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- 2026-04-29 05:11:00
- Policy
- 29 new drugs with 45 ingredients reimb this year
- by Lee, Tak-Sun Dec 31, 2024 05:55am
- This year, 45 new drugs with 29 ingredients were listed for reimbursement benefits under Korea’s health insurance. Among them, the only homegrown new drug was 'Zastaprazan citrate', a P-CAB-based gastroesophageal reflux disease treatment. As of the 30th, 45 new drugs were listed for reimbursement in Korea’s National health insurance system from January to December 2024, improving patient access. In January alone, five 5 drugs were reimbursed, including the anti-cancer drugs ‘Braftovi Cap,’ and ‘Bosulif Tab,’ ulcerative colitis treatment ‘Zeposia Cap,’ asthma and COPD treatment ‘Trimbow Inhaler,’ and neurofibromatosis treatment ‘Koselugo Cap.’ In February, two new drugs, ‘Kerendia Tab’ for chronic kidney disease and ‘Luxturna Inj’ for inherited retinal dystrophy, were approved, followed by ‘Trelegy 200 Elllipta Inhaler’ for asthma in March. In April, four new drugs were covered by health insurance, including cytomegalovirus treatment ‘Livtencity Tab,’ plaque psoriasis treatment ‘Sotyktu Tab,’ and anticancer drugs ‘Poteligeo Inj,’ and ‘Enhertu Inj.’ In May, the atopic dermatitis treatment ‘Adtralza Prefilled Syringe’ and the iron deficiency treatment ‘Ferrinject Inj’ were covered, and in June, morning sickness treatment ‘Diclectin Enteric-coated Tab’ were covered for the first time under the government's health insurance program. New Drugs reimbursed in 2024 in Korea, (number of items) New drug approvals continued into the second half of the year. In July, 3 new drugs were introduced, including the eosinophilic asthma treatment ‘Fasenra Prefilled Syringe,’ the hemophilia treatment ‘Idelvion Inj,’ and the anti-cancer drug ‘Xpovio Tab.’ In August, the CAPS treatment ‘Ilaris Inj’ and schizophrenia and bipolar disorder treatment ‘Latuda Tab’ were listed. No new drugs were listed in September, but five came out at once in October. The glaucoma treatment ‘Rhopressa Eye Drops,’ secondary hyperparathyroidism treatment ‘Orkedia Tab,’ the domestic new drug GERD treatment ‘Jaqbo Tab,’ COVID-19 treatment ‘Paxlovid Tab’ and ‘Veklury Inj’ were covered by health insurance, reducing the financial burden on the patients. In November, ‘Empaveli Inj,’ a treatment for paroxysmal nocturnal hemoglobinuria, was added to the list, and in December, new drugs such as ‘Vyxeos Liposome Inj,’, a treatment for acute myeloid leukemia, ‘Qarziba,’ a treatment for neuroblastoma, and ‘Camzyos Cap,’ a treatment for obstructive hypertrophic cardiomyopathy, were added to the reimbursement list. Of the new drugs on the list, 12 were covered by risk-sharing agreements, which accounts for more than 40% of the total listed items. Ten drugs accepted the average price of alternative drugs and skipped insurance price cap negotiations and only negotiated on the estimated claim amount. Next January, apremilast, an ingredient used for psoriatic arthritis and psoriasis, will be reimbursed for the first time. The five drugs that will be reimbursed are all generics. The original apremilast-based drug was Amgen's Otezla Tab, but it failed to gain reimbursement and was withdrawn from the Korean market. This is the first time that a group of domestic generic companies have entered Korea’s health insurance reimbursement market.
