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- 2026-05-19 23:41:50
- Opinion
- [Reporter's View] It's up to pharmaceutical companies
- by An, Kyung-Jin May 17, 2021 05:53am
- Drug quality management is at stake. Over the past two months, four companies, including Binex, Vivozon, Chong Kun Dang and Hanall Biopharma, have been caught violating drug quality control. A total of 62 products are under administrative disposition due to violations of quality control by four companies. Including pharmaceutical companies in consignment contracts, the impact is even greater. Thirty-four pharmaceutical companies that have entrusted production to four companies are also focusing to whether the MFDS will dispose of them further. A total of 38 companies are on the verge of being kicked out of the market because of the trustee's deviant behavior. The pharmaceutical industry fears it will spread to distrust of consignment generics. It is only a matter for some companies, and the consignment act itself should not be a problem. In July 2018, the Valsartan crisis, which shook the global pharmaceutical market, was unprecedented in overseas countries as carcinogenic substance N-Nitrosodimethylamine (NDMA) was detected in Valsartan manufactured by China's Zhejiang Huahai. NDMA was not originally subject to standard checks on Valsartan. Until Zhejiang Huahai reported that more NDMA was detected than the standard, no pharmaceutical company in the world cared about NDMA detection. The FDA and the EMA were not aware of the need for inspections, but rushed to investigate and come up with measures to determine the cause. It was just an unexpected accident. Chinese raw medicine and generic are starting to be blamed as if they were the causes of "low quality." It is also from this time that regulations on consignment generic have been tightened in Korea. Health authorities set up a "Generic Drug System Improvement Council" and began to come up with measures to curb generic disorder. The MFDS has removed all deregulation granted to Entrusted generic. From next year, mandatory production of licensed products, which had been exempted from consignment generics, will be implemented again. It is also pushing to exclude consignment generics from generic exclusivity. Following the reorganization of the drug price system, which took effect in July last year, the standard for calculating the drug price of consigned generic has also been lowered. The 53.55% upper limit price can be maintained compared to the original drug before the patent expires only when all requirements are met to conduct biological equivalence tests directly and use registered raw material drugs. The regulation on joint development of drugs under discussion at the National Assembly is also key to restricting the permission of consignment generic. Some amendments to the Pharmaceutical Affairs Law, which limits the number of drugs licensed in one clinical trial, passed the Health and Welfare Committee, leaving procedures for future plenary sessions, the Legislation and Judiciary Committee, and the plenary session. The government's justification for tightening regulations on generic seems to be somewhat out of standard. The MFDS defines "generic" as a officially licensed drug based on the same quality as the original developed drug. It is not appropriate that the large number of generic drugs authorised by the Government is of low quality. Nevertheless, pharmaceutical companies are largely to blame. If unreasonable regulations and misunderstandings are unfair, they should prevent repeated violations and come up with self-rescue measures to improve competitiveness in drug quality. The drug quality control agenda has already been controversial, although it was not originally due to generic. It is up to pharmaceutical companies to restore generic drug reputation.
- Policy
- Off-label use of Olumiant and Botox denied
- by Lee, Hye-Kyung May 17, 2021 05:53am
- An application for the use ‘Olumiant(baricitinib) in patients with alopecia areata was rejected by the health authorities in Korea. In addition, the application to administer Botox injections for the primary suture of facial lacerations and recurrent pancreatitis was also disapproved due to lack of medical evidence. The Health Insurance Review and Assessment Service (HIRA) reviews applications in advance for the off-label use of drugs beyond the scope approved by the Ministry of Food and Drug Safety (MFDS) to prevent the use of medicines that lack medical evidence or have potential safety concerns. According to the cases of off-label use disapprovals recently disclosed by HIRA, 8 cases of disapprovals including Olumiant and Botox were added this month, to make the cumulative number of disapproved cases to 209 in total. In the case of Olumiant, a medical institution had applied to prescribe the 2mg or 4mg Olumiant tablet to a patient with alopecia areata for 12 months, but the application was turned down due to lack of medical evidence. The application for the off-label use of Botox was for its use in patients who receive primary suture for facial lacerations and avulsions at emergency centers or outpatient clinics, and for patients with recurrent pancreatitis that have been excluded from all causes of acute pancreatitis such as gallstone, alcohol, hereditary, and autoimmune manifestations and is at high risk of pancreatitis due to ERCP procedures. The application was also denied approval. Also, applications to administer ‘Carmine Injection 0.8%’ to women in the childbearing age who were diagnosed with infertility, or is suspected of infertility due to tubal factors (fallopian tubes, fallopian tube adhesions, paratubal cyst, fallopian tube plastic surgery subjects) to check the bilateral tubal patency of the fallopian tubes during laparoscopic surgery; and to administer ‘Antiroid tablet’ to patients in need of taste tests whose information on their PROP phenotype is deemed clinically useful, were also disapproved. In addition, applications for the off-label use of 'Mabthera injection', 'Eglandin injection', and 'Valcyte 450mg' on RPGN patients, hospitalized patients after kidney transplant, and patients with glioblastoma without kidney failure, respectively, were rejected on the grounds of lacking medical evidence.
