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- 2026-03-11 15:17:11
- Policy
- Jardiance under review for expanding reimb to kidney disease
- by Lee, Tak-Sun Apr 29, 2024 05:49am
- Boehringer Ingelheim Korea 'Jardiance tab (empagliflozin, Boehringer Ingelheim Korea),' SGLT-2 class of treatment, is considered for expanding reimbursement to kidney disease, in addition to its current reimbursement for diabetes and cardiac failure. As Forxiga, a competing drug in the same class as Jardiance, is expected to withdraw from the Korean market in the second half of the year, Jardiance’s expanded areas may lead to an increase in market share. According to industry experts on the 25th, Jardiance 10 mg is undergoing review by the Health Insurance Review and Assessment Service (HIRA). HIRA has recently received academic opinions and supplementary documents from the pharmaceutical compnay. The efficacy and effectiveness of Jardiance 10 mg have been demonstrated in three diseases, including type 2 diabetes, chronic cardiac failure, and chronic kidney disease. Among these diseases, Jardiance is covered by reimbursement for type 2 diabetes and chronic cardiac failure. For chronic cardiac failure, Jardiance is reimbursed when administered at a safe dosage as part of standard treatment for patients with chronic heart failure characterized by reduced systolic heart failure, with an ejection fraction measurement under 40%. Last October, it was approved for chronic kidney disease indication. Regardless of the status of accompanying type 2 diabetes, Jardiance can be used to reduce the risk of death caused by the progression of kidney disease or cardiovascular diseases. The company has applied for reimbursement expansion at the HIRA following receiving additional indication approval from the Ministry of Food and Drug Safety (MFDS). Its competitor, Forxiga (dapagliflozin, AstraZeneca Korea), also has indications for diabetes, cardiac failure, and kidney disease. While it is reimbursable for diabetes and cardiac failure, patients need to cover the cost out of pocket when using it to treat kidney disease. Forxiga is expected to withdraw from the market in South Korea in the second half of the year. When Forxiga withdraws, Jardiance will become the only remaining original product with three indications in diabetes, cardiac failure, and kidney disease. If Jardiance is approved for reimbursement for chronic kidney disease, it is expected to have a more significant share in the SGLT-2 inhibitor market. However, reports indicate that Forxiga’s indications are being transferred to its joint-sales partner HK inno.N’s generics. Consequently, HK inno.N may pursue reimbursement expansion for these generics. Pharmaceutical companies in South Korea are preparing to launch a generic version of Jardiance in March 2025.
- Policy
- Pharma companies with 'superior R&D·K-made drug ingredients
- by Lee, Jeong-Hwan Apr 26, 2024 05:48am
- Starting this year, under the 2nd comprehensive National Health Insurance Plan (hereafter, referred to as NHI Plan), the government will provide preferential drug pricing for new drugs developed by pharmaceutical companies with high R&D costs. Additionally, the plan will expand the scope of the risk sharing agreement (RSA) for severe diseases. This year’s plan includes offering preferential drug pricing for national essential medicines that use drug ingredients manufactured in South Korea. Additionally, it includes a process for promptly increasing the price of medicine with a supply shortage. On the 25th, the Ministry of Health and Welfare (MOHW) held the 9th Health Insurance Policy Review Committee, conducted a review, and made a decision on the implementation of the 2nd comprehensive National Health Insurance Plan 2024. This year's implementation plan for the NHI Plan consists of four major directions: ▲Ensuring essential healthcare supply and fair compensation ▲ Reducing healthcare disparities and ensuring a healthy life ▲ Improving the financial sustainability of health insurance ▲ Establishing a stable supply system and a good circulation structure. The plan includes the 15th primary task and the 75th detailed task. Based on stable financial management, the MHOW has announced plans to invest over KRW 1.4 trillion in essential medical areas this year to support the implementation of the four major tasks outlined in the previously announced healthcare reform measures. Will establish a stable supply chain·good circulation structure Pharmaceutical companies are expected to focus their