- Policy
- Yungjin Pharm wins the 1st trial against Ofev
- by Kim, Jin-Gu Dec 31, 2024 05:44am
- Yungjin Pharm has won the usage patent dispute for Ofev (nintedanib), a treatment for idiopathic pulmonary fibrosis (IPF). Based on the victory, Yungjin is one step closer to the early launch of its generic version of Ofev. The pharmaceutical industry suggests this decision is significant beyond Yungjin Pharmaceutical's avoidance of Ofev's usage patent. It may serve as a patent-avoidance strategy for generics. Yungjin Pharm wins the first trial for Ofev's usage patent…brings closer to the early launch of generic According to the pharmaceutical industry on December 20, the Korean Intellectual Property Trial and Appeal Board (IPTAB) recently issued a decision of 'claim upheld' in a passive rights scope confirmation trial filed by Yungjin Pharm against Boehringer Ingelheim regarding the usage patent of 'Ofev Soft Cap.' In September, Yungjin Pharm filed claims for a passive rights scope confirmation trial against the usage patent of Ofev. Following that, Cosmax Bio and Daewoong Pharmaceutical also filed claims for the same avoidance trials. Among these companies, Yungjin Pharm was the first to win.. Product photo of OfevOfev is protected by at least three patents: a substance patent expiring in January 2025, a usage patent expiring in September 2026, and a formulation patent expiring in June 2029. Only the substance patent is listed in the Ministry of Food and Drug Safety's (MFDS) patent registry, while the usage·formulation patents are unlisted patents. Having won the first trial for the usage patent, Yungjin Pharm is now closer to the early launching its generic version of Ofev. On December 12, Yungjin Pharm received approval for its generic version of Ofev as 'Nintebro.' The generic can be launched after the substance patent expires on January 25. The unlisted formulation patent remains to be solved but nullifying the substance patent is easier than the substance patent or usage patent. Yungjin Pharm is expected to enter the KRW 5.7 billion (USD 4.3 million) nintedanib market with the sole generic version of Ofeb if it launches its product. According to pharmaceutical market research firm IQVIA, Ofev's sales in 2023 totaled KRW 5.7 billion. Despite not being covered by national health insurance, Ofev has steadily increased its sales, reporting KRW 1.8 billion in 2020, KRW 3.3 billion in 2021, KRW 5.6 billion in 2022, and KRW 5.7 billion last year. A single clause in the generic's indication was the key to determining the patent dispute outcome The pharmaceutical industry closely examines the reasons behind Yungjin Pharm's victory in the usage-patent dispute. This success is due to the company's innovative strategy to address the usage-patent conflict, setting it apart from traditional methods. The key to the victory was the MFDS' acknowledgment of the 'exclusion clause.' Nintebro approval was the first time the MFDS has acknowledged 'excluding X.' Ofev is approved for the following indications: ▲Treatment of IPF ▲Delay of pulmonary function decline in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD) ▲Treatment of chronic fibrosing interstitial lung diseases with a progressive phenotype (excluding IPF). For Nintebro, it is approved for the following indications: ▲Delay of pulmonary function decline in patients with SSc-ILD ▲Treatment of chronic fibrosing interstitial lung diseases with a progressive phenotype, excluding IPF. Boehringer Ingelheim Yungjin Pharm The analysis suggests a key element in the trial outcome in this usage-patent dispute was the 'excluding IPF' clause in Nintebro's second indication. Yungjin Pharm strategically focused on the remaining indications of Ofev, deliberately excluding IPF to circumvent the drug's usage patent. If the MFDS had not acknowledged the 'exclusion clause,' Yungjin Pharm's strategy may not have been successful. Even if the company removed Ofev's first indication, IPF could be interpreted as being included within Ofev's third indication. In other words, if Yungjin Pharm had not included the exclusion clause in the Nintebro indication, the company would have won the avoidance only if it had deleted Ofev's first and third indications. However, the MFDS recognized the wording 'excluding IPF' for Nintebro's second indication, which Yungjin Pharm strategically emphasized during the patent dispute. Ultimately, the Korean IPTAB accepted Yungjin Pharm's argument, ruling that Nintebro did not infringe on Ofev's usage patent. MFDS has acknowledged the 'excluding X' clause for the first time…will this become the new patent avoidance strategy? Until now, the MFDS has not acknowledged phrases such as 'excluding X' in the indication section during the drug approval process. Generic manufacturers have repeatedly requested MFDS to acknowledge such exclusion clause to circumvent originator companies' specific use patents. However, until now, only the deletion of certain indications was permitted, which was a more passive approach. In the Nintebro case, the MFDS broke from its traditional practices, approving an active approach that recognizes indications excluding certain conditions for the first time. The pharmaceutical industry positively views this precedent as a new strategy for patent avoidance. If generic manufacturers focus on obtaining approval for exclusionary language such as 'excluding X' during the regulatory process, they could secure a significant advantage in subsequent usage patent challenges. "Previously, avoiding patent infringement was difficult if the 'active exclusion clause' was not included in the efficacy and effectiveness section of a generic," Park Jong Hyuk, Yungjin Pharm's patent attorney, said. "The company received the ruling by including the exclusion clause in the efficacy and effectiveness section of the generic. It will now open a new door for avoiding patient group-specific discovery," Park said. Industry experts view that the recent ruling is expected to expand access to nintedanib for patients with rare pulmonary diseases in South Korea. Ofev has not yet been listed for reimbursement under the national health insurance system, leaving patients to pay approximately KRW 3 million monthly for the medication. The high cost has prompted a public petition for its inclusion in the reimbursement list. Now, the generic version of Ofev can be launched earlier. Patients will be able to access medication at a lower price.
