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- 2026-03-19 08:09:25
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- Cenobamate, received the grand prize for KNDA
- by Lee, Seok-Jun Feb 26, 2020 06:29am
- SK Biopharmaceuticals announced on the 24th that a new epilepsy drug, Cenobamate (USA Product Name: Xcopri), was selected as the grand prize for Korea New Drug Award (KNDA). This year's 21st KNDA is the only award in the domestic and international pharmaceutical biohealth industry new drug development sector, sponsored by the private sector and supported by the government (the Ministry of Science and ICT, the Ministry of Health and Welfare, and the Ministry of Trade, Industry and Energy ). The Korea Drug Research Association was established in 1999. According to SK Biopharmaceuticals, Cenobamate is the First-in-class drug approved by the US FDA for the treatment of partial seizures in adults. FDA approval was based on two randomized, double-blind, placebo-controlled trials and large-scale, multi-center open-label safety trials in patients who were taking 1~3 epilepsy medications and did not stop partial seizures. Cenobamate recorded statistically significant 'seizure reduction rate' and 'complete seizure loss rate'. Complete seizure loss means that the seizure does not occur during the medication period and the patient's routine returns to normal. SK Biopharm independently conducted the entire process from the discovery of pipeline drugs to clinical development, application for marketing authorization (NDA). Cenobamate is the first domestic drug that has been developed independently without technology exports and has been approved for marketing by the US FDA. US sales are expected in the second quarter. SK Life Sciences, a US subsidiary of SK Biopharm, will directly launch the marketing and sales of Xcopri.
- Company
- COVID-19 delays Cancer Deliberation Committee review
- by Eo, Yun-Ho Feb 25, 2020 06:12am
- The 2019 novel coronavirus, COVID-19, is even affecting pharmaceutical reimbursement listing procedure. According to pharmaceutical industry source, the Korean health authority has canceled the Cancer Treatment Deliberation Committee’s meeting initially scheduled on Feb. 26. Pharmaceutical companies that have been waiting for the deliberation outcome are at a loss. The February’s review agenda had star anticancer treatments like AstraZeneca’s targeted therapy Tagrisso (osimertinib) and Ono Pharmaceutical and Bristol-Myers Squibb’s Opdivo (nivolumab). Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) Tagrisso has an ongoing deliberation over expanding its reimbursed indication to cover a first-line treatment for EGFR-mutated non-small cell lung cancer (NSCLC). PD-1 inhibitor Opdivo has a number of indications seeking for reimbursement, such as renal cell carcinoma-treating first-line combination therapy with Yervoy, second-line treatment for renal cell carcinoma, second-line treatment for relapsed or metastatic head neck squamous cell carcinoma, and second-line treatment for classical Hodgkin’s disease. But, the controversial indication of second-line treatment for NSCLC regardless of expression of PD-L1 was omitted from the application. Due to the canceled meeting, the listing procedure would get delayed as well. The government means to decide whether to reschedule it in March or to review the agenda in the next regular meeting in six weeks, depending on the COVID-19 outbreak status. A global pharmaceutical company insider commented, “We think it was an inevitalbe call made due to the state of emergency. However, it is regrettable that patients in need for the treatment would have to wait longer with delayed listing approval.” A few pharmaceutical companies, on the other hand, gained some time with the delayed schedule. MSD with PD-1 inhibitor Keytruda (pembrolizumab) is the case. Keytruda was anticipating for the committee to deliberate reimbursement feasibility of its expanded indication in February. The company’s application included the indication as first-line treatment for NSCLC, bladder cancer and Hodgkin’s lymphoma, which have been denied previously, but also two new indications of first-line treatment for metastatic non-squamos NSCLC as a combination therapy with pemetrexed and platinum chemotherapy, and first-line treatment for metastatic squamous NSCLC as combination therapy with carboplatin and paclitaxel were included as well. However, the government did not include Keytruda’s expanded reimbursement review on the February agenda. Details of the reason were not disclosed, but now that the meeting schedule is pushed, MSD has a chance to appeal Keytruda’s need for reimbursement and financial impact before the rescheduled meeting. Moreover, the Cancer Deliberation Committee was expected to review Ipsen’s Cabometyx (cabozantinib) in the February meeting as well. After receiving reimbursement as a second-line treatment for advanced renal cell carcinoma, Cabometyx aims to receive more reimbursement on its liver cancer indication. Cabometyx could be a second-line treatment option for the indication covered by Eisai’s Lenvima (levatinib).