- Policy
- 1+3 restrictions bill for generics & IMDs was passed
- by Lee, Jeong-Hwan May 17, 2021 05:53am
- The number of joint biological equivalence tests and joint clinical trials of generic and data IMDs is expected to be limited to three consignment companies per manufacturer. Only three additional medicines can be licensed for biological equivalence tests or clinical trials. However, biological drugs such as high-tech new drugs and vaccines and medicines designated by the head of the MFDS may be exempted from regulations on "Common Biological Equivalence Testing and Clinical 1+3 Restriction." On the 28th, the National Assembly's Health and Welfare Committee passed the 1+3 restrictions bill on drug co-development. The first bill subcommittee of the Welfare Committee voted to revise the bill of Seo Young-seok and Seo Jung-sook. Only three additional medicines can be licensed for biological equivalence tests or clinical trials. The first bill subcommittee of the National Assembly's Health and Welfare Committee on the 28th passed some revisions to the Pharmaceutical Affairs Law proposed by Seo Young-seok and Seo Jung-sook, respectively, reflecting the MFDS' amendment. The bill subcommittee's resolution will succeed in legislation if it passes the procedures of the Welfare Committee, the Legislation and Judiciary Committee and the plenary session. It was designed to establish a sound pharmaceutical industry by limiting the number of items in the pharmaceutical market. In particular, recent GMP violations by the domestic companies such as Binex, Vivozon, and Chong Kun Dang have increased the feasibility of legislating regulations on generic and IMD regulations. The MFDS, which had previously considered IMD regulations carefully, also expressed its support for regulations on IMDs after the GMP crisis, helping pass both bills. Specifically, if the same manufacturing process is manufactured by the same manufacturer with the same manufacturing method as the pharmaceutical company's drug that directly conducted the BA test, the use of biological equality data will be limited to three times. In short, the number of consent to use biological equivalence test data for one drug is up to three items. Clinical trial data can also be used for up to three items other than drugs from pharmaceutical companies. However, non-Rx drugs, biological preparations such as advanced biopharmaceuticals and vaccines, and other medicines determined by the head of the MFDS are not subject to the 1+3 restriction.
- Policy
- Combination of Epidiolex & Clobazam are reimbursed
- by Lee, Hye-Kyung May 17, 2021 05:52am
- Starting this month, detailed standards for the health insurance application of "Epidiolex (Cannabidiol)," used to treat seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex, have been unveiled. The HIRA recently released 'Question and Answer on Applying Benefit Standards to Epidiolex' and guided details on targets and methods of evaluation. Epidiolex was Emergency Use Medication by the MFDS for the use of "the treatment of Lennox-Gastaut syndrome and seizure related to Dravet syndrome" in patients over the age of two. It was supplied to Korea through the Korea Organ & Essential Drug Center from April 1st. Epidiolex can be reimbursed if ▲ the requirements for not showing a reduction in seizure frequency with other antiepileptic drugs are met or ▲ has a history of administration of antiepileptic drugs before Epidiolex. However, the history of administration of antiepileptic drugs before administration of the drug means "the history of more than five of the 11 antiepileptic drugs prescribed in the detailed recognition criteria for care benefits being administered at sufficient internal medicine capacity." The administration history should be checked by detailed medical records. The requirement for patients who have not shown a decrease in seizure frequency with other antiepileptic drugs refers to "the frequency of seizures did not decrease by more than 50% compared to the time of initial antiepileptic drugs even though more than five of the 11 drugs were administered with sufficient internal medicine." Patients who administer Epidiolex only can be reimbursed in combination with Clobazam. If Clobazam cannot be administered, Epidiolex will be reimbursed if detailed medical records confirm it. The HIRA also detailed the 'methods of assessment for sustainable investment'. It explained that for an additional 3 months after the first 3 months of Epidiolex administration, the seizure frequency should be reduced by more than 50% for the first 3 months of the drug, and for continuous additional administration after the first 6 months of the drug, the seizure frequency should be reduced by 50% or more. In order to evaluate the appropriateness of continued administration of Epidiolex and prevent drug abuse, patients or guardians should fill out the seizure log with frequency of seizures and whether Epidiolex is administered, and medical institutions should manage it. As for patients who have already been administered Epidiolex since April 1st, it is considered to meet the requirements for the benefit ▲if the criteria for detailed recognition of medical benefits at the time of initial administration of the drug, ▲if the 'subject to administration' requirements are met and can be verified through the details of the medical records, and ▲ five or more of the 11 types of antiepileptic drugs can be checked in detail in the medical records, and the necessity and appropriateness of the drug launch are considered to meet the requirements of the benefit unit if confirmed by a specialist. It can be administered continuously if the assessment method for patients three months after Epidiolex administration for non-reimbursement meets Da-1 of the criteria for detailed recognition of medical benefits at the time of initial effectiveness assessment (three months after administration of the drug), or if the seizure frequency is maintained by more than 50% compared to the initial dose of the drug, or if it is confirmed by experts that treatment effects and continuous administration are necessary after the drug is started.
