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- 2026-05-18 18:57:47
- Policy
- PPIs benefit from ranitidine’s market removal
- by Lee, Jeong-Hwan Aug 19, 2021 06:03am
- MFDS notice regarding ban on ranitidine drugs With proton pump inhibitors (PPI) enjoying reflective interest in sales from the market removal of ranitidine, which was banned due to detection of the potentially carcinogenic substance NDMA(N-Nitrosodimethylamine), criticism is rising that national health insurance finances are being unnecessarily wasted. The point is that PPIs cost on average twice to three times more than tidine-class H2 receptor blockers, and the increased use of the PPIs not only increases NHI expenditures but also increases the financial burden borne by the patients. On the 17th, the pharmaceutical industry was been busy analyzing the changes in the peptic ulcer treatment market brought on by the banned sales of ranitidine drugs after the rise of its NDMA impurity issue in 2019. After ranitidine was removed from the market due to the detection of NDMA impurities, a significant amount of prescriptions have moved from H2 receptor blockers to PPIs. Annual prescription sales from 2018 to 2020 also show that prescription sales of PPIs have increased from ₩454.9 billion in 2018 to ₩523.4 billion in 2019, and ₩633.5 billion last year. On the other hand, prescription of H2 receptor blockers decreased from ₩346.5 billion in 2018 to ₩296 billion in 2019 when NDMA impurities were detected and relevant products were banned from the market, then fell to ₩132.5 billion last year, to be reduced to 1/3 in just 3 years. Numbers show that the size of the peptic ulcer prescription market has rather grown compared to 2018 due to an increase in PPI prescriptions despite the removal of the ranitidine ingredient. The growth of the prescription market was influenced by the increased use of PPIs that cost on average twice to three time more than H2 receptor blockers. More specifically, H2 blockers cost ₩276 to ₩360 a day at an average of ₩314/day, whereas PPIs cost from ₩527 to ₩1,300 at an average of ₩314/day. Due to this, some have criticized that replacing ranitidine prescriptions with the high-priced PPIs that are of a different class when other lower-priced H2 blockers in the same class as ranitidine with no NDMA detected are available increases waste of NHI finances. Their position is that changing prescriptions to higher-priced drugs not only increases NHI expenditures but also increases the financial burden borne by patients in the long term. To resolve the issue, industry experts had suggested that the authorities should provide same-class drug prescription recommendations in the event inevitable recalls and substitution of drugs arise due to safety issues as in the NDMA case, Industry experts believe efforts such as introducing pop-up windows in the DUR system that show same-class drug recommendations when HCPs select and prescribe drugs should be made to prevent an unnecessary increase in NHI expenditures. An official from a domestic pharmaceutical company said, “I am positive about the government’s decision to promptly recall and discontinue sales of the potentially harmful ranitidine substance, but it is unfortunate that there were no specific guidelines on its replacement and that it caused an increase in NHI expenditures. It is a waste of NHI finances as well as an increased financial burden on the patients to substitute ranitidine to high-priced PPIs when there are other, lower-priced drugs available in the same class with the same indications.” He continued, “The replacement process for hazardous drugs should be further improved and advanced using the DUR system, etc. It is the doctor’s responsibility to select or switch drugs due to their lack of effect in the treatment process, however, the use of same-class low-priced drugs should be prioritized for substitutions due to external factors."