- Company
- Prescription guidance and label change for Xeljanz on UC
- by Nho, Byung Chul Feb 25, 2020 06:11am
- The Korean health authority is predicted to narrow down the use of Pfizer’s treatment for patients with ulcerative colitis, Xeljanz (tofacitinib citrate) soon. Ministry of Food and Drug Safety (MFDS) is expected to conclude its decision on pharmaceutical safety and revising related indication of Xeljanz, as discussed in-depth with Pfizer Korea over last year. MFDS could not disclose details of the revised indication, but the ministry would highly likely to follow decisions by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA). In last July, the U.S. FDA has pushed down the treatment line of Xeljanz from first-line treatment for ulcerative colitis to second-line treatment. After negotiating with FDA, the U.S. headquarter of Pfizer has inserted Black Box Warning in its labeling, and changed its indication for treating ulcerative colitis. With the change in the U.S., now Xeljanz is reserved to treat patients with ulcerative colitis, who have failed or do not tolerate conventional therapy, or tumor necrosis factor (TNF) blockers. In last November, EMA has recommended that 10 mg high-dose of Xeljanz should not be prescribed to all patients at high risk of blood clots in lung, including individuals taking hormonal contraceptives or hormone replacement therapy or scheduled to have a major surgery, unless there is no other option. The European authority has recommended patients with high risk of blood clots, who absolutely need high-dose of treatment for ulcerative colitis, should avoid Xeljanz but use other alternative option. After reviewing interim data from ongoing safety clinical trial of Xeljanz and TNF blocker-class Humira and Remicade, the U.S. and European health authorities have made the decisions. According to the interim data, 19 cases of blood clots in the lung out of 3,884 patient-years of patients administered with Xeljanz demonstrated a meaningful difference compared to three cases out of 3,982 patient-years in patients administered with TNF blockers. Xeljanz is indicated to treat patients with rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. 5 mg dose is administered twice-daily for rheumatoid arthritis, and for ulcerative colitis, 10 mg is administered twice-daily for eight weeks and continue the process with either 5 mg or 10 mg of Xeljanz twice-daily depending on treatment response. Ministry of Health, Labour and Welfare of Japan has also added venuous thromboelism as a ‘serious adverse reactions’ on Xeljanz’ label in last August. The ministry recommended medical professionals to consider other alternative when prescribing the drug on patients with high risk of cardiovascular events.
- Company
- Fresenius labor union conflict with management intensifies
- by An, Kyung-Jin Feb 25, 2020 06:11am
- The conflict between labor union and the management of Fresenius Medical Care (FMC) has emerged as the union intensified the fight against the management, who has been uncooperative in paying employees over 14 months and inking an agreement. Korea Democratic Pharmaceutical Union’s FMC Chapter has co-convened a press conference with UNI-Global Union on Feb. 21 at a National Assembly conference hall and denounced the company’s violation of Labor Standards Act. Headquarters in Bad Homburg, Germany, Fresenius is a large healthcare company earning EUR 30 billion annually from 100 countries around the globe. The company has 290,000 employees at the moment. Fresenius Kabi Korea, mainly supplying nutritional supplements in Korea, and Fresenius Medical Care, providing kidney dialyzer, dialysate, and dialysis service, are two business branches in Korea. The FMC Korea Chapter was founded in November, 2018, as a part of Korea Democratic Pharmaceutical Union, consisting of Korean pharmaceutical industry employees. Currently, 140 employees of FMC Korea are part of the chapter. Banners denouncing FMC violating the Labor Standards Act are hung in front of FMC Korea office located in Gangnam-gu, Seoul UNI-Global Union claimed, despite high-income structure of FMC, the company has not paid the Korean employees for their overtime and paid-vacation. And even after two years since the labor union was founded, the company has been refusing to discuss basics like recognition of labor union and time-off for