- Policy
- K-CAB, Enteresto, Olumiant, Rinvoq signs PVA agreements
- by Lee, Tak-Sun Dec 30, 2024 05:57am
- HK.InnoN The domestic P-CAB-based gastroesophageal reflux disease treatment 'K-CAB Tab (tegoprazan, HK Inno.N) and heart failure treatment 'Entresto Film Coated Tab (sacubitril-valsartan-sodium salt complex) the oral JAK inhibitors Olumiant Tab (baricitinib, Lilly), and Rinvoq ER Tab (Upadacitinib hemihydrate, AbbVie) have agreed on a price-volume agreement (PVA) upon negotiations with the National Health Insurance Service. As a result, the refund rate for K-CAB was adjusted, while the price of Entresto and Olumiant will be reduced next month. According to industry sources on the 27th, 3 products recently agreed to a ‘PVA B type’ negotiations with the NHIS to adjust reimbursement and the price ceiling amounts. Since 2021, K-CAB has been reimbursed under a refund-type PVA agreement with the NHIS. Under the agreement, the pharmaceutical company refunds the NHIS for the increase in usage amount instead of reducing the upper limit amount. The new agreement is likely to have adjusted the refund amount for K-CAB. Since the reimbursement agreement, K-CAB has undergone 2 PVA negotiations with the NHIS and the company refunded an amount to make up for its increased usage. By adjusting the refund rate, it has maintained its price ceiling of KRW 1,300 per tablet since its listing in 2019. The price of the heart failure drug Entresto will be reduced to KRW 1,599 per tablet from KRW 1,683 per tablet for 3 products through the PVA. Entresto’s sales had been KRW 59.4 billion in 2023 according to IQVIA, up 29% YoY. Lilly's Olumiant was also unable to escape PVA negotiations due to increased usage this year. Olumiant also generated KRW 17.9 billion in sales last year, up 16% YoY. The deal will lower the price of the 4mg tablet from KRW 20,635 to KRW 20,172 and the 2mg tablet from KRW 13,757 to KRW 13,448. Another JAK inhibitor, Rinvoq XR tablets, will also see its price ceiling reduced through PVA type B negotiations. The price of the 15mg product will go from KRW 19,831 to KRW 18,740, and the 30mg product will go from KRW 31,628 to KRW 29,850. Rinvoq XR tablets generated KRW 20.7 billion in sales last year, up 81% YoY, according to IQVIA. Type B negotiations will be conducted when the insurance price ceiling has been adjusted through Type A negotiations, or 4 years have passed since the ceiling amount has been adjusted by negotiation without Type A negotiations and the claims of the same product group have increased by 60% or more than 10% from the previous year's claims more than four years after the date of first listing or the date the ceiling amount was adjusted by negotiation, and the increased amount exceeds KRW 5 billion. Two other products, including Janssen's autoimmune disease treatment Tremfya prefilled syringe Inj (guselkumab), will also receive a price cut through PVA Type B negotiations. This is the second year the price reductions were made in a row. For the second year in a row, the insurance price ceiling for Tremfya Prefilled Syringe and Tremfya One-Press Auto-Injector will be adjusted from KRW 1.5493 million to KRW 1.524511 million. Five products of Sanofi's hemophilia B treatment Alprolix will also have their insurance price ceiling reduced from KRW 1,081 to KRW 1,088 through PVA type B negotiations. The price adjustments will be made effective January 1, 2025.
