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- 2026-07-01 12:03:09
- Policy
- The PVA exception to COVID-19 cold drug is actively applied
- by Lee, Tak-Sun Aug 22, 2022 05:52am
- Pharmaceutical Industry Says "Response After Gathering Internal Opinions" The Ministry of Health and Welfare said it would actively apply the correction method to the pharmaceutical industry's request to exclude cold drugs used in COVID-19 from PVA. Although it is not excluded from the negotiation, the policy is to actively apply exception rules to prevent damage to drug price cuts. First, the pharmaceutical industry plans to collect opinions on the proposal and respond through a public-private consultative body. However, as the Ministry of Health and Welfare's official position has been reported, the pharmaceutical industry is also expected to consider using the correction method in a more advantageous way. According to the industry on the 18th, the Ministry of Health and Welfare sent an official letter to pharmaceutical organizations such as KPBMA, saying that if the COVID-19 drug is selected for negotiations, it will be actively applied. The KPBMA suggested that COVID-19 drugs be excluded from PVA to actively support the production of COVID-19 symptom treatments. Prime Minister Han Duck-soo said at a meeting of the COVID-19 Central Disaster and Safety Countermeasures Headquarters on the 12th, "As the number of COVID-19 confirmed patients increases, we will encourage and support the expansion of supply and demand of cold medicines such as antipyretics. He said, "We will ease PVA, which cuts prices when the use of drugs increases, so that manufacturers can increase production." The pharmaceutical industry also had some expectations for Prime Minister Han's remarks. The plan proposed by the Ministry of Health and Welfare is interpreted as an extension. The Ministry of Health and Welfare and the NHIS also conveyed their intention to correct the COVID-19 cold medicine in accordance with related regulations through a public-private consultative body, so not all demands from the pharmaceutical industry to be excluded from the negotiation were accepted this time. According to the provisions of Article 10 (2) of the PVA Negotiation Detailed Operation Guidelines, exceptions are made when applying PVA in the case of drugs used to support the treatment of infectious diseases. The Ministry of Health and Welfare explained that if the cold medicine that the Ministry of Food and Drug Safety encourages production for the treatment of COVID-19 is selected as a PVA target, the relevant regulations will be actively applied. When calculating the negotiation reference price, the amount of use prescribed for COVID-19 treatment is excluded, or the amount of use at a specific time (e.g., February to August) is excluded. However, the correction method will be decided after sufficient discussion with related associations through a public-private consultative body. The pharmaceutical industry plans to seek countermeasures after internal discussions. An official from the Pharmaceutical Association said, "We would like to hear the opinions of pharmaceutical companies on the proposal of the Ministry of Health and Welfare and communicate with the government through a public-private consultative body at the end of the month." As the government's policy has become official, the industry is expected to discuss countermeasures accordingly. This is because the demand to continue to be excluded from the negotiation target may work against the discussion process.
- Company
- Ibrance safety is OK even in male breast cancer patients
- by Eo, Yun-Ho Aug 19, 2022 05:53am
- Breast cancer treatment Ibrance has added safety-related product information in male patients. The Ministry of Food and Drug Safety recently added a phrase that male patients also showed consistent safety profiles with women in post-marketing experience through updating the permits of CDK4/6 inhibitor Ibrance of Pfizer Korea. The measure was based on the results of post-marketing surveys and electronic health records in the United States, and the U.S. FDA expanded its indication to prescribe Ibrance to male patients based on the data in 2019. Male breast cancer is a rare disease that accounts for about 1% of all breast cancers, and most of the patients' mammary tumors are expressed in hormone receptors and are generally treated with endocrine therapy, and Ibrance combined therapy is possible for progressive cancer. But, Ibrance has not secured an indication for male breast cancer in Korea. Meanwhile, Ibrance recently reaffirmed its effectiveness, including the Overall Survival, through a large-scale Real World study. The study, published in the European Society for Medical Oncology Breast Caner 2022, retrospectively analyzed the data of 2888 actual patients prescribed Ibrance combination therapy and Aromatase inhibitor monotherapy. As a result, OS median of Ibrance was 53.4 months, and Aromatase inhibitor alone was 40.4 months. The risk of death in Ibrance combination therapy was 33% lower.