attention primarily on this year’s NHI Plan, particularly on innovative new drugs and supply stabilization. The MOHW announced that it would improve the system for supporting the development of innovative medical technology that provides treatment options for diseases without treatment and also the system for addressing supply shortages. For innovative new drugs, the MOHW will specify the criteria for innovativeness, aiming to offer a flexible scope for the consideration of economic evaluation. The plan will provide preferential pricing for drugs developed by pharmaceutical companies with a high proportion of R&D investment. It also includes measures to expand the scope of RSA for treatments used to treat severe diseases that irreversibly worsen the quality of life. In terms of stabilizing supply shortages, the plan will set the basis for providing preferential drug pricing for national essential medicines that use ingredients manufactured in South Korea. And it will also include a process for promptly increasing the prices of drugs with supply shortages. In addition, it will establish a system for selecting and monitoring essential medical supplies facing shortages. In terms of medical devices, the plan involves expanding the deferment criteria and period for innovative medical devices' evaluation and extending their pre-use period in medical settings. Furthermore, it aims to expand the utilization of the National Health Insurance data for public and scientific research purposes and for self-directed health management. It will also support international cooperation efforts. The plan involves increasing the provision of big data to private entities, allowing the external transfer of low-risk pseudonymized information, and supporting the utilization of medical data through health information highways. This year’s National Health Insurance fund is estimated to be KRW 2.6 trillion, currently in the black. However, the MOHW announced plans to manage the finances efficiently, considering prolonged use of the emergency medical system, changes to medical usage, and other circumstances. Additionally, over KRW 1.4 trillion will be invested in this year’s essential healthcare field. The MOHW will ensure stable finance management and support the implementation of the reform package announced in February. In Q1, over KRW 1.12 trillion will be invested to strengthen compensation in shortages such as childbirth, pediatrics, and critical emergencies. Additionally, in Q2, more than KRW 27.6 billion will be allocated to enhance compensation in medical fields focusing on severe disease and essential healthcare. In Q3, KRW 50 billion will be invested to compensate the field focusing on severe psychological disorders. In Q4, over KRW 150 billion will be invested to expand the implementation of an alternative payment system to solve the regional and essential healthcare gaps. Will provide essential healthcare·reasonable compensation Investments will be increased in pediatric surgery and treatments, as well as in closed wards within tertiary general hospitals with high workloads and resources but relatively low evaluation. In 2023, medical institution revenue and expenses, the impact of the third phase of relative value unit revision, the expansion of panel hospitals, and cost surveys and analyses for fee adjustments will be analyzed. The results report is scheduled to be released in the second half of this year. A public policy cost will be introduced to maintain maternity infrastructure and to sustain personnel and facilities in the severe pediatric field. The MOHW plans to implement six pilot businesses with an alternative payment system. This system will offer differential compensation based on the quality of medical assessments and the achievement of treatment goals, not quantity. In detail, the post-management compensation of the hospitals offering services of children’s public specialized medical centers will be expanded from 9 to 14 hospitals. The first-year business will be implemented for hospitals participating in strengthening cardio-cerebrovascular disease network and a medical system for severe diseases. The implementation of a pilot business will be reviewed following a research on establishing a model for an emergency medical center·a mother and child medical center·a regional medical program pilot business. The MOHW also plans to establish a basis for payment system reform, including measures for innovative accounts or innovative centers and an achievement-centered review and evaluation system.