- Company
- The Supreme Court again rejected α-GPC suspension
- by Chon, Seung-Hyun Aug 19, 2021 06:02am
- The Supreme Court again rejected α-GPC suspension to negotiate the withdrawal of Choline alfoscerate. Pharmaceutical companies finally lost the withdrawal negotiations. According to an industry on the 17th, the Supreme Court's special department 2 decided to reject discontinuance of trials in negotiations on the recovery of the Choline alfoscerate system filed by 27 companies including Chong Kun Dang on the 12th. Discontinuance of trials is a system that does not accept appeals if it is judged that there is no specific reason. At the end of last year, the MOHW ordered the NHIS to sign a medical care contract for the system. It means that if the clinical trial fails, the MFDS should proceed with a recovery negotiation to return the entire amount of the health insurance prescription to the NHIS from the date of submission of the clinical plan to the date of deletion. It means that if the clinical re-evaluation of the Choline alfosculate system, which is being pursued by the MFDS, fails, pharmaceutical companies will have to return the prescription results to the NHIS from the date of submission of the clinical plan to the date of cancellation of the permit. Pharmaceutical companies filed an administrative litigation and suspension of execution against the MOHW's order to negotiate the recovery. The lawsuit was divided into 28 companies including Daewoong Bio and 28 companies including Chong Kun Dang. The suspension of execution, which was raised by the Chong Kun Dang and others, was rejected in May after the ruling was rejected in January. Chong Kun Dang and others filed for a re-appeal, but it was rejected again. Following the first and second trials, the Supreme Court ruled in July that Daewoong Bio and others rejected discontinuance of trials. The suspension of execution, which was requested by pharmaceutical companies, was finally rejected. Pharmaceutical companies have also claimed suspension of execution for re-ordering the recapture negotiations. When the MOHW ordered renegotiation in June, 26 companies, including Chong Kun Dang, and 26 companies, including Daewoong Bio, were divided into an action for nullity and suspension of execution. On the 6th of last month, Daewoong Bio's request for suspension of execution was dismissed, and on the 8th of last month, the decision was made to dismiss the suspension of execution, which was raised by Chong Kun Dang and others. Chong Kun Dang and others have filed another appeal for suspension of execution.
- Policy
- It plans to expand its supply of Moderna vaccines in Aug/Sep
- by Kim, Jung-Ju Aug 19, 2021 06:02am
- It plans to expand its supply of Moderna vaccines in August and September. Samsung Biologics' distribution in Korea is still pending. A government delegation to the U.S. announced the results after visiting Moderna The government received an apology from Moderna for the disruption in the domestic supply of COVID vaccines and announced that it will receive more domestic supplies this month and next month and move up the supply schedule early next month. However, the government avoided giving a definite answer as there are many obstacles such as contracts between companies regarding supplying models or products that Samsung Biologics is consigned to Korea first. At the COVID-19 Central Disaster and Safety Counters Headquarters, video conference held today (the 17th), the delegation consisting of Kang Do-tae, the second vice minister, and Ryu Geun-hyuk, the presidential secretary for social policy, reported last week's visit to the U.S. Moderna headquarters, and the company's recent discussion on vaccine supply disruption and supply stabilization. According to the MOHW and Central Disaster and Safety Counters Headquaters, during the visit, Moderna apologized for the government and people's difficulties caused by sudden supply disruptions, and explained that the manufacturing laboratory problems at cooperative manufacturers are now being resolved and gradually released in July. The government asked the company to provide supplies that could not be supplied from August to early September, and to inform the schedule by this week, and Moderna said it would do its best to supply supplies and notify the government of its supply plan. In particular, the government has not received a clear answer on how it can supply production volume of Samsung Biologics, which is consigned to produce Moderna vaccines, to South Korea. In an answer to a regular briefing question, Vice Minister Kang Do-tae said, "It is desirable that domestic consignment production supplies are supplied to Korea in terms of securing safety in the supply of vaccines and streamlining the distribution process. He added, "There is a need for continuous consultation on the contractual relationship between Samsung Biologics and Modena, and the interrelationship between companies and domestic administrative procedures" According to the government, there will be no significant disruption to the age-specific vaccination plan and achievement of the target.
- Company
- Will AML drug Xospata be reimbursed through PE exemption?
