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- 2026-04-11 06:00:36
- Policy
- Pediatric drugs eligible for PE exemptions from January
- by Kim, Jung-Ju Dec 01, 2022 05:46am
- Chang-Hyun Oh, Director of MOHW The government expects the ‘Measures to Improve Patient Access and Reinforce Reimbursement Management for High-Priced Severe Disease Treatments’ that gained industry attention for increasing the scope of use of the pharmacoeconomic evaluation exemption system (PE exemption system) will be applied to drugs that apply for reimbursement in January. In other words, the government plans to confirm and apply final revisions in December. The revisions to the Health Insurance Review and Assessment Service’s guidelines are currently complete and are being reflected in the National Health Insurance Service’s detailed standards for negotiations (negotiation guidelines). After the process is complete, it will be possible to extend the application of the PE exemption system to pediatric new drugs that apply for reimbursement in January. In the case of the 200 set as the ‘small number of patients’ standard, the government reaffirmed its position that extending PE exemption to drugs for adults deviates from the purpose and priority of reimbursement while emphasizing the flexibility of the Drug Reimbursement Evaluation Committee review as it had responded at the last NA audit. Chang-Hyun Oh, Director of the Pharmaceutical Benefits Division replied so at the QA session on pending issues at a recent meeting with the multinational pharmaceutical company press on the 29th. Also, Oh drew the line and said that it was different from the government’s intentions regarding the market’s prediction that the measures will be immediately applied from November upon notice. The following is the QA script between the press corp and Director Oh. ▶After the administrative notice, HIRA has not yet publicly announced the expansion of the PE exemption system to pediatric drugs. Were there any problems in the implementation process? “We are currently changing the NHIS negotiation guidelines. The Measures to Improve Patient Access and Reinforce Reimbursement Management for High-Priced Severe Disease Treatments does not only include expanding PE exemptions to pediatric drugs. It also includes the expedited listing of severe disease treatments and expanding the scope of reference countries to A9 which is set for December 11. These revisions have to be made collectively (none of them have been publicly announced yet). We will be able to confirm and revise the plan in December. ▶The pharma and bio industry expected the measures to be implemented immediately upon notice this month (in November) and awaited HIRA’s public notification. But at the current pace, the system will be applied next year at the earliest. Is this a delay or a deferment? “Since other revisions that need to be implemented also need to be reviewed and unilaterally implemented, the measure will be applicable to drugs that apply for reimbursement from January. Since the government had not announced that it will be implemented from November, it is not a delay." ▶The industry is still strongly voicing the need to extend the PE exemptions to drugs used in adults.” “A clause ‘drugs used to treat pediatric patients that are therapeutically equivalent or has no available treatment option, and demonstrates improvement in quality of life or is otherwise approved by the committee’ has been added to HIRA’s guidelines. At the same time, ‘when the drug’s main indication is for pediatric patients’ condition has been added to NHIS’s reimbursement standard procedure improvement plan. As these two are being applied together, reimbursement will be extended to drugs whose main indication is for ‘pediatric’ patients among drugs used for both children and adults. Therefore, the extension will be applied to pediatric patients. There have been many requests for expanding the reimbursement benefit to drugs that affect adult patients. We can review it, but our current priority is in benefiting pediatric patients rather than adults.” ▶The NA and others have pointed out how the extension had rather raised the threshold for PE exemptions and reimbursement. What is the government’s opinion on this? "I have already explained the reason why the ‘small number of patients’ clause had been included at the past NA audit. The restriction was set to clarify that PE exemptions are applied when the drugs have difficulty producing evidence. DREC had answered to the National Assembly that it will deliberate reimbursements in consideration of the severity of the disease for drugs that affect a small number of patients. The same is true for the 200 range that had been set. Considering the severity of the disease, even if the number of patients exceeds 200, the drug can be considered and reviewed as a drug that affects a small number of patients. I believe DREC will make a reasonable decision."
- Company
- When will Xocova be approved in Korea?