- Policy
- Manufacturing for development allowed during suspensions
- by Lee, Hye-Kyung Aug 19, 2022 05:53am
- An interpretation that manufacturing activities for the purpose of product development, not for commercial sale, is possible during the manufacturing business suspension disposition period. According to industry sources on the 18th, the Ministry of Food and Safety announced that not-for-sale manufacturing activities, such as those for product development or to prepare data for approval changes, are allowed during the manufacturing suspension period. This interpretation was provided after a number of queries on 'whether manufacturing for the purpose of product development is allowed during the suspension of manufacturing business period, and whether such manufactured units can be sold,’ were submitted on the national e-petition website, e-People. According to Article 76 of the Pharmaceutical Affairs Act, if a manufacturer of drugs or its importer violates the Pharmaceutical Affairs Act or any order issued under the Pharmaceutical Affairs Act, the Minister of Food and Drug Safety may revoke permission, approval, or registration held by the manufacturer of drugs, issue an order to prohibit manufacturing or importing products, or issue an order to fully or partially suspend his or her business for a period of up to one year. Also, according to Article 95, Annex 8-10 of the ‘Regulation on Safety of Medicinal Products,’ if companies perform the suspended business during the suspended period, their license or registration may be revoked. Regarding the provisions, the industry posted an inquiry on the e-People website on whether companies subject to manufacturing suspension dispositions may conduct manufacturing activities for the purpose of preparing submission data for the product’s approval change (change of consignee) or product development (and if allowed, whether the manufactured lot may be sold). After review, the MFDS said, “acts of manufacturing for non-sale, product development purposes (to prepare data for approval changes, etc.) are allowed during the manufacturing suspension period. However, the sale of the lot manufactured for approval changes, etc. or product development during the manufacturing suspension period is not allowed."
- Company
- US FDA approves Samsung Bioepis' high conc Humira biosimilar
- by Kim, Jin-Gu Aug 19, 2022 05:53am
- On the 18th, Samsung Bioepis announced that the U.S. Food and Drug Administration (FDA) approved the high-concentration formulation of its Humira biosimilar, ‘Hadlima 100mg/mL’ on the 15th (local time). The company plans to market the high-concentration Hadlima in the US market in July next year through its US marketing partner, Organon. Hadlima is used for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, and plaque psoriasis. To improve patient convenience, the formulation will be offered to patients in a prefilled syringe (PFS) or autoinjector. The approval of the citrate-free, high-concentration Hadlima was based on clinical data from a clinical study that compared the pharmacokinetics, safety, tolerability, and immunogenicity of two formulations of Hadlima (100 mg/mL vs 50 mg/mL) in healthy volunteers. The low-concentration formulation (50 mg/mL) of Hadlima was previously approved by the FDA in July 2019. More than 5 million prescriptions of Hadlima had been made under various brand names since 2018. Byoungin Jung, VP and Team Leader of Regulatory Affairs at Samsung Bioepis, said, “With the FDA approval, we are now able to expand our treatment options to both the low- and high-concentration versions of Hadlima in the US. By leveraging our R&D expertise, manufacture, and supply chain management capabilities, we will continue our efforts to provide quality drugs to patients around the globe.”