- Company
- Negotiations on the drug price of Onivyde have begun
- by Eo, Yun-Ho May 14, 2021 05:50am
- The new pancreatic cancer drug "Onivyde" is in the final stages of listing insurance benefits. According to related industries, Servier Korea has recently entered pharmaceutical negotiations with the NHIS for the registration of Onivyde (Irinotecan HCl) under the order of the MOHW. As a result, attention is being paid to whether a new insurance benefit application drug can be created in the area of pancreatic cancer, which does not have many treatments. Onivyde's application for benefits, which passed the HIRA's Pharmaceutical Benefits Advisory Committee on the 8th of last month, was approved. It is a combination of 5-FU/LV and secondary treatment in patients who fail Gemcitabine based primary care. Through a global multi-organ three-phase clinical NAPOLI-1 study, Onivyde significantly improved treatment performance in combination with the existing secondary treatment option 5-FU/LV in patients who failed to receive Gemcitabine-based primary care. Yoo Chang-hoon, a professor of oncology at Asan Medical Center in Seoul, said, "We currently talk a lot about secondary and tertiary drugs with a considerable number of pancreatic cancer patients. Since benefits are not applied, we will also examine whether there is an Indemnity Health Insurance Plan. "Onivyde has global phase 3, Asian data, and Korean RWE, but it's a pity that benefits are not yet applied." Leclaza (Lazertinib), the third-generation epithelial cell growth factor receptor (EGFR) of Yuhan, which passed the Pharmaceutical Benefits Advisory Committee with Onivyde, is also under drug negotiation. Considering the negotiation deadline, it is expected that the registration of both drugs will be decided between June and July.
- Policy
- Will vaccination gather pace? MFDS approves 2.6 M doses
- by Lee, Tak-Sun May 14, 2021 05:50am
- Vaccination in Korea is expected to speed up as a large number of COVID-19 vaccines have been approved national lot release. Through the fast track review and approval system, the Ministry of Food and Drug Safety also (MFDS) approved the national lot release of AstraZeneca’s vaccine earlier than expected. Since the 12th, as many as 2,640,000 doses were approved for lot release. According to the MFDS on the 13th, 2,203,000 doses of AstraZeneca’s COVID-19 vaccine manufactured by SK Bioscience were approved national lot release on the 12th. This is even more than the 1,574,000 doses that were granted last February. The approved vaccines will be used as booster shots and as first shots for older adults aged 65 to 75 who will start inoculations on the 27th. As of 12:00 a.m. on the 13th, the vaccination reservation rate of seniors aged 70 to 74 was 51.6%. The 438,000 doses of the Pfizer vaccine that arrived on the 12th were also immediately granted lot release on the 13th the next day. The Pfizer vaccines are being given to seniors aged 75 or older. Currently, only booster shots are being administered but the government will resume administration of the first dose from the end of this month. The COVID-19 vaccines approved on the 12th and 13th are in total, 2,640,000 doses, which makes up about 40% of all the doses that were released until now. In addition, 835,000 doses of the AstraZeneca vaccine arrived in Korea through the COVAX facility on the 13th. These vaccines, which were imported vaccines manufactured in Italy, were granted emergency use as it was not yet approved in Korea. These vaccines will be swiftly supplied as products approved for emergency use do not need to be reviewed for national lot release, Vaccinations in Korea are expected to speed up with improved procurement. By the first half of the year, the government plans to inoculate a total of 13 million people, mainly those in their 60s or older. A total of 18.32 million doses will be brought to Korea during the first half of the year, which is sufficient for achieving the target. As of 12:00 a.m. on the 13th, the cumulative number of people who received their first shots was 3.71 million. To enable faster vaccination, the MFDS has expedited the national lot release approval for vaccines. For example, for initial approval, the first three lots manufactured are approved within 20 days, and those manufactured thereafter within 10 days, and products with the same lot number are approved within a day. Through the national lot release system, the MFDS conducts one final quality test before biologics like vaccines are marketed.