- by Eo, Yun-Ho Aug 18, 2021 05:52am
- Whether the new leukemia drug Xospata that is attempting reimbursement through the PE exemption track will be able to be listed for insurance benefit in Korea is receiving attention. According to industry sources, Astellas Korea’s acute myeloid leukemia (AML) treatment Xospata (gilteritinib), which applied for reimbursement through the PE exemption track, passed the Health Insurance Review and Assessment Service’s RSA subcommittee last June. However, after passing the subcommittee, the drug’s reimbursement was no put on as an agenda of the Pharmaceutical Benefit Assessment Committee in July or August, therefore making no progress in its discussions. Accordingly, speculation is rising that ‘applying 80% of the A7-adjusted lowest price for PE exempted drugs', which has recently emerged as a hot topic in the industry, may be the cause of the delay. Xospata is the first FLT3-targeted anticancer therapy to be approved by the Ministry of Food and Drug Safety in Korea to treat FLT3 mutation-positive (FLT3mut+) relapsed or refractory AML. The drug targets both FLT3-ITD and FLT3-TKD of the FLT3 mutations and may be self-administered orally once daily as monotherapy at home without frequent hospital visits. Also, the drug demonstrated better efficacy and safety compared to chemotherapy. Xospata has received the highest - ‘Category 1’ - recommendation in the NCCN Clinical Practice Guidelines for treating patients with relapsed or refractory (R/R) AML with an FLT3 mutation. Interest in Xospata is high as a treatment option that had never existed before. In fact, the Korea Alliance of Patients Organization had delivered their opinion requesting prompt reimbursement of new drugs including Xospata at a roundtable with the Ministry of Health and Welfare’s Division of Pharmaceutical Benefits in May. Healthcare professionals have also shown high expectations for the drug. Hee-Je Kim, Professor of Hematology at the Catholic University of Korea’s Seoul St. Mary’s Hospital said, “The approval of Xospata in Korea has resolved the specific concern of patients having to endure the condition without a proper treatment option. Of course, the cost remains a problem, however, if the drug is listed for the insurance benefit, I believe it will quickly settle as the standard of care in for its indication." Kim added, “FLT3mut+ R/R AML patients need to promptly receive adequate treatment as they have a poor prognosis and are at risk of rapid disease progression. This is why Xospata is being continuously being prescribed even without reimbursement.”
- Company
- Hanmi & Organon maintain ₩70 billion worth contract
- by Kim, Jin-Gu Aug 18, 2021 05:52am
- Hanmi has maintained a copromotion contract with Organon, which is separated from MSD. According to the Financial Supervisory Service on the 18th, Hanmi signed a domestic copromotion contract with Organon in the second quarter. The contract is due at the end of this year. The items include hair loss treatment Propecia, prostate hypertrophy treatment Proscar, and osteoporosis treatment Fosamax. The total amount of prescriptions last year amounted to ₩67.7 billion. Propsia's prescription amount is ₩41.3 billion, Prosca's prescription amount is ₩14.3 billion, and Fosamax's prescription amount is ₩12.2 billion. Hanmi had already signed a contract with MSD to promote its products. However, the contract was changed as Oganon spun off the MSD earlier this year. In the end, Hanmi and Organon signed a new contract with the same contents. Hanmi has signed contracts with MSD and Organon for more than 10 years. The renewal of the contract is also due to the contract made in 2014. At that time, the two companies drew attention by signing a two-way contract to mutually promote products from each company, rather than a one-way contract for domestic companies to promote items from multinational companies. Hanmi has decided to jointly sell MSD's Propecia, Proscar, Fosamax, Andriol, Livial, Cosopt-S, Emend, Invanz, and Ezetrol. MSD has decided to co-promote Hanmi (such as PalPal and Tamsulosin). Earlier in 2009, MSD signed an overseas export contract with Amosartan, a hypertension combination drug of Hanmi. It was the first time a multinational pharmaceutical company sold a drug developed by a domestic company. It is currently sold in more than 50 countries under the name Cozaar XQ. Last year, MSD signed a license agreement with Hanmi to develop, manufacture, and commercialize dual agonist for non-alcoholic fatty hepatitis (NASH) treatments, which was canceled due to the return of Janssen's rights. In March this year, Hanmi's hyperlipidemia combination drug Rosuzet was released in Mexico under the name of NAXZALLA, and Organon is in charge of local marketing. Hanmi signed an export contract with MSD in 2017 to 23 countries, but the contract was recently changed following the establishment of Organon.
