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- 2026-05-18 18:57:48
- Company
- Downfall of Cialis·Viagra…market taken over by generics
- by Chon, Seung-Hyun Sep 06, 2021 05:59am
- ‘Viagra,’ which had once held a commanding lead over the erectile dysfunction treatment market, is having trouble making a comeback. After being taken over by domestic generics Palpal,’ and ‘Sendom,’ it had also been outrun by another local generic, ‘Gugu.’ Lilly’s Cialis is also having trouble making a comeback due to generic competition. According to the pharmaceutical research institution IQVIA, the oral erectile dysfunction treatment market in Q2 marked ₩29.5 billion, showing a 48% YOY increase. Also, this was a 3.1% increase from the previous quarter. The erectile dysfunction treatment market had seen a reduction in sales in Q1 and Q2 of last year and had only started making a recovery since the second half of last year. In 1H last year, the reduced number of patients’ hospital visits as well as restrictions in sales and marketing due to the spread of COVID-19 had slowed down sales, but the market recovered to the previous year's level from the second half of the year. Generics from domestic companies are showing increasing influence over the market. Hanmi Pharm’s Viagra generic Palpal sold ₩5 billion in Q2, solidifying its lead in the market. Palpal’s sales had fallen 4.4% YOY, but still had a far lead over the runner-up by that makes around ₩2 billion in quarterly sales. Palpal, which was released immediately after Viagra’s patent expiry in 2012, had surpassed Viagra’s sales in Q2 2013 and Cialis’s sales in Q4 2015, then has been holding the lead in the erectile dysfunction treatment market for 6 years. Chong Kun Dang’s Cialis generic Cendom kept its 2nd place by selling ₩2.7 billion in Q2, a 5.6% YOY increase. Cendom, which was released after Cialis’s patent expired in September 2015, gradually increased its share in the market to surpass its original Cialis in Q4 2017 and Viagra in Q4 2018 and reach second place in the overall erectile dysfunction treatment market. Hanmi Pharm’s Cialis generic Gugu also marked 3rd place for the first time since its release. Gugu sold ₩2.2 billion in Q2, making a 9.5% YOY increase. Gugu’s sales had surpassed Cialis in Q2 2019 and Viagra for the first time in this term. On the other hand, originals from multinational pharmaceutical companies had not shared such positive performance in sales. Viatris Korea’s Viagra sold ₩2.1 billion in Q2 and increased 1.0% YOY, but still gave way to Gugu and lost its 3rd place in the market. This was the first time Viagra had ranked 4th in the erectile dysfunction treatment market. Viagra lost its lead in 2013 to Palpal, then became 3rd place in 2018 being outrun by Cendom. Since then, the product had stayed in its place for 2 years but then was surpassed by Gugu this year. Viagra, which had once represented the erectile dysfunction treatment market, is now selling less than half of what Palpal sells. Sales of Lilly’s Cialis also fell 6.5% YOY to mark ₩1.5 billion in Q2. The drug had held a strong lead in the market for 3 years, from Q3 2012 to Q3 2015, but had to hand over the lead in the domestic erectile dysfunction treatment market to Hanmi’s Palpal upon patent expiry. Since then, Pfizer's Viagra and Chong Kun Dang’s Cendom had sequentially exceeded Cialis’s sales. In 2018, Lilly had signed an agreement with its former sales partner, Handok, for the domestic distribution, marketing, and sales of Cialis, but saw no recovery in sales.
- Product
- Take Ibuprofen after Pfizer COVID vaccine??
