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- 2026-04-03 16:42:54
- Company
- NMOSD drug Enspryng’s reimbursement expanded in KOR
- by Whang, byung-woo Aug 01, 2025 06:16am
- Pic of Enspryng Roche Korea announced on the 31st that the reimbursement criteria for Enspryng (satralizumab), a treatment for neuromyelitis optica spectrum disorder (NMOSD), will be expanded from August 1st per a notification from the Ministry of Health and Welfare. Enspryng is indicated for the treatment of adult patients with anti-aquaporin(AQP4) antibody-positive NMOSD. It selectively targets the interleukin-6 (IL-6) receptor, a key pathogenic factor in the disease, to inhibit IL-6 signaling. As the only subcutaneous injection formulation approved for NMOSD, it allows for maintenance therapy with a single subcutaneous injection every four weeks. This revision of the reimbursement criteria comes about a year and a half after Enspryng was first listed for reimbursement in December 2023. Under the revised notification, the criteria for Enspryng’s reimbursement, which previously required at least two symptom relapses within the last two years, have been relaxed to allow reimbursement only after at least one symptom relapse within the past year. Under the previous reimbursement criteria, patients had to wait for their second relapse of symptoms, even if they experienced their first relapse during initial treatment, before they could be prescribed Enspryng. However, with the revision, the treatment environment has been improved so that patients can quickly receive reimbursement for Enspryng even if they experience only one relapse during existing treatment. The expansion is expected to allow more patients with relapsing NMOSD to enjoy Enspryng’s treatment benefits. NMOSD is an inflammatory autoimmune disorder of the central nervous system that can cause lifelong physical weakness. Eight to nine out of ten patients experience recurrent relapses, and as even a single relapse can cause severe neurological deficits, early and aggressive relapse prevention treatment is crucial. Enspryng’s safety and efficacy in reducing the risk of relapse were demonstrated through two global Phase III trials - SAkuraStar and SAkuraSky - that were conducted on adult NMOSD patients. Study results showed that in anti-aquaporin-4 antibody-positive patients, approximately 9 out of 10 patients receiving combination therapy with immunosuppressants and approximately 7 out of 10 patients receiving monotherapy with Enspryng remained relapse-free at approximately 2 years (96 weeks). No cases of death or anaphylaxis (hypersensitivity reactions) were reported following Enspryng administration in either clinical study, and most adverse reactions were mild to moderate in severity. In particular, recently published real-world data from Japan showed that 96.6% of patients treated with Enspryng did not experience recurrence at 6 months (26 weeks). "Enspryng is an innovative treatment that has demonstrated its effect in reducing the risk of recurrence in patients with NMOSD in multiple clinical studies,” said Ezat Azem, General Manager of Roche Korea. “With the reimbursement expansion, patients who experience relapse with existing treatments will be able to use Enspryng more quickly without unnecessary delays, which will contribute to improving treatment outcomes and quality of life for patients.”
- Opinion
- [Reporter's View] KRPIA opts for 'maintain' over 'change'
- by Eo, Yun-Ho Aug 01, 2025 06:15am
- The Korea Research-based Pharma Industry Association (KRPIA) has chosen continuity over change. The KRPIA recently confirmed the appointment of Vice Chairman Lee Young-shin (68) to the position of Executive Vice Chairman, who is currently leading the association. This decision was made after amending the articles of incorporation to address the appointment of the Executive Vice Chair. Initially, the articles of association permitted only one re-appointment to the Vice Chair. Vice Chair Youngshin Lee had already been re-appointed once since his initial appointment in 2019. Therefore, a change in Vice Chair was highly probable upon the expiration of his term, but the association decided to amend its articles of incorporation and maintain the existing system. Historically, KRPIA has favored former government officials for the position of Executive Vice Chair. Given the nature of multinational pharmaceutical companies, whose core business is the supply of new drugs, communication with ministries related to the drug pricing system is crucial, and government connections are indeed crucial. Due to various reasons, the association has not appointed any former government officials since the resignation of former Vice Chair Lee Sang-seok, and Vice Chair Youngshin Lee 's second re-appointment has been confirmed. There must be a reason for this unusual decision. KRPIA has seen significant changes in its personnel composition over the past few years. While the reduction in the number of board members is an unavoidable consequence of the reassignments inherent in multinational company CEO positions, the frequent departures of government relations personnel, including former Policy Director Min-Young Kim, have led to substantial personnel gaps. Additionally, since February of last year, In-hwa Choi, the current Executive Director of Policy and External Affairs, has been appointed, and other vacant positions have been filled, resulting in the current state. New drugs and drug pricing are currently at a more critical juncture than ever before. Amid concerns about 'Korea Passing' due to the Trump administration's pressure on South Korea's drug pricing policy and a flood of high-priced drugs, the future policy direction could significantly impact public health in Korea. South Korea's drug pricing system, including that of generics, could face significant challenges. Moreover, a new government has just taken office. KRPIA's role will undoubtedly be paramount. The decision has been made, and now it's time to move forward. Beyond merely defending drug prices, we look forward to the association operating with rational and sharp judgment to find common ground with health authorities and lead to agreement on the overarching premise of 'improving patient accessibility.' This, along with a re-evaluation of the priorities for past government activities and policy proposals.