- Policy
- Indication extensions filed by Abilify generics increase
- by Lee, Tak-Sun Aug 18, 2021 05:51am
- Otsuka After Yungjin Pharm finally succeeded in invalidating the use patent of Abilify (aripiprazole·Korea Otsuka Pharmaceutical) after 6 years of patent dispute, other generics products of Abilify are now seeking to extend its indications. The use patent that was in dispute had protected Abilify’s ‘bipolar disorder’ indication, due to which generic companies other than Yungjin Pharm were unable to include the indication in their Abilify generics. According to the Ministry of Food and Drug Safety on the 16th, applications containing the 'treatment of acute manic and mixed episodes related to bipolar disorder' indication are being continuously filed for Abilify generics. Bipolar disorder, commonly known as 'manic-depressive disorder,’ causes extreme mood swings that include a pattern of emotional highs (mania or hypomania) and lows (depression). Abilify is a representative central nervous system (CNS) drug that has many indications, including schizophrenia, bipolar disorder, major depressive disorder, irritability associated with autism, and Tourette syndrome, etc. However, Otsuka had registered use patents for each indication at the time of indication expansion, restricting the use of generics for such indications. As a result, most domestic companies with Abilify generics had released their product in the market with only 1 to 2 indications, such as schizophrenia and Tourette syndrome. On the other hand, Yungjin filed an invalidation suit on the use patent registered for Abilify’s bipolar disorder and received approval for the said indication. The patent suit continued for 5 years from March 2015 when the invalidation claim was first filed. In the first trial, the Intellectual Property Trial and Appeal Board turned down Yungjin’s claim and ruled in favor of Otsuka. However, in the second trial, the Patent Court of Korea overturned the first trial decision and rule in favor of Yungjin Pharm. Last April, the Supreme Court ruled the use patent invalid, ending the fierce dispute in Yungjin Pharm’s victory. For Yungjin, the trial could have ended in immense claims for damages from patent infringement. Moreover, when the Patent Trial and Appeal Board rejected the claim, reducing the possibility of patent invalidation, other generic companies had taken a step back, withdrawing their claims and deleting their indications. After twists and turns, Yungjin, the only company to continued the suit, succeeded in invalidating the use patent. The win came with less than a year left until patent expiry, as the patent was scheduled to expire on January 29 of next year. Yungjin’s win has affected indications filed by other generic companies as well. Daewoong Pharmaceuticals and Pharvis Korea had already received approval for the bipolar disorder indication for their generics. The companies’ products are produced by Yungjin Pharma under a CMO agreement. Other companies have also recently applied for approval of their generics that contain the bipolar disorder indication. As the patent had expired due to patent invalidation, and the number of generics with the bipolar disorder indication is expected to continue to increase in the future. Abilify is a blockbuster drug that posted 45.4 billion won in sales last year. Even after its substance patent expired and generics were introduced to the market, the drug maintained its high market share with its use patents. However, the continued patent challenges filed by generic companies are expected to continue to challenge Abilify's throne in the market.
