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- 2026-05-18 18:57:17
- Policy
- NA LJC to review ‘1+3 bill for generics’ tomorrow
- by Lee, Jeong-Hwan Jun 25, 2021 05:51am
- The National Assembly's Legislation and Judiciary Committee will review the revision of the Pharmaceutical Affairs Act that contains the bill for the ‘1+3 restriction for bioequivalence and clinical test’ of generics and drugs requiring data submission an agenda for review at the NA Legislation and Judiciary Committee’s general meeting that will be held on the 25th. If the revision passes the Legislation and Judiciary Committee, it will be processed and deliberated at the plenary session that is planned on the 29th, and may likely be legislated by June. On the 24th, the vice-chairpersons of the ruling and opposition party of NA’s Legislation and Judiciary Committee are discussing the agendas that will be presented at the plenary session on Monday. One thing to note is that the bills passed by the Health and Welfare Committee on the 16th, including the one to revise the Pharmaceutical Affairs Act, have also been included as agendas at the Legislation and Judiciary Committee meeting. The revised Pharmaceutical Affairs Act passed by the Health and Welfare Committee includes the ‘1+3 restriction for bioequivalence and clinical test’ of generics and drugs requiring data submission, designation of Day of Medicine as a Statutory Anniversary, mandatory preparation and submission of Contract Sales Organization (CSO) expenditure report, penalizing illegal purchasers of specialty drugs, and compulsory marking of safety precautions in Braille and voice codes. The revision also includes the bills to legislate the conditional approval system for Phase III trials, mandatory registration of oversees API manufactories, increasing the number of Central Pharmaceutical Affairs Council members to 300 at most, strengthening regulations for the cancelation of false or unlawfully approved National Lot Release drugs, and the establishment of the Vaccine Safety Technology Support Center. In other words, whether the bill to regulate generics and drugs requiring data submission will be able to pass the final legislative threshold by passing the plenary session of the National Assembly this month will depend on deliberations of the Legislation and Judiciary Committee on the 25th. The Legislation and Judiciary Committee can decide to pass or continue to review the bills passed by the Health and Welfare Committee. If the bill is passed by the Legislation and Judiciary Committee, the final procedure will be carried out at the plenary session on the 29th. When the government finally promulgates the bill, the individual bills will then come into effect according to the by-laws. An official from the Legislation and Judiciary Committee said, “Discussions on the agenda for the plenary session have not yet been completed by the vice-chairpersons. For now, the bill by the Health and Welfare Committee, including the revised Pharmaceutical Affairs Act, is included in the agenda for the plenary session."
- Policy
- MFDS investigates impurities of Sartan and Varenicline
- by Lee, Tak-Sun Jun 25, 2021 05:50am
- The MFDS has launched a full investigation as the risk of impurities in Sartan and Varenicline, a non-smoking treatment supplement, has been raised among hypertension drugs. Recently, some products have been recalled due to the detection of impurities such as carcinogens in Canada and other countries. However, in the case of Sartan, both raw materials and finished products are planned to be investigated, and in the case of Varenicline, only the finished products were ordered to be tested by related companies. The MFDS announced on the 22nd that it is conducting a safety investigation of high blood pressure treatment containing satan series and Varenicline, a non-smoking treatment aid. Antihypertensive drugs including satan are the three components of Irvesartan, Losartan, and Valsartan. The survey will be conducted to verify the safety of domestic products as impurities exceeding provisional management standards were detected in overseas-related medicines. The MFDS has already sent an official letter to a local pharmaceutical company to encourage them to review their own investigation as a precautionary measure. An official from the MFDS said, "We will work closely with related companies to obtain test results as soon as possible, and put safety first according to the results and promptly take necessary measures." "There have been no cases of impurities detected in the drug in Korea yet," he added. AZBT which is not a nitrosamine, but is known to have a mutation (the property that causes genetic mutations). The MFDS estimates that AZBT occurs due to the reaction of Br-OTBN (4'-Bromomethyl-2-cyano-biphenyl) and Sodium Azide (NaN3). The impurity of Varenicline is "N-nitroso-varenicline," which is said to be caused by the reaction of nitrite and Varenicline remaining in the finished drug manufacturing process. The MFDS said that Varenicline is an example of the original company Pfizer's own discovery of the problem, and that drugs from the same manufacturer as those recovered from overseas have not been distributed in Korea, and are under investigation by Pfizer's own investigation.