- Policy
- 7 pharmas newly win 'Innovative Pharmaceutical
- by Lee, Tak-Sun Dec 30, 2024 05:57am
- Seven pharmaceutical companies, including Dong-A ST, have newly acquired the 'Innovative Pharmaceutical Companies Certification.' Five companies, including Ildong Pharmaceutical, received extensions on their certifications. The Ministry of Health and Welfare (MOHW) announced the result of reviewing the 'Innovative Pharmaceutical Companies Certification' candidates for 2024 through the Pharmaceutical Industry Development and Support Committee meeting held on December 27 (Friday). The result of reviewing the According to the 'Special Act on Pharmaceutical Industry Development and Support,' the MOHW has been issuing companies that have invested substantially in R&D and those demonstrating superior R&D outcomes for new drugs the 'Innovative Pharmaceutical Companies Certification' since 2012. For instance, the standards for companies based on their pharmaceutical sales are as follows: 7% spending in R&D investment for companies with sales of KRW 100 billion or below, 5% spending in R&D investment for companies with sales of KRW 100 billion or more, and 3% spending in R&D investment in companies that have obtained the U.S·Europe GMP (good manufacturing practice). The 'Innovative Pharmaceutical Companies Certification' for new types is conducted every two years, and for extension cases, it is conducted every three years. When certified, companies can maintain the status for three years. Those certified receive benefits, including added points for participating in government-funded R&D projects, drug price advantages, tax benefits, and regulatory approval support. This round of review for the 'Innovative Pharmaceutical Companies Certification' included both new certification and extension of certification. Twenty-five companies were candidates for new certifications. Seven pharmaceutical companies have passed the certification review, including Dong-A ST, Amgen Korea, Onconic Therapeutics, Curocell, Hanall Biopharma, SK Bioscience, and SK Biopharm. For Dong-A ST, the company won the title again five years after failing the cut due to rebate issues in 2019. List of companies certified as innovative pharmaceutical companies (49 companies as of December 28, 2024). 33 general companies, 12 biotech venture companies, and 4 foreign pharmaceutical companies received the title. For extension reviews, five companies were considered for the review, including Alteozen, ABL Bio, Ildong Pharmaceutical, AstraZeneca Korea, and Janssen Korea, and they all passed. As a result, a total of 49 companies received notifications for obtaining the title of innovative pharmaceutical companies. "Innovative pharmaceutical companies have played a crucial role in advancing the Korean pharmaceutical industry by investing more in R&D than other pharmaceutical companies," Director General Jung Eun-young of the Bureau of Health Industry, MOHW, said. "We will continue to establish support systems and improve policies to encourage these companies to continue to expand their R&D investments, enhance innovativeness, and create values."
- Policy
- Movizolo Tab subject to drug shortage prevention program
- by Lee, Tak-Sun Dec 27, 2024 05:56am
- Pharmbio Korea’s Movizolo Tab, a prucalopride succinate-based drug used to treat chronic constipation, will be designated as a drug shortage prevention drug, resulting in an increase in drug price. Until now, prucalopride-based drugs have faced supply challenges due to low drug prices. According to industry sources on January 26, Pharmbio Korea’s Movizolo Tab will be designated as a drug shortage prevention drug as of January next year. The first formulation among the same ingredient drugs to be commercialized was YooYoung Pharm’s Rucalo Tab. The original drug is Korea Janssen's Resolor Tab, however, the drug has been supplied without reimbursement as of now. YooYoung became the first to become reimbursed amount a prucalopride succinate-based drugs in 2020. The problem arose afterward. The price of the drug was directly reduced ex officio by 53.55% of the original price when a generic drug was approved. YooYoung has been challenging the enforcement of the price cut through lawsuits, but the reduction in the reimbursement price was unavoidable. Since then, the company has repeatedly stopped supplying Rucalo Tab due to rising costs. The same goes for generic drugs that are covered under Korea’s reimbursement system. Generic drugs have also struggled to keep up with the rising costs. From 6 reimbursed drugs available for the ingredient, only YooYoung Rucalo Tab and Pharmbio Korea’s Movizolo remain. Most of the licensed drugs are currently distributed without reimbursement. In this situation, Pharmbio has applied for designation as a drug shortage prevention drug for its Movizolo Tab. If accepted, the company will be able to preserve Movizolo Tab’s manufacturing costs. However, it is reported that YooYoung Pharmaceutical, the manufacturer of Rucalo Tab, did not apply separately for its designation as a drug shortage prevention drug. As a result, the price of Pharmbio’s Movizolo Tab 1mg will increase from KRW 70 to KRW 114 and 2 mg will increase from KRW 102 to KRW 202 starting in January. It will be interesting to see if this will address the chronic shortage of reimbursed prucalopride succinate drugs.