- Policy
- Prolia and Ryaltris adjust drug pricing
- by Lee, Tak-Sun Apr 23, 2024 05:40am
- Prolia. Amgen Korea and Chong Kun Dang Pharmaceutical will voluntarily reduce the price of 'Prolia,' which they are jointly selling. As the government expanded the administration guidance of osteoporosis medicines, Prolia, which is expected to see an increase in sales following the reimbursement expansion, voluntarily adjusted the ceiling price of the drug. Prolia recorded sales of KRW 151.1 billion last year (according to IQVIA), ranking second in the domestic pharmaceutical sales in Korea, following Keytruda. Some products, such as Yuhan’s 'Ryaltris Nasal Spray,' will lower the ceiling price due to increased usage. According to industry sources on the 22nd, the ceiling price of Prolia Prefilled Syringe (denosumab) will be reduced from KRW 162,600 to KRW 156,100 starting May 1st. This measure was taken as part of the reimbursement expansion. The government aims to support senior healthcare by increasing the reimbursable period to two years after treating osteoporosis, which has a preventative effect on bone fractures. The drug is currently reimbursable when the bone density is below -2.5 (T-score value). But starting in May, it is reimbursable for up to two years when the T-score is below -2.0 or up to -2.5. The expanded reimbursement scope is expected to benefit 44,773 patients. As part of the reimbursement scope expansion, the company selling Prolia voluntarily lowered the drug pricing under the agreement with the National Health Insurance Service (NHIS). The impact of the reimbursement expansion of osteoporosis medicines, following the voluntary drug pricing reduction, on the first annual finance is expected to be around KRW 5.6 billion. Prolia has dominated the osteoporosis medicine market since its domestic launch in 2017. Its co-promotion agreement with Chong Kun Dang Pharmaceutical yielded synergistic effects. In 2019, Prolia became the top-selling drug after receiving reimbursement coverage as a first-line osteoporosis treatment. This drug is a biologic that targets RANKL, which is essential for the formation, activation, and survival of bone-destructing osteoclasts. Last year, Prolia was ranked second among the medicines with the highest performance in South Korea. According to IQVIA’s report on sales figures, Prolia recorded sales of KRW 151.1 billion, second only to the anticancer immunotherapy drug Keytruda, which generated KRW 398.7 billion. Its voluntary price reduction is anticipated to relieve the patients’ co-payment burden and save National Insurance funds. Ryaltris. Meanwhile, Yuhan’s allergic rhinitis treatment, 'Ryaltris Nasal Spray (momethasone furoate/olopatadine),' which was included in reimbursement, saw a more than 30% increase in claimed amount compared to the expected amount. As a result, the reimbursement ceiling price was adjusted under the negotiated agreement based on the price-volume agreement (PVA, Type GA). Initially, an agreement was reached during the drug pricing negotiations for an expected claim amount of KRW 1.02 billion for this drug. However, it is expected that the actual sales will exceed this amount. Based on the outpatient prescription sales reported in last year's UBIST data, it was KRW 3.3 billion. Starting in May, the price of Ryaltris Nasal Spray (18 mL) will be adjusted from KRW 6,197 to KRW 5,893, and Ryaltris Nasal Spray (31 mL) will be adjusted from KRW 12,396 to KRW 11,789.
- Policy
- HK inno.N starts developing a Lixiana generic
- by Lee, Hye-Kyung Apr 23, 2024 05:36am
- HK inno.N is joining the race to develop a generic version of the NOAC (novel oral anticoagulant) drug Lixiana (edoxaban). The Ministry of Food and Drug Safety recently approved clinical trials to evaluate the bioequivalence of the Lixiana generic ‘IN-G00002’ and IN-R00002 (Lixiana). The IN-G00002 bioequivalence trial will evaluate the candidate’s efficacy in ▲reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF); ▲treating deep vein thrombosis and pulmonary embolism, and ▲reducing the risk of recurrence of deep vein thrombosis and pulmonary embolism. The clinical trial will be conducted at Suck Kyung Medical Foundation Central Hospital from July this year to July next year, and involve 60 adults aged 18 and older. Although Lixiana's patent expires on Nov. 10, 2026, the drug's PMS (post-marketing surveillance) period ended on Aug. 24, 2021, leading to applications for approval of follow-on drugs. Hanmi Pharmaceutical, Kolmar Korea, HK inno.N, Kolmar Pharma, Hutecs Korea, Chong Kun Dang, Samjin Pharm, Dong-A ST, and Sinil Pharmaceutical filed a passive trial to confirm the scope of the composition patent that expires on August 21, 2028, and received a confirmation in July 2020. As a result, 29 generics have been approved, starting with Dong-A ST's Edoxia ODT in December 2021. However, the substance patent for Lixiana is valid until November 10, 2026, so there are still 2 more years left before the generics can be released into the market. Against this backdrop, the NOAC market has been growing constantly. According to the market research institution UBIST, the NOAC market, which was worth KRW 147.2 billion in 2018, reached the KRW 200 billion mark in 2021, posting KRW 222.9 billion. In 2022, the market expanded further to KRW 242.5 billion.
- Policy
- Atopic dermatitis drug Adtralza will be reimb in May
- by Lee, Jeong-Hwan Apr 22, 2024 05:45am
- Leo Pharma Korea’s atopic dermatitis treatment, Adtralza (tralokinumab), will be reimbursed from May 1 in Korea. The reimbursement standards for osteoporosis drugs will also be improved, and patients who show