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- 2026-04-29 00:39:41
- Policy
- Approval of new ulcerative colitis drug Velsipity near
- by Lee, Tak-Sun Apr 28, 2026 09:46am
- ‘Velsipity 2mg Tab (etrasimod),’ a new ulcerative colitis treatment being introduced in Korea by Everest Medicines Korea, cleared a key hurdle toward domestic marketing authorization.According to industry sources on the 26th, the Ministry of Food and Drug Safety recently completed the safety and efficacy review for Velsipity Tab. As the safety and efficacy review is considered the most rigorous step in the new drug approval process, the likelihood of Velsipity receiving domestic marketing authorization within the year has significantly increased.Velsipity is a next-generation selective sphingosine-1-phosphate (S1P) receptor modulator developed by Pfizer. It works by blocking the release of lymphocytes from lymph nodes, thereby preventing their migration to inflamed areas in the gastrointestinal tract.It is indicated for adult patients with moderate to severe active ulcerative colitis. In particular, its once-daily oral dosing is considered a strong competitive advantage in a treatment environment traditionally dominated by injectable therapies.Velsipity has demonstrated efficacy through global Phase III trials (ELEVATE UC 52 and ELEVATE UC 12). According to trial results, it achieved significantly higher clinical remission rates compared to placebo at both week 12 and week 52.Currently, the domestic ulcerative colitis market is dominated by biologics as well as JAK inhibitors such as ‘Rinvoq’ and ‘Xeljanz.’ If approved, Velsipity is expected to form an S1P modulator market alongside the first-in-class drug Zeposia, providing patients with a new treatment option.Everest Medicines has secured commercialization rights in the Asia-Pacific region, including Korea, through an agreement with Pfizer and has been proceeding with the domestic approval process. With the completion of the safety and efficacy review, the company is nearing the acquisition of marketing authorization.An industry official said, “Passing the safety and efficacy review means that the MFDS has recognized the clinical value of the drug. Upon final approval, Velsipity is expected to have a significant impact in the ulcerative colitis treatment field, where there is a high preference for oral medications.”
- Policy
- Innovative Pharma Company certification reform…"application opens in August"
- by Lee, Jeong-Hwan Apr 28, 2026 09:46am
- The Ministry of Health and Welfare (MOHW) plans to begin accepting applications from pharmaceutical companies as early as August to implement the reformed "Innovative Pharmaceutical Companies" certification system, following the completion of remaining administrative procedures.As both domestic and multinational pharmaceutical companies have shown strong interest in the reformed certification system, the MOHW has decided to implement an absolute evaluation method, granting the designation of an Innovative Pharmaceutical Companies to all companies that score 65 points or higher.If applications are accepted in August as scheduled, the final list of certified pharmaceutical companies is expected to be officially notified (announced) by the end of December following the review process.On the 26th, Lim Kang-seop, director of the Pharmaceutical and Bio Industry Division at the MOHW, explained the administrative plan to reform the "Innovative Pharmaceutical Companies" certification system during a meeting with KSPA News.The MOHW has issued legislative and administrative notices regarding the enforcement decree·enforcement rules for related notifications of the "Special Act on Fostering and Support of Pharmaceutical Industry" as of the 26th of last month.The Ministry plans to finish gathering opinions by the 6th of next month, followed by an internal review, a regulatory review by the Prime Minister's Office, and a review by the Ministry of Government Legislation.The reform plan will be implemented immediately upon finalization and promulgation. The MOHW plans to start accepting applications for innovative pharmaceutical companies based on the new criteria as early as the beginning of or mid-August and continue through the end of September.Key indicators for the certification review include whether the R&D-to-revenue ratio meets the standards and whether any disqualifying factors exist. Disqualifying factors include illegal drug rebates and unethical conduct by executives or employees. Exceeding the threshold in these areas will result in failure to obtain certification.Lim explained that there will be no limit on the final number of innovative pharmaceutical companies, and certification will be granted through an absolute evaluation.Lim stated, "Certification as an innovative pharmaceutical company is possible if a minimum score of 65 points is achieved. The review will be conducted as an absolute evaluation," and added, "After the Korea Health Industry Development Institute (KHIDI) conducts an initial document review of the applicant companies, those that pass the criteria will undergo deliberation by the committee. We expect