- Company
- Roche's HR+ breast cancer drug 'Itovebi' wins nod in Korea
- by Whang, byung-woo Aug 01, 2025 06:15am
- Product photo of ItovebiRoche Korea announced on July 30 that it has received approval of the breast cancer treatment Itovebi (inavolisib) from the Ministry of Food and Drug Safety. Itovebi, recently approved, can be used for the treatment of PIK3CA mutation-positive, hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer patients. Itovebi is indicated to be used in combination with palbociclib and fulvestrant therapy in adult patients with locally advanced or metastatic HR+, HER2-, and PIK3CA gene mutation-positive breast cancer that has recurred within 12 months during or after adjuvant endocrine therapy. For patients with a history of CDK4/6 inhibitor treatment as adjuvant therapy, it must be more than 12 months since the end of the CDK4/6 inhibitor treatment. For premenopausal and male patients, LHRH agonists are co-administered. Hormone receptor-positive breast cancer is the most common type, accounting for approximately 60% of all breast cancers, and about 40% of these are estimated to have a PIK3CA gene mutation. Activation of the PIK3CA mutation results in the dysregulation of the PI3K signaling pathway. Thus, existing treatments alone are often insufficient, resulting in a poor prognosis. The current approval is based on the Phase 3 INAVO120 study, which confirmed the clinical utility and safety of Itovebi. In 161 patients with locally advanced or metastatic HR+, HER2-, and PIK3CA mutation-positive breast cancer whose disease progressed within 12 months during or after adjuvant endocrine therapy, and who had no prior systemic treatment, Itovebi in combination with palbociclib and fulvestrant therapy showed a significant overall survival (OS) benefit compared to the control group (n=164) receiving placebo in combination with palbociclib and fulvestrant. Additionally, a median follow-up of 34.2 months, the median overall survival (OS) for the Itovebi treatment group was 34 months (95% CI, 28.4-44.8), and the risk of patient death was reduced by 33%. In contrast, the median overall survival for the control group (at a median follow-up of 32.3 months) was 27 months. Professor Seock-ah Im of Seoul National University Hospital's Department of Hemato Oncology, who led the INAVO120 study, explained, "The PIK3CA mutation promotes tumor growth and rapidly progresses the disease, which can lead to a poor prognosis, thus creating a significant unmet need for new treatments in this area." She added, "Itovebi has not only confirmed more than double the extension of progression-free survival (PFS) compared to existing standard therapies in patients with PIK3CA mutations, but it is also the only PI3K inhibitor to confirm overall survival extension." Ezat Azem, CEO of Roche Korea, said, "We are pleased to provide a new first-line treatment option for domestic PIK3CA gene mutation breast cancer patients, for whom treatment options have been limited," and added, "As a leader in breast cancer treatment, we will continue to contribute to the advancement of the breast cancer treatment environment in Korea." Meanwhile, Itovebi is Roche's first targeted therapy in the hormone receptor-positive field, following its leading position in HER2+ breast cancer treatment with Herceptin, Kadcyla, Perjeta, and Phesgo. Itovebi received Breakthrough Therapy designation from the U.S. FDA in May 2024 and FDA approval in October of the same year.
