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- Company
- Companies produced KRW 66.7B finished drugs a year
- by Chon, Seung-Hyun Jan 24, 2025 05:52am
- The average production performance of pharmaceutical companies has been gradually increasing. As the scale of the pharmaceutical industry grew, the average production value of both finished drugs and raw materials also continued to grow. For both finished drugs and raw materials, the share of small companies with annual production of less than KRW 10 billion was overwhelmingly large. According to the MFDS’s '2024 Food and Drug Statistical Yearbook,' 399 pharmaceutical companies produced a total of KRW 25.57 trillion worth of finished drugs in 2023. On average, each pharmaceutical company produced KRW 64.1 billion’s worth of finished drugs. The average value of finished pharmaceutical products produced by pharmaceutical companies increased by 34.5% over 10 years from KRW 49.6 billion in 2013. As the pharmaceutical industry continues to grow, the average production value of pharmaceutical companies has also expanded. In 2023, the number of finished drug items produced by each pharmaceutical company was 53.4. This is the 8 less in nine years since 2014 when it reached 61.4. The production value per finished drug item in 2023 was KRW 1.249 billion, up 4.1% year-on-year from KRW 1.249 billion in 2022. The average production value of finished pharmaceutical products has increased by 60.6% over nine years, from KRW 777.93 million in 2014. This means that pharmaceutical companies are restructuring their products, reducing the number of finished drug items they own, and becoming larger companies with higher production values per item. However, the pharmaceutical industry as a whole was dominated by small companies. Of the 403 producers of finished pharmaceutical products in 2023, 204 companies with a production value of less than KRW 10 billion accounted for 50.6%. This means that more than one in two pharmaceutical companies are SMEs with annual production of less than KRW 10 billion. There were 126 manufacturers with less than KRW 1 billion in finished drug production. This means that one out of every three manufacturers is a small business with less than KRW 1 billion in annual production. The number of companies producing less than KRW 1 billion in finished pharmaceuticals has tripled in 10 years, from just 45 in 2013. In 2023, 73 companies produced more than KRW 100 billion in finished pharmaceutical products, an increase of 8 companies from the previous year. Compared to 38 companies in 2013, the number of companies with a production value of KRW 100 billion or more increased by 92.1%. The number of companies producing more than KRW 500 billion in finished pharmaceuticals has tripled in 10 years, from 4 in 2013 to 12 in 2023. Raw material drug companies are also scaling up their businesses, but the share of small companies is still large. In 2023, 296 raw material drug makers produced a total of KRW 3.768 trillion. Each raw material drug company produced an average of KRW 12.7 billion. The average production value of raw material drug companies has more than doubled in 10 years from KRW 5.9 billion in 2013. The average number of items produced by raw material drug companies decreased by 6 over 10 years, from 27.1 items in 2013 to 21.1 items in 2023. Similar to finished pharmaceuticals, raw material drug manufacturers are also analyzed to improve their quality by reducing the number of products they handle while increasing the average production scale. In 2023, 239 of the 296 producers of raw material pharmaceuticals made under KRW 10 billion, accounting for 80.7%. The number of companies producing less than KRW 1 billion was 137, or 46.4%. Almost half of the companies produced less than KRW 1 billion in annual output. The number of companies producing less than KRW 1 billion in raw materials decreased by 106 over the 10 years from 243 in 2013. The number of companies producing more than KRW 100 billion in raw materials more than doubled in 10 years, from just three in 2013 to seven in 2023.