to be able to notify the final list by the end of December this year."Given the high interest from both domestic and foreign pharmaceutical companies, with over 100 companies expected to apply, the specific schedule for the official notification of the list may change.Lim plans to hold briefing sessions and public-private consultations regarding the certification system for domestic and foreign pharmaceutical companies between May and June.Lim also noted that further review by the MOHW is required regarding the specific evaluation methods and score allocations for new indicators, such as supply chain stabilization for medicines experiencing supply instability.Lim stated, "This time, both quantitative and qualitative indicators will be reviewed together. Quantitative indicators are being simulated on a 5-point scale, while qualitative indicators will be evaluated according to guidelines for the reviewers," and said. "We are working with the KHIDI to determine evaluation methods suited for new indicators like supply chain stabilization."Lim further stated, "Once the detailed review guidelines are established, we plan to provide briefing sessions or further guidance. A briefing session could be held around late May or early June," and added, "There are requests to include compliance management indicators related to pharmaceutical rebates in the review process, but these are already reflected in the qualitative indicators."Lim concluded by stating that "The qualitative evaluation already accounts for instances where a pharmaceutical company has independently adopted a Compliance Program (CP) and operated a compliance management program following the discovery of rebates," and added, "The legislative notice contains only the broad framework of review items, and the method of qualitative evaluation will be determined by the KHIDI's reviewer guidelines and the items in the documents submitted by the companies. Even if there were past rebates, companies will be able to appeal by demonstrating how they have since strengthened internal controls."Meanwhile, Semi-Innovative Pharmaceutical Companies are also expected to be reviewed and selected through an absolute evaluation based on R&D standards and disqualifying factors, similar to the process for Innovative Pharmaceutical Companies.
- Policy
- Implementation of fast-track listing pilot project imminent
- by Jung, Heung-Jun Apr 28, 2026 09:46am
- The list of drugs eligible for the fast-track listing pilot project for rare disease treatments, along with contract terms, is expected to take shape in the first half of this year.Among rare disease treatments, certain drugs will be selected for initial application, and follow-up measures reflecting reimbursement after post-evaluation will be included in contract terms.According to industry sources and relevant agencies on the 27th, the National Health Insurance Service (NHIS) and the Health Insurance Review and Assessment Service (HIRA) have begun working-level preparations for implementing the fast-track listing pilot project.Fast-track listing is a government plan to reform the drug pricing system by reducing the listing period for rare disease treatments from 240 days to 100 days, with the aim of improving patient access to treatment.The Ministry of Health and Welfare announced at the end of March, through the Health Insurance Policy Deliberation Committee, that it will prioritize the pilot project this year and institutionalize it starting next year. From 2028, it will be expanded to innovative new drugs.The pilot project is expected to include selected drugs among rare disease treatments, considering factors such as patient population. NHIS and HIRA are reviewing detailed selection criteria and negotiation contract conditions.Since there are already designation criteria for orphan drugs set by the Ministry of Food and Drug Safety, additional conditions are expected to be added to these existing standards.HIRA and NHIS need to significantly simplify the existing listing process. Since it is not possible to accommodate all rare disease treatments, HIRA is carefully reviewing the criteria for selecting items.In addition, HIRA is conducting a research project through the end of the year to evaluate clinical efficacy using real-world evidence (RWE). The results will be reflected in the institutionalization of the fast-track listing system next year.Both HIRA and NHIS share the view that post-listing mechanisms must be strengthened as the listing period is significantly shortened.NHIS is focusing on strengthening follow-up measures based on post-evaluation. While reducing the drug price negotiation period with pharmaceutical companies from 60 days to one month, fast-track listing negotiations will focus mainly on expenditure caps and supply obligations.NHIS is also reviewing including clauses in negotiation contracts with pharmaceutical companies that allow for price adjustments or the re-establishment of reimbursement criteria after post-evaluations.Consequently, reaching a concrete agreement on post-listing adjustment conditions during negotiations with pharmaceutical companies is expected to be a key issue.