the union staff, and deliberately delaying the negotiation procedure. UNI-Global Union official urged, “We have been reported by the Korean employees at FMC that the company has not responded to their request to negotiate with disrespectful attitude. We have confirmed that the management is persisting on basic rules in negotiating various benefits, such as the labor union’s participation in Penalty Committee, and overtime, night-work and paid-vacation payment.” The official added, “Not only has the management violated basic positive law, like providing a labor union office space and time-off for the union staff, but also it tried to minimize the membership of the union. Such deeds of gravely violating labor rights are unforgivable.” According to the provided statement, FMC labor union has conducted 20 sessions of negotiation with the management over 14 months, but the talk fell through on Feb. 6. On Feb. 10, the union has requested National Labor Relations Commission Seoul Office for arbitration. The first session was convened on Feb. 18, but no progress has been made. In last May, the company’s malpractice was reported to Ministry of Employment and Labor, which indicted the company for violating the related law and transferred the case to prosecutors. The FMC labor union plans to initiate strike against the management if it fails reach the middle ground at the second arbitration session scheduled on Mar. 2. Already 97 percent of 140 members have agreed to join the fight. Kim Gyu-nam, the FMC Chapter Head of Korea Democratic Pharmaceutical Union, reproached the company that “A German company with advanced labor relations culture has been ignoring an enforced labor law in Korea and refusing to recognize the labor relations. Over 70 employees are suffering from 30,000 hours of overtime every year. In payment, it would be worth around 600 million won.” Kim argued the management has never acknowledged the existence of the labor union by ignoring the duty of the labor union head, limiting labor union membership, and enforcing Early Retirement Plan (ERP) on employees working over 15 years. These are direct violation of Article 56 of the Labor Standard Act. Prior to Fresenius stockholders’ general meeting scheduled in coming May, UNI-Global Union forewarned of globally voicing the malpractice of Fresenius management at a forum co-organized by UNI, PSI, and IndustriALL. The forum would denounce the suspected tax avoidance of Fresenius executives and urge them to honor the labor rights. UNI-Global Union is the world’s biggest labor union, specifically protecting office workers in finance, mass media, IT, commerce, media and entertainment, postal service, sports and game industry. It represents 15 million members from over a thousand labor unions in 120 countries. Regarding the talks between the management and the union, the German company official was unable to provide detailed comments. FMC official said, “The management has continued to engage with the labor union to find the best means for everyone in past one year. And we have reached agreement on some of the topics. We respect their establishment and activity of the union, according to the Korean law. The company would continue to strive for consolidating advanced labor relations and to settle one an agreement.”
- Company
- Pneumonia vaccine & immune booster sales surged
- by Kim, Jin-Gu Feb 25, 2020 06:11am
- COVID-19 outbreak lasted for one month, and sales of pneumococcal vaccines and immune boosters also increased. Prevenar 13According to the industry on the 20th, Pfizer's pneumococcal vaccine, Prevenar 13, Prevena 13 sales soared during COVID-19 outbreak. According to Chong Kun Dang, which is currently in charge of domestic sales of Prevenar, Prevena 13 sales soared since February, when the COVID-19 crisis began in earnest in Korea. An official from Chong Kun Dang said, "There is no accurate statistics, but the sales volume so far has increased by 50% compared to last month. By the end of this month, it is expected to grow 900% from last year". "Vaccinations are usually the highest in October-December because of the nature of vaccines, and it is currently observed that sales volume is at the level of November-December", he said. In some regions, there are also concerns about out of stock. An official of Pfizer Pharmaceuticals, a manufacturer, said, "We understand