- by Nho, Byung Chul Nov 30, 2022 05:53am
- With the new oral COVID-19 treatment Xocova starting prescriptions in Japan after obtaining emergency regulatory approval from the Ministry of Health, Labour and Welfare (MHLW), attention is rising on whether it will be approved in Korea as well. In Korea, the Korea Disease Control and Prevention Agency determines the need and grants Emergency Use Authorizations to drugs after expedited review, rather than choosing among companies that submitted applications. Although no news has been heard on whether Xocova is being officially undergoing approval processes yet, news has been heard that the government will start a review, and Ildong Pharmaceutical has started preparations for Emergency Use Approval. Xocova is an oral antiviral that contains ensitrelvir that selectively inhibits the viral 3CL protease and suppresses SARS-CoV-2 replication. Xocova demonstrated clinical symptomatic efficacy through a Phase II/III trial that was conducted in Japan and Korea. Trial results showed that the mean time to initial relief of COVID-19 symptoms in patients that received Xocova was 167.9 hours, a significant reduction from the 192.2 hours in the placebo group. Xocova also met its secondary endpoint — reduction in viral RNA — in the trial. Reduction in viral RNA on day 4 following the third dose in the ensitrelvir-treated group was 1.4 log10copies/ml more than that in the placebo group. Regarding its safety, no serious adverse events or deaths have occurred from the use of ensitrelvir, and was also found to be well tolerated. Its convenience in intake has also been regarded as an advantage. Unlike conventional treatments that are administered for 5 days, twice a day, and three tablets per administration, patients only need to take Xocova once daily for 5 days as a single tablet. With the opinion that the drug has shown a positive effect in Japanese hospitals after starting prescriptions, local healthcare professionals have been welcoming the diversification of COVID-19 treatment options. The fact that Xocova can be manufactured locally in Korea if it is granted marketing authorization in Korea is also an added advantage. Ildong Pharmaceutical had previously signed an agreement with Shionogi to jointly conduct Xocova’s clinical trial. After successful development, Ildong Pharmaceutical will directly be in charge of the local manufacturing and distribution of Xocova. In other words, Xocova will be locally manufactured. However, it is true that other treatments have been previously developed and imported and the need for COVID-19 treatments is not as urgent as before. But with more than 70,000 people still being confirmed as of the 1st, and further resurgences to come, many have stressed the need to establish treatment sovereignty by securing a treatment that can be manufactured in Korea. An industry official said, “A new COVID-19 treatment option is needed as there are considerable limitations on the use of existing treatments. In particular, if we can locally manufacture a COVID-19 treatment, it will be of great support in stably supplying treatments in cases of emergency.”
- Company
- Doveprella, the first new tuberculosis drug in 50 years,
- by Eo, Yun-Ho Nov 30, 2022 05:52am
- Doveprella, a new tuberculosis drug that appeared 50 years, is expected to be listed on the insurance benefit list. According to related industries, Viatris' multidrug-resistant tuberculosis treatment Doveprella recently concluded a drug price negotiation with the NHIS. After passing the HIRA's Drug Benefit Evaluation Committee in September, the negotiation process began as soon as possible, drawing positive results. As a result, if only the Health Insurance Policy Review Committee passes, the benefit will be applied without any major problems. Doveprella, which was approved domestically in October last year after U.S. approval in September 2019, can be used as a combination of Bedaquiline and Linezolid in adult patients with extensive drug-resistant pulmonary tuberculosis, treatment intolerance, or non-reactive multidrug-resistant pulmonary tuberculosis. This drug is the first new treatment in more than 50 years. The tuberculosis treatment market has been shunned by front-line pharmaceutical companies for its poor drug economy. In fact, Doveprella is a drug created through a collaboration between Viatris and a non-profit organization called TB Alliance. Multidrug-resistant tuberculosis (MDR-TB) is tuberculosis that is resistant to two or more tuberculosis treatments, including Isoniazid and Rifampin, which are the two most effective anti-tuberculosis drugs for the treatment of tuberculosis. The causes of the outbreak are divided into primary and acquired resistance, which is infected with tuberculosis bacteria, which are resistant from the beginning, and acquired resistance during the treatment process due to discontinuation of drug use and irregular administration. MDR-TB has only a 50% treatment success rate, so treatment efficiency is low and secondary drugs used for treatment have more side effects than primary drugs. The treatment period is also long, ranging from 18 to 24 months, so the cost is high, and in some cases, the lesion should be removed through surgery. The combined treatment of seven drugs, including Bdq, which is currently used for standard treatment of MDR-TB, is not well used in Korea due to high drug resistance, and the treatment period is still long at 9-12 months, making it difficult for patients to manage medication and high treatment failure rates. Doveprella proved its validity through a phase 3 clinical Nix-TB study. Doveprella confirmed its potential as a new short-term combination therapy, with a successful treatment effect of 92% in MDR-TB patients and 89% in a broad range of drug-resistant pulmonary tuberculosis patients in 6 months with Bedaquiline and Linezolid. The existing treatment period of 18 to 24 months was shortened to 6 months, and almost all extensive drug-resistant pulmonary tuberculosis and sputum culture-negative of MDR-TB patients were confirmed within 16 weeks. BPaL therapy was the first ready-to-use combination therapy consisting only of oral agents and showed complete data in about 90% of patients with extensively drug-resistant tuberculosis at 6 months of treatment.