- Company
- Sillajen acquirer GFB seeks further partnership opportunity
- by Jun 24, 2021 05:55am
- "Using ShillaJen’s anticancer virus platform, we can add many new substances to be developed as novel drugs. Korea owns many excellent early-stage novel drug candidates, and we also may additionally introduce promising new substances in Korea." At the interview with DailyPharm, Ajit Gill, CEO of Greenfire Bio, Ajit Gill expressed his strong will to build additional partnerships with Korean bio-ventures in Korea. CEO Ajit Gill Greenfire Bio (GFB), a U.S. joint bio-venture firm of M2N that recently acquired Sillajen for 6 billion won, has been established by various industry experts including the company’s CEO Agit Gill who had previously headed Nektar Therapeutics, and CBO Sanjeev Munshi who had served over 20 years at MSD (U.S. Merck) as a BD reviewing and introducing new substances. During his service as head of Nektar Therapeutics from 1999 to 2006, Gill had contributed to raising the company’s market value to more than 20 trillion won. CBO Munshi had been in charge of searching biotech companies around the world to develop new drugs for intractable diseases such as Alzheimer's and NASH at MSD. Hanmi Pharmaceutical’s ‘efinopegdutide’ for nonalcoholic steatohepatitis (NASH) is also one of the numerous new drug substances he introduced at MSD, GFB, which has been developing the bio business with M2N Chairman Seo Hong-min, has been interested in developing new drugs using next-generation technology. In this context, Sillajen’s anticancer virus platform has caught the company’s interest. Anticancer virus, or oncolytic virus, induces immunogenic cell death (ICD) by loading viruses that have excellent penetration capabilities with anticancer substances. Globally, the interest in oncolytic virus is high, but no ‘game changer’ has emerged yet. Amgen’s Imlygic that was first introduced in the field did not produce a satisfactory return compared to the investment. However, GFB has a strong belief in the potential of the oncolytic virus market. Gill said, “With immuno-oncology drugs having a response rate around 30%, adding oncolytic virus to the immunotherapy can increase the rate to 50 to 60%. The vaccinia virus used in Sillajen’s next-generation platform has the benefit of being able to load various anticancer substances, due to its large size. Just looking at the monoclonal antibody market, we see many cases in which the bio-industry makes explosive growth with follow-up products that have been improved to complement the shortcomings of the earlier drugs, so there is no concern about the potential of the anticancer virus market." CBO Sanjeev Munshi He added, “For new technology, securing safety is important. Sillajen has the advantage in the market as the company had identified the safety of its platform through clinical trials for many years,” and expects that their accumulated new drug development know-how and financial firepower will create synergy when met with Sillajen’s leading technology. Regarding the increased market concern over the discontinuation of the Phase III trial on Pexa-Vec in 2019, Gill said, “Failing Phase III trials is common in the bioindustry. The point to focus on is whether we own a potential platform. However, we would need to establish a richer pipeline. Just one success is all we need to significantly raise the value of the company.” However, Gill took a cautious stance on the development of Pexa-Vec will continue, stating that the decision will be made after observing the data that will be released after a year. Instead, GFB is eagerly searching for new substances to apply to Sillajen’s platform. CBO Munshi has been focusing on discovering a substance with the highest possibility of success based on his experience at MSD as BD. Munshi said, “We have reviewed over 200 substances over the past 6 months. We want to find the most promising pipeline. Self-development is also a possibility, but it is more likely that we will acquire a substance through external partnerships.” In this sense, GFB is deeply interested in partnering with Korean bio ventures. Munshi said, “Korea owns abundant early-stage research data, but lacks development experience in the US., which is the world’s largest market. GFB can complement this area as the company has a high understanding of the global market and owns extensive global network experience. Please don’t hesitate to reach out anytime if you have an innovative new drug technology. Gill said, “Nektar Therapeutics was also once a 4-person company. It grew to a company with 800 employees when I left. In that time, I had signed countless contracts and raised the 1.5 billion fund in various ways. When combined, GFB’s BD expertise, M2N’s high capital, and SillaJen’s technology will be the right mix of all the essential elements necessary for the development of a blockbuster drug.”