- Policy
- Eyes on approval of ‘acetaminophen+ ibuprofen’ combo OTCs
- by Lee, Tak-Sun May 14, 2021 05:50am
- 미국에서 OTC로 발매된 최초의 아세트아미노펜+이부프로펜 복합제 The Ministry of Food and Drug Safety (MFDS) is reviewing the approval of an acetaminophen and ibuprofen combination therapy as an over-the-counter drug (OTC). The two ingredients are well-known antipyretic-analgesics, however, the combination of only these two ingredients was not commonly used as the two have different mechanisms of actions. However, with the U.S Food and Drug Administration (FDA) approving the first acetaminophen and ibuprofen combination drug as an OTC, the possibility of seeing the combination in Korea is also rising. According to the MFDS on the 13th, the members of the Central Pharmaceutical Affairs Council will be discussing whether to classify the acetaminophen and ibuprofen combination as an OTC and the appropriateness of its approval at the meeting on the 17th. No combination drug with only the acetaminophen and ibuprofen ingredients has been approved in Korea yet. However, the combination has been approved overseas. In March last year, the U.S. FDA approved GSK’s ‘Advil Dual Action,’ which contains acetaminophen and ibuprofen. This was the first case where an ibuprofen and acetaminophen combination drug was approved as OTC in the U.S. Advil Dual Action contains 250 mg of ibuprofen and 500 mg of acetaminophen. In clinical trials, a fixed-dose combination of the two components demonstrated a superior effect compared to the individual components alone. The drug was officially released as an OTC in the U.S market in September last year. There had been attempts to receive approval of the ibuprofen and acetaminophen combination as an OTC in Korea as well. In 2017, Hanmi Pharmaceutical submitted an application for the approval of the combination as an OTC but was rejected. The Central Pharmaceutical Affairs Council that discussed the OTC designation of the combination then did not approve the product due to concerns about drug abuse. The product contained 500 mg acetaminophen and 200 mg ibuprofen. The members of the council were concerned that people would be taking the drug regardless of their pain intensity, and that the approval will unintentionally increase the maximum dose intake of the two ingredients. As a result, only 3 of the 8 members of the council agreed to the OTC permit, and the others opposed the decision. The MFDS also expressed concerns over its safety. MFDS opposed the OTC designation saying that the adverse reactions that occur from the two ingredients were similar and that there was a risk of gastrointestinal bleeding. However, with the U.S FDA's approval of the drug as an OTC last year, the situation may change this time. The MFDS and the experts usually refer to approvals abroad, especially those from the U.S FDA when making decisions. Therefore, the possibility exists for the combination to see different results this time around at the Central Pharmaceutical Affairs Council meeting that will be held on the 17th. An MFDS official confirmed that “It is true that a relevant product has applied for approval.”
- Policy
- MFDS has begun testing the second supply of AZ vaccine
- by Lee, Tak-Sun May 14, 2021 05:50am
- The MFDS has begun a national test on the second supply of AZ COVID-19 vaccines produced by SK Bioscience. The vaccine will be supplied 7.23 million doses from the 14th to early June. According to the MFDS on the 12th, SK Bioscience recently applied for a lot release for the second supply of AZ vaccine. The MFDS plans to approve the lot release within 10 days through a quick test. The MFDS approves shipments of 3 lots produced after the approval within 20 days, production within 10 days, and the same lot number volume immediately after the supply. In the case of the AZ COVID-19 vaccine produced by SK Bioscience, more than 1,574,000 doses were lot released on February 17 after being approved on January 29. Lot release completed within 20 days. In the case of the Pfizer vaccine, more than 501,000 doses were lot released on the 28th of the same month. Since the second supply of the AZ vaccine, which will be distributed this time, is produced after the initial 3 lots, it aims to release the lot within 10 days of the test. The vaccine, which will be distributed this time, is expected to be used for vaccination for senior citizens aged 60 to 74, which will begin on the 27th. 83.5 million doses of the COVAX AZ vaccine, which will arrive tomorrow, will be introduced in Korea without going through a national lot release process as it has received Emergency Use Authorization as an unlicensed Italian product.