- Company
- Oluminant's sales are higher than Xeljanz's
- by Kim, Jin-Gu Nov 30, 2022 05:52am
- (From left) Oluminant, Rinvoq, Xeljanz.Xeljanz lost its market lead by falling sales by 13% due to safety issues. The market for JAK inhibitors, an oral autoimmune disease treatment drug, is fluctuating. While long-time market leader Pfizer Xeljanz faltered, Lilly's Oluminant took the lead. On top of that, Abbvie Rinvoq quickly expanded its sales, signaling fierce competition. ◆↑ Olumiant 30% of sales According to IQVIA, a pharmaceutical market research firm, Oluminant's cumulative sales in the third quarter of this year were 11.7 billion won. It increased by 30% compared to the cumulative 9 billion won in the third quarter of last year. Oluminant is a drug used for autoimmune diseases such as rheumatoid arthritis and atopic dermatitis. In December 2017, it was approved in Korea as the second JAK inhibitor after Xeljanz. Sales have steadily increased since November 2018 when salaries were applied as a treatment for rheumatoid arthritis. In May last year, the scope was expanded due to atopic dermatitis. In the fourth quarter of last year, it surpassed the sales of Xeljanz, an existing market-leading product. Since then, it has consistently recorded higher sales than Xeljanz. The third JAK inhibitor, Rinvoq, has a steeper growth rate. Cumulative sales in the third quarter of this year were 8 billion won, up about six times in a year from the cumulative 1.4 billion won in the third quarter of last year. Domestic permits were the latest in June 2020, compared to competing drugs, but sales have risen vertically since benefits were applied as a treatment for atopic dermatitis in May last year with Oluminant. In the third quarter of this year, quarterly sales exceeded 3 billion won for the first time. The gap with Oluminant, the No. 1 product in the market, has narrowed to 700 million won. ◆ Oluminant·Rinvoq Rising, Additional Effects of Atopic Dermatitis Indication The growth of Oluminant and Rinvoq is interpreted as a result of active indication expansion. In particular, it is analyzed that it led to sales growth by securing atopic dermatitis, which is not in Xeljanz, as an indication. Oluminant was first licensed as a treatment for rheumatoid arthritis. In May last year, atopic dermatitis was added as an indication. Oluminant is seeking to expand the indication even with hair loss. Lilly applied for the expansion of the indication with severe circular hair loss last month. Rinvoq was also approved for rheumatoid arthritis, and in October last year, additional indications for ▲ psoriatic arthritis ▲ ankylosing spondylitis ▲ atopic dermatitis were approved. Ulcerative colitis was added this year. Rinvoq currently has the most indications of JAK inhibitors. ◆ Xeljanz sales dropped 13% in a year Xeljanz's cumulative sales in the third quarter of this year were 10.2 billion won, down 13% from 11.7 billion won a year earlier. After being released in March 2015, Xeljanz expanded its influence as the only oral autoimmune disease treatment until 2018. From 2019, sales of around 4 billion won were maintained every quarter. Sales plunged 16% year-on-year in the fourth quarter of last year. Since then, it has been maintaining quarterly sales in the early 3 billion won range. It is analyzed that safety issues affected the decline in sales in the fourth quarter of last year. Based on the results of a large-scale random safety study in September last year, the U.S. Food and Drug Administration (FDA) added a black box warning, saying that JAK inhibitors, including Xeljanz, increase the risk of heart attack, stroke, cancer, and death. The Ministry of Food and Drug Safety distributed the same safety letter. In October this year, the standards were changed to be limited to patients aged 65 or older, patients in high-risk groups in ▲ the cardiovascular system, and patients at risk of ▲ malignant tumors. Pfizer plans to once again expand its influence in the JAK inhibitor market through Xeljanz's follow-up drug, Cibinqo. Like Oluminq and Rinvoq, Cibinqo is targeting atopic dermatitis. It was approved in Korea in November last year and is currently being prescribed non-reimbursed. In August, it passed the HIRA and approached the application.