- Company
- Beyfortus likely to face restrictions on public advertising
- by Whang, byung-woo Jul 31, 2025 06:15am
- Sanofi is now compelled to revise its strategy as public advertising of Beyfortus (nirsevimab), an RSV preventive antibody injection, faces regulatory obstacles in Korea. Pic of Beyfortus According to Dailypharm’s coverage, the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) Drug Advertising Review Committee ruled that Beyfortus is “not subject to advertising review.” In South Korea, vaccines for the prevention of infectious diseases are classified as prescription drugs or over-the-counter drugs, and are allowed some advertising to the general public. However, under the Regulations on Prior Review of Pharmaceutical Advertisements, vaccine advertisements must undergo prior review by the KPBMA’s Advertising Review Committee. In effect, the KPBMA’s decision has made it difficult for Beyfortus to be advertised on TV or online to general consumers. Beyfortus is an antibody injection that is administered once to all newborns and infants under 12 months of age to prevent RSV infection for at least 5 months, and it was approved by the Ministry of Food and Drug Safety in April last year. Inoculation with Beyfortus began in domestic hospitals and clinics starting in early February and has been administered to infants and young children, and is now being approved by drug committees in general hospitals as well. Sanofi has been working to raise awareness of RSV disease with the launch of its product. A representative example is the “RSV Story Contest,” which aims to collect and share experiences about the disease. However, in the case of Beyfortus, the company will face limitations in building brand awareness and expanding market reach through public advertising, which is the most straightforward way to promote the product. With the approval of Beyfortus, Sanofi has taken steps to raise awareness of the disease. The current Pharmaceutical Affairs Act imposes strict regulations on advertising for prescription drugs. According to Article 68, Paragraph 6 of the Pharmaceutical Affairs Act, prescription drugs, except for vaccines, may only be advertised in specialized media or academic journals targeting medical and pharmaceutical professionals. Public media advertising is exceptionally permitted for vaccines used for preventive vaccination, but public advertising for other prescription drugs is prohibited. Beyfortus is approved for preventive purposes, but as it was approved as an antibody drug, not a vaccine, it is not covered by this exception. The advertising ban has caused quite a stir. First, the company now has an urgent need to raise awareness of the product through other means. Normally, when a new vaccine is released, a large-scale vaccination campaign is launched through TV commercials and online promotions, but this is rendered difficult for Beyfortus. In addition, existing premium vaccines have employed strategies such as using celebrities as models to naturally promote specific vaccines as “OOO vaccines,” but this has also become difficult. In other words, Sanofi, which wanted to promote Beyfortus in the domestic market through advertisements, will inevitably face restrictions on its future marketing strategies. As a solution, Sanofi is expected to shift its sales and marketing focus to medical professionals, akin to the prescription drug market. With general consumer advertising blocked, Sanofi is likely to prioritize product promotion through medical professional channels such as academic conferences and symposia. This is an indirect marketing approach that aims to increase consumer awareness through indirect promotional activities centered on departments such as pediatrics, obstetrics and gynecology, and infectious diseases. In fact, it is rumored that several obstetrics and gynecology hospitals have already begun recommending Beyfortus vaccinations to parents of newborns. In this regard, Sanofi is still awaiting the results of KPBMA’s preliminary review. A Sanofi official stated, “The possibility of advertising Beyfortus to the general public is currently under review by the KPBMA, and we are awaiting the results of the review.”