- Company
- Benlysta can be reimbursed in general hospitals
- by Eo, Yun-Ho Jun 24, 2021 05:55am
- Benlysta, which has been covered by insurance benefits for the first time in seven years, can be reimbursed in general hospitals. According to related industries, GSK's Benlysta (Belimumab) has passed the drug committee (DC) of 20 hospitals nationwide, including Aju University Hospital, Chungnam National University Hospital and Hanyang University Hospital. Benlysta, prescribed for treatment of active systemic erythema lupus adult patients who are autoantibody positive, was non reimbursed by the Pharmaceutical Benefits Advisory Committee twice in December 2015 and November 2018. This is because it was difficult to prove cost-effectiveness as old drug such as Prednisolone, Hydroxychloroquine and Azathioprine are alternative drugs. Benlysta is eligible for active systemic ▲Lupus 18 years of age or older, who has been treating autoantibody positive for more than 3 months with standard therapy, if both ▲SELENA-SLEDAI 10 and above ▲ Anti-dsDNA antibody positive ▲ low complement (C3 or C4) conditions. Patients can be treated with 10% of their copay through special cases of calculating rare diseases. The administration method according to the benefit standard is recognized for an additional 6 months if SELENA-SLEDAI is reduced by more than 4 weeks after initial administration ▲ If the evaluation results of the first 24 weeks are maintained, the use is recognized for an additional 6 months. Lupus invades a variety of organs throughout his life, especially in major organs such as the heart, lungs, kidneys, and nerves, which can lead to irreversible damage and death Due to the nature of the disease, most patients are women of childbearing age, and 19% of pregnant women suffer from fetal death, loss of fetal development, low birth weight, and premature birth.
- Policy
- Zopista's price cut by 23%, Gefitinib by 22%
- by Kim, Jung-Ju Jun 24, 2021 05:54am
- The premium pricing period for Huons' Zopista has ended., and the price will fall by 23.9% at most for its strengths. Also, Hanmi Pharmaceutical applied for a voluntary price cut of its ‘Gefitinib Tab,’ and its price will fall by 22.1%. The premium pricing term for five zoledronic acid monohydrate products including Boryung Pharmaceuticals’ ‘Zoledron inj. 5mg/100mL’ will return to its original price upon expiry of their premium pricing term. The MOHW will make an amendment to the ‘Drug benefit list and maximum ceiling price table’ that contains the abovementioned changes on July 1st. ◆Term expiry for newly listed premium pricing items = The government has been providing a premium of 59.5% for newly listed generics for 1 year from the date of its initial listing. The premium rate applied increases to 68% for innovative pharmaceutical companies. However, if products of the same ingredient are produced in 3 or fewer companies even after the 1-year term has expired, the premium applied is maintained for a maximum of 5 years until the number of products increases to 4 or more. Five newly listed zoledronic acid products face premium pricing term expiry next month. The products are Boryung Pharmaceutical's Zoldron Inj. 5mg/100mL, Penmix's Penmix Zoledronic Acid Inj. 5mg/100mL, PharmGen Science's Oncebone Inj. 5mg/100mL, Dongkwang Pharm.'s Dongkwang Zoledronic Acid Inj. 5mg/100mL, and Dong Sung Bio Pharm's Zomedron Inj. 5mg/100mL. The products will be applied a price of 164,163 won from next month. ◆Term expiry for extended premium pricing items = The government allows products to maintain the premium pricing until 4 or more products of the same ingredient are listed even after the period of 1 year if the products with the same ingredient are produced in 3 or fewer companies. Nine extended premium pricing products containing the eszopiclone ingredient face premium pricing term expiry next month. The discounts that will be applied for each product and strength are as follows: Huons' Zopista Tab. 1mg, 2mg, 3mg by 23.9%, 23.7%, 23.2%, respectively; Yungjin Pharmaceuticals Yungjin Zopiclone Tab. 1mg, 2mg, 3mg by 4.1%, 5.4%, and 6% respectively; and Myungin Pharm's Zoss Tab. 1mg, 2mg, and 3mg by 10.3%, 10.3%, and 9.9% respectively. ◆Price ceiling adjustments according to voluntary price cut applications = When a pharmaceutical company submits a request to lower its drug price to an amount lower than the ceiling price set for the product, the government adjusts the insurance drug price of the product to the requested amount. The price of Hanmi Pharmaceutical's ‘Gefitinib Tab.’ will be reduced by 22.1%, and Jinyang Pharm’s ‘Jintozet Tab. 10/40mg’ will be adjusted to a 17.3% lower price.
