Unit: KRW million, Source: IQVIA) Biogen's Spinraza made a surprise blast with sales of ₩20.4 billion in the third quarter. The company did not generate sales until the second quarter, but sold more than ₩20 billion at a stretch. Spinraza is a rare disease treatment that treats hereditary diseases of the neuromuscular system, in which the muscles are contracted by damage to the spinal cord and brain stem motor neurons, called spinal muscular atrophy (SMA). Cognitive function is normal, but muscle tension is poor, tongue muscle contractions, such as normal life is difficult. Spinraza, which was approved in Korea in December 2017, was listed on the health insurance list at the maximum price of ₩92.3 million in one bottle (5ml) in April after drug pricing negotiating with National Health Insurance Service. Spinraza does not have a large number of patients and must undergo a rigorous procedure that requires prior review before administration. However, due to the high price, it made ₩20 billion in sales. Roche's anti-cancer drug 'Avastin' was ranked 3rd overall with sales of ₩30.7 billion, up 18.1% from the previous year. Avastin, which is used for metastatic colorectal cancer, metastatic breast cancer, and non-small cell lung cancer, surpassed the annual sales of ₩100 billion for the first time since its domestic approval last year. Cumulative sales for the third quarter of this year stood at ₩89.2 billion, which is likely to exceed ₩100 billion for two consecutive years. Abbvie's autoimmune disease treatment product, Humira, recorded ₩24.4 billion in sales in the third quarter up 12.4% from the previous year. Humira is a TNF-alpha inhibitor that inhibits the expression of tumor necrosis factor (TNF-α). and continues to rise due to the merits which has the most indications among the TNF-alpha inhibitors. Humira's 3rd quarter cumulative sales increased 15.1% year-on-year to ₩71.3billion. AstraZeneca's anti-cancer drug Tagrisso jumped to fifth place in the third quarter with sales of ₩21.1 billion. The growth rate was 42.0% year-on-year. Tagrisso is a second-line treatment prescribed for patients with non-small cell lung cancer (NSCLC) who developed resistance after conventional EGFR tyrosine kinase (TKI), such as Iressa, Tarceva, and Gilotrif. It is called a third generation drug because it overcomes the resistance of the existing EGFR-TKI. Tagrisso, which was launched in December 2017, received nearly ₩60 billion in sales last year, making it the leading EGFR anticancer drug. Revenue continued to rise after exceeding ₩20 billion in the previous second quarter. Gilead's hepatitis B treatment, Viread, which was once the leader in overall sales, recorded only ₩20.7 billion in the third quarters sales, down 29.3% from the previous year. After patent expiration, market share dropped sharply due to drug price cuts and generic emergence.
- Product
- The Minister Lee, Enhanced post-de-factor management
- by Jung, Heung-Jun Nov 18, 2019 10:21pm
- Lee Eui-kyung, the Minister of MFDS has released a long-term follow-up plan to strengthen the post-de-factor safety management system. On the 15th, the Minister Lee attended Korean Academy of Social & Managed Care Pharmacy and presented the four directions of drug safety management in four categories: patient safety, accessibility, safety ecosystem, and globalization. In particular, the Minster Lee emphasized that she will lead to a paradigm shift centered on patients by strengthening post-de-factor management. She said, "In the meantime, in the event of Invossa’s case , it was most of the time that the license was revoked or changed. In the future, we will thoroughly control the side effects, operate the long-term follow-up management system, and carefully regulate the damage. I will lead the paradigm. " For 3,000 patients for injecting Invossa, she will select 20 medical institutions and conduct a long-term follow-up survey for 15 years. "We have registered for 80 to 90 percent of our patients." she said, "Patients have used 400 medical institutions, but the concern is about cancer. So long-term follow-up should be in a hospital with oncology." "We plan to track them all at large hospitals, and we will also carry out causality research of cancer." On this day, the “Long-term patient tracking survey system (Draft)”, which will be applied to future risk medicines, was announced. According to the plan, when the MFDA issues a follow-up order, companies make a plan and MFDA goes through approval process. Companies conduct follow-up investigations. Causality evaluations and follow-up actions are conducted with the MFDS. The Minister Lee said, "We still have to be specified liability compensation. The government thinks that product defects should be shouldered by pharmaceutical companies. But, pharmaceutical companies have different positions that they are not responsible for what they didn't know at the time. We are discussing the responsibility with the relevant committees” ◆Strengthen practical use of RWD (Real World