- by Kim JiEun Sep 06, 2021 05:58am
- Following Tylenol, the purchase of related drugs is increasing as Ibuprofen-containing painkillers have been raised to prevent side effects of COVID vaccines in certain companies. According to outpatient pharmacies on the 6th, patients who have recently been vaccinated (Pfizer vaccines) have frequently sought Ibuprofen-containing anti-inflammatory drugs. If manufacturers have purchased Tylenol before or after COVID vaccine, they have recently been looking for Ibuprofen, particularly IBU 600mg, among Pfizer vaccine or Moderna vaccine. The reason why people only look for Ibuprofen is that videos of some specialists have been affecting online or YouTube recently. This is because some media have suggested that myocarditis, and pericarditis caused by Moderna vaccine or Pfizer vaccine should be prevented by Ibuprofen's anti-inflammatory action. Some of the experts who actually run YouTube recommend taking Ibuprofen if they find chest pain after vaccination or prevention of myocarditis, one of the possible side effects of Pfizer vaccine. Pharmaceutical companies with Ibuprofen also posted advertisements in online malls exclusively for pharmacists to take medicine for abnormal reactions such as fever and pain after vaccination. A pharmacist in Seoul said, "There are quite a few patients who get Ibuprofen 600mg," explaining on YouTube that it is good to take Ibuprofen-containing anti-inflammatory pain medication for muscle pain after getting the shot. "I dion't know how to explain this," he said. As the number of patients wishing to purchase Ibuprofen-containing anti-inflammatory painkillers before vaccination increases, many pharmacists are also explaining the related information through blogs and YouTube. Outpatient pharmacists are struggling with medication guidance to patients who believe in in information that has not been immediately confirmed. Another pharmacist in Seoul said, "Acetaminophen was initially recommended after COVID vaccine because it was believed that taking anti-inflammatory anti-inflammatory drugs could interfere with antibody formation. If there are any side effects to Acetaminophen, it is okay to take other anti-inflammatory drugs. However, it is not true to say that Ibuprofen is the only drug after the Pfizer vaccination. Another pharmacist said, "Patients mistakenly believe that Pfizer vaccine can lead to cardiomyopathy, and that Ibuprofen can cure myocarditis" However, if the patient still wants to take Ibuprofen, we have no choice but to do so.
- Policy
- Insurance benefit denied for 3 Soliris and 1 Ultomiris cases
- by Lee, Hye-Kyung Sep 06, 2021 05:58am
- Last month, ‘Soliris (eculizumab)’ and ‘Ultromiris (ravulizumab),’ which both require prior approval to be administered with reimbursement, saw mixed results in the rate of approval of their preliminary applications. In July, the Health Insurance Review and Assessment Service’s Healthcare Review and Assessment Committee deliberated reimbursement applications for Soliris, Ultomiris, ‘Spinraza inj. (nusinersen),’ ‘Strensiq inj.,’ and hematopoietic stem cell transplantation. Deliberation results that were released on the 3rd showed that 3 new applications were filed for Soliris for its atypical hemolytic uremic syndrome indication but were denied. For Ultomiris, 40 of the 41 applications filed were approved for its paroxysmal nocturnal hemoglobinuria indication. One application for Soliris was denied as the patient was deemed unsuited for administration as defined in Soliris' indication as active thrombotic microangiopathy due to observed improvement in his/her schizocytes, or has secondary thrombotic microangiopathy due to malignant tumor or use of anticancer drugs. One application for Ultomiris was denied as the patient exceeded the normal upper limit of LDH by 1.5 times and was determined ineligible for administration as paroxysmal nocturnal hemoglobinuria. Among 37 applications filed for Spinraza month, 3 were new applications. Among the 3, 2 were approved and 1 was denied. The other 34 monitored cases were all approved. One application for Spinraza’s reimbursement was denied as the patient’s symptoms and signs related to SMA were not clearly identifiable in patients less than 3 years (36months) of age. Further details of the deliberation can be found on HIRA’s business portal, biz.hira.or.kr.
