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- 2026-05-14 05:31:34
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- 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.
- Policy
- Avastin biosimilar will be reimbursed starting next month
- by Lee, Tak-Sun Nov 29, 2022 05:53am
- Celltrion VegzelmaCelltrion's Avastin biosimilar Vegzelma will be listed on the 1st of next month. As a result, Roche, which owns the original Avastin, has joined Alvogen Korea, a biosimilar company, Samsung Bioepis, and Celltrion, making the market competition a four-way race. According to industries on the 25th, Celltrion Vegzelma's 0.1g and 0.4g will be listed at 208,144 won and 677,471 won, respectively, on the 1st of next month. The price is the same as Samsung Bioepis' Onbevezy and Alvogen's Arimcis. Bevacizumab formulations are anticancer drugs used in various carcinomas, with the domestic market reaching about 100 billion won. The original Avastin recorded 38.1 billion won in the first half of last year based on IQVIA. In September last year, Samsung Bioepis Onbevezy received a salary and was released for the first time in Korea as a biosimilar. This product is currently being sold by Boryung Pharmaceutical. Onbevezy's one-year monopoly in the biosimilar market was broken when Albogen Korea released Arimcis last month. Arimcis is sold by Daewoong Pharmaceutical. Competition for Bevacizumab formulations is expected to begin in earnest as Celltrion joins in December. Although biosimilars are less popular in the domestic market, Celltrion is also looking forward to Bevacizumab as it is only Remsima that performs as well as the original. Since the drug price difference between the original and biosimilars is not significant, the performance difference is expected to appear depending on marketing and distribution capabilities. However, the fact that Alvogen Arimcis is limited in use in relation to ovarian cancer due to patent problems is considered a weakness in the indication. Although Samsung Bio and Celltrion are raising their stock prices with biosimilars overseas, it is true that they have been negligent in marketing in the domestic market, which is small in size. However, the Avastin biosimilar is expected to be active in investing in domestic sales due to its large domestic market size. Attention is focused on who will win the four-way race for biosimilars.
- Company
- First targeted PIK3CA Piqray reapplies for reimb
- by Eo, Yun-Ho Nov 28, 2022 05:51am
- An anticancer drug that targets the PIK3CA gene will once again attempt reimbursement listing in Korea. According to industry sources, Novartis Korea submitted a reimbursement application for the reimbursement of its breast cancer treatment Piqray (alpelisib) recently. The drug was unable to pass deliberations by the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee in February this year. Piqray, which was approved in Korea in May last year, is a 'PIK3Caα-inhibitor that blocks the overactivation of the PI3K enzyme which, when overactivated because of a mutation in the PIK3CA gene, stimulates cancer cells to divide and grow in an uncontrolled fashion. The targeted cancer therapy is prescribed in combination with Faslodex (fulvestrant) to treat metastatic and advanced-stage, hormone-receptor-positive/ HER2-negative breast cancer in patients who failed previous treatment. Piqray’s safety and efficacy were demonstrated in the SOLAR-1 trial, which was conducted on 572 postmenopausal women, and men, with HR+, HER2- advanced (locoregionally recurrent or metastatic) breast cancer whose disease had progressed or recurred on or after an aromatase-inhibitor-based treatment (with or without CDK4/6 combination) Results showed when used in combination with Faslodex, Piqray improved the median PFS (Progression- Free survival) of cancer patients with the PIK3CA mutation from 5.7 months to 11 months. The Objective Response Rate (ORR), which indicates the proportion of patients whose tumor size was reduced by over 30%, was 35.7% for the combination therapy group, which is twice more than the 16.2% in the fulvestrant monotherapy group. The secondary endpoint, Overall Survival (OS) in patients with PIK3CA mutations, was 39.3 months in the combination therapy group. This was 8 months longer than the 31.4 months in the fulvestrant monotherapy group but did not have statistical significance.