- Policy
- Leclaza will be reimbursed for non-small cell lung cancer
- by Lee, Hye-Kyung Jun 24, 2021 05:54am
- From July 1, Yuhan Corporation's "Leclaza (Lazertinib)" will be reimbursed at the stage of secondary administration of non-small cell lung cancer. The HIRA announced that it will conduct an opinion inquiry until the 25th on the revised announcement (proposal) based on drugs prescribed and administered to cancer patients. If there is no disagreement, it will be applied from 1 July. Leclaza was approved by the MFDS on January 18 as an anti-cancer drug used to treat patients with EGFR-TKI-positive local progressive or metastatic non-small cell lung cancer. According to the HIRA's review of textbooks, guidelines, and clinical papers to set the standards, there was no mention of the drug in textbooks or guidelines as a new drug developed domestically. As a result of a single-group, phase I/II of clinical trial of local progressive or metastatic non-small cell lung cancer patients previously treated with EGFR-TKI, the median value of the progressive survival period was reported to be 9.5 months. In addition, T790M positive patients with 240mg of FDA approval content showed a median value of 11.0 months and an objective response rate of 57.9%, which is currently approved and paid for the same certificate of medical utility. The standard was set the same as Tagrisso( Osimertinib). Cross-dosing benefits are not recognized if a Tagrisso-administered patient intends to change to Leclaza after the disease progresses. However, if a patient want to change the administration to Leclaza due to serious side effects after Tagrisso is administered, it can be recognized on a case-by-case basis.
- Policy
- Standards for Trelegy Ellipta will be established
- by Kim, Jung-Ju Jun 24, 2021 05:54am
- Five drugs, including Trelegy Ellipta, a treatment for COPD are scheduled to be registered for insurance in accordance with next month's schedule, and salary standards will be established and changed accordingly. The MOHW has partially amended its notice of 'details on the criteria and methods of applying care benefits' to ensure proper insurance coverage of the drug and has entered into an inquiry. The drugs that will be applied to the revision include Trelegy Ellipta, Rosuvaco Soft Cap, Rosumega Soft Cap, and Pentosin 350mg and Ultomiris, which will be registered on June 1st. Among them, the drugs listed as of June 7 are likely to be partially changed following the Health Insurance Policy Committee's deliberation and resolution. ◆Trelegy Ellipta = COPD treatment, Trelegy Ellipta (Vilanterol trifenate + Flutisone furoate + Umeclidinium inhaler), is scheduled to be listed on the 1st of next month. The MOHW has made sure that patients who are being administered with the same compound and single drugs at the same time with the drug will be paid even if they want to switch to the drug. ◆Omega-3-acidethylesters 90 and Rosuvaco Soft Cap = Omega-3-acidethylesters 90 and Rosuvaco Soft Cap, a complex type of dyslipidemia treatment such as Rosuvaco Soft Cap and Omega-3-acid ethyl esters 90), are scheduled to be registered as of June 1st. ◆Pentosin 350mg, etc.= Compound skin infections caused by Gram-positive bacteria and Pentosin 350mg, an antibiotic, are scheduled to be registered on June 7, and the standards will be established to be used as secondary drugs within the scope of permission for Daptomycin. Detailed criteria for recognition should include nursing benefits if administration fails to administer Vancomycin or Teicoplanin to Staphylococcus aureus, which includes endocarditis by Meticillin-resistant strains, or if they cannot be administered due to side effects of both drugs. ◆Ultomiris= Adult PNH Treatment Ultomiris is scheduled to be registered on June 7, and the standards will be established by referring to the existing PNH Treatment Standards. PNH in adults is a disease in which hemolysis and blood clots occur in blood vessels due to acquired abnormalities of hematopoietic stem cells and damage to organs in the body, such as kidney function abnormalities. The benefit will be recognized within the scope of permission, and the patient will have to pay the full price of the medicine. Because it increases sensitivity to major meningococcal infections, all patients must be given a meningococcal vaccine at least two weeks before administration, and re-vaccinated in accordance with the latest vaccination guidelines. However, if the drug needs to be administered immediately, the meningococcal vaccine will be administered at the same time and antibiotics can be treated at the same time. Details of the procedures, methods, and composition of the committee for the pre-approval of the drug were determined by the director of the HIRA, and matters requiring medical judgment in the pre-approval of the drug were subject to the committee's decision. The MOHW has decided to confirm the revision after a review of opinions by the 25th..