- Policy
- JAK Inhibitors increases heart attack
- by Lee, Tak-Sun Sep 06, 2021 05:58am
- The health authorities warned that taking JAK inhibitors, which are used as a treatment for rheumatoid arthritis, could cause serious heart problems such as heart attacks. The target items are Tofacitinib, Baricitinib, and Upadacitinib, which have been actively used in the market recently, so medical professionals will need to examine them more closely. Sales in related markets are expected to be rapidly reduced as the FDA will restrict the drug to certain patients who do not respond to TNF inhibitors or are not drug resistant. The MFDS includes Tofacitinib, Baricitinib, and Upadacitinib, which are used in the treatment of rheumatoid arthritis. The company announced that it has distributed the Dear Health Care Professional Letter, which states that preparation of Upadacitinib can increase the risk of developing severe heart-related diseases such as heart attacks. Tofacitinib, Baricitinib and Upadacitinib are JAK inhibitors and used to treat chronic inflammatory diseases such as arthritis or ulcerative colitis, and a total of 51 items (46 companies) are licensed in Korea. The items include Pfizer's Xeljanz, Lilly's Olumiant, and AbbVie's Rinvoq SR. After checking and reviewing the contents of the U.S. Food and Drug Administration (FDA) letter on the 1st, it explained that it was necessary to provide related safety information to domestic medicine experts and consumers. The U.S. FDA reported that a large randomized trial of Tofacitinib's safety confirmed that the risk of heart attack, stroke, cancer, thrombosis and death increased when the drug was taken. In addition, Baricitinib and Upadacitinib, which have the same mechanism as Tofacitinib, are considered to carry similar risks, adding ▲ severe heart disease, cancer, thrombosis, and death risks and ▲consider the benefits and risks of patients at the initiation or continuation of the drug administration. It also announced that the use of ▲ TNF inhibitors will be restricted to certain patients who do not react or are not drug resistant. The MFDS announced that it plans to quickly take necessary safety measures for patients by reviewing domestic and foreign licensing status, and action status of the drug, including expert advice. Hospitals in South Korea stressed that the information should be checked when administering the ingredients to patients.
- Company
- Forxiga will become a basic treatment for chronic kidney dz
- by Sep 06, 2021 05:58am
- "SGLT-2 inhibitors are no longer diabetes drugs. It will be recognized by doctors of kidney medicine as a basic medicine that protects kidney function and is good for use with other medicines." Physicians expect SGLT-2 inhibitors, which have expanded their scope to kidney treatments. Choi Bum-soon, a professor of kidney medicine at the University of Catholic Medicine at Eunpyeong St. Mother's Hospital, commented on the new treatment option "Forxiga (Dapagliflozin)" that appeared in more than 20 years at an online press conference. From the left, Professor Ko Kang-ji of Korea University Guro Hospital, Professor Yang Chul-woo of Seoul St. Mary AstraZeneca's Forxiga was the first SGLT-2 inhibitor to obtain kidney medication. Forxiga, which began with diabetes drugs, was foreseen through several studies. Forxiga showed decreased cardiovascular events, kidney protection benefits, and decreased albuminuria in the DECLARE-TIMI 58 study of diabetics. The subsequent DAPA-CKD study demonstrated excellent kidney protection in patients with chronic kidney disease with a tetrahedron filtration rate of 25 to 75μg/min/1.73㎡, regardless of type 2 diabetes. "There have been few drugs to help patients not to deteriorate their kidney function," said Koh Kang-ji, a professor of kidney medicine at Korea University's Guro Medical School, at a meeting on the 30th to commemorate the addition of Forxiga chronic kidney disease. "The RAAS blocker worked, but it was 20 years ago that Forxiga was very welcome, and because it effectively reduces the pressure in the glomerulus as a different mechanism than the RAAS blocker, it can be used complementively." Professor Ko emphasized Forxiga's role in early patient treatment. "If we use Forxiga in early patients, we can effectively reduce chronic progression by increasing eGFR and we can use it effectively and safely," he said. "We need to make various efforts to increase the diagnosis rate of mild patients and quickly apply Forxiga." Choi gave advice on the proper use of drugs through Forxiga. The DAPA-CKD study found that the Forxiga administration group had a lower eGFR than the control group at the beginning. Professor Choi said, "Because the graph crossover over time, it is important for the medical team to confidently talk about patients' anxiety." "A 10% decrease compared to the baseline is a temporary phenomenon, and if more than 30% changes, we choose to temporarily stop and rewrite medicine." He added, "Since using Forxiga may cause dehydration, it is recommended to be careful of use in elderly people and patients scheduled for endoscopy and surgery the next day, and urinary tract infections are not worth worrying about." In its revised guidelines for treating heart failure announced this month, the ESC recommended SGLT-2 inhibitors such as Forxiga and Jardiance as primary treatments for patients with HFrEF. As Jardiance demonstrated its effectiveness in cardiac output coefficient-preserving heart failure (HFpEF) patients, the scalability of SGLT-2 inhibitors was further broadened. The medical team predicted that SGLT-2 inhibitors will become a major treatment option even in kidney disease. Yang Chul-woo, professor of kidney medicine at Catholic University's Seoul St. Mary's Hospital, said, "In order to live a long life as a joke, anti-hypertensive drugs such as Aspirin, Statins, and RAAS are essential, and the fourth drug is Forxiga (SGLT-2 inhibitor)." "We believe that SGLT-2 inhibitors will become a basic drug, and Forxiga is playing an important role as a leader," he said.