Data), R &D investment extension. In addition, MFDS will strengthen the use of RWD (Real World Data) and RWE(Real World Evidence) next year to strengthen patient safety management It plans to establish big data utilization system such as clinical site RWD and RWE in clinical trial RCT. To this end, it will actively invest in R & D costs. She said, “We will make an official announcement in January about the plans for using big data. MFDS R & D expenses rose from ₩85 billion to ₩100 billion this year. But most of them are the cost of experimentation. I'm going to turn this into RWD study”. She also announced that she will soon disclose ways to improve safety for conditional phase3 permits. "There is a lot of controversy about whether a conditional phase3 permit will guarantee the patient first, or if he will give the opportunity after ensuring full safety, if there is no alternative." We will soon release to the media on how to make it work more securely. ” ◆As new drug development countries become more important, permit strengthening of MFDS expertise She said that as Korea is actively developing new drugs, licensing is becoming more important, so the MFDA will also strengthen its expertise. She said, “If the drugs were reviewed at least once because foreign new drugs were introduced into the country in the past, currently there is a need to be more burdensome in terms of initial authorization and to reinforce professionalism since new drugs are being developed in Korea. Only about 350 people are screened by the MFDS, but there are 6,000 Ph.D in US. The MFDS will focus on strengthening its expertise in the future.” She also said “MFDS or pharmaceutical companies can’t do it alone, Infrastructure maturity must increase” "The long-term policy is needed to fundamentally improve the problem," She said. It is true that there is a lack of policy research think tank, ” She also recognized the necessity of analyzing and evaluating the future system.
- Policy
- Champix patent expires soon, follow-ons eager to launch
- by Lee, Tak-Sun Nov 18, 2019 10:21pm
- Despite a joint sales deal with Pfizer Korea on a quit-smoking medication Champix (varenicline tartrate), Yuhan Corporation is currently developing a follow-on medicine of the original. Seemingly, Yuhan is preparing for the Pfizer’s Champix’s patent to expire in next July. On Nov. 11, Ministry of Food and Drug Safety (MFDS) approved an investigational new drug application for Phase 1 clinical trial on Yuhan’s candidate medicine, ‘YHP190’. The study protocol states it aims to compare and evaluate pharmacokinetics of healthy adult subject arms taking 1mg of YHP1903 and 1mg of Champix tablet, respectively. The commercial clinical trial is to be initiated for the regulators to approve Champix’s follow-on medicine. Yuhan’s development of Champix’s follow-on drug and its clinical trial has gotten the industry’s attention as the company is currently co-promoting the original Champix with Pfizer Korea. In September last year, Yuhan signed a joint sales deal with Pfizer Korea. It was a co-promotion strategy to defend Champix’s market share from incrementally modified drug (IMD) launching in November same year. The IMD with a change in saline substance of Champix was able to enter the Korean market as it evaded extended term of the original’s substance patent. The Intellectual Property Trial and Appeal Board ruled the IMD does not infringe the original’s patent with extended term. However, the table turned in last January, as the Supreme Court on other case ruled that an IMD with changed saline substance does not evade extended patent. The Champix’s IMD released in November last year stopped most of its manufacturing after January. Korean court is expected to hand down the ruling on Champix’s IMD on coming Dec. 20. On the other hand, MFDS has already approved of 72 IMDs related to Champix. But initially Yuhan did not submit a follow-on drug approval application, due to its joint sales deal. Although the sales of IMDs are blocked at the moment, it would resume from July next year when the extended patent term expires on July 19, 2020. There are saline substance and composition variant patents expiring on Jan. 31, 2023, but most of Korean companies are evading the patent as they are using different substances. At last, July next year would be the long-awaited start of the heated smoking-cessation medication market competition. While many companies are eager to launch items in same class, the pharmaceutical industry is keeping a close eye on Yuhan with co-promotion deal over the original, to see if it would also join the follow-on drug market competition. Meanwhile, IQVIA reported Champix sales in the first half of the year plummeted by 51.1 percent, compared to same time last year, and that the drug only generated 11.5 billion won. The sudden drop of sales was affected by the original’s price reduction due to release of IMDs and decreased number of participants applying for government-supported quit-smoking program.