that the sales volume has increased, and we’ll our best to supply smoothly". Chong Kun Dang has been in charge of domestic distribution of prevenar for adults since December 2017. Previously, Yuhan Corporation was in charge of distribution. Prevenar is the top seller in the global pneumococcal vaccine market. In Korea, the company records annual sales of ￦30 billion. Prevenar has not been shown to be effective in preventing pneumonia caused by COVID-19. Prevenar, a pneumococcal vaccine, is literally a vaccine against pneumococcal infection. Pneumococci are one of the leading causes of pneumonia, accounting for 27-44% of the causes of pneumonia. The causative organism is different from COVID-19, and in principle it is impossible to prevent it. However, some experts recommend that inoculation of pneumococcal vaccines may help relieve symptoms. Although pneumonia caused by COVID-19 cannot be prevented, it helps to pass through only the mild symptoms of pneumonia. Aronamin productsIn addition to Prevenar, sales of immunity-related products also surged. It is a vitamin B·C product. Ildong Pharmaceutical's Aronamin product is a typical example. Ildong Pharmaceutical official said, "As we know, the sales volume of the aronamine product has increased by 40~50% compared to in January". In addition, Daewoong's 'Impactamine' and Chong Kun Dang's 'Benfobel' are reported to have increased in February. It is analyzed that it is influence of COVID-19 outbreak. Although it is not a vitamin product, Echinaforce, a respiratory immune enhancer of Hanwha Pharm, suffered a temporary out of stock situation early in the outbreak. According to Hanwha Pharmaceutical, the supply of this product was resumed on the 20th. An official of Hanwha Pharm said, "COVID-19 is showing signs of spreading, which is unexpected, leading to inquiries about products, and we did our best to supply urgently". Echinaforce is mainly derived from the raw material Echinacea. Hanwha Pharm explained that it could help to boost antiviral, anti-inflammatory and immunity.
- Company
- Reimbursed Imfinzi available for stage 3 lung cancer soon
- by Eo, Yun-Ho Feb 24, 2020 06:28am
- The first immunotherapy option for patients with stage 3 lung cancer, Imfinzi, would soon receive healthcare reimbursement. According to pharmaceutical industry, AstraZeneca and National Health Insurance Service (NHIS) have reached an agreement on the pricing of PD-11 inhibitor Imfinzi injection (duvalumab). The reimbursed indication is to treat patients, previously treated by chemotherapy and radiotherapy, with locally advanced stage 3 non-small cell lung cancer. The treatment was cleared for marketing in Korea from December 2018, and Health Insurance Review and Assessment Service’ (HIRA) Drug Reimbursement Evaluation Committee (DREC) green lit it from last November. Taking the refund type risk sharing agreement (RSA), the treatment’s reimbursement decision would be deliberated and finalized by Health Insurance Policy Deliberation Committee (HIPDC) soon. While three other immunotherapies, including PD-1 inhibitor Keytruda (pebrolizumab) and Opdivo (nivolumab) and PD-L1 inhibitor Tecentriq (atezolizumab), have been approved before focusing on stage 4 lung cancer treatment, Imfinzi has an exclusive market with its unique indication. Imfinzi’s approval was based on Phase 3, randomized, double-blinded, placebo-controlled, multicenter PACIFIC trial, conducted with 713 patients in 235 institutes in 26 countries. The trial found the Imfinzi patient group has prolonged median progression-free survival (mPFS) to 16.8 months, about 11.2 months longer than the placebo group. Regardless of PD-L1 expression, Imfinzi also reduced risk of death by 32 percent and improved overall survival (OS) significantly. In 2019, American Society of Clinical Oncology (ASCO) presented three-year OS rate analyzed from PACIFIC trial. 43.5 percent higher than the placebo group, Imfinzi group demonstrated significantly higher OS rate of 57.0 percent. Imfinzi is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumor’s immune-evading tactics and releasing the inhibition of immune response. Based on a patient’s body weight, 10 mg/ kg dose of Imfinzi is administered by intravenous infusion over 60 minutes for every two weeks. It can be used until the disease is progressed or unacceptable level of toxicity is developed.