- Product
- Disturbance to secure inventory of Diovan and Exforge
- by Jung, Heung-Jun Sep 05, 2021 08:26pm
- Pharmacists suffered from inventory after six products, including Diovan and Exforge, by Novartis Korea, were announced to local pharmacies on the afternoon of the 1st. When there were concerns that impurities were detected, Novartis Korea explained that the quality was fine, but it was a lot release that was decided due to administrative delays. According to local pharmacies on the 1st, four products including Diovan, Co-Diovan, Exforge, and Entresto by Novartis Korea and Kotarec and Tarec by Sandoz Korea will be suspended from September. It said the lot release was suspended because it did not submit safety inspection data to the MFDS until the end of August. Upon hearing the news, pharmacists rushed to secure inventory, and all products were sold out at pharmacies-only online malls. Pharmaceutical companies immediately explained that the decision to suspend lot release is not a matter of quality. "Azido impurities were not detected in Valsartan raw materials used in that product," a Novartis Korea official said. "We have been conducting investigations for many years to confirm that there is no problem, and right after the incident, the headquarters submitted the manufacturing process verification data to major European and overseas countries and confirmed that there was no problem." Although the related documents were recently submitted to the MFDS, it took some time to confirm, so the lot release was inevitably decided from September 1. "Lot release is scheduled as soon as the reply comes," the company added. Later in the day, Novartis sent an official letter to hospital doctors and pharmacists, explaining that there was no problem with the quality of the products mentioned. A pharmacist in Seoul said, "We received an answer that we will try to release the product as soon as possible once we prepare the prescription with our inventory." "I'm glad to hear that." Another pharmacist in Gyeonggi do (in an online mall) seems to have hoarded some pharmacies because of anxiety. "I think it's going to work out faster than I thought."
- Policy
- The Committee discusses the permission for Mifegymiso
- by Lee, Tak-Sun Sep 05, 2021 08:25pm
- Mifegymiso, which Hyundai has applied for permission, will be discussed at the Central Pharmaceutical Advisory Committee, the MFDS' legal advisory body. The Central Pharmaceutical Advisory Committee's consultation is expected to determine whether Mifegymiso will conduct a bridging study in Korea. The MFDS will hold a meeting at the Central Pharmaceutical Advisory Committee on the 2nd to ask whether Mifegymiso-related safety and validity are reasonable. The meeting is expected to receive comments on the current controversial Bridging Study. "We will discuss Mifegymiso's Bridging Study at the Central Pharmaceutical Advisory Committee," said an official at the MFDS. "Based on the results of the consultation, we will review the direction of the item permit review." If Mifegymiso is granted, it will be the first for the medical termination of a regency in Korea. The MFDS has changed its registration to allow abortion to be introduced in accordance. Since there have been no medications for termination of pregnancy, other medications have been used for termination of pregnancy. In July, Hyundai applied for permission from Mifegymiso (Mifepristone and Misoprostol), an oral medication. The drug is supplied by British pharmaceutical company Linepharma International and will be supplied exclusively by Hyundai. The MFDS has also begun a full-fledged review. It is heard that screening such as safety, validity, quality, and GMP is currently underway. Some in the medical community argue that bridging study should be carried out to secure safety for Koreans before using the drug. The women's community argues that Mifegymiso's Bridging Study should be omitted and approved quickly because Bridging Study has no substitute and can be exempted if necessary. As a result of social controversy, the MFDS has formed an expert to ask whether it is bridging study. If the Central Pharmaceutical Advisory Committee decides on the pros and cons of Bridging Study, the MFDS is likely to accept it. If bridging study is carried out, the item permit is expected to be delayed due to a period of about a year. Attention is focusing on what scientific conclusions the MFDS will reach amid controversy.