- Company
- Boryung, start patent challenge for liver cancer drug Lenvim
- by Kim, Jin-Gu Nov 30, 2022 05:52am
- Boryung challenged Eisai's patent for Lenvima, a liver cancer treatment. It is interpreted as a strategy to spur the anti-cancer drug business, which has been strongly driving since 2020. According to the pharmaceutical industry on the 29th, Boryung recently filed a passive judgment on the scope of rights and a judgment on invalidity in three Lenvima patents at the same time. Lenvima is a treatment for liver cancer in Eisai. It is used in the primary treatment of liver cancer along with Nexavar and Tecentriq+Avastin. According to IQVIA, a pharmaceutical market research firm, Lenvima's sales last year were 15.8 billion won. It has increased by 30% compared to 12.2 billion won in 2020. This year, it posted 11.1 billion won in sales until the third quarter. Lenvima is protected by a total of four patents. They include material patents that expire in April 2025, usage patents that expire in March 2028, salt and crystalline patents that expire in June 2028, and pharmaceutical patents that expire in March 2031. Boryung requested a trial for invalidation of a patent for use except for a material patent, and a trial for confirming the scope of passive rights to salt and crystalline patent and a formulation patent, respectively. If Boryung succeeds in targeting three patents, it will be eligible to release generic after 2025, when the material patent expires. Boryㅕng plans to further expand its anti-cancer drug portfolio by targeting Lenvima patents. Boryung's all-around anti-cancer drug patent challenge began in earnest after the independence of the "ONCO (anti-cancer) sector" in May 2020. Boryung has filed a patent trial for five original anticancer drugs in the past two years, including Lenvima. The number of patents amounts to 13. In May this year, Novartis filed a trial on four patents for Tasigna, a leukemia treatment. Prior to this, a patent trial was filed with Ibsen's liver cancer treatment Cabometyx in April this year, Pfizer's breast cancer treatment Ibrance in March, and BMS' acute lymphocytic leukemia treatment Sprycel in December last year.
- Company
- Samsung Bioepis occupies 25% of Avastin mkt 1yr since launch
- by Nov 30, 2022 05:52am
- Samsung Bioepis’s Avastin (bevacizumab) biosimilar ‘Onbevzi’ is enjoying its market preoccupation effect. In only one year since its release, the share of its similar reached nearly 25% in the market. With Alvogen and Celltrion’s biosimilars succeeding to be released with reimbursement from the next month, the competition between biosimilars is expected to intensify further. Onbevzi enjoys ‘first mover’ benefit... original’s sales reduced 35% Pic of Avastin On the 29th, according to the market research institution IQVIA, Samsung Bioepis’s Onbevzi raised sales of KRW 6.4 billion in Q3 this year. Such sales have been made only 1 year since its release. Onbevzi quickly took over the market as the only bevacizumab biosimilar for 1 year since its release. Onbevzi, which had been released in September last year, raised sales of KRW 1.8 billion in Q1. In Q2, its sales surged to KRW 4.1 billion. Its sales exceeded KRW 10 billion only 1 year after its release. Onbevzi is a biosimilar of Roche’s anticancer drug Avastin. Avastin, which is the first VEGF inhibitor ever introduced, is used in various cancer types including colorectal cancer, breast cancer, lung cancer, ovarian cancer, and renal cell carcinoma. Its annual sales last year reached KRW 112.3 billion. In Q3 this year, Onbevzi accounted for 24.2 % of the market. Samsung Bioepis’ Onbevzi has been enjoying the ‘first mover’ effect as the ‘first biosimilar.’ Onbevzi, which was released with reimbursement in September last year, has rapidly increased its share of the market with support from Boryung Pharmacuetical. Boryung Pharmacuetical, which opted to partner with Samsung Bioepis, is a company that is demonstrating its potential, achieving sales of KRW 100 billion in the second year of the establishment of its ONCO (oncology) division. Data: IQVIA Onbevzi’s lack of ovarian cancer indication had been pointed to as its weakness. However, after making an agreement with Genetech, Avastin’s original developer, Samsung Bioepis was able to obtain an additional indication for ovarian cancer last month. The delay in the reimbursement listing of the second biosimilar also worked as a favor for Onbevzi. However, sales of the original Avastin have remained stagnant since the introduction of the biosimilar. The biggest issue was in how sales of the original drug is cut by 30% ex-officio after the listing of generics or biosimilars. Since then, Avastin’s price was reduced further by 5% with its reimbursement extended to be used in combination with Tecentriq in May. Avastin’s current ceiling price is set at KRW 218.782 (0.1g/4mL) and KRW 712,093 (0.4g/16mL). Avastin's sales had seemed to gain momentum after being granted reimbursement as first-line treatment for liver cancer. However, the momentum was offset by further price cuts and has been