- Policy
- Moderna apologized to the gov for the disruption in supply
- by Kim, Jung-Ju Aug 18, 2021 05:51am
- Kang Do-tae, the second vice minister of welfare, and other delegations visited the U.S. headquarters for an interview. The government visited the U.S. headquarters of Moderna that supplies the vaccine worldwide to protest against the supply disruption and ask for quick measures. The delegation, composed of Kang Do-tae, the second Vice Minister of health and welfare, and Ryu Geun-hyuk, secretary to the President for Social Policy, received an official protest and apology from the U.S. headquarters of Moderna today. After the meeting, Vice Minister Kang said, "The government asked for a faster supply of COVID vaccines," adding, "Moderna expressed its apology and promised to do its best." However, the company failed to respond to the government's request to move it up as soon as possible, so it plans to hold additional consultations. Therefore, detailed information is expected to be released on the 16th when the team returns back. "Today's meeting was an opportunity for the government and Moderna to enhance mutual understanding," Kang said. "I asked them to move up the schedule as soon as possible. We will make an official announcement after further consultation with the company after returning to Korea. Moderna is experiencing disruptions in supply not only to Korea but also to the world due to production disruptions. Some of its supplies were already delayed once last month in Korea, and this time, the supply was reduced by less than half. As a result, the government has extended the interval between 1st and 2nd vaccinations of mRNA-based vaccines such as Moderna and Pfizer from 4 weeks to 6 weeks. The KDCA signed a contract on the 13th to purchase 30 million doses of Pfizer vaccine and 30 million optional doses to secure the vaccine early. The optional doses is the amount of volume that can be added according to the mutually agreed period and conditions, if necessary. Up to 60 million batches could be supplied. In addition, 300,000 Janssen vaccines, which the U.S. government decided to donate, will arrive at Incheon International Airport on the 15th.
- Company
- Will GSK-SK Bioscience distribute flu vaccines?
- by Aug 18, 2021 05:51am
- It is not clear whether the distribution contract for Fluarix Tetra, a seasonal flu vaccine under way between SK Bioscience and GSK, will be distributed ahead of the inoculation season. According to the pharmaceutical industry on the 13th, SK Bioscience is likely not to market GSK's Fluarix Tetra this year. Sanogi's flu vaccine, Vaxigrip, is expected to be distributed only in part. Initially, SK Bioscience decided not to produce its flu vaccine SKY Cellflu this year to focus on producing COVID vaccine. Instead, it discussed a joint sales contract with its competitor GSK for Fluarix Tetra. Last year, GC Pharma distributed Fluarix Tetra. It also signed a Vaxigrip supply contract with Sanofi. If the contract is signed, SK Bioscience has planned to supply Fluarix Tetra since early October. SK Bioscience's sales marketing and consumer counseling office guided the supply schedule of Fluarix to hospitals and clinics and received inquiries to confirm the contract between the two companies. Suddenly, the two companies' contract discussions are on the verge of breaking up. Although no specific reason has been revealed, GSK is expected to find alternative partners. The flu season began in September, and GSK does not have much time. Clinics are also confused. "I was informed that SK Bioscience will supply Fluarix this year, but I am currently at a loss where to contact," said clinic A in Seoul. An employee of pharmaceutical company B, which distributes the flu vaccine, also said, "There are a lot of inquiries at the headquarters about supplying Fluarix Tetra instead of SK Bioscience." "It is true that the Fluarix Tetra supply contract is under discussion, but it has not been finalized," SK Bioscience said. "Sanofi's supply of Vaxigrip will be supplied in the fourth week of September as scheduled." GSK also said, "The final contract with SK Bioscience has not been finalized," adding, "We are continuously discussing various things to find Fluarix Tetra's partners."