- Company
- Boryung released Avastin Biosimilar for the first time
- by An, Kyung-Jin Sep 05, 2021 08:24pm
- View of Boryung headquarters buildingBoryung announced that it will sell its anti-cancer biosimilar "Onbevezy" introduced by Samsung Bioepis in the domestic market from the 1st. Onbevezy is a biosimilar product of the blockbuster anti-cancer drug Avastin (Bevacizumab) developed by Roche. Samsung Bioepis proved the equivalent effect and safety of its original product Avastin through Phase 1 and Phase 3, and received approval for domestic items as the first biosimilar of Bevacizumab in March. It has indications such as metastatic direct colon cancer, metastatic breast cancer, non-small cell lung cancer, progressive or metastatic neoplasm, glioblastoma, epithelial ovarian cancer, ovarian cancer, primary peritoneal cancer, and cervical cancer. In May, Boryung signed an exclusive contract with Samsung Bioepis for Onbevezy 100mg and 400mg. It plans to expand its influence in the anti-cancer drug market by releasing products simultaneously with the listing of drug benefits on September 1. By adding biosimilar anti-cancer drugs to its portfolio, it is also expected to increase its competitiveness in the anti-cancer drug sector. As of 2019, Avastin recorded about ₩8.8 trillion in sales in the global market. In South Korea, it formed a market worth ₩118 billion (IQVIA) based on accumulated sales last year. Onbevezy is 37 % cheaper than the original Avastin. It has a longer expiration date from 24 months to 36 months. "Onbevezy is cheaper than Avastin," said Kim Young-seok, head of the Boryung anti-cancer drug division. It will be an alternative to ease the financial burden of patients and increase the performance of treatment. "We will actively try to settle in the market quickly through synergy between Samsung Bioepis' product power and Boryung's sales competitiveness."
- Company
- Academia supports 1st-line reimbursement of Tagrisso
- by Eo, Yun-Ho Sep 03, 2021 06:03am
- The lung cancer societies are supporting the need to extend insurance benefits for ‘Tagrisso’ to 1st line treatment in lung cancer. In July, AstraZeneca Korea had reduced the standards and reapplied to extend reimbursement to the reduced scope for its 3rd generation EGFR TKI Tagrisso (osimertinib). However, the Health Insurance Review and Assessment Service had decided not to deliberate Tagrisso’s reimbursement as an agenda at the Cancer Disease Deliberation Committee meeting in September. However, still, HIRA had sought opinions from relevant societies, including the Korean Association for Lung Cancer, the Korean Society of Medical Oncology, and the Korean Cancer Study Group. All the societies have expressed support for Tagrisso’s 1st-line indication and submitted opinion statements that a reimbursement extension is necessary, even for the reduced standard. The key strategy for approval of the insurance benefit this time is in the reduced benefit standards. In its application, AstraZeneca reduced the scope of its reimbursement to ‘1st-line treatment of patients with EGFR exon 19 deletion or those with brain metastasis’ rather than in line with its indication of ‘NSCLC patients whose tumors have EGFR mutations, with exon 19 deletions or exon 21 (L858R) mutations.’ In other words, the company adopted the strategy to increases the justification of Tagrisso’s efficacy and treatment benefits. Narrowing the scope of reimbursement would naturally allow for a broader discussion on its fiscal impact. So HIRA decided to collect the society’s opinion on the proposal for the reduced scope of reimbursement. On this, the lung cancer societies have submitted an opinion statement that states “Tagrisso needs to be reimbursed for 1st line NSCLC according to its indication. Therefore, the society sees no problem reimbursing the drug for the reduced scope of standards, and support its coverage extension.” An official from one lung cancer society said, “The drug has already demonstrated statistically significant benefit through a Phase III study and should be reimbursed according to this indication. However, as the agenda continues to be unable to pass the CDDC review stage, we submitted an opinion statement that reimbursement should be first approved for patients in