- Company
- GSK-Pfizer Consumer Healthcare JV to kick-off on Feb. 24
- by An, Kyung-Jin Feb 21, 2020 06:37am
- Pfizer Pharmaceutical Korea and GlaxoSmithKline Korea (GSK Korea) have finalized the decision on their joint venture in Korea. Two years since the headquarters have signed a merger deal on consumer healthcare divisions, the two companies are finally ready to begin the joint venture. Pharmaceutical industry source reported on Feb. 20, the Korean branches of Pfizer and GSK have decided to kick-off their consumer healthcare joint venture on Feb. 24. In the morning of Feb. 20, GSK Korea and Pfizer Pharmaceutical Korea have co-convened a second meeting on Working Condition Agreement regarding ‘unfair changes in working condition’ for the consumer healthcare division employees to vote. Among 51 Pfizer Consumer Healthcare employees, except for 12 employees who refuse to be transferred to GSK, the companies surveyed if the rest of 39 employees would like to comply with GSK’s working condition after the transfer. 22 employees, more than the half of 39, voted ‘yes’ and passed the Working Condition Agreement. Contrasting to the majority of the employees voting ‘no’ at the first vote on Feb. 14, the table has turned completely in merely a week. Pfizer Pharmaceutical Korea’s labor union official said, “On Feb. 19, a day before the second meeting, GSK has reportedly notified the employees of Pfizer Consumer Healthcare division that ‘the company would pay out 10 million won as M&A bonus if the Working Condition Agreement passes. But, if it falls through then the joint venture establishment could be postponed indefinitely.’” Based on the voting result, GSK would be able to lessen the burden of handling working condition discrepancies between employees. However, how many Pfizer Consumer Healthcare employees would actually get transferred is still unknown. But as GSK has set the deadline of transfer agreement submission on Feb. 21, 39 employees are apparently contemplating on either staying at Pfizer or transferring to GSK. Pfizer’s labor union insider hinted the Consumer Healthcare employees are feeling increasingly insecure about their job security, regardless of taking any option. The labor union has decided to convene a general assembly on Feb. 21 to initiate forming a new labor union to secure their jobs even after the transfer. Pfizer’s labor union is also pondering on means to protect employees, who have decided to stay at Pfizer. Pfizer Pharmaceutical Korea insider said, “So far, 12 employees have made the decision to stay. We are closely paying attention on the other 39 employee’s decision. We do not know how many would decide to stay, but the union is planning to negotiate with the management to protect them.” Both companies have reached an agreement on the kick-off date for the consumer healthcare joint venture. GSK Korea official said, “As of now, we can only disclose that the two companies have agreed the joint venture would sail on from Feb. 24. For Pfizer Pharmaceutical Korea’s Consumer Healthcare Division employees to sufficiently understand the two companies’ stances, we would continue to engage with them in various communication channels.” Pfizer Pharmaceutical Korea official commented, “We would fully cooperate with everyone to process the rest of the procedure.”
- Company
- SCD Pharm confirms Eylea's US partner
- by Lee, Seok-Jun Feb 21, 2020 06:35am
- Jeon In-seok, SCD Pharm’s CEO In-seok Jeon, SCD Pharm’s CEO, said on the 18th that he had selected US and European partners for Eylea’s Biosimilar (SCD411). Only Senju Pharmaceutical in Japan contracted SCD411. According to CEO Jeon’s remarks, additional export announcements (disclosures, etc.) are imminent. SCD411 is about to launch its global phase III study in the first half of this year. In addition to SCD411, Jeon said, "We are developing oral diabetes drugs (insulin, GLP-1) and anticancer drugs (Enbrel and Herceptin) as oral drugs". The reason why global pharmaceutical companies are having their eye on SCD411? The CEO mentioned five things about SCD411 competitiveness. Those five things are △ original formulation patents and overseas applications (US, JP, EU, etc.) △2000L CMO production line construction Completed pre-verification regarding IND △development of the same product line as the original △completed pre-validation of IND-related products such as quality, non-clinical, clinical, etc. with each country's permit holders (outside Japan, Europe, and the US) △ development of the same product line as the original. Jeon said, “The meaning of certification and securing the 2000L production facility is that it lowered the risk of quality equality during the scale-up process. The cost competitiveness is more than three times cheaper than 500L, and That's the capacity to cover global demand. Non-clinical studies were conducted with the global CRO Cobans, but some of them were delayed due to Cobans issues. However, the delayed part was replaced with a three-phase preparation process, which minimized time leakage. In particular, he emphasized the same product development sector as the original. The CEO analyzed that the same vials products as Eylea and PFS (Pre-filled Syringe, Pre-filled Syringe) have been developed, 24 weeks long-acting (long-lasting) products are also under development and SCD Pharm is the only company with this lineup. Following Japan, the US and European partners have been confirmed, and Eylea’s Biosimilar of the existing formulations is expected to start sales in U.S.A & Japan in 2023 and Europe in 2024. 