- Policy
- We need to increase the rate of PO tx for COVID-19 crisis
- by Lee, Jeong-Hwan Aug 19, 2022 05:53am
- In order to respond to the increase in the number of patients with COVID-19, it was pointed out that the prescription rate of treatments such as Paxlovid should be raised more than now, while continuing to maintain an environment where prescriptions are quickly prescribed. It was also suggested that the fast track of the COVID-19 high-risk oral drug prescription currently prepared by the government should be repeatedly checked, and the fast track system should not be predicted to continue to be sustainable. On the 17th, Jeong Ki-seok, chairman of the National Advisory Committee on Infectious Disease Crisis Response, made this announcement at a regular briefing on COVID-19. Chairman Chung Ki-seok positively assessed that the prescription rate of oral treatments, which stood at only 4% earlier this year, has now risen to 20%. Chung's assessment is that the prescription rate of PO drugs must rise steadily to be effective in responding to critical patients. He stressed that it is very important to secure a system that can prescribe PO drugs quickly and continue to check. Chairman Chung said, "The government is preparing a lot of PO drugs, but the medicine does not solve it." He said, "The system that can be prescribed the fastest in the right time is important. This is why experts strongly recommended fast-track operation to the government," he explained. Chairman Chung added, "We are operating a fast track, but the government should check for other system that allows high-risk groups to receive treatment first and receive treatment first," adding, "We should not predict that this will continue to be sustainable just because we have it in place." The Ministry of Health and Welfare announced that it will do its best to secure additional medical institutions and pharmacies handling oral drugs. Currently, there are only 274 places that prescribe treatments taken at or above the general hospital level and only 7 upper-level general hospitals. Park Hyang, head of the central disaster management headquarters, said, "There are about 10,000 one-stop hospitals, but it is true that the number of high-level general hospitals or general hospitals that can be opened at night is small." There will be more medication in the future," she said. "I heard opinions on why the drug progress is slow at the medical field, and there were problems with pharmacy issues and outpatient prescriptions," Park Hyang said. "In the case of Paxlovid, it seems still difficult to combine them." "Although 2,000 pharmacies have been previously secured, we are preparing to designate additional pharmacies at any time if there is an additional on-site request," she said. She added, "We will continue to listen to opinions from the medical field and supplement them."
- Company
- Indication of Norvatis Beovu's DME was expanded
- by Aug 19, 2022 05:52am
- Novartis Korea announced on the 17th that Beovu, an Age-related macular degeneration treatment, has added diabetic macular edema (DME). Beovu is a treatment that inhibits neonatal vascular expression and retinal effusion leakage in combination with VEGF-A. The Beovu dose for DME treatment is administered once every 6 weeks, 6 mg (0.05 mL) for the first 5 times, and once every 12 weeks thereafter. Patients with disease activity can be administered once every eight weeks. The administration interval is determined based on disease activity evaluated on vision and/or anatomical criteria. This permission was based on the results of 2 phase 3 clinical trials, KESTREL and KITE, which directly compared the efficacy and safety of the existing treatment, Aflibercept. The clinical trial was conducted on 926 patients with type 1 or type 2 diabetes (566 KESTREL and 360 KITE) aged 18 or older with impaired vision due to diabetic macular edema. In the Beovu medication group, loading dose was administered 5 times every 6 weeks, then administered every 12 weeks, and patients with confirmed disease activity were administered every 8 weeks. The control group was administered 5 times every 4 weeks with loading dos according to the drug's permission and then administered every 8 weeks. At the first year (52 weeks), the median was administered 7 times in the Beovu medication group and 9 times in the control group. The researchers said that existing anti-VEGF treatments that treat DME were usually administered monthly when administering loading dose, making it difficult to improve the patient's treatment burden and resulting symptoms, and based on the results of this study, Blucizumab-dbll will be a new treatment option to reduce the treatment burden for diabetic macular edema. DME is a disease that causes swelling in the macula by increasing vascular endothelial growth factors and proliferating new blood vessels as exudates flow from damaged microvascular vessels due to the inability to control high blood sugar. According to a paper published in 2011, DME is a major disease that causes blindness in adults in developed countries, with 12% of type 1 diabetes patients and 28% of type 2 diabetes patients being affected. Cho Yeon-jin, executive director of Novartis Korea's ophthalmology division, said, "We are pleased to expand treatment options to patients suffering from vision damage following Lucentis with the expansion of indications for the treatment of diabetic macular edema." Executive Director Cho Yeon-jin explained, "Novatis will continue to have leadership in the field of eye disease treatments and make efforts to introduce treatments with efficacy and safety to clinical sites."
- Company
- Why is the exp. date of the Sanofi flu vaccine short?