- Policy
- MOHW seeks measures to attract domestic investment
- by Lee, Jeong-Hwan Jul 31, 2025 06:15am
- The government is seeking ways to encourage multinational pharmaceutical companies to strengthen domestic investment, including the establishment of new pharmaceutical production plants in Korea. However, international trade issues and other obstacles remain to be overcome to attract domestic investment from multinational pharmaceutical companies, and it remains uncertain whether practical measures can be established. On the 30th, the Ministry of Health and Welfare announced this plan in response to the National Assembly Health and Welfare Committee's inquiry regarding the current status of domestic investment by global pharmaceutical companies and incentives. The MOHW agreed with the committee in that in order for South Korea to become a pharmaceutical and bio powerhouse, it is essential to not only expand investment by domestic pharmaceutical companies but also attract investment from global pharmaceutical companies. As an example of a global pharmaceutical company establishing a factory or production base in South Korea, the MOHW cited Janssen Vaccines, which operates a biopharmaceutical manufacturing plant in Songdo, Incheon. Another example is Otsuka Pharmaceutical Korea, which operates a factory in Hwaseong, Gyeonggi Province, capable of synthesizing active pharmaceutical ingredients and producing finished pharmaceutical products. The MOHW announced that it will investigate whether multinational pharmaceutical companies are willing to invest in Korea, what their difficulties are, and what incentives would be effective in attracting investment. To this end, the MOHW is expected to meet with the Korean Research-based Pharmaceutical Industry Association (KRPIA) to discuss the multinational pharmaceutical companies’ interest in domestic investment. The MOHW stated, “Domestic investment by global pharmaceutical companies has many positive effects in terms of securing infrastructure and creating jobs,” adding, “We will work with relevant associations to identify the investment intentions and difficulties of global pharmaceutical companies in Korea and come up with measures to attract investment.”
- Company
- MSD Korea begins Januvia drug price difference compensation
- by Son, Hyung Min Jul 31, 2025 06:14am
- Product photo of Januvia products There are changes regarding the Januvia drug price difference compensation issue, which had been stalled for nearly two years. MSD Korea has officially informed the distribution industry that it will begin accepting applications for Januvia compensation starting next month, August 1. However, this compensation is limited to the quantity sold before the transfer of marketing rights to Chong Kun Dang, and whether compensation on sales will be made still requires discussion. According to industry sources on the 31st, MSD Korea sent an official letter to the Korea Pharmaceutical Distributors Association on the 29th, stating that it will begin accepting applications for compensation due to the Januvia drug price reduction starting August 1st. This compensation will apply only to the quantity directly sold by MSD Korea before July 15, 2023, the date when Chong Kun Dang acquired exclusive domestic marketing rights for Januvia. Until now, the disagreement between MSD Korea and Chong Kun Dang regarding Januvia drug price difference compensation had not narrowed, leading to ongoing confusion in the distribution industry and local pharmacies. However, with MSD Korea announcing the compensation procedure for the drug price reduction, it is expected that discussions on compensation will begin. An MSD Korea official said, "We believe a significant portion of the inventory still exists with pharmaceutical distributors and healthcare institutions." They added, "We will proceed with compensation through prompt and accurate procedures to minimize damage." They further added, "We have continuously put efforts into responding responsibly regarding compensation for the price difference due to the Januvia drug price reduction," and explained, "We plan to begin accepting compensation applications starting August 1st and officially proceed with the procedures." However, the party responsible for compensation for sales made after July 15, 2023, the date of the marketing rights transfer, has not yet been determined. The drug prices for the Januvia family products, including Januvia, Janumet, and Janumet XR, were sequentially reduced between September and October 2023 due to patent expirations. MSD Korea stressed its position that it has no responsibility for compensation for the period after September 2023, the time of the Januvia drug price reduction, as Chong Kun Dang took over exclusive sales and revenue rights for Januvia following the marketing rights transfer agreement. Januvia is a DPP-4 inhibitor, containing sitagliptin, used to treat diabetes and is developed by MSD. Following Januvia's launch, MSD and Chong Kun Dang have been jointly promoting these products since 2016. However, in 2023, MSD Korea reorganized its chronic disease business unit to focus on its oncology and vaccine businesses, transferring the rights for the Januvia Family to Chong Kun Dang. Chong Kun Dang has been exclusively handling the domestic sales of Januvia as of July 15, 2023. MSD Korea's position is that since the marketing and revenue rights were already transferred at that time, they bear no responsibility for compensation related to the drug price reduction after September 2023, when the price cut occurred. MSD Korea said, "We transferred all domestic rights, including marketing and manufacturing rights, for Januvia products to Chong Kun Dang in July 2023, transferring exclusive sales and marketing authority," and added, "Accordingly, Chong Kun Dang is responsible for price difference compensation due to drug price reductions that occurred after that point." Chong Kun Dang believes that it is unfair to transfer the responsibility for compensation when the marketing authorization holder had not been officially changed. Therefore, difficulties in negotiation are anticipated. The marketing authorization was indeed transferred to Chong Kun Dang on July 23, 2024, after which the business transitioned to a global direct import structure. An official from the Korea Pharmaceutical Distributors Association said, "As MSD Korea has delivered an official letter stating its position on compensation, Chong Kun Dang is also expected to clarify its stance soon," and added, "It is a desirable direction for both companies to clearly define their areas of responsibility and proceed with compensation." They further commented, "We suffered significant losses by not receiving price difference compensation for over a year. We faced severe difficulties in the middle, and we hope to find an amicable solution."