'S-Pass Application', Injection → Oral Development 'Hidden Card' CEO Jeon also unveiled their future strategic projects for the first time. The projects are about the non invasive glucose monitor, S-CHECK, oral development of injectable diabetes treatments such as insulin and GLP-1, and No Needle platform Biz development of injectable anticancer drugs such as Enbrel and Herceptin. The CEO explained that S-CHECK proved similar to the blood glucose meter Roche’s Accu-Check. There was no difference between the blood glucose meter and S-CHECK, non invasive glucose monitor. He said that S-CHECK is 100% blood free, no additional calibration, no need to replace sensors and cartridges and will quickly replace the glucose meter market in the future. It also shared the S-Pass platform, which converts injections into oral ones. S-Pass platform is Nano Micelle + Protein Complex and the Advantages are △GI (gastrointestinal + small intestine) absorption (Quick Acting → Quick Onset) △ encapsulation (permeability and absorption increase) ) △digestion inhibition/high bioavailability(cost reduction and price competitiveness) △Avoiding FDA approved excipients and oils(Ease/permit and minimize side effects) △No antacids and surfactants (Minor side effects for long-term chronic patients) A related advantage is the lack of features for companies looking to develop oral injections. SCD Pharm has filed a patent application for S-Pass last August. The CEO Jeon said, "We are developing Diabetes treatment such as insulin and GLP-1 as well as anti-cancer drugs such as Enbrel and Herceptin as oral drugs using the S-Pass platform. After that, it will be the cornerstone of growth of SCD Pharm after Eylea’s Biosimilar".
- Company
- Long-waited reimbursed Ibrance+Faslodex in arm’s reach
- by Eo, Yun-Ho Feb 20, 2020 06:42am
- From top, Ibrance, Verzenio and Kisqali After two long years, Pfizer is finally in proximity to win reimbursement on Ibrance plus Faslodex combination therapy. Pharmaceutical industry source reported, Drug Reimbursement Evaluation Committee (DREC), under Health Insurance Review and Assessment Service (HIRA), has cleared the combination therapy consisting of Pfizer’s CDK4/6 inhibiting Ibrance (palbociclib) and AstraZeneca’s Faslodex (fulvestrant). Both companies have each applied for expanded reimbursement last year, in which Ibrance took the risk sharing agreement (RSA) expansion track and Faslodex took the general reimbursement expansion track. Faslodex would need to undergo HIRA’s financial impact review for its general reimbursement status, whereas Ibrance, reimbursed with RSA, would have to negotiate pricing with National Health Insurance Service (NHIS). ◆ Processing health insurance benefit for Ibrance plus Faslodex combination therapy: Although the final decision on the benefit is just around the corner, Pfizer has gone through a lot until now. The needs for the combination therapy was voiced since 2017, when the ‘Ibrance incident’ occurred. In November of the same year, Ibrance was just listed for reimbursement as a first-line treatment, and Faslodex had not been listed, yet, as a monotherapy. In fact, Faslodex has been approved to market in Korea for over a decade. AstraZeneca has struggled to find the middle ground with the health authority over the cost-effectiveness of Faslodex monotherapy. But as the public’s interest on Ibrance combination therapy has heightened, the needs for reimbursed Faslodex also soared. With the increasing needs for it, the combination therapy first applied for reimbursement in the first half of 2018. While AstraZeneca submitted the application without fully processing the Faslodex monotherapy listing, Pfizer submitted the application to expand Ibrance’ reimbursed indication. However, the government requested AstraZeneca to withdraw the application as the monotherapy has not been listed, yet, and rejected Pfizer’s application as its drug was already listed. Since then, AstraZeneza accepted pricing lower than the weighted average price of alterative options to list Faslodex as monotherapy, and finally received reimbursement in last April. When the monotherapy listing was technically finalized in last March, Pfizer immediately