analyzed to have made no significant changes to Avastin sales. In terms of its quarterly sales, Avastin’s sales had only increased slightly from KRW 19.3 billion in Q1, KRW 18.8 billion in Q2, then to KRW 20 billion in Q3. Alvogen·Celltrion succeeds in reimbursement listing...sparks 4-way race With Alvogen and Celltrion’s biosimilar being listed for reimbursement, competition between the original and its biosimilars is expected to intensify further in the bevacizumab market. Alvogen has succeeded in listing its Avastin biosimilar ‘Alymsis’ with reimbursement in October. Alymsis, which was approved in January, has canceled its reimbursement application once due to patent litigations. This was one reason why Onbevzi’s sole reign in the market had been extended. Alymsis was listed for reimbursement after deleting the ovarian cancer indication whose patent the company had not been able to overcome. Its ceiling price had been set at the same price as Onbevzi. Alvogen selected Daewoong Pharmaceutical as its local partner. Daewoong Pharmaceutical is selling, ‘Ogivri,’ its biosimilar of the breast cancer drug Herceptin. Adding Daewoong Pharmaceutical’s sales power, the company plans to rapidly increase Alymsis’s sales in the market. Celltrion will also jump into competition in the market in December. Celltrion succeeded in receiving reimbursement for the Avastin similar ‘Vegzelma’ on the 26th. Its price is set the same as Onbevzi and Alymsis. Celltrion plans to start its sales in earnest in December after it receives reimbursement.
- Company
- Rolontis and Leclaza make their place in Korea
- by Chon, Seung-Hyun Nov 29, 2022 05:54am
- Leclaza and Rolontis, the homegrown drugs that have gained attention as promising new global drugs, have made a smooth start in the domestic market. Yuhan Corp’s Leclaza’s annual sales exceeded KRW 10 billion in the second year of release, and Hanmi Pharmaceutical’s Rolontis has also started making sales in earnest in the Korean market. ◆Yuhan’s Leclaza’s sales exceed KRW 10 billion in only 3 quarters... nears FDA approval According to the market research institution IQVIA on the 28th, Leclaza’s sales in Q3 were KRW 4.6 billion, a threefold increase from the KRW 1.5 billion in the same period of the previous year. Leclaza is the 31st novel drug to be developed in Korea. It received approval as a non-small-cell lung cancer treatment for patients with EGFR T790M mutation-positive, locally advanced or metastatic NSCLC who were previously treated with an EGFR-TKI. It inhibits the signal transduction that is involved in lung cancer cell proliferation and growth to inhibit the proliferation and growth of lung cancer cells. Leclaza entered the Korean prescription market in earnest with its reimbursement listing in July last year. It first made sales of KRW 1.5 billion in Q3 last year and then sold KRW 2.6 billion in Q4. Its sales continued to rise further this year. In Q1 and Q2 this year, it raised sales of KRW 3.2 billion and KRW 3.7 billion and continued its growth in Q3. Leclaza recorded cumulative sales of KRW 11.5 billion in Q3 this year and then exceeded KRW 10 billion in its second year of release. Among new anticancer drugs developed in Korea, Leclaza is the first to raise annual sales that exceed KRW 10 billion. Other homegrown new anticancer drugs that were approved before Leclaza include Il-Yang Pharmaceuticals’ Supect, Dongwha Pharm’s Milican, Chong Kun Dang’s Camtobell, Sam Sung Pharmaceutical’s Riavax, Hanmi Pharmaceutical’s Olita. None of the products have exceeded annual sales of KRW 10 billion. In the early stages of its release, Leclaza is evaluated to have made a smooth start. As anticancer drugs are usually used in large medical institutions, they are only allowed to make prescriptions only after passing drug committee reviews in their respective institutions. Also, as the new drugs need to directly compete with promising new drugs from multinational pharmaceutical companies, it is not easy for local homegrown new anticancer drugs to achieve commercial results. Leclaza passed reviews in drugs committees of major large-scale medical institutions in Korea and started speeding up market penetration. Leclaza is also speeding up entry to the US market. Yuhan Corp made a licensing deal with Janssen biotech in November 2018. Since then, Janssen has been developing the drug in combination with its own EGFR-MET bispecific antibody ‘amivantamab.’ The CHRYSALIS trial which had been the first trial initiated after the agreement was signed, has been now expanded to study its combination with other platinum-based anticancer therapies including ‘carboplatin,’ ‘pemetrexed.’ Janssen is also expected to apply for FDA approval for such combinations within the year at the earliest. The global Phase III trial for the first-line therapy is also in smooth progress. According to a phase III trial recently announced by Yuhan Corp, Leclaza reduce the risk of disease progression or death by 55% compared to Iressa and statistically significantly improved progression-free survival, the primary endpoint. PFS is an important evaluation index used to confirm the efficacy of anticancer drugs and refers to the period that a patient lives with the disease without progression or death. The Phase III trial has been conducted on 393 treatment-naive patients with EGFR-positive locally advanced or metastatic non-small-cell lung cancer. Yuhan Corp received approval to conduct the clinical trial in December 2019 from the Ministry of Food and Drug Safety, and 119 institutions in 13 countries participated in the trial. Based on the trial results, the company plans to apply for its use as a first-line treatment. ◆Hanmi’s Rolontis first makes KRW 1.5 billion this year... starts sales in the US market Hanmi Pharmaceutical’s Rolontis which recently entered the US market started to raise sales in earnest in Korea. 2 Rolontis recorded KRW 1 billion in the Korean market in Q3. It made sales for the first time in Q1 this year and then sold KRW 0.4 billion in Q2. As of Q3, its cumulative sales reached KRW 1.5 billion. Rolontis is a new biological drug that Hanmi Pharmaceutical transferred the technology to Spectrum in 2012. It is administered to prevent or treat neutropenia in cancer patients that receive myelosuppressive chemotherapy. The drug has a similar mechanism of action to Amgen’s blockbuster drug ‘Neulasta (pegfilgrastim),’ by increasing the G-CSF receptor to stimulate neutrophil production. The drug was approved as the 33rd homegrown new drug in March and started to be sold in Korea after receiving reimbursement in November last year. Rolontis was approved under the brand name Rolvedon by the US FDA in September this year and succeeded in commercialization 10 years after its technology transfer. Rolvedon is now recorded as the 6th product to pass FDA review among new drugs developed with a Korean company’s technology. LG Chem’s Factive was the first among homegrown new drugs to pass the US gates in 2003. Then, Sivextro that Dong-A ST licensed out was approved by the FDA in 2014. Then, in 2016, SK Chemical’s hemophilia drug Abstyla received FDA approval. In 2019, SK Biopharmaceutical’s narcolepsy drug Sunosi and new epilepsy drug Xcopri received FDA approval. Rolontis is the first drug to receive marekting approval from the FDA among Hanmi Pharmaceutical’s products. It is the first new drug to be produced in the US market and produced at a domestic plant (Pyeongtaek Bio Plant) that has received on-site inspections from the FDA. It is the first new drug to be produced in the U.S. market and produced at a domestic plant (Pyeongtaek Bio Plant) that has received an on-site FDA inspection. Rolontis started selling in the US market in earnest last month. The US neutropenia treatment market is worth KRW 3 trillion a year. With Spectrum failing to introduce another anticancer drug it brought in from Hanmi Pharmaceutical, poziotinib, to the US, the company has expressed aims to focus on the commercial success of Rolontis. After failing to receive approval for poziotinib, Spectrum planned to start restructuring, including a 75% reduction in R&D personnel by the end of the year, and concentrate the saved operating funds on Rolontis.
- Opinion
- [Reporter's view] Opinions surrounding the multinational ERP
- by Eo, Yun-Ho Nov 29, 2022 05:54am
- Every office worker has a fear of restructuring. Companies have no choice but to consider layoffs in terms of cost reduction when circumstances are difficult. This year, a number of multinational pharmaceutical companies have either cut their jobs or are in progress. In the case of these multinational pharmaceutical companies, the number of people is often reduced through a method called the Early Retirement Program (ERP). ERP literally takes the form of 'voluntary'. But it doesn't really go spontaneously. Since ERP is also restructuring, the media is also dealing with it somewhat negatively, and in severe cases, labor-management conflicts may occur. In particular, older sales workers may be implicit targets of ERP. However, domestic pharmaceutical companies are often envious of multinational companies' ERP because they often proceed with job cuts without specific compensation. In fact, some employees of multinational companies are seeking to raise a large amount of money through ERP. Industry workers can transfer to other companies as much as they want depending on the demand for each position. For them, ERP could be a form of luck. Under these circumstances, multinational corporations' ERP compensation packages are always at the top of the agenda. "How much more does it give you for two years' salary?", Stories such as "Company A is the best in package" become the subject of common industry drinking stories. The situation in which the company sends people out is not a laughing matter. The issue of coercion, which is exercised behind the word hope, is a problem that must be solved, and the scale of the reduction should not be matched like a puzzle. It is also true that if it is a restructuring that is going on anyway, it is better to have compensation. There will be no beautiful job cuts, but I hope ERP will be the next best.