- Policy
- First public-private meeting on drug pricing system reform imminent
- by Jung, Heung-Jun Apr 26, 2026 01:45pm
- Photo of the Health Insurance Policy Review Committee meetingThe first meeting of the public-private consultative body, which will determine the specific details of the drug pricing system reform, is imminent. Schedules for working-group meetings are being discussed for next week, and the pharmaceutical industry is forming a Drug Pricing System Task Force (TFT).With the system implementation set for the second half of the year, strategic discussions between the government and the private sector are expected to intensify within this tight timeframe.According to industry sources on the 23rd, the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) recently formed a Drug Pricing System Response TFT after receiving applications from all pharmaceutical member companies.Five distinct TFTs have been established, including ▲Reorganization of calculation standards ▲Essential and withdrawal-prevention-drugs ▲Raw materials ▲Innovative and semi-innovative models ▲New drugs. The public-private consultations that will decide the specifics of the drug pricing reform will be addressed primarily through these TFTs.The government is also preparing to set the negotiation table, with plans to coordinate the schedule for working-group meetings as early as next week.Among the drug pricing reform measures, the government has scheduled the implementation of price cuts for currently listed drugs, price premiums for innovative and semi-innovative models, and the management of multi-item listings for the second half of the year.This is a tight schedule if discussions are to be finalized by the end of the first half. While behind-the-scenes discussions have already begun, the process of determining details through the public-private consultative body is expected to proceed at a breathless pace.Pharmaceutical companies are particularly focused on reorganizing calculation standards, including price reductions for existing listings and multi-item management. It is reported that most pharmaceutical companies expressed interest in participating in the "calculation standards reform TFT."Among these, the most heavily debated issue is the criteria for determining the timing of price cuts for currently listed drugs. Based on the 2012 listing date, tiered price adjustments will be implemented in Stages 1 and 2; however, the interpretation of combination drugs and data-submission drugs could become a major point of argument.For instance, matters requiring negotiation include how to classify combination drugs that mix single-agent components from both Stage 1 and Stage 2, and how to categorize data-submission drugs that were listed after 2012 but share the same ingredients and administration routes as reference products listed before 2012.Furthermore, regarding 'Multi-item listing management,' where prices are significantly reduced one year after the listing of 13 or more items, it is anticipated that voices will emerge demanding exception clauses for categories such as first generics.Like previous briefings on 'International drug price comparison re-evaluation,' fierce debates over each point of items are expected during public-private consultative body meetings for drug pricing reform.
- Policy
- Will the DoctorNow Prevention Act pass the National Assembly?
- by Lee, Jeong-Hwan Apr 23, 2026 10:51am
- Whether the amendment to the Pharmaceutical Affairs Act, which prohibits non-face-to-face medical treatment platforms from operating as pharmaceutical wholesalers, can be tabled and passed during the final plenary session of the 22nd National Assembly, scheduled for the 23rd, is drawing significant attention.The bill, called the "Doctor Now Prevention Act," was originally expected to be processed in a plenary session last year alongside the amendment to the Medical Service Act to institutionalize non-face-to-face treatment. However, it has been pending for over five months due to opposition from some ruling and opposition party lawmakers, as well as the Ministry of SMEs and Startups, for the reason that it undermines the revenue-generating models of startups.On the 21st, the ruling and opposition parties agreed to holding a plenary session on the 23rd to wrap up the first half of the 22nd National Assembly ahead of the June 3 local elections.In particular, the ruling party has expressed its determination to process as many livelihood bills awaiting final disposal as possible at this closing point of the first-half session, citing that approximately 120 bills are currently pending in the plenary session.This is why all attention is on whether the inclusion of the Doctor Now Prevention Act to the Pharmaceutical Affairs Act can be tabled and passed during this plenary session.For now, the Democratic Party of Korea’s Policy Committee maintains the position that there is no reason for the bill not to be processed. Their view is that it is irrational and abnormal to delay the passage of the bill due to backlash