- Company
- PARP inhibitors for primary ovarian cancer can be reimbursed
- by Jun 23, 2021 05:54am
- PARP inhibitors "Jejula" and "Lynparza" are expected to be applied to primary maintenance therapy for ovarian cancer as early as the third quarter. This is limited to BRCA mutations, and most patients without mutations do not benefit. According to the pharmaceutical industry on the 21st, Takeda followed by Lynparza (Olaparib) of AstraZeneca.The pharmaceutical company Zejula (Niraparib) also passed the Pharmaceutical Benefits Advisory Committee of the HIRA and is in negotiations with the NHIS. It is predicted that both products will complete the process of registering their benefits in third quarter. 80 to 90% of all ovarian cancer patients with BRCA negative effects will be excluded from the benefits. Zejula applied for the benefit as an All-Comer regardless of the mutation, but the HIRA's Cancer Drugs Benefit Apparel Committee only recognized positive mutations. Takeda Pharmaceutical has chosen a strategy of preferentially registering salaries for training BRCA. For secondary and higher maintenance, both Lynparza and Zejula have BRCA negative adaptations, but they also did not pass. This is why ovarian cancer patients filed a petition to allow them to use new drugs for BRCA negative. The monthly cost of medicine for non reimbursement is about ₩4.5 million. Lynparza's quarterly sales have been on a gentle rise from ₩2 billion last year to ₩3.7 billion in the first quarter of this year. Zejula, on the other hand, closely followed Lynparza in the first quarter of this year at ₩3.2 billion, up from ₩1 billion last year.
- Company
- Pfizer Korea suspends distribution of Champix
- by Kim, Jin-Gu Jun 23, 2021 05:54am
- Pic. of Champix Domestic supply of ‘Champix (varenicline),’ a smoking cessation product, has been suspended altogether. Pfizer Korea, which is in charge of supplying the product, explained that this was a preemptive measure made regarding the impurity issue. According to industry sources on the 23rd, Pfizer Korea had sent an official notice to domestic distributors that Champix 0.5mg and 1mg is nearly out of stock. In the notice, Pfizer Korea explained that this was due to a ‘disruption in the global distribution.’ Pfizer Korea’s position is that this is a preemptive measure that was made with regards to the concerns over impurities in the product. The Champix supplied in Korea is manufactured in Belgium, and is different from the products that were recalled by the health authorities in Canada earlier this month. Those were a part of the products manufactures in a Pfizer plant located in Quebec, Canada. The Ministry of Health and Welfare also said that the pharmaceutical products manufactured by the same company as those recalled in Canada are not being distributed in Korea. However, Pfizer Korea explained that this preemptive measure was made in consideration of the potential possibility that the impurities may have arisen in the manufacturing process of the finished product, and that the company will suspend supply of the product while testing for the impurities. The MFDS presumes that the impurity in question, ‘N-nitroso-varenicline’ may have developed by a reaction between varenicline and the nitrite that remained during the manufacturing process of the finished product. An official from Pfizer Korea said, “An investigation is being conducted at the global headquarters level on the detection of impurities," he said. "We plan to temporarily suspend domestic supply until the results of the impurities test is released." He continued, “We will submit related data to MFDS as soon as the results of the impurities investigation are released from our HQ. Pfizer Korea will faithfully follow MFDS instructions.” Korean generic companies plan to first focus on testing for the impurities as requested by MFDS. Because their production scale is not large, the companies believe that separate measures to stop supply will not be necessary. Currently, 34 companies in Korea are approved to manufacture CHampix generics. Among these, 12 companies have generated revenue in the first quarter of this year. Hanmi Pharmaceutical’s ‘Nokotine S,’ recorded 500 million won in quarterly sales, and the other companies have recorded less than 100 million won in the same period. An official from a domestic company that sells a Champix generic said, “We plan to first focus on conducting an independent test for impurities. And we will promptly take necessary measures according to its results.” Another official from a different company said, “We currently only hold a permit for the generic. We have discontinued production and supply of our generic since last year. It seems that some of the products that were previously released are still being distributed., but we do not plan to halt that supply or separately recall the products.” he explained.