- by Aug 18, 2022 01:06pm
- With domestic and foreign pharmaceutical companies starting to distribute flu (influenza) vaccines, the expiration date of the Sanofi vaccine is about three months shorter than that of other products. This means that the Sanofi vaccine must be discarded in April, when Korea is still considered to be a flu epidemic period, so it cannot be used. Sanofi explained that it is the best way to speed up the introduction of Korean products. According to the pharmaceutical industry on the 17th, domestic and foreign pharmaceutical companies such as Sanofi, GC Pharma, Boryung Biopharma, Ilyang Pharmaceutical, and Korea Vaccine have started supplying vaccines in preparation for the 2022-2023 seasonal flu epidemic. According to the current status of the seasonal flu vaccine lot release for domestic use released by the Ministry of Food and Drug Safety, a total of 9.32 million people were approved for shipment from July 18 to the 12th of this month. Among them, the expiration date of Sanofi's flu vaccine Vaxigrip is about seven months later, until March 31, 2023, which is particularly shorter than other vaccines. Sanofi received Lot releases for each lot of Vaxigrip on August 1, 2, 4, and 9, which were valid for the same period as March 31 next year. The flu vaccine is usually valid for one year. The validity period of other flu vaccines approved for shipment at the same time is around June-July next year, about a year later. For example, GC Pharma's GC FLU , which received a Lot release on August 1, has an expiration date of June 12, 2023, and Korea Vacine's Kovax-Flu validity period, which was approved on the same day, is June 23, 2023. On August 10, Boryung Bio Pharma's Boryung Flu, which was released on August 10, is specified to expire on July 5, 2023. Ilyang Pharmaceutical Terrestrial Pfs, which received a lot release on July 19, ahead of Sanofi, also has an expiration date of June 14, 2023. This means that the expiration date of Vaxigrip is about three months shorter than that of other flu vaccines, so Vaxigrip must be discarded in April next year, when the flu vaccine is in vogue. In Korea, the flu epidemic is expected from October to April of the following year. The government's national flu vaccination project is also in line with this. The expiration date is not a problem when receiving national shipping approval, but vaccine manufacturers generally distribute vaccines that can be received until the end of the business period. This is because if the expiration date ends within the epidemic period, products that need to be discarded can be inoculated to consumers, and common sense believes that it is inappropriate to supply products that need to be discarded within the business period. Some raise suspicions that the reason why Sanofi supplied the flu vaccine so early is because of the expiration date. Originally, Sanofi distributed the flu vaccine in Korea from September to October every year with GSK. In the case of imported finished products, unlike domestic manufactured vaccines, it takes longer to finish production at foreign factories and enter Korea through a certification process. However, this year, Sanofi began supplying vaccines at the same time as domestic manufacturers. Previously, the expiration date was longer than this, so there was no big difficulty in supplying from September to October, but this year, the expiration date had to be advanced as the expiration date was less than eight months away. An official from a vaccine manufacturer said, "As Sanofi distributes vaccines with a short distribution period in Korea, confusion is expected in the vaccine market," adding, "Some analysts say that Sanofi is accelerating the introduction as it has to quickly exhaust its products this year." Sanofi explained that it brought in products produced relatively early so that domestic consumers could receive vaccines quickly. Unlike previous years, influenza strains that will be prevalent in the southern and northern hemispheres this year were consistent, so there was no need for a technical process to change the strain, which allowed the production of vaccines for the northern hemisphere to be accelerated. Imported finished products have more testing processes and are more difficult than domestic companies, so no matter how fast they speed up, the remaining validity period is bound to be shorter than other domestic vaccines that have been released at the same time. An official from Sanofi said, "Korean corporations have tried to advance the timing due to the late introduction schedule of imported products in Korea, and we have secured vaccines as soon as possible as we can produce Northern Hemisphere products early this year due to the same strain." "The introduction process may be complicated and the expiration date may be relatively short, but we did our best to supply the product at a similar time to other vaccines. Also Vaxigrip Tetra whose expiration date is from May to July 2023 is going to be supplied sequentially in Korea," he said.