from a specific company, especially after the bill already passed the committees, including the Health and Welfare Committee and the Legislation and Judiciary Committee, with bipartisan agreement.Furthermore, despite the strong determination of the Ministry of Health and Welfare to pass the bill, the leadership of the Democratic Party reportedly views it as unprecedented for a bill, which is only awaiting plenary processing following legitimate legislative procedures, to be suddenly modified because a related ministry, the Ministry of SMEs and Startups, raised a differing opinion, leading to inter-ministerial conflict.Nevertheless, the outlook for tabling and processing the Pharmaceutical Affairs Act amendment in the plenary session on the 23rd remains challenging. This is because the legislative opposition from lawmakers in 'Unicorn Farm,' a bipartisan research group for startups and ventures, remains intense, and internal party alignment has not been definitively settled.Consequently, the Ministry of Health and Welfare has been placed in a position where it can do nothing but wait for the National Assembly's decision. Even if a non-face-to-face treatment brokerage platform establishes and operates its own pharmaceutical wholesaler to generate revenue through management that carries a high risk of conflict of interest, the ministry has no choice but to remain a bystander.An official from the ruling party explained, "The Democratic Party’s Policy Committee views that a platform's operation of a wholesaler cannot be regarded as startup innovation or a legitimate revenue model, and thus believes it is necessary to pass the Pharmaceutical Affairs Act in its original form in the plenary session on the 23rd," and added, "This bill is also essential for the institutionalization of non-face-to-face treatment. However, the fact that some disagreements within the party remain is an issue that must be resolved promptly."
- Policy
- CPAC agrees on designating GLP-1 obesity drugs as medicines of concern
- by Lee, Tak-Sun Apr 23, 2026 10:50am
- The majority of members of the Central Pharmaceutical Affairs Council agreed on the need to designate GLP-1 obesity treatments as 'drugs of concern for misuse or abuse.' There were also reactions suggesting that the designation is expected to raise awareness among the public who may not recognize these as prescription-only medications.According to the minutes released on the 21st regarding the meeting held by the Central Pharmaceutical Affairs Council (CPAC) on ‘Validity of Designating GLP-1 Class Obesity Treatments as Medicines of Concern for Misuse or Abuse,’ committee members unanimously agreed that the designation is appropriate to curb indiscriminate use by patients and the sharing of misinformation online.As a result of the meeting, all 9 attending members voted in favor of the designation, and the motion was passed. The CPAC members assessed the current situation where GLP-1 class treatments are being misused by the general public despite being prescription-only drugs as serious.One member stated, “The designation can provide a reminder to the public that these are prescription drugs,” supporting the designation.Another member pointed out, “We need a mechanism to eradicate inappropriate behaviors, such as the sharing of reviews on platforms like YouTube describing how people ‘splitting’ expensive medications.”The fact that the need for this designation has been consistently raised by the media and the National Assembly, as well as the need for equity with other medications, were cited as key grounds for the decision. One of the key regulatory measures of this designation is restricting handling in pharmacies located in areas exempt from the prescription–dispensing separation system, specifically blocking purchases without prescriptions.Committee members viewed prescription restrictions in these exempt areas as necessary to prevent cases where the drugs are prescribed to inappropriate groups, such as pregnant women or children.One committee member emphasized that “pharmaceutical companies are unlikely to suffer significant losses from this designation,” stressing that the public interest outweighs the administrative burden of the regulation.The designation includes liraglutide (Saxenda), semaglutide (Wegovy), and tirzepatide (Mounjaro).In particular, the MFDS explained that ‘Mounjaro,’ which is used to treat both diabetes and obesity, is subject to the ‘drug of concern for misuse or abuse’ designation because it includes an obesity indication.However, some committee members added, “We are concerned that designating these drugs as ‘drugs of concern for misuse or abuse’ may create a negative perception of the medication in a situation where obesity should be treated as a disease.”Based on the results of this review, the MFDS plans to require the phrase ‘drug of concern for misuse or abuse’ to be printed on the packaging of GLP-1-based obesity treatments and to strengthen oversight to ensure they cannot be sold without a prescription, even in exception areas.