- Policy
- Actilyse's price to rise 15% from next month
- by Kim, Jung-Ju Nov 28, 2022 05:50am
- The price of Boehringer Ingelheim’s acute myocardial infarction treatment Actilyse Inj. (alteplase) will rise 15% from next month after applying for drug pricing adjustments. Aju Pharm’s acute back pain reliever (aceclofenac, eperisone hydrochloride) will newly receive a 10% premium for 1 year. Also, the 30.4% premium pricing for Hanmi Pharmacueetical’s allergic rhinitis treatment Potastine OD Tab (bepotastine calcium dihydrate) will be maintained due to the small number of companies producing the same product, and Kyowa Kirin Korea voluntarily opted for a 1.5% reduction in the price of its Romiplate 250μg (romiplostim). According to industry sources, the Ministry of Health and Welfare is working to amend the ‘drug reimbursement list and reimbursement ceiling price table’ to implement the changes above for implementation on December 1st. First, Aju Pharm’s Afexon Tab has been newly listed with premium pricing for 1 year. The premium pricing rate will be wet at 10%. For incrementally modified combined new drugs, the government applies a 59.5% premium for first generics for one year from listing. For drugs from innovative pharmaceutical companies, the premium is set at 68% of the original drug price in the first year, then subsequently lowered to 53.55% after the term is terminated. The premium pricing for Hanmi Pharmaceutical’s Potastine OD Tab will be maintained for the time being due to the small number of companies manufacturing the same item. The premium rate of the drug is set at 30.4%. The government applies premium pricing to drugs when there are 1 or less companies that produce a drug with the same route of administration, ingredient, and formulation as the first-listed incrementally modified new drug. However, if no other companies produce the same product even after the 5-year premium pricing period, the premium pricing is maintained until the number of companies becomes 2 or more. On the other hand, some companies have opted for strategic price reductions for marketing, etc. Kyowa Kirin Korea applied for drug pricing adjustments to reduce the price of its Romiplate 250μg by 1.5%, and the reduction will be applied from the next month. Boehringer Ingelheim Korea applied for a price increase for its Actilyse Inj. (alteplase), and after undergoing negotiations, the price of Actilyse will be raised by 15% for each strength from next month. The application to adjust the ceiling price for price increases can be submitted when the drug is ▲essential to the treatment of patients, ▲has no alternatives, ▲is supplied by one company and its administration is cheaper than its alternatives. After the drug passes deliberation by the Health Insurance Review and Assessment Service’s Drug Reimbursement Review and Assessment Service and undergoes drug pricing negotiations with the National Health Insurance Service.
- Opinion
- [Reporter's view]There should be no recurrence of COVID kit
- by Lee, Hye-Kyung Nov 28, 2022 05:50am
- Demand for self-examination kits is increasing rapidly as Twindemic, where COVID-19 and seasonal flu are prevalent at the same time, becomes a reality. According to the pharmacy site data analysis service Care Insight (www.careinsight.co.kr), 12,629 self-kits were sold at 396 pharmacies in the 47th week of this year (11/13-19), with daily sales of about 4.56 pharmacies. As the average daily sales per pharmacy in the 43rd week of this year increased every week from 2.45 to 2.87 (44 weeks) → 3.28 (45 weeks) → 3.91 (46 weeks), some are concerned about the recurrence of the supply shortage of self-kits in the first half of this year. The Ministry of Food and Drug Safety said it is continuously monitoring domestic production and inventory, adding that it is not at a stage where it is concerned about the reproduction of supply shortages. The reason is that as of November 15, the inventory of self-kits is 70 million people, which can produce about 40 million people a week. Front-line pharmacies are concerned that if the number of people looking for self-kits increases due to the Twindemic, the supply shortage that occurred earlier this year could be reproduced if demand suddenly increases more than supply. In particular, as pharmacies were confused by the Ministry of Food and Drug Safety's management system, which changes every day at the time of the supply of self-kits, they have no choice but to worry about securing inventory of self-kits in preparation for Twindemic. When the shortage of self-kits occurred in February, the government's policy changed several times in just 10 days. On February 11, the Ministry of Food and Drug Safety announced a ban on online sales on February 10, followed by then Prime Minister Kim Boo-kyum's "consideration of introducing the highest price system," limiting sales to pharmacies and convenience stores, allowing small sales, and limiting purchases. Pharmacists could not trust the government as they announced the designation of 6,000 won for each sale on Feb. 14, announced the application of 50 quotas per seller, and changed their words to abolish the 50 quota system on Feb. 16. The problem occurred once more last August. Complaints from pharmacies have increased as convenience stores that have not reported medical device sales businesses have been allowed to sell their own kits from July 20 to September 30. It is said that the supply of self-kits is sufficient now, but if there is a shortage again, the Ministry of Food and Drug Safety is expected to actively intervene as in the cases in February and July. However, if another unprepared policy and plan to ignore the existing system are announced, trust will eventually be broken. The Ministry of Food and Drug Safety should predict demand with experts in advance and create natural solutions together, not urgent measures so that there is no confusion and dissatisfaction at the site.