- Company
- GSK Korea appoints Gunnar Riediger as new General Manager
- by Whang, byung-woo Jul 31, 2025 06:14am
- Gunnar Riediger, new Country President & General Manager of GSK Korea GSK Korea announced on the 30th that it has appointed Gunnar Riediger as its new General Manager, effective August 1. The new GM joined GSK in 2004 through the company's global talent development program, the “Future Leaders Program,” and has led healthcare operations across Latin America for over 20 years. He has held key roles including Vaccines Business Unit Head, BioTech Business Unit Head, and Global Vaccines Market Lead at GSK Brazil. Based on these experiences, as a seasoned leader, Riediger worked to maximize the potential of GSK's pipeline, pioneered innovative market entry strategies, and consistently invested in leadership development programs focusing on challenging thinking and accountability, achieving outstanding results. Ridiger then served as Country President & General Manager of GSK Colombia since 2023, successfully launching key products across the company’s vaccine, specialty medicine, and oncology portfolios. Based on these achievements, GSK Colombia has been recognized as one of the fastest-growing multinational pharmaceutical companies in Colombia in 2024, among other accolades. “I am honored to join GSK Korea, a company that has achieved remarkable results to date,” said Riediger. “I look forward to driving the next chapter of GSK Korea's growth by continuously supplying innovative vaccines and medicines to improve the quality of life for Korean patients and strengthening collaboration to advance Korea’s biopharmaceutical industry.”
- Policy
- MFDS says, abortion drug approval cannot be reviewed
- by Lee, Hye-Kyung Jul 30, 2025 06:16am
- Product photo of Hyundai Pharm filed a marketing authorization application for oral abortion drug 'Mifegymiso Tab (mifepristone·misoprostol)' last year. However, it has been confirmed that, under the current state of legislative void, the review cannot even begin. On the 30th, the Ministry of Food and Drug Safety's (MFDS) Pharmaceutical Approval Management Division responded to an inquiry from specialized journalists, stating, "The review of Mifegymiso Tab can only commence once a legal basis is established, and currently, review is not possible." They added, "Hyundai Pharm also understands that the efficacy, indications, dosage, and administration, etc., can only be set once the allowance and permissible gestational age for medication-induced abortion are clearly defined by law." Mifegymiso is a drug that induces early pregnancy termination. It is already used in over 90 countries, including the United States and France, since the World Health Organization (WHO) designated it as an 'essential medicine' in 2005. In South Korea, Hyundai Pharm signed an exclusive supply agreement with LinePharma UK and submitted its third marketing authorization application in December 2024, following previous submissions in 2021 and 2023. The two previous applications were voluntarily withdrawn due to requests for supplementary data. An MFDS official explained, "The establishment and review of key assessment items, such as efficacy, effect, dosage, administration, and Risk Management Plan, are only possible once the allowance and permissible gestational age for medication-induced abortion are legally defined." They added, "Hyundai Pharm is also aware of this and has agreed through internal discussions that it is difficult to proceed with approval at this time." Under the current legal framework, only surgical abortion methods are permitted, and medication-induced termination lacks a legal basis. Although the Constitutional Court of Korea ruled the abortion ban unconstitutional in 2019, amendments to the Criminal Act and the Mother and Child Health Act have not yet been made, leading to an ongoing legislative void. Consequently, MFDS has not yet taken official action, such as refusing approval or suspending review, for Mifegymiso Tab. It is being formally managed as 'under review.' The official emphasized, "Internal discussions regarding alternative methods, such as conditional approval or restricted use, have not reached a feasible level." The MFDS's position is that it cannot make a judgment alone, as this is an issue that requires prior social consensus, possibly in the form of legal amendments. Hyundai Pharm announced the submission of the Mifegymiso marketing authorization