- Policy
- Kanarbzet, Sogroya newly reimbursed next month
- by Lee, Jeong-Hwan Apr 23, 2026 10:50am
- Boryung Pharmaceutical’s triple-combination drug for hypertension and dyslipidemia, ‘Kanarbzet Tab,’ will be newly reimbursed from next monthBoryung Pharmaceutical’s triple-combination drug for hypertension and dyslipidemia, ‘Kanarbzet Tab,’ and Novo Nordisk Pharmaceutical’s long-acting growth hormone ‘Sogroya’ will be newly listed for reimbursement next month (May).Viatris Isoptin Inj, Epic Cholestyramine Powder, and Senra 5-HTP, supplied through the Korea Orphan & Essential Drug Center, will also newly obtain reimbursement.Ono Pharmaceutical’s Opdivo Inj(120 mg) and the autoinjector formulation of GSK’s Nucala will be newly listed for reimbursement, while Daewon Pharmaceutical’s Pelubi and Janssen’s Erleada will have their reimbursement price ceilings reduced.LG Chem’s Zemidapa, which had been scheduled for a price reduction, will retain its current price.On the 21st, the Ministry of Health and Welfare partially revised and issued the “Drug Reimbursement List and Reimbursement Price Ceiling Table” containing these changes.Boryung’s Kanarbzet Tab, a combination of the antihypertensive drug Kanarb (containing fimasartan) and the hyperlipidemia drugs atorvastatin and ezetimibe, will be priced at KRW 1,644 per tablet for the 30/10/10 mg formulation, the 30/20/10-milligram formulation is KRW 1,646, the 60/10/10-milligram formulation is KRW 1,753, and the 60/20/10-milligram formulation is KRW 1,755.Sogroya Prefilled Pen 15mg/1.5ml will be listed for reimbursement at KRW 277,624 per pen, and Opdivo Injection 120mg at KRW 1,318,822 per vial.The price of Viatris Isoptin 5 mg Inj is set at KRW 3,491 per 2 ml vial, Epic Cholestyramine Powder for Susp at KRW 1,604 per 4 g packet, and Cenra 5-HTP 100 mg Cap at 2KRW 790 per capsule. The price of the Nucala autoinjector is set at KRW 1.28 million per pen, the same as the existing injectable formulation.Among already listed drugs, Pelubi Tab and Pelubi SR Tab will have their reimbursement ceilings reduced by 46.7% and 23.0%, respectively, on the 1st of next month. Among these, the reimbursement ceiling for Pelubi SR Tab will be further reduced by 23.5% starting August 1.The reimbursement ceiling for Janssen’s Erleada Tab will also be reduced by 29.3% on the 1st of next month, while Kyowa Kirin’s Orkedia Tab 1 mg and 2 mg will each be reduced by 2.0%.Kolon Pharmaceutical’s Kotuss 50 mg will be reduced by 0.4%, and Chong Kun Dang’s Dilatrend SR 32 mg by 0.1%Meanwhile, Zemidapa Tab, which had been scheduled for a 15.5% reduction next month, will maintain its current ceiling, and the reduction will be postponed to May 1 next year.