- Policy
- "Viread generic have saved KRW 400B in drug cost over 9 yrs"
- by Lee, Hye-Kyung Dec 27, 2024 05:56am
- It has been reported that market entries of 84 generics, which obtained priority marketing authorization, for 12 pharmaceuticals listed between 2015 and 2023 have saved medication costs of KRW 804.2 billion. Specifically, it lowered the listed pharmaceutical costs by KRW 536.3 billion and saved through drug substitution by KRW 267.9 billion, totaling KRW 804.2 billion worth of medication cost cuts. Sales from fourteen generics totaled KRW 397.3 billion, accounting for 49.4% of the total reduction in medication cost. Among these generics was 'Tefovir Tab,' a Viread generic with priority marketing authorization and showed the highest price impact over the past nine years. Generics that were introduced between 2015 and 2023 have resulted in savings of KRW 804.2 billion in medication cost These figures were included in the '2024 Pharmaceutical Drug Approval-Patent Linkage System Impact Assessment (organized by Lee Myung-hee, Researcher at Korea Institute of Intellectual Property),' presented by the Ministry of Food and Drug Safety (MFDS). As Pharmaceutical Drug Approval-Patent Linkage System Impact Assessment is conducted every year, the long-term impact assessment was conducted for the first time this year to overcome the limitations of the previous impact assessment. The previous impact assessment evaluated the priority sales period spanning nine months. The research team suggests that such evaluation results in a loss of information because pharmaceuticals falling into the criteria typically enter the market 1-2 months after the priority sales period. The long-term impact assessment involves sales-banned items and priority marketing authorization items. However, sales-banned items have been excluded from the long-term impact assessment to enhance the protection of pharmaceutical patents and to solve patent disputes between patent holders and pharmaceutical companies with generics before the launch of generics. The assessment involved pharmaceuticals subjected to impact assessment from 2016 to 2021. Two generic groups (12 listed pharmaceuticals and 84 generics) that generated the highest sales each year, totaling 58 generics with statements of financial position by NICE Information Service. Yearly medication cost savings from Gilead Science Korea's 'Viread,' a listed pharmaceutical that entered the market with priority marketing authorization. Its price decreased from KRW 4,850 to KRW 4,727 in April 2018, then to KRW 4,677 in September 2018, KRW 3,275 in December 2018, KRW 2,505 in November 2019, and finally KRW 2,403 in January 2022. Viread generics' market share significantly rose during the priority sales period. Their market share was 55.6% in October 2021, recording KRW 466.1 billion in medication cost savings from reducing Viread tab price (KRW 397.2 billion) and drug substitution with generics (KRW 68.9 billion). It was reported that Chong Kun Dang's 'Diquabel Eye Drops,' a generic version of 'Diquas Eye Drops 3%,' showed the most substitution impact. Diquabel Eye Drops' market share began to rise during the priority sales period, reaching 90.8% by December 2022, ultimately substituting the listed pharmaceutical Diquas Eye Drops. Yearly medication cost savings from Diquas Eye Drops 3% and Pazeo 0.7% Eye Drops (unit: KRW 1 million) Over the six years, it saved a medication cost of KRW 100.2 billion from the price cut of Diquas Eye Drops 3% (KRW 3.7 billion) and generics substitution (KRW 96.2 billion). This outcome resulted from the patent victory of six pharmaceutical companies, including Chong Kun Dang, producing The research team determined that "Such an outcome indicates that medication cost savings during the priority sales period may be significant factors for market share in the long-term." Yearly long-term impact assessment included 'Amosartan' in 2015, 'Stalevo Film Coated Tab' in 2016, 'Iressa Tab' and 'Pletal SR Cap' in 2017, 'Viread' and 'Layla Tab' in 2018, 'Diquas Eye Drops 3%' and 'Pazeo 0.7% Eye Drops' in 2019, and finally 'Alitoc Soft Cap' in 2020.
- Policy
- Generic verision of Citus Tab will be reimb-listed next mo.
- by Lee, Tak-Sun Dec 27, 2024 05:55am
- SAMA Pharm The generic version of 'Citus Tab,' SAMA Pharm's treatment for respiratory asthma and allergic rhinitis, will be reimbursement listed in January 2025 for the first time. Four pharmaceutical companies, including Dasan Pharmaceutical, are set to enter the market early through patent avoidance. According to industry sources on December 26, four products by four pharmaceutical companies, including Dasan Pharmaceutical's 'Prituss Tab. 50mg,' will be listed for reimbursement on January 1. Among these four products are DongKook Pharmaceutical's 'Pranpid Tab' 50mg, Green Cross' 'Neopran Tab. 50mg,' and Daewoong Bio's 'Cituone Tab. 50mg.' These products were approved in November and also approved for priority marketing authorization. The priority marketing authorization is valid until August 5, 2025. The companies successfully avoided Citus' ingredient patent (expires on June 1, 2035) and obtained priority marketing authorization. In October, Korea's Intellectual Property Trial and Appeal Board ruled in favor of generic companies in the passive trials to confirm the scope of a right. Citus is SAMA pharms' key item that generates sales of approximately KRW 50 billion annually. Based on last year's UBIST, its outpatient prescription sales amounted to KRW 42.6 billion. SAMA Pharmaceutical has begun to hold the market share with various product lineup, including CITUS Chewable Tab. Citus lineups includes Citus tab, Citus Disperable Tab, CITUS Chewable Tab, and Citus Dry Syrup. Dasan Pharmaceutical will be responsible for providing consignment production services for products that are set to be reimbursement-listed. Dasan Pharmaceutical has met all required criteria, and its generics will be listed at KRW 344 per tablet with an advantage. The other three companies only met one of the required criteria, so their generics will be listed at KRW 263 per tablet. Considering that SAMA Pharm's Citus Tab's ceiling price is KRW 526, the price has been reduced by half. Consequently, attention has been drawn to whether half-priced generic will shift the market share. "Citus tab is a pharmaceutical that showed skyrocketing sales during the surge of respiratory diseases," A pharmaceutical industry worker remarked. "The generic companies are likely to fiercely promote their products to take the share of KRW 50 billion worth market."