application through a public disclosure on December 31 last year. The disclosure contained results from three clinical trials conducted in the U.S. and Mexico, where Mifegymiso showed abortion success rates of 94.9%, 96.2%, and 97.3%, respectively. Hyundai Pharm explained that these study results demonstrate the effectiveness of the regimen, which involves taking 200mg of oral mifepristone followed by 800mcg of misoprostol, for terminating pregnancies up to 63 days (9 weeks) of gestation. Mifegymiso is a combipack product consisting of one 200mg mifepristone tablet and four 200mcg misoprostol tablets. The method involves first taking mifepristone, which inhibits the action of progesterone (essential for maintaining pregnancy), and then, 1-2 days later, taking misoprostol, which promotes uterine contractions. This is the method for medical abortion up to 63 days (9 weeks) of gestation recommended by the WHO. An official from Hyundai Pharm stated, "There have been no new updates since the marketing authorization application in December 2024." They added, "We are striving to introduce a safe and effective drug based on the results of three clinical trials conducted in the U.S. and Mexico." Meanwhile, in April 2019, the Constitutional Court of Korea ruled the criminal code's abortion ban unconstitutional, citing respect for women's right to self-determination over their bodies. Consequently, abortion procedures became de facto legalized as of January 1, 2021. In the 21st National Assembly, a total of seven bills related to the abolition of the abortion ban, including amendments to the Criminal Act and the Mother and Child Health Act, were proposed but ultimately expired without proper discussion. In the 22nd National Assembly, Democratic Party of Korea lawmakers Nam In-soon and Lee Su-jin recently proposed amendments to the Mother and Child Health Act.
- Company
- Lixiana solely leads DOAC mkt… Xarelto, Eliquis↓
- by Kim, Jin-Gu Jul 30, 2025 06:16am
- (From top left clockwise) Lixiana, Eliquis, Pradaxa, and Xarelto Original direct-acting oral anticoagulant (DOAC) drugs have faced mixed fortunes in the Korean market. Prescription sales of Lixiana (edoxaban) increased by 8% year-on-year, solidifying its lead in Korea’s market. Its market share in the DOAC market expanded to 49%, and the analysis is that Lixiana will continue its lead in the market until the expiration of its substance patent next year. Eliquis (apixaban) and Xarelto (rivaroxaban) showed sluggish performance. Lixiana saw a 30% decline in prescriptions due to price reductions following the launch of generics in the fourth quarter of last year. Xarelto, whose patent expired earlier, has also shown a clear downward trend in sales in recent years. DOAC prescriptions in the first half of the year reach KRW 122.4 billion...Lixiana solidifies sole lead in the market According to the pharmaceutical market research institute UBIST on the 28th, the domestic DOAC market prescription volume in the first half of this year was KRW 122.4 billion. This is a 4% decrease from the KRW 127.1 billion it had rendered in the first half of last year. DOACs are anticoagulants that prevent blood clots by directly acting on blood coagulation factors. They have replaced warfarin, which inhibits vitamin K metabolism, and are increasingly being used in clinical practice. In Korea, Xarelto was approved in 2009, followed by Pradaxa and Eliquis in 2011, and Lixiana in 2015. When the product first appeared, it was commonly referred to as NOAC (New Oral Anticoagulant), but as it has been more than 10 years since its initial approval, it is now called DOAC (Direct Oral Anticoagulant), referring to its mechanism of action that directly acts on coagulation factors. Quarterly major DOAC prescriptions (Lixiana, Eliquis, Eliquis generic, Xarelto, Xarelto generics, Pradaxa) Lixiana has further strengthened its lead in the market. Lixiana’s prescription sales in the first half of this year reached KRW 59.9 billion, an 8% increase from the KRW 55.7 billion in the same period last year. Lixiana was the last DOAC to be released, but the drug quickly increased its prescription sales and has maintained its market leadership since 2019. With an annual growth of around 10%, prescriptions rose from KRW 60.4 billion in 2019 to KRW 117.5 billion last year, nearly doubling in five years. Its share in the total DOAC market expanded to 49% in the first half of this year. This means