- Policy
- First Forxiga follow-on Dapapro listed at KRW 684
- by Lee, Tak-Sun Nov 29, 2022 05:54am
- The first follow-on of the antidiabetic SGLT-2 inhibitor ‘Forxiga Tab (dapagliflozin, AstraZeneca)’ will be listed at ‘Dapapro Tab’ with reimbursement at KRW 684 on December 1. The price has been set at 90% of the original due to premium pricing as a data submission drug due to salt modification, etc. Dapapro Tab succeeded in avoiding the duration of the substance patent as a prodrug that has a different chemical structure from the original. According to industry sources on the 28th, Dapapro Tab will be listed for reimbursement at KRW 684 on December 1. This is 10% lower than the KRW 760 set for Forxiga. In general, generics are listed at 53.55% of the original’s ceiling price, but as a data submission drug, the price was set at 90% of the original. Dapapro's ceiling price will be maintained as is until another generic with the same ingredient is listed. Until February, the release of Dapapro had been unclear until before the substance patent expiry. Dong-A ST had filed a claim to confirm the scope of rights for Forxiga’s substance patent, claiming that its drug does not impede the scope of rights of Forxiga’s substance patent, but the Patent Court of Korea reversed the decision of the Intellectual Property Trial and Appeal Board that had admitted the company’s claim. Nevertheless, Dong-A ST newly challenged the patent again and received an admission in the trial to confirm the scope of rights on the 2nd. In other words, the court accepted the claim that the 917 days added to the patent term for Forxiga’s substance patent does not apply to Dong-A ST’s product. Based on this, Dong-A ST started its reimbursement process and succeeded in listing its drug with reimbursement on the 1st of the following month. Forxiga’s substance patent will expire in April next year, and if Dapapro is released with reimbursement, it will be marketed before the expiry of the substance patent. With Dong-A ST planning to release Dapapro by February next year, the product is expected to be the first drug sold among Forxiga follow-on drugs. Also, it will be the first SGLT-2 class follow-on to be released into the market as well. Also, Dong-A ST owns its new antidiabetic drug ‘Suganon.’ The addition of the SGLT-2 antidiabetic Dapapro to its portfolio is expected to expand the company’s share in the domestic diabetic drug market. In particular, with Dapapro being released earlier than the generic versions of Forxiga, it is expected to further occupy the follow-on drug market.
- Company
- Keytruda has booked high sales in the domestic market
- by Chon, Seung-Hyun Nov 29, 2022 05:53am
- Keytruda, an immuno-cancer drug, has reserved a leading position in the domestic pharmaceutical market for 3 consecutive years. New drug products recently released by multinational pharmaceutical companies such as Gardasil 9 and Dupixent continued to be high. According to IQVIA, a pharmaceutical research firm, MSD Keytruda posted 161.6 billion won in sales in the first three quarters of this year, the largest among all medicines. Compared to the same period last year, it increased by 11.1%, firmly maintaining its leading position. Keytruda's sales in the first quarter were 40.4 billion won, down 8.4% from the previous year. At that time, the decline in sales was blamed for the drug price cut. Keytruda's insurance upper limit was lowered by 25.6% in March as the scope of health insurance benefits was expanded to primary treatment for non-small cell lung cancer. However, Keytruda recovered its upward trend from the second quarter. Sales in the second quarter rose 9.7% year-on-year to 53.9 billion won, and sales in the third quarter rose 28.8% to 67.2 billion won. It is analyzed that Keytruda's primary treatment benefit application effect occurred in earnest. In the case of sales in the third quarter, considering the drug price cut rate, it is calculated that usage increased by more than 60% compared to the same period last year. Keytruda, released in Korea in 2015, is an immune checkpoint inhibitor that treats cancer by inhibiting PD-1 protein on the surface of immune cell T cells to prevent binding to PD-L1 receptors and activate immune cells. In Korea, 21 indications were granted in 16 carcinomas, including melanoma, lung cancer, and head and neck cancer. Currently, the cancers that can use Keytruda have reached ▲ lung cancer, ▲ head and neck