- Policy
- MFDS' drug data protection to be implemented next year
- by Lee, Hye-Kyung Dec 24, 2024 06:22am
- Starting next year, innovative new drugs (IND) or those developed with new indications will have their approval data protected for up to six years, drawing attention to whether this will encourage domestic pharmaceutical companies to conduct more clinical trials. The Ministry of Food and Drug Safety (MFDS) will implement the Pharmaceutical Data Protection System starting February 21 to enhance the current post-marketing surveillance (PMS) system. The new data protection system has been established as a regulatory measure for integrating the systems for post-marketing safety, including the re-examination system and risk management plan. Under this system, clinical trial data submitted for marketing authorization of a drug will be protected to ensure it cannot be used by any entity other than the original submitter to obtain approval for a similar product. The Pharmaceutical Data Protection System, which is to be added to the Pharmaceutical Affairs Act on February 21. Data Protection Period: 1. Orphan Drug: 10 years from the date of marketing authorization (Additional 1 year if adding pediatric indication), 2. New Drug: 6 years from the date of marketing authorization, 3. Drug requiring submission of new clinical trial data due to a material change to a drug already approved, as prescribed by the Prime Minister The amendment specifies that data protection will apply to drugs with significant changes to their active ingredients or other essential properties (called incrementally modified drugs) to improve safety·efficacy·utility, and other necessary data protection cases. According to Article 31-6(1)(3) of the Pharmaceutical Affairs Act, drugs with significant changes to their active ingredients or other essential elements are granted a data protection period of six years. Specifically, ▲Clinical trial data submitted at the time of approval to demonstrate the efficacy of combination therapies for prescription drugs with a different composition or ratio of active ingredients compared to already approved drugs ▲Clinical trial data submitted at the time of approval for prescription drugs with the same active ingredients as already approved drugs but with a different administration route. For example, clinical trial data for drugs where the route of administration is changed from continuous intravenous infusion, requiring more than 24 hours after hospitalization, to subcutaneous injection to improve patient convenience will be protected for six years. Clinical trial data for combination drugs with different active ingredients compared to already approved drugs will also be protected for six years. Meanwhile, combination drugs that are developed using two active ingredients, both already approved for combination therapy, do not qualify for data protection Under Article 31-6(1)(4) of the Pharmaceutical Affairs Act, a data protection period of four years is granted for 'Other cases that require data protection.' In detail, ▲Clinical trial data submitted to demonstrate clearly different therapeutic effects or to add distinctly different indications ▲Clinical trial data submitted at the time of approval for studies conducted in children under 12 years old ▲Drugs deemed necessary for data protection by the MFDS (such as new isomers, salts, formulations, or dosage strengths of already approved drugs to improve usage and dosage. These cases will be reviewed individually based on newly submitted clinical trial data) ▲Drugs for which expert consultations, such as those conducted by the Central Pharmaceutical Affairs Advisory Committee (CPAC), have determined that data protection is required. Phase 3 clinical trial data can also be included for pharmaceuticals deemed necessary for data protection by the MFDS. Pharmaceuticals eligible for data protection criteria indicate that each case will be reviewed individually for clinical trial data (Phase 3) submitted to demonstrate improvements in dosage and administration for already approved drugs and data submitted for adding 'other indications or effects' that are not distinctly different from existing uses of the same active ingredients and administration routes. Technically, clinical trial data eligible for protection must consist of new data required for approval. Data submitted for the approval of drugs that are identical to existing ones (regarding active ingredients, specifications, dosages, forms, indications, and routes of administration) do not qualify for protection.