- Company
- Will long-acting HIV treatment be included in the reimb list
- by Eo, Yun-Ho Jan 24, 2025 05:52am
- The long-acting HIV treatment 'vocabria+rekambys' gets attention whether it will be included in the National Health Insurance reimbursement list, two years after receiving approval in South Korea. According to industry sources, GSK Korea and Janssen Korea have recently entered drug price negotiations for their new HIV drugs, vocabria (cabotegravir) and rekambys (rilpivirine), respectively. GSK will be responsible for conducting negotiations. The combination therapy 'vocabria+rekambys' passed the Drug Reimbursement Evaluation Committee (DREC) review of the Health Insurance Review and Assessment Service (HIRA) in December last year. These two drugs were approved by the Ministry of Food and Drug Safety (MFDS) in February 2022 as the combination therapy for the treatment of HIV-1 infection in adult patients who are virologically suppressed, no prior virological failure with cabotegravir or rilpivirine, and without past and present evidence of viral resistance. In South Korea, the vocabria+rekambys therapy was approved as an injectable that can be administered monthly or twice monthly. The benefit of this combination therapy is reported to be convenience. Prior HIV treatment required once-daily administration of a tablet-type medication. These two injectables can be given once a month or bi-monthly as intramuscular injections, decreasing the administration frequency and increasing satisfaction. The marketing authorization of this therapy is projected to reduce the patient burden. These two drugs were initially developed as oral formulations, and subsequently, each was formulated as an injectable. Although it cannot cure the HIV infection, it is a long-acting injectable that can target white blood cells and help lower and maintain the amount of HIV. The efficacy and safety of the combination therapy were demonstrated in a group treated once every 4 weeks or once every 8 weeks, and the vocabria+rekambys therapy received approval in Europe in December 2020. In the clinical trial, the most adverse reactions observed in a group treated with vocabria+rekambys were injection site reactions, headache, fever, vomiting, fatigue, lack of strength, and muscle aches. It is to be closely watched whether this combination therapy will be recognized by the healthcare authority for its benefit of convenience and receive approval for inclusion in the reimbursement list.
- InterView
- Approval called for drug switching in atopic dermatitis
- by Whang, byung-woo Jan 24, 2025 05:51am
- Atopic dermatitis treatment settings are changing quickly. New treatment options are available as new drugs with fewer side effects and superior treatment effectiveness than existing therapies emerge. There is a growing interest in how atopic dermatitis can be treated rather than just treating it, as changes have been brought to the treatment paradigm. According to health experts, considering many factors contibute to the nature of atopic dermatitis, even if the same medication is used, the treatment effects may vary by patient. Dr. Yang Won Lee, Professor in the Department of Dermatology at Konkuk University Medical Center, who has the latest expertise in this field stresses, the importance of treatment choice based on potential treatment effects and side effects and the need for improvement to the system. "New drugs for atopic dermatitis have shifted the treatment paradigm" Dr. Lee says the most significant change he has experienced following the introduction of new drugs for atopic dermatitis is the treatment effects and patient awareness. "In the past, patients were reluctant to receive therapy or even avoid getting one because of the notion that atopic dermatitis treatment is not efficacious and long-term steroid therapy may result in side effects. However, the launch of biological agents and targeted therapies such as JAK inhibitors have changed the care settings," Dr. Lee says. New drugs for atopic dermatitis are good news because treatment effects vary greatly depending on the patient's sensitivity. "Atopic dermatitis is a multifactorial disease where it is not affected by just a single factor but caused by various contributing factors, such as genetic factors, skin barrier issues, and dysfunctional immune responses," Dr. Lee stated. "Due to varying patient sensitivity, even if the same medication is used, patients may experience varying treatment effects." For instance, it means that even if biological agents or JAK inhibitors of the same class are used, patient treatment can differ depending on the mechanism. More treatment options became available this year and will likely change the treatment setting. On January 9, Lily