cancer, ▲ Hodgkin lymphoma, ▲ urinary epithelial cancer (Bladder cancer), ▲ esophageal cancer, ▲ melanoma, ▲ renal cell cancer, ▲ endometrial cancer, ▲ gastric cancer, ▲ small intestine cancer, ▲ pancreatic cancer, ▲ biliary cancer, ▲ cervical cancer 16, ▲ cervical cancer. It can be used in the largest number of cancer types among immuno-cancer drugs licensed in Korea. Keytruda's sales began to rise rapidly after insurance benefits were applied as a secondary treatment for non-small cell lung cancer in August 2017. Sales exceeded 10 billion won in the first quarter of 2018 and 30 billion won in the second quarter of 2019. In the first quarter of 2020, Lippito was brought down to the second place and ranked first overall, and since then, he has maintained the lead for 11 consecutive quarters. New drug products recently released by multinational pharmaceutical companies were strong at the top of drug sales. MSD's cervical cancer vaccine Gardasil 9 ranked third overall, with cumulative sales of 85.3 billion won in the third quarter, up 68.0% from the same period last year. Gardasil 9 saw its sales rise 39.2% year-on-year to 24.3 billion won in the first quarter, while sales in the second and third quarters grew 98.9% and 66.1% year-on-year, respectively. Gardasil 9 is an HPV (human papillomavirus) vaccine product that adds five serum types (31, 33, 45, 52, 58) to four serum types (6, 11, 16, and 18 types) owned by Gardasil. It includes most HPV types of cervical cancer vaccines. In addition to cervical cancer, the number of male vaccinations is also increasing every year due to word of mouth that Gardasil 9 can prevent HPV-related diseases such as anal cancer, reproductive demons, and precancerous lesions. Since July 2020, the recommended age for vaccination has expanded from 9 to 26 years old women to 27 to 45 years old women, and the rate of re-vaccination of adults who have previously been vaccinated against cervical cancer has also increased significantly. Sanofi's atopic dermatitis treatment Dupixent recorded 75.9 billion won in cumulative sales until the third quarter, up 45.2% from the previous year. Sales in the first and second quarters increased 77.0% and 47.6% year-on-year, respectively, while sales in the third quarter increased 23.8% from the previous year. Dupixent is the first targeted biological drug developed for the treatment of moderate to severe atopic dermatitis, where topical treatments are not recommended or symptoms are not properly controlled. It acts as a mechanism that selectively suppresses the signal transmission of interleukin-4 and interleukin-13, which are known to be the causes of atopic dermatitis. Dupixent, which received domestic permission in March 2018, has seen its sales expand rapidly since January 2020 when it was covered by salaries for severe atopic dermatitis. Dupixent's sales were only 3.3 billion won in the first quarter of 2020, but quadrupled to 13.5 billion won in the first quarter of last year. It has recorded sales of 20 billion won since the third quarter of last year. Ono's immuno-cancer drug Opdivo's cumulative sales in the third quarter were 79.8 billion won, up 32.6% from the previous year. Opdivo, which was licensed in 2015, began to see a significant increase in sales after it was listed as an insurance benefit in 2017. Opdivo surpassed 10 billion won in quarterly sales for the first time in the first quarter of 2018 and has recorded sales of 20 billion won since the third quarter of last year. Amgen's Prolia ranked fourth overall, with sales rising 28.6% from the previous year to 83.8 billion won in the first and third quarters. Released in Korea in November 2016, Prolia is a biomedical osteoporosis treatment that targets the protein RANKL, which is essential for the formation, activation, and survival of bone-destroying osteoporosis. Prolia began to see an upward trend in sales after salaries were applied only to secondary treatment therapy in 2017. Since April 2019, Prolia's sales have exploded as insurance benefits have been recognized in primary treatment. Among the new drugs developed by Korean companies, HK inno.N's anti-ulcer drug K-CAB ranked seventh overall with sales of 77.9 billion won in the third quarter, up 20.1% from the previous year. K-CAB, released in March 2019, is a new mechanism of action that inhibits gastric acid secretion by competitively combining proton pumps and potassium ions located in the final stage of acid secretion.