that Lixiana accounts for nearly half of the KRW 260 billion in the DOAC market. The industry expects the market dominance to continue until the end of next year. The substance patent for Lixiana will expire in November next year. About 20 domestic pharmaceutical companies are expected to release generic versions at that time. Currently, 13 companies have been approved to sell generic versions of Lixiana, including Nexpharm Korea, Dong-A ST, Samsung Pharm, Shinil Pharmaceutical, Shinpoong Pharm, Anguk Pharmaceutical, Ildong Pharmaceutical, Genuone Science, Union Korea Pharm, Korea Prime Pharm, Hutecs Korea Pharmaceutical, and Handok Pharm. In addition, Samjin Pharmaceutical, HLB Pharmaceutical, Theragen Etex, and DongKwang Pharm have filed for an invalidation trial (passive scope confirmation trial) regarding the Lixiana formulation patent. If they win the first trial, they will be able to release generic versions in line with the expiration of the substance patent, like other companies. Furthermore, Alico Pharmaceutical and Korean Drug have been approved to conduct bioequivalence tests for the release of their generic versions of Lixiana. Eliquis·Xarelto sales in clear decline…due to the release of generic versions and drug price cuts On the other hand, Eliquis and Xarelto are in a clear downward trend. The sales decline of both products is analyzed to be affected by patent expirations and the subsequent entry of generics. Eliquis sales fell 30% from KRW 38.8 billion in the first half of last year to KRW 27.1 billion in the first half of this year. This is due to the impact of price reductions caused by the entry of generics. Eliquis’ price was reduced by 30% in September last year. Quarterly prescriptions of Eliquis and Eliquis generics Eliquis generics re-entered the DOAC market in the fourth quarter of last year. Eliquis generics were originally released in June 2019. At that time, generic companies released their products based on the first and second instance rulings in favor of them in patent litigation. However, the situation reversed in April 2021 when the Supreme Court overturned the first and second court rulings. The generic drugs were immediately withdrawn from the market. Following the expiration of Eliquis' substance patent in September last year, the generics returned to the market after three and a half years. Eliquis generics have been expanding prescriptions since their return to the market, reaching KRW 200 million in the fourth quarter of last year, KRW 600 million in the first quarter of this year, and then KRW 1.1 billion in the second quarter. By product, the situation is similar to that before the generics withdrew from the market three and a half years ago. At the time, the top two generic products in terms of prescription sales, Chong Kun Dang’s ‘Liquisia’ and Samjin Pharmaceutical's ‘Elxaban,’ have maintained their positions as the top two generics even after re-entering the market. Xarelto recorded sales of KRW 15.3 billion in the first half of this year, maintaining its prescription sales as in the same period last year. However, the downward trend has been evident since 2021. Compared to KRW 28.9 billion in the first half of 2021, sales have decreased by half in four years. This is due to the entry of generic drugs. Xarelto generics first appeared in the second quarter of 2021. About 40 products were released simultaneously in line with the expiration of Xarelto’s substance patent. Subsequently, prescriptions steadily increased, reaching KRW 4 billion in the first half of 2022, KRW 8 billion in the first half of 2023, KRW 12.4 billion in the first half of 2024, and KRW 13.7 billion in the first half of this year. Quarterly prescriptions of Xarelto and Xarelto generics By product, Hanmi Pharmaceutical's Riroxban recorded KRW 4.3 billion, Samjin Pharm’s Rivoxaban KRW 2.5 billion, and Chong Kun Dang’s Riroxia KRW 2.2 billion. The remaining products had prescription sales of less than KRW 1 billion in the first half. As sales of the original product slowed down, generics expanded their influence, and the market share of generics in the rivaroxaban-containing DOAC market reached 47% as of the first half of this year. Another original product, Pradaxa (dabigatran), is struggling to gain traction in the DOAC market. Pradaxa's prescription sales in the first half of the year were KRW 4.7 billion, a slight decrease from the KRW 4.8 billion in the same period last year.