- Policy
- Original 'Otezla' withdraws, whereas 5 generics get listed
- by Lee, Tak-Sun Dec 23, 2024 05:50am
- Dong-A ST Generics to Otezla (apremilast, Amgen), which is used to treat psoriatic arthritis and psoriasis, will be reimbursed starting January 2025. The ceiling price has been set as KRW 5,840 per tablet. According to industry sources on December 20, Dong-A ST's 'Otelia,' Daeowoong Pharmaceutical's 'Apsola,' Chong Kun Dang's 'Otebell,' Dongkoo Bio's 'Otemila,' and Hanlim Pharm's 'Psopre Tab' as two tablets per package will all be listed for reimbursement. The ceiling price has been set as KRW 5,840 per tablet. The 27-tablet package will cost KRW 141,328. The drug prices are the same for all five companies. Otezla received approval from the Ministry of Food and Drug Safety (MFDS) in South Korea in November 2017. However, the company withdrew from the Korean market due to difficulty listing the drug for reimbursement. Amgen voluntarily withdrew approval in June 2022. The original has not been reimbursement listed. Yet, recognizing apremilast's superior effectiveness and marketability, Korean pharmaceutical companies have been putting efforts into registering the drug in the reimbursement market ahead of the original drug. Pharmaceutical companies with generics successfully avoided two cases of active ingredient patents registered in South Korea. They have successfully overcome the patent challenge by signing an agreement with Amgen for the remaining usage patent. Based on these outcomes, they received approval from the MFDS in April. The Drug Reimbursement Evaluation Committee (DREC) review held in October ruled that medicines would be appropriate for reimbursement coverage if the company accepted the drug price below the evaluated amount. Analysis suggests that relevant pharmaceutical companies have accepted the drug price below the evaluated amount and proceeded with the negotiation phase with the NHIS. Considering that the negotiation has been completed early, most companies may have accepted a drug price negotiation exemption criterion when they accept the drug price below the evaluated amount. After that, the company have likely to proceed with the negotiations for the expected claim amount. Korean companies developing generics have successfully obtained reimbursement listings in the Korean market, where the original drug company withdrew. Attention has focused on how much sales they will generate. Otezla is a highly marketable product, recording No.1 in global sales among oral psoriasis treatments last year. Its global sales last year amounted to US$3.984 billion (about KRW 5.5 trillion). Whether generics will continue to generate sales in South Korea is to be followed.
- Policy
- New drug approval fees to increase next year
- by Lee, Hye-Kyung Dec 23, 2024 05:50am
- The Ministry of Food and Drug Safety has completed preparations to raise the fee for new drug approvals to KRW 410 million from January 1 next year. Since mid-October, the agency has formed the ‘Consultative Body for Discussions on New Drug Approval and Review Procedures' and completed the 'New Drug Approval and Review Business Procedures (Guidelines for Officials)' after 4 meetings. The MFDS expects the increase in new drug approval fees to be the first step towards improving the system to the level of the U.S. FDA and the European EMA. (From the left) Director Sang-Ae Park, Director Young-Joo Kim, Director Chun-Rae Kim, The MFDS press corp recently met with Director Young-Joo Kim, Head of the Pharmaceutical Approval Management Division at MFDS; Director Chung-Rae Kim, Head of the Pharmaceutical Policy Division at MFDS; and Director Sang-Ae Park, head of the Pharmaceutical Standardization Division at the National Institute of Food and Drug Safety Division to learn more about the 'Notification of Partial Amendment to the Fee Regulations for Approval of Pharmaceuticals, etc.' that was announced on the 8th of last month. The following is the Q&A transcript of the meeting. ▶ The MFDS issued an administrative notice of the proposed revision from September 9 to November 8, and in the process disclosed the business procedures for approving and reviewing new drug items. What progress has been made since then? “In October, we created a council to discuss the new drug approval process. A total of 32 people, including 8 from the Ministry of Food and Drug Safety, 6 from the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, 9 from the Korean Research-based Pharmaceutical Industry Association, 3 from the Korea Pharmaceutical Traders Association, and 6 from the Korea Biomedicine Industry Association, took part in the council. Various discussions were made during the meeting, starting with a moratorium on fee hikes. After 4 meetings to collect opinions, the final guidelines were created. There was much industry input and I think we've reached something near of a consensus. The system is ready to be implemented.” ▶The KRPIA had strongly insisted on a moratorium on the fee hike last November, have you reached a consensus?. Director Young-Joo Kim “The MFDS is on a level where we can show the approval process, transparency, and predictability of advanced regulatory agencies such as the FDA and EMA. We have fully discussed concerns through the council, and the KRPIA has no objection. Procedurally, we have increased the number of face-to-face consultations and allow GMPs to be performed within 90 days, and I think this will be a step towards creating a system that can allow new drugs to be approved within 295 days. Some companies are already preparing for the increased fees. I