applied for reimbursement on the combination therapy and received its long waited reimbursement. ◆ Pfizer letting the competitor join while waiting: Regardless of the fruitful outcome, it also seems somewhat unfair for Pfizer. When the company waited for Faslodex to get listed, other follow-on CDK4/6 inhibitors have been approved and started the listing procedure. And there are two competitors. First is Lilly’s Verzenio (abemaciclib), which has submitted application for reimbursement last May immediately after MFDS’ approval. As CDK4/6 inhibitor plus Faslodex combination had not been listed before, Verzenio was able to apply for RSA-based reimbursement on the specific indication. The second is Novartis’ Kisqali (ribociclib). Unlike the others, Kisqali is indicated as first-line combination therapy with Faslodex, except for female patients before menopause. Approved by MFDS last October, Kisqali has started listing procedure expecting to get the a positive final decision. Following the decision by Cancer Deliberation Committee in last September, Verzenio is waiting for deliberation by DREC. Running behind the others, Kisqali has just passed Cancer Deliberation Committee last month. As a result, CDK4/6 inhibitor plus Faslodex combination therapy would be listed for reimbursement without much of difference among three items. More than anything, their pricing negotiation period may overlap. According to Market Access representative at a multinational pharmaceutical company stated, “The government could enhance negotiation power and lower financial risk when discussing listing of competing drugs at a same time, but as for patients, their waiting time could get longer. Either way, the decision would have to be made carefully.”
- Company
- Jeil·Hanlim’s authorized generics, challenge to the market
- by Nho, Byung Chul Feb 20, 2020 06:42am
- Circadin‘s authorized generics are expected to be released to the market as early as next month. According to the industry, Jeil, Hanlim, and CMG will release their products sequentially in March, April, and May through Kuhnil. The reason for launching Circadin‘s authorized Generics seems to be aimed at the market for the patent expiration scheduled for this June. Once the launch of authorized generics is completed in the first half, more than 10 pharmaceutical companies, including Boryeong, SK Chemicals, Yungjin, and Daewoong Bio, are expected to start pouring out in November. Introduced in the domestic market in July 2014, Kuhnil’s Circadin is a sleep-inducing agent based on Melatonin. Circadin was developed by Neuroim Phamaceuticals, a company specializing in the development of CNS-based senile diseases, and is currently marketed in 43 countries, including the UK, France and Italy.. Domestic copyright is monopolized by Kuhnil and forms ₩7~10 billion units in six years since its launch. The market is expected to expand further if authorized generics and generics are added. Circadin’s authorized generic drugs sold by Jeil, Hanlim, and CMG will be imported from Guhnil and supplied to these pharmaceutical companies. Circadin, licensed as a prescription drug, currently costs ₩1,000 to ₩1200 per tablet. The authurized generics seen by the industry are also expected to be formed at this price range. The generic price is expected to be set at around ₩400 per party. Circadin is the first drug to treat insomnia that restores brain and body function by controlling Melatonin. Melatonin is a hormone secreted by the brain that can cause insomnia if it is not secreted or secreted less. Circadin is the first sustained-release Melatonin released similarly to endogenous melatonin, which not only improves sleep quality but also has lower side effects than conventional drugs. Indeed, domestic clinical trials of insomnia patients over the age of 55 have shown that the quality of sleep, time to sleep, total sleep time, sleep efficiency, and daytime activity after taking Circadin have improved, but no special side effects occur. In addition, existing sleeping pills are limited to 3 to 4 weeks once for psychotropic drugs, whereas Circadin can be prescribed for up to 13 weeks once as a non-psychotropic drug. Existing sleeping pills act on the GABA receptors that suppress the central nervous system, leading to adverse reactions such as daytime lethargy and addictiveness, but Circadin does not act on the GABA receptor and no such adverse event is observed. Melatonin has been widely used as a food since the 1990s, as it has been proved to be effective and safe through long research. However, Melatonin used in foods has a short half-life of 35 to 50 minutes and has a disadvantage in that it does not exhibit sufficient effect. Circadin has been developed to exert its effects throughout sleep by increasing the half-life to about 4 hours with a sustained release technology to release a certain amount for 8-10 hours.