- Product
- Platforms promote Wegovy's lowest price is ₩390,000
- by Kang, Hye-Kyung Jul 30, 2025 06:10am
- Non-face-to-face treatment platforms are facing backlash from pharmacies after launching activities promoting the lowest prices for non-reimbursable drugs. Doctornow, a leading non-face-to-face medical consultation platform, is being criticized for encouraging price competition for non-reimbursable drugs and causing confusion among consumers. A local pharmacist stated, “Recently, Doctornw has posted promotional content on its social media accounts, such as ‘How to buy diet injections for KRW 200,000 less,’ 'The real way to buy semaglutide diet injections for KRW 390,000,‘ and 'Hair loss medication consultation fee + medication cost: KRW 9,060.’ I believe this is likely to cause distrust and confusion among consumers toward pharmacies.” For example, in a video titled ‘How to buy diet injections for KRW 200,000 less,’ it says, 'Wow! I used to buy weight-loss injections for KRW 600,000, but I was paying KRW 200,000 more. If you don't know the latest way to buy diet injections cheaply, you're losing out 100%. If you know this method, you can get a prescription for KRW 200,000 less, at an unbelievable price!“ The video states that all you need is to access Doctornow. The video explains that you can find the lowest price at a pharmacy near you by clicking ”Find a Pharmacy,“ then clicking ”Get a Prescription" to select a nearby and affordable doctor, going to the hospital for a consultation, and then getting the injection at the lowest-priced pharmacy. However, the video has been criticized for causing consumer distrust and confusion about pharmacies. This pharmacist said, "Doctornow claims that the real price for semaglutide diet injections is KRW 390,000. It suggests that pharmacies are taking a middleman margin. However, the purchase price of the semaglutide diet injection, Wegovy, far exceeds the 390,000 won suggested by Doctornow.” When credit card transaction fees are added to the purchase price, it is practically impossible to meet the criteria for ”buying cheaply and well" suggested by Doctornow. When Dailpharm searched for the lowest price of Wegovy on Doctornow, the price varied depending on the region, but was usually over KRW 430,000. It was found that there are pharmacies in the Gyeonggi area that sell the drug for KRW 394,000 and KRW 395,000, but in the Gyeongsangbuk-do, Chungcheongbuk-do, and Gyeongsangnam-do areas, the price of the non-reimbursable injectable was set around KRW 430,000 to KRW 450,000. Doctornow also presented KRW 9,060 as the lowest hair loss medication consultation fees available. Another pharmacist said, “There are differences between pharmacies when it comes to the price of non-reimbursable drugs. However, I think it is problematic under the Pharmaceutical Affairs Act for non-face-to-face consultation platforms to arbitrarily set the lowest price and misrepresent it as the ‘standard’. Shouldn't sanctions be imposed on the platform for such excessive promotional activities?” Pharmacists also voiced concerns about the institutionalization of telemedicine, as the majority of non-face-to-face prescriptions made are for non-reimbursable drugs for cosmetic purposes. According to a survey conducted by the Guro District Pharmaceutical Association and the Jungnang, Gwangjin, and Gangdong District Pharmaceutical Associations among their members, 46% of pharmacists stated that they had accepted non-face-to-face prescriptions in the past three months. When asked about the proportion of non-face-to-face prescriptions for cosmetic purposes, such as hair loss, weight loss, and eye drops, among the prescriptions received, over 80% of respondents answered that they accounted for the majority of non-face-to-face prescriptions. The associations stated that the majority of pharmacists who accepted non-face-to-face prescriptions in the last three months responded that they were for cosmetic purposes. We are concerned about the reality that non-face-to-face medical consultations are being used as a means to purchase non-reimbursable drugs for cosmetic purposes, such as hair loss, diet, and eye drops, which deviates from the original purpose. We believe that non-face-to-face prescriptions for cosmetic purposes should also be excluded or restricted by the system, similar to psychotropic drugs.” Meanwhile, during her confirmation hearing as nominee for Minister of Health and Welfare, Eun-kyung Jeong stated, “The institutionalization of telemedicine should be aimed at ensuring the stability of medical care and improving primary care, rather than expanding platform profits. During discussions with the National Assembly, appropriate regulatory measures should be discussed to address concerns that platforms will effectively take over clinics and pharmacies or promote profit expansion.”