urgent need of such prescriptions.” Tagrisso had added the indication for 1st-line treatment of lung cancer in Korea in December 2018 and aimed to expand its reimbursement to the indication in 2019. However, at the Cancer Disease Review Committee meeting in October, the committee decided to defer the decision until the full data from the Phase 3 FLAURA trial that studied the overall survival (OS) of NSCLC patients in 1st line is disclosed. Although AstraZeneca had submitted the full FLAURA data and expressed their will to accept most of the cost-sharing plan proposed by the government, the reimbursement fell through due to opposition from committee members (specialists) due to issues on the drug’s clinical efficacy. AstraZeneca had attempted to reverse the decision by submitting the OS evidence confirming Tagrisso’s OS benefit in Asian patients from the FLAURA China study, but the committee’s response was, once again, a ‘No.’ After Tagrisso failed to receive reimbursement in April, 1,713 lung cancer patients and their families sent an appeal to the government, the Korean Association for Lung Cancer, and AstraZeneca, “imploring approval for the 1st-line reimbursement of Tagrisso.”.
- Policy
- GOV to bring 1.5 mil COVID-19 vaccines from Romania
- by Kim, Jung-Ju Sep 03, 2021 06:03am
- The Korean government has secured 1,503,000 doses of Pfizer and Modena’s COVID-19 vaccines from Romania and will bring the vaccines to Korea in two shipments this week and next week. The swap was made in line with cooperation for preventive measures against the pandemic that was discussed between the two countries from last month to exchange vaccines with medical supplies. Presided by Vice Head 2 Hae-Cheol Jeon, The COVID-19 Central Disaster and Safety Countermeasures Headquarters (Head: Prime Minister Boo-Kyum Kim) today reported on the progress made for the ‘KOR-RO vaccine cooperation’ to central ministries and 17 metropolitan councils at the Central Government Complex’s virtual meeting room. According to the CDSCH, a total of 1,503,000 doses - 1,053,000 doses of the Pfizer vaccine and 450,000 doses of the Moderna vaccine – will arrive on the 2nd and 8th at the Incheon International Airport through the KOR-Romania vaccine cooperation, 526,500 doses of the Pfizer vaccine will first arrive on the 2nd, then the 526,500 doses of the remaining Pfizer vaccine as well as 450,000 doses of the Moderna vaccine will arrive via DBI at 3:00 p.m. on the 8th next week. The two governments had started discussions on the 10th last month to exchange vaccines and medical supplies to cooperate in areas needed to prevent and control the pandemic, at a time when the world was suffering vaccine shortages. As a result, Korea was able to purchase 1,053,000 doses of Pfizer’s vaccine and receive a contribution of 450,000 doses of the Moderna vaccine from Romania in exchange for a contribution of needed medical supplies from Korea. The two countries have been strengthening healthcare cooperation as strategic partners since the COVID-19 crisis. Romania had expressed gratitude to Korea for providing diagnostic kits to Romania in the early stages of the COVID-19 outbreak, which was the 60th year since establishing diplomatic ties with Romania. This vaccine cooperation is part of the country’s efforts to boost global solidarity and efficiency in cooperation to overcome the pandemic. The government expected the vaccine cooperation to further strengthen the ties between the two countries. The 1,053,000 doses of Pfizer’s vaccine supplied are from Pfizer Belgium and are set to expire on the 30th of this month. The 450,000 doses of the Moderna vaccine are from Rovi in Spain and are set to expire from November 12th to December 5th. The 1,503,000 doses of the Pfizer and Moderna vaccines will be used to inoculate those aged from 18 to 49 as soon as it arrives in Korea. The government also announced its plans to continue various efforts to ensure a stable supply of vaccines in Korea. Also, as global exchange, donation, and repurchase of vaccines are actively being implemented to make up for the gap in vaccine procurement between countries, the Korean government also plans to contribute to the efficient use of vaccines and international cooperation to respond to COVID-19.