think the KRW 410 million fee will be fully compensated by receiving approvals a month earlier.” ▶ You said that you had held 4 meetings, and it seems that the guidelines have changed somewhat after the meetings, such as the addition of a pre-registration process to provide supplementary materials to MFDS in advance during the first and second supplement request processes, and the allowance to request an explanatory meeting based on the submitted material. Director Young-Joo Kim “As you can see from the table of guideline changes, slight changes have been made to the guideline. The biggest difference from the draft is the addition of the preliminary consultation session before fee payment to increase the predictability of the approval process before paying the fee. However, pre-consultations are limited to one session per item. Instead, we added more face-to-face consultations, so that each supplementation to their application can be consulted and reviewed in advance. In the past, there were many claims on how the MFDS makes unexpected supplement requests at the last minute. The goal is to increase predictability in this area. Through prompt communication, we aim to shorten the approval period by reducing unnecessary waste of time. We plan to also further the approval process by formally recording the minutes of our meetings. In general, by improving the transparency and predictability of the new drug approval review process, we hope to bring new drugs to market sooner, making the industry more competitive and enabling a faster supply of medicines.” ▶ How does the prior consultation process work? Director Young-Joo Kim “In the case of new drugs, I think that companies that have already prepared enough data will proceed with the prior consultation session with the goal of applying for approval so that a dedicated team will be created from this stage. I can’t ensure the details as we haven't established the team yet, but the team will be decided based on which department should examine the safety, efficacy, and quality of each drug with consideration into the ingredients and efficacy, so we plan to proceed with a preliminary team dedicated to each item to allow the drugs to be approved. In the preliminary consultation stage, we will discuss the future schedule, the point of application submission, and the establishment of a dedicated team.” ▶ Are there any companies that have expressed their intention to apply for approval after the fee hike increase in January next year? Director Young-Joo Kim "We are aware of some companies that have applied for approval. We are receiving inquiries for preliminary consultation from the companies. I cannot disclose the names of the companies, but there are several domestic and multinational pharmaceutical companies that have expressed their intention to apply for approval.” ▶You are aiming for 295 calendar days from application to approval. Do you think this can be achieved? Director Young-Joo Kim “If there is a delay in the preparation of supplementary data, the period may exceed 295 days. This means that the term can be extended by the length of the extension period. However, we have created a lot of consultation processes to shorten the time for the companies’ supplement preparation. The goal is to shorten the time between the company preparing the supplementary data and the MFDS’s review of it as much as possible through consultation. Frequent communication with companies is expected to reduce the number of supplement requests and time consumption. It will be an opportunity to advance our system forward to a global-level review system.” ▶I understand that you are recruiting specialized reviewers for new drug approvals Director Sang-Ae Park “We have been recruiting reviewers from the 13th to the 22nd. We are hiring reviewers as soon as possible and plan to finalize the recruitment process by January. We have actively promoted our recruitment through various channels such as college of pharmacies, academic societies, and social media.” ▶ I understand that the reviewers hired this time do not include doctors. It seems that physician reviewers will also be needed. Director Chung-Rae Kim "This recruitment was made to recruit highly competent reviewers to add to our existing workforce. We opened the recruitment process to meet the need to increase the number of reviewers, and we will continue to recruit doctors and other experts periodically over the next year after completing the transition of the first- and second-level personnel. In addition, once the revision of the fee notification is finalized, we will increase the overall salary of our reviewers.” ▶ There will be some items that apply for approval in Korea for the first time, even before the FDA and EMA. Do you think the MFDS owns the capacity to approve them in 295 days? Director Chung-Rae Kim "Korea was listed on the WLA last year and is a member of ICH. I think we should believe that the competence of our reviewers stands at a global level. If there is a shortcoming of the MFDS, it is in the difficulty of recruiting human resources. Even if the new drug is first to come to Korea, I think it will be possible to approve it if the manpower is reasonably replenished along with the fee increase and the number of highly competent reviewers is filled.” Director Sang-Ae Park "I would like to emphasize that the increase in the new drug approval fee is just the start of our challenge. This is just the beginning. I don't think we can reach the FDA's review level in a short period of time, but we believe it is significant that the challenge has begun.”