- Company
- Yuhan invests ₩23.1B in Yuhan USA over 4 years
- by Chon, Seung-Hyun Aug 18, 2022 05:48am
- Yuhan Corp is making aggressive investments in its US subsidiary. Investing ₩23.1 billion during the past 4 years after establishing Yuhan USA in 2018, the company has been making broad steps to advance into the global market. According to the Financial Supervisory Service on the 17th, Yuhan Corp had invested ₩7.7 billion in Yuhan USA, and acquired 6 million shares in the second quarter of this year. Yuhan USA, which was established in 2018, is the regional subsidiary of Yuhan Corp that is responsible for investing in promising bio-ventures, global clinical trials, and technology exports. As a fully-owned subsidiary of Yuhan Corp, it has been serving as the bridgehead for the company’s global advancement. Yuhan USA has two offices, one in the East, in Boston, and the other in the west, in San Diego. Boston is regarded as the mecca of the global bio-industry, and San Diego is also a rising major bio cluster. An official from Yuhan said, “Yuhan USA has been serving as a bridgehead for the company, strengthening R&D capabilities by quickly acquiring advanced information by engaging in active networking activities in the US for delivery to Yuhan’s Central Research Institute.” Yuhan USA visits local companies, research labs, and universities in the US to directly invest in promising technology and new drug candidates. It also makes indirect investments in bio venture funds in the US and established its own fund to attract local bio-ventures and investors to visit Yuhan USA. The company also directly licensed out Yuhan’s gastroesophageal reflux disease (GERD) treatment in 2020. Yuhan licensed out its GERD treatment candidate 'YH12852' to Processa Pharmaceutical in August 2020 for the exclusive rights to its development, manufacture, and commercialization worldwide, except for Korea. The amount totals a maximum of $408.5 million (₩500 billion). Yuhan had received $2 million of Processa common stock as a non-refundable, non-creditable upfront payment. Processa Pharmaceutical is an R&D specialized company headquartered in Maryland, US that was founded in 2016. Yuhan USA had directly sought technology export partners and conducted negotiations in the US, and made the final deal with Processa Pharmaceutical. Yuhan USA also took part in increasing the possibility of technology exports for Yuhan's new drug candidates by attending major international conferences in the U.S. and introducing their clinical data. At the American Association for Cancer Research (AACR) meeting that was held in April this year, Taewon Yoon, CEO of Yuhan USA, personally attended and presented preclinical data on the company's immuno-oncology drug candidate 'YH32367.' Yuhan had first invested ₩1.9 billion in Yuhan USA upon its establishment in 2018. Since then, the company additionally invested ₩3.5 billion and ₩3.6 billion in 2019 and 2020, respectively, and then ₩6.4 billion last year. With this year’s investment, the total amount sums up to ₩23.1 billion in 4 years. The company is speeding up global market entry by increasing the investment amount every year. Yuhan USA has also been contributing to the development of ‘lasertinib,’ Yuhan’s key technology export project. Yuhan had made a licensing deal with Janssen bBotech for its EGFR targeted therapy ‘lasertinib’ in November 2018. Including the upfront payment of $50 million with no obligation of return, the company will receive a maximum of $1.205 billion under the deal. Yuhan USA is said to be continuously exchanging with its partner Jansen for the commercialization of lasertinib. After making the deal for lasertinib, Janssen has been actively developing the candidate in combination with its self-developed bispecific antibody ‘amivantamab.’ The CHRYSALIS study, the first study initiated by Janssen using lasertinib, is known to be in smooth progress. The study is not only investigating the ‘leclaza+amivantamab’ combination but its combination with platinum-based anticancer therapies such as ‘carboplatin,’ and ‘pemetrexed,’ etc. Yuhan has been making aggressive investments to reinforce the capabilities of its subsidiaries. Yuhan had invested ₩12.3 billion in Yuhan Care since last year. After acquiring 1,469,768 shares of Yuhan Care for ₩5.4 billion, it additionally invested ₩6.9 billion in Q1 this year. Yuhan also invested ₩21.4 billion and ₩0.9 billion last year and this year, respectively, in its IV product subsidiary, MG. The funds Yuhan invested in MG were used for the expansion and improvement of the company’s IV facilities.