- Policy
- INN Prescribing Bill may be excluded from April subcommittee
- by Lee, Jeong-Hwan Apr 22, 2026 08:54am
- The Health and Welfare Committee of the National Assembly has decided to hold a legislative subcommittee meeting on the 28th. However, as the ruling and opposition parties have agreed not to table bills under debates, the legislation that would partially mandate International Nonproprietary Name (INN) prescribing by physicians is expected to be excluded from the review agenda.The bill, a national task for the Lee Jae Myung administration and proposed by members of the ruling Democratic Party of Korea, is strongly opposed by the medical community. Furthermore, lawmakers from the main opposition People Power Party maintain a stance of cautious review or outright opposition. Consequently, the likelihood of reaching a bipartisan agreement to include the bill in this month's subcommittee has diminishedIf the bill is excluded this month, after failing to gain a review opportunity last month due to medical community resistance, the INN Prescribing Bill is expected to be considered during the subcommittee meetings held after the June 3 local elections.On the 20th, the executive secretaries of the Health and Welfare Committee agreed to hold the 1st and 2nd Legislative Subcommittees on the 28th. The plan involves reviewing bills under the jurisdiction of the 1st subcommittee in the morning and the 2nd subcommittee in the afternoon. On the following day, the 29th, a Petition Subcommittee will be held, followed by a plenary session to process the bills passed by the subcommittees.The executive secretaries have requested that individual members' offices submit the bills they wish to have reviewed. While the final agenda is determined through bipartisan consultation, the agreement to prioritize 'non-controversial bills' makes it highly likely that the bill mandating INN prescribing for national essential drugs and medicines in unstable supply, a major point of interest in the healthcare sector, will be excluded for the second consecutive month.The proposed amendments to the Medical Service Act and the Pharmaceutical Affairs Act, introduced by Rep. Jang Jong-tae and Rep. Kim Yun of the Democratic Party, would legally mandate physicians to use active ingredient names rather than brand names when prescribing national essential medicines or drugs with unstable supply.While the legislation aims to address social inconveniences, such as patients "pharmacy hopping" due to long-term drug supply instability, the medical community remains adamantly opposed. Kim Taek-Woo, president of the Korea Medical Association (KMA), has repeatedly stated that if the INN Prescribing Bill is tabled, the KMA will gather physicians nationwide for outdoor protests.Since the People Power Party sympathizes with the medical community's opposition, a bipartisan agreement is unlikely even if the Democratic Party requests a review.Furthermore, as this month's subcommittee is condensed into a single day for both the 1st and 2nd subcommittees, unlike the usual practice of dedicating a full day to each, the probability of tabling a highly contentious bill like INN prescribing is even lower.An official from a member's office on the Health and Welfare Committee explained, "We are currently at the stage of selecting bills for review as requested by each office. Since this subcommittee is being held just a month before the June 3 local elections, both parties have agreed to table and process only non-controversial bills."The official added, "The INN prescribing bill is an issue with significant disagreement, including opposition from doctors, making it difficult to include in this subcommittee's agenda. If it is not reviewed this time, it will likely only be possible after the National Assembly is formed in the second half of the year following the local elections."
- Policy
- Government mobilizes full effort to stabilize medical product supply
- by Kang, Shin-Kook Apr 22, 2026 08:54am
- The government is launching an all-out response, including additional syringe production and increases in fees for treatment materials, in order to resolve the supply instability of pharmaceuticals and medical devices caused by the prolonged war in the Middle East.The Ministry of Health and Welfare (Minister Eun-kyeong Jeong) held the “4th Meeting of Health and Medical Organizations in Response to the War in the Middle East” on the morning of the 21st at Conference House Dalgaebi in Jung-gu, Seoul, together with 12 health and medical organizations and relevant ministries, and discussed medical product monitoring results and future action plans.At present, production volumes of major medical products such as syringes, needles, medicine pouches, and syrup bottles are not much different from the previous year, but measures are being implemented to preemptively block concerns over supply instability.First, regarding syringes, which had raised significant concerns about supply instability, Korea Vaccine has agreed to produce an additional 500,000 units per week for seven weeks, totaling 3.5 million units, through special overtime work. The units produced in this manner will be prioritized for supply to hemodialysis clinics, pediatric and adolescent medicine clinics, and obstetric medical institutions via the Korean Medical Association’s ‘Syringe Hotline,’ and some will be distributed to medical institutions through online stores.Medicine pouches and syrup bottles are likewise not in short supply in the first quarter, but the government plans to continue supporting manufacturers so that raw materials can be supplied to them on a priority basis.Economic support measures have also been put in place to alleviate the cost burden on companies caused by the recent rise in exchange rates.The Ministry of Health and Welfare has decided to increase the average reimbursed health insurance fee by 2% for approximately 27,000 separately billed medical supplies to compensate for the rise in prices of imported raw materials.At the same time, it will respond strictly to acts that disrupt the distribution order. Beginning this week, the Ministry of Food and Drug Safety is deploying a 70-member ‘special syringe and needle crackdown team’ to intensively inspect hoarding and other illegal activities. It plans to take severe measures against any confirmed violations.Regulatory relief measures to alleviate on-site difficulties are also being pursued. The Ministry of Climate Change, Energy and Environment, and the Ministry of Health and Welfare are reviewing a plan to temporarily extend the disposal cycle for general medical waste, on the premise that management will be strengthened so that no infection risk occurs.Minister Eun-kyeong Jeong said, “Production volumes of key items such as syringes are being managed stably at last year’s levels. We will do our utmost to ensure that necessary medical services are provided to the public without disruption through close monitoring.”