Korea's Ebglyss (ingredient name: lebrikizumab), used to treat moderate to severe atopic dermatitis, was launched. Ebglyss was launched six months after obtaining approval from the Ministry of Food and Drug Safety (MFDS) in August 2024. It is a new biologic treatment that selectively blocks interleukin (IL)-13. The efficacy and safety profile of Ebglyss have been confirmed in the Phase 3 clinical trials. Once a patient meets the clinical response after 16 weeks treatment, the drug can be administered every 4 weeks with a maintenance dose (250 mg). Dr. Lee focused on fewer side effects associated with Ebglyss compared to conventional therapies. "While long-term use of cyclosporine or steroids can lead to various side effects, Ebglyss, a biological treatment, is relatively free from such concerns in terms of side effects. It has the advantage of long-term prescriptions and greater efficacy than existing treatments," Dr. Lee says. The basis of approval for Ebglyss was ADvocate-1 and ADvocate-2 Phase 3 studies. According to the results, the most common adverse reactions are conjunctivitis (6.9%), injection site reactions (2.6%), allergic conjunctivitis (1.8%), and dry eye (1.4%). Although dupilumab, a representative treatment for atopic dermatitis, is effective, some patients may experience side effects, including worsening conjunctivitis or facial and neck dermatitis. Therefore, therapies like Ebglyss are seen as potential alternatives. "Compared to dupilumab, Ebglyss shows a relatively lower frequency and severity of side effects such as conjunctivitis or facial and neck dermatitis," Dr. Lee said. "Additionally, if clinical response is achieved, Ebglyss can be administered monthly after 16 weeks. If the efficacy and side effects are comparable, drug adherence can be considered to reduce patient burden." Switching drugs for atopic dermatitis treatment has limitations…"We must provide broader range of treatment options to provide patient-customized treatments" However, there are challenges to overcome to achieve this. The remaining issue is a 'drug switching' between treatments. Last year, the Korean Atopic Dermatitis Association (KADA) submitted a statement to the health authority illustrating that drug switching should be allowed in the field of atopic dermatitis. The government is reviewing this matter, but it is expected to take time. The reimbursement criteria for special cases of atopic dermatitis patients switching treatments are complicated. For example, if patients transition from a biological therapy to a JAK inhibitor, they must meet complicated eligibility requirements from the beginning. Similarly, the same applies when switching from a JAK inhibitor to a biological therapy. "Patients often feel discomfort from the side effects of their current treatments, but due to the reimbursement requirements, which mandate waiting periods of three to four months, they often give up on switching therapies," Dr. Lee explained. "Meeting these conditions is burdensome, leaving patients in a situation where they must continue treatments despite experiencing side effects." "From the patient's perspective, having a broader range of treatment options is essential, and from the doctor's perspective, it is crucial to have multiple tools to combat a disease like atopic dermatitis. Therefore, the drug switching is vital," Dr. Lee emphasized. "If drug switching becomes more accessible, doctors will have a wider range of options for treatment, and patients can look forward to achieving better therapeutic outcomes." Dr. Lee particularly mentioned that if drug switching for atopic dermatitis is approved, the treatment options among drug types and the number of limitations must be discussed. "Patients who do not respond to existing treatments should be able to switch medications immediately. They should be able to choose from the same drug type, such as a biological agent or JAK inhibitor," Dr. Lee says. "In my opinion, not limiting the number of possible drug switching will broaden the range of treatments." "Drug switching is permitted for psoriasis, which is the same inflammatory skin disease. However, unlike psoriasis, atopic dermatitis is significantly limited. Like psoriasis, the treatment setting for atopic dermatitis should improve quickly," Dr. Lee said. Ultimately, Dr. Lee advised actively treating atopic dermatitis with a wider range of treatment options. "In the past, patients treated for atopic dermatitis often experienced several side effects or did not fully benefit from their treatment. However, new drugs provide opportunities for patients. Because many opportunities are open for patients with severe disease who need treatment, we hope patients will participate in getting treatment," Dr. Lee said.