- Opinion
- [Reporter's view] Legalization of Non-face-to-face Care
- by Lee, Jeong-Hwan Aug 18, 2022 05:48am
- Non-face-to-face treatment has become a social topic beyond the health and medical community. Non-face-to-face treatment, which has been temporarily allowed since February 2020, has been on the rise for three years, and the public and domestic medical systems, which are users, have naturally become accustomed to non-face-to-face treatment. Non-face-to-face treatment, which has become a hot topic, is now beyond temporary permission and the need for legislation is emerging. This is because the current medical law and pharmaceutical law principles are shaking due to excessive expediency and some illegal acts of non-face-to-face treatment platform companies derived from temporary permission. The Ministry of Health and Welfare recently reiterated its willingness to institutionalize non-face-to-face treatment to the National Assembly's Health and Welfare Committee and submitted a position to strongly control illegal attempts by delivery pharmacies or non-face-to-face treatment platform companies. The Ministry of Health and Welfare plans to start legislating within the year based on the non-face-to-face treatment bill pending in the National Assembly, and believes that the current face-to-face treatment alone cannot solve the problem of access to medical services such as islands and wallpaper. One more thing is needed to strengthen the legislation of non-face-to-face care. It is an interest in non-face-to-face treatment of the power of the ruling people. Currently, two cases (Choi Hye-young, Kang Byeongwon) have been proposed in the main opposition Democratic Party of Korea alone, including the legislation of non-face-to-face treatment. Shin Hyun-young, the main opposition Democratic Party, also announced plans to propose additional non-face-to-face treatment bills. In the power of the people, the non-face-to-face treatment bill has not yet been proposed. The Ministry of Health and Welfare and the Democratic Party are waiting for the ruling party's representative to propose a bill to strengthen the legislation of non-face-to-face care, but no lawmaker is reportedly interested in the bill yet. Non-face-to-face treatment should start discussions on legislation to strengthen the management of platform companies and the current medical law and pharmacology law principles at the same time as the need to stipulate the system itself as a law. At a time when the number of users of non-face-to-face treatment and non-face-to-face treatment services is exploding, there may be many side effects that need not be experienced if related regulations are established too late. Starting with the representative presentation of the non-face-to-face treatment bill, the ruling party should make efforts to improve legislative completeness by widely accepting the needs of the Ministry of Health and Welfare, the medical community, the Pharmaceutical Association, and the platform companies. It is a way to improve the stability of the health care industry and to prevent the principles of medical law and pharmacology law from being disturbed. It is expected that the ruling party will make an agile move to prevent platform companies from making mistakes in shaking the domestic health care system by neglecting non-face-to-face treatment with some expedient and illegal methods.
- Policy
- KDCA opposes use of Paxlovid in healthy 50s
- by Lee, Jeong-Hwan Aug 18, 2022 05:48am
- The disease control and prevention authorities have expressed opposition to the plan to lower the prescription age for Pfizer’s oral COVID-19 treatment, Paxlovid, to those in their 50s, on grounds of domestic Emergency Use Authorization standards. The decision was influenced by the fact that eligibility for Paxlovid had already been extended to those over the age of 50 with underlying diseases and that no efficacy evaluation results exist for its use in healthy adults in their 50s. On the 16th, the Korea Disease Control and Prevention Agency said, “Paxlovid can be prescribed to patients aged 12 years or older including those in their 50s that have risk factors such as underlying diseases.” NA Health and Welfare Committee member Jong-Seong Lee of the People Power Party had pointed out the need to review lowering the prescription age for Paxlovid to those in their 50s. Paxlovid is currently granted emergency use without an official marketing authorization in Korea. Under the EUA, patients who are confirmed with mild-to-moderate COVID-19 and are at high risk for progression to severe disease must satisfy additional standards to receive Paxlovid. The patient must additionally satisfy one or more of the following standards: 60 years or older who are immunocompromised, or 40 years or older with underlying diseases (diabetes, cardiovascular diseases, chronic kidney diseases, chronic lung disease, BMI over 30kg/㎡) The KDCA, which made the decision to expand Paxlovid’s eligibility to those in their 50s with underlying diseases in February (effective from February 7th), expressed skepticism on increasing the scope to those in their 50s who do not have underlying diseases. The KDCA said, “The subjects eligible for Paxlovid's use were set based on the efficacy evaluations results within the Emergency Use Authorization granted by the Ministry of Food and Drug Safety, in patients with risk for progression to severe disease because Paxlovid was found effective in the set target group.” The KDCA added, “Also, if a patient has risk factors such as underlying diseases, etc.. patients not only over the age of 50 but those who are 12 years or older may be prescribed Paxlovid.”