- Policy
- Xtandi generics signal June showdown as patent expiry nears
- by Lee, Tak-Sun Apr 21, 2026 07:33am
- Astellas’ newly launched ‘Xtandi Tab’GL Pharma has thrown its hat into the ring for the generic market of Astellas Pharma Korea’s blockbuster prostate cancer treatment, ‘Xtandi (enzalutamide).’ With the compound patent set to expire in June, domestic pharmaceutical companies are securing approvals one after another, and fierce competition is expected in the second half of the year to gain market leadership.GL Pharma’s ‘Proenza’ approved… expands generic lineupAccording to industry sources on the 20th, the Ministry of Food and Drug Safety (MFDS) granted marketing authorization for GL Pharma’s ‘Proenza Soft Cap 40mg.’ This product is manufactured under a contract manufacturing (CMO) arrangement with Cosmax Pharma.With this approval, the number of domestic companies holding approvals for Xtandi generics has increased to include GL Pharma, joining existing holders Alvogen Korea (Anamide), Daewon Pharmaceutical (Enzadex), Hanall Biopharma (Enzaluta), Menarini Korea (Enzal-X), and Hanmi Pharmaceutical (Enzaron).In particular, following Hanmi Pharmaceutical’s approval last month for the first domestically manufactured product, GL Pharma has also secured a domestically produced product, improving supply stability.AI-generated imageFormulation patent through 2033 also avoided… launch barriers eliminatedThe patent barriers, which had been the biggest obstacle for generic companies, have in effect all been removed. Xtandi had been protected mainly by two patents.The compound patent (diaryl hydantoin compound) expires on June 27, 2026. Generic drugs are expected to enter the market starting at this point.The formulation patent (enzalutamide formulation) was scheduled to expire in September 2033. However, five domestic companies, including GL Pharma, Hanmi Pharmaceutical, Chong Kun Dang, JW Pharmaceutical, and Alvogen Korea, recently succeeded in circumventing it by securing a favorable ruling after obtaining favorable decisions in passive scope confirmation trials.As a result, domestic companies have fully secured the legal basis to launch generics early, from June 28.Astellas’ last stand “tablet conversion”… can it defend the market?The defense strategy of the originator company, Astellas Pharma Korea, is no less formidable. Astellas moved to defend the market by abruptly listing ‘Xtandi Tab (40 mg, 80 mg)’ for reimbursement this month, immediately before generic launch, which improves ease of administration.Compared to the existing 40 mg soft capsule, the 40mg tablet version is about half the size, and with the addition of the 80 mg high-dose product, the daily dosage has also been reduced. Consequently, the medication burden of patients who had to take four 40 mg capsules per day is expected to be significantly eased.The price for the 40mg product remains unchanged at KRW 14,167 per tablet, the same as the existing soft capsules, while the 80mg product is priced at KRW 21,251 per tablet. Notably, for the 80mg product, the monthly medication cost (based on 56 tablets) is approximately 25% lower than that of the existing 40mg capsules (112 capsules), which is expected to reduce the financial burden on patients.Astellas’ strategy is to use the tablet formulation to penetrate the generic drug market, which currently consists solely of capsule formulations.According to pharmaceutical market research firm UBIST, Xtandi recorded KRW 38 billion in sales last year, up 26% from KRW 30.2 billion the previous year. Industry attention is focused on whether Astellas can defend the market with the new tablet product.A pharmaceutical industry source said, “With GL Pharma joining the fray, the scale of generics to be launched in line with the June compound patent expiry has grown even larger. Going forward, who secures pricing competitiveness will be one of the decisive factors.”