- Company
- Patients implore for 1st line reimbursement of Tagrisso
- by Jun 23, 2021 05:54am
- After a series of failures in receiving reimbursement extension for the EGFR targeted therapy ‘Tagrisso’ in the first-line setting of lung cancer, the patients have taken the reimbursement issue into their own hands and implored the government to review its reimbursement again. On the 22nd, the 1,713 lung cancer patients and their families delivered a letter of appeal to the government, the Korean Association for Lung Cancer, and AstraZeneca Korea, expressing their “sincere hope for the first-line reimbursement of Tagrisso.” The letter said, “With Tagrisso’s first-line reimbursement thwarted numerous times during the past 3 years despite the desperate hope of patients and the medical community, patients and families that had to use Tagrisso as first-line treatment have been suffering from the immense financial burden imposed by the high-price of the drug. The Health Insurance Review and Assessment Service’s Cancer Drug Review Committee had turned down the application to extend reimbursement of Tagrisso to the first-line setting of non-small cell lung cancer (NSCLC). Since adding this first-line indication in Korea in December 2018, AstraZeneca Korea had been attempting the reimbursement expansion since 2019 but was unable to pass the threshold of the Cancer Drug Review Committee. The Cancer Drug Review Committee’s had an issue with the sub-analysis results of the global FLAURA trial in Asians, although the drug demonstrated an improvement in overall survival in the total population. On this, AstraZeneca further submitted results from the FLAURA China trial on the Chinese cohort patients, however, the reimbursement was once again turned down in April. Faced with this high barrier, patients and families came forward and organized an online signature-gathering campaign. In only one day, over 1,000 people signed the petition, and in one week, 1,713 people joined the campaign. The patients and families implored, “We don’t need the clinical trial results on Asians that was conducted on Chinese patients. Just the domestic cases are enough to recognize that Tagrisso has the best treatment effect in lung cancer and can even prevent brand metastasis and recurrence. We are deeply hurt that the current government, which promised to improve the medical environment for cancer patients, neglected the promise to ‘actively review reimbursement for first-line treatment with Tagrisso’ that was made at a national audit last year.” They continued, “We earnestly ask that you understand the sincerity of our claim, rather than simply dismissing our request for the first-line reimbursement Tagrisso in lung cancer as a ‘protest.’ We sincerely ask you to reconsider the reimbursement of Tagrisso as first-line treatment in lung cancer,” asking for the prompt reimbursement of Tagrisso. They also asked for the Korean Association for Lung Cancer’s support for this initiative. “Many professors in the field recommend Tagrisso as first-line treatment, however, the members of HIRA’s Cancer Drug Review Committee keep deferring reimbursement claiming that it lacks clinical usefulness.” To AstraZeneca Korea, they said, “We feel hopeless faced with the reality of having to pay over 6 million won every 4 weeks for the treatment,” and asked for the company’s additional and multidimensional effort for approval.