- Policy
- 'Lixiana' patent expires next year, good news for
- by Lee, Hye-Kyung Jan 24, 2025 05:51am
- As the patent of 'Lixiana (edoxaban),' a Direct Oral Anti-Coagulant (DOAC), is set to expire, generic companies are entering the competition. On January 21, the Ministry of Food and Drug Satefy (MFDS) approved bioequivalence tests, which are open-label, randomized, two groups, single time-point, cross-over Phase 2 trials involving healthy adult study participants oral administration on an empty stomach, for Hanlim Pharm's 'Edoxaban' and Daiichi Sankyo Korea's 'Lixiana Tab 60 mg.' The Lixiana patents listed in the Ministry of Food and Drug Safety's (MFDS) patent registry are two types: the substance patent, which is set to expire on November 2026, and the composition patent, which is set to expire on August 2028. For the Lixiana composition patent, 10 companies, including Boryung, Dong-A ST, HK inno.N, Samjin Pharm, Shinil Pharma, Chong Kun Dang, Kolmar Pharma, Kolmar Korea, Hutex, and Hanmi Pharmaceutical, have successfully avoided the patent through passive rights scope confirmation trials. Korean companies that won patent avoidance can launch their generics when the substance patent expires in November 2026. To meet this schedule, these companies have been applying for approvals of generic Lixiana and bioequivalent tests since 2023. Dong-A ST was the first to obtain approval for its generic version of Lixiana in 2021. However, despite winning patent avoidance, the company did not meet the requirement for being the first request for trial, so it failed to obtain a right to priority sale. Without a right to priority of sale, 12 companies, including Genuone Sciences, Genu Pharma, Hutex Korea Pharmaceutical, Handok, Shinil Pharma, Ahngook Pharm, Shinpoong Pharm, Nexpharm Korea, Samsung Biologics, Korea Prime Pharm, and Union Korea Pharm, have received approvals for 29 generic products. Additionally, as companies such as CMG Pharmaceutical, Hanlim Pharm, Theragen Etex, and Vivozon conduct bioequivalence tests, competition intensifies in the generic market even before product launches. Lixiana has been ranked top for a long time in the DOAC market, with yearly prescription sales of KRW 100 billion. According to a pharmaceutical market research firm, UBIST, Lixiana's prescript sales for 2023 amounted to KRW 105.3 billion, up 9% from KRW 96.7 billion in 2022. It recorded KRW 55.7 billion in the first half of last year. Lixiana has maintained a leading position in the market since it ranked first in 2019. Analysis suggests that joint sales with Daewoon have contributed positively to the increase in prescription sales.
- Policy
- Hokunalin Patch has been removed from Korea’s reimbursement
- by Lee, Tak-Sun Jan 24, 2025 05:51am
- Hokunalin Patch, asthma and bronchitis deodorant based on tulobuterol, will be removed from the reimbursement list. The move was made upon the expiry of the item’s marketing authorization last month. As a result, only domestic generic versions of the drug are available in South Korea. According to industry sources on Jan. 22, Abbott's 3 versions of Hokunalin Patch (0.5 mg, 1 mg, and 2 mg) will be removed from the reimbursement list on Jan. 1 next month. The drug's domestic license expired on Jan. 1. The medication is an adhesive strip that is applied to the skin. It is characterized by its 24-hour effectiveness after a single application. In particular, it is used for infants and children suffering from asthma as well as acute and chronic bronchitis, as it has fewer side effects than oral medications and can be used from the age of 6 months. Abbott has already announced that it will discontinue the domestic supply of Hokunalin in 2022. The reasons included the end of the contract with the manufacturer and the rising cost of raw materials. However, the company had maintained the domestic marketing authorization for the drug, and with the expiration of the license and the removal from the reimbursement list, Hokunalin Patch will disappear into history. However, there is a six-month grace period before August 1 to apply for insurance reimbursement benefits. The withdrawal of Hokunalin from the domestic market was also due to the emergence of generic drugs. Generic versions of the drug have been available since 2010, and 19 pharmaceutical companies currently maintain licenses. The use of Tulobuterol Patch has been increasing due to the recent surge in respiratory diseases. In response, the government designated the transdermal tulobuterol patch as a national essential medicine in November 2023. In addition, in March last year, the upper insurance price limit was raised by up to 27.2% to address the supply-demand imbalance. However, the field reports that there is still a shortage of tulobuterol deodorant. The number of products being withdrawn is also increasing. From August 2023 to January this year, 21 products from nine pharmaceutical companies did not renew their licenses. “Tulobuterol patch is a product with a high production cost and not much profit,” said an industry official. ”Recently, the price of raw materials has risen, and due to intensified competition between generic companies, more and more companies are leaving.”
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- Approval called for drug switching in atopic dermatitis
- Dr. Yang Won Lee, Professor in the Department of Dermatology at Konkuk University Medical Center
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