- Policy
- 835,000 doses of Covax AZ vaccines arriving tomorrow
- by Lee, Tak-Sun May 14, 2021 05:49am
- AstraZeneca vaccine produced in Italy will be introduced into Korea as a supply of Covax. Imported AZ vaccines are introduced through Emergency Use Authorization as they do not have domestic permission. The pan-government vaccine introduction TF (Team Leader: Kwon Deok-cheol, Minister of Health and Welfare) said 835,000 doses of the Covax AstraZeneca vaccine will arrive at 19:00 tomorrow (13th). Adding 7.23 million doses of AstraZeneca vaccines, which will be supplied from May 14 to early June, and 835,000 doses, which will be supplied this time, a total of 806.5 million doses, and 5 million doses of vaccines, will fully support the first vaccination target of 13 million people in the first half of the year. In addition, the remaining 835,000 doses of the Covax AstraZeneca vaccine, which is scheduled to be introduced in the first half, will be supplied in June. AstraZeneca vaccine, which will be supplied through Covax this time, will be used for the first round of vaccinations starting May 27 under the second round of vaccination and the "COVID-19 vaccination May-June implementation plan." Some of them will be used for the second round of vaccinations starting May 14, and the rest will be used for vaccinations of 60 to 74-year-olds (born in 1947 to 1961), and primary vaccinations for teachers working in kindergartens, daycare centers and elementary schools (first and second graders). The government plans to proactively proceed with administrative procedures so that the Covax AstraZeneca vaccine can be supplied to Korea as quickly as possible. The KCDA asked the MFDS for approval under the Special Act on the Promotion and Emergency Supply of Public Health Crisis Medical Products. The AstraZeneca vaccine is a product produced by Catalent, Italy, and is listed in the WHO Emergency Use Listing. The MFDS approved emergency use after deliberation by the Public Health Crisis Response Medical Product Safety Management and Supply Committee, considering that the vaccine is already in use at home and abroad. This is a system that allows importers to import and supply overseas vaccines if urgent domestic supply is needed to properly cope with the public health crisis, which is the same as special imports under the existing "pharmaceutical affairs law." The government later stressed that it plans to expedite customs clearance and transportation so that the vaccine can be used smoothly for vaccination. Kwon Deok-cheol, head of the pan-government vaccine introduction TF, said, "We will continue to introduce vaccines through close communication with Covax and make utmost efforts to achieve collective immunity in November."
- Company
- Will Lipitor Plus be able to continue Lipitor’s legacy?
- by Eo, Yun-Ho May 13, 2021 05:57am
- Whether Viatris Korea, which owns the original atorvastatin ‘Lipitor,’ will be able to perform as well in the ‘ezetimibe’ combination therapy market, is drawing attention. Recently, the use of combination therapy in dyslipidemia patients has become more than a strategic treatment option - it has become a main trend in the market. In line with the trend, Viatris Korea, which has been leading the dyslipidemia treatment market with its ‘Lipitor(atorvastatin), and Jeil Pharmaceutical have jointly launched ‘Lipitor Plus,' a combination drug that contains atorvastatin and ezetimibe. With many combination therapies containing the same substances already in the market, whether Lipitor Plus will be able to continue on the original Lipitor’s legacy remains to be seen. The combination market, which is represented by MSD’s ‘Atozet,' is expected to have over 100 competitors fighting for a share of the pie. Viatris Korea’s strategy is to penetrate the market with the brand power of its Lipitor and by highlighting their use of the original API. In the case of Atozet, the drug is a combination of original ezetimibe and generic atorvastatin. As Lipitor Plus on the other hand uses Lipitor’s original API atorvastatin, these differences will be actively used in the promotion of Lipitor Plus. In addition, Lipitor Plus was approved at a lower price than Atozet under the new tiered pricing system. As a result, Lipitor Plus has a lower price than other therapies despite its use of the original API. An official from Viatris Korea said, “We also improved drug compliance of our patients by reducing the tablet size. For patients with chronic diseases who have to take multiple drugs, this can also work as an edge over other drugs.” An official from the company added, “The release of the combination drug Lipitor Plus in addition to our Lipitor hold significance as it completes our Lipitor lineup that covers both first-line statin therapy and second-line statin+ezetimibe therapy options recommended by major dyslipidemia treatment guidelines in Korea and around the globe.” Viatris Korea is the Korean subsidiary of the Viatris Group that was launched in November 2020 through a merger between Global Pfizer’s business division Upjohn and the global healthcare company Mylan. The company changed its name to Viatris Korea in February.