- Company
- Medication imports in July are the largest ever
- by Kim, Jin-Gu Aug 17, 2021 05:53am
- Pharmaceutical exports of ₩700 billion have remained strong since last year. In July, domestic drug imports reached ₩1 trillion, the highest record ever. It is analyzed that it is a phenomenon caused by the full-fledged import of vaccines from Pfizer and Moderna. ◆Monthly import amount is close to ₩1 trillion, up 25% year-on-year According to the Korea Customs Service on the 16th, Korea's drug imports amounted to $819.58 million in July, the highest ever. Compared to $657.91 million in July last year, it rose by 25%. It is analyzed that the increase in COVID vaccines has affected. In fact, imports of vaccines (export and import codes 3002.20) in Korea averaged only $28.77 million (approximately ₩34 billion) last year, but this year, it started to increase rapidly. When Pfizer vaccine began to be imported in earnest, it increased to $49.82 million (about ₩58 billion) in March and ₩120 billion in June, when moderna vaccine began to be imported in earnest. In July, the figure nearly doubled to $211.62 million. Monthly drug imports, excluding vaccine imports, are maintaining around $600 million, similar to last year's. ◆₩710 billion in exports in July Drug exports amounted to $611.09 million, up 20% from July. Domestic pharmaceutical exports have been steadily rising since last year. The monthly average amount of drug exports last year was $574.46 million, which is more than $646.71 million until July this year. Like last year, biosimilar is leading drug exports. Celltrion recorded ₩789.5 billion in exports through Celltrion Healthcare in the first half of this year. Compared to ₩777.2 billion in the first half of last year, it increased by 2%. The sales of Remsima and Remsima SC totaled ₩337.3 billion, Truxima's sales of ₩273.3 billion, and Herzuma's sales of ₩102.2 billion. Although Samsung Biologics' sales performance in the first half of the year is not specific yet, considering that its provisional sales in the first half of the year increased 31% year-on-year, CMO exports centered on biosimilars are also expected to have increased significantly. In addition, domestic diagnostic kits were exported to $77.34 million in July, up 14% from a year earlier. Exports of diagnostic kits have been maintained at $70 million to $80 million this year. Exports of domestic botulinum toxin in July amounted to $16.67 million, which was not much different from the same period last year ($16.96 million).
- Company
- Insulin·GLP-1 combo Xultophy lands in ‘Big 5’ hospitals
- by Eo, Yun-Ho Aug 17, 2021 05:52am
- The insulin and GLP-1 receptor agonist combination drug ‘Xultophy’ can now be prescribed in general hospitals. According to industry sources, Xultophy FlexTouch inj., a fixed-ration combination of Novo Nordisk Korea’s insulin Tresiba (insulin degludec)’ and the GLP receptor antagonist ‘Victoza (liraglutide injection),' has passed the drug review of drug committees (DCs) of 50 medical institutions in Korea, including the Big-5 general hospitals - Seoul National University Hospital (SNUH), Asan Medical Center (AMC), Seoul St. Mary’s Hospital, Samsung Medical Center (SMC), and Severance Hospital. The drug is reaching practice quickly after being listed for insurance benefits in May. Xultophy was approved in August 2019 in Korea for the treatment of patients with insufficiently controlled type 2 diabetes even after taking a combination of GLP-1 receptor agonist and oral hypoglycemic agents or basal insulin and oral hypoglycemic agents. The drug demonstrated superiority or noninferiority in reducing HbA1c levels, reduced incidence of hypoglycemic episodes, and better weight control in various DUAL clinical trials (DUAL I ~ IX) over control groups using the unique complementary mechanism of action brought from the insulin degludec and liraglutide combination. In particular, In the 26-week DUALⅤstudy that was conducted on 557 Type 2 diabetes patients with type 2 diabetes inadequately controlled by insulin glargine U100 and metformin, Xultophy showed superior HbA1c lowering effect over basal insulin, significant weight loss control effect, and a significant decrease in the incidence of hypoglycemia events with a lower dose of daily insulin. In the DUAL V study, the Xultophy-administered group showed a superior HbA1c level reduction effect of -1.81% over the insulin glargine U100-administered group’s -1.13%. Also, in weight change, the Xultophy arm's weight loss was -1.4kg compared to the +1.8kg of the insulin glargine U100 arm, amounting to a total of -3.2kg weight loss in total. Also, Xultophy reduced hypoglycemic episodes by 57% compared to the insulin glargine U100 arm. Xultophy is a pen-type injector that contains a combination of basal insulin and GLP-1 analogue that can be administered once daily at any time of the day, with or without meals. The maximum daily dose of Xultophy is 50 dose steps, and for those transferring from insulin therapy that includes a basal insulin component, the recommended starting dose of Xultophy is 16 dose steps, after which dose adjustment is required based on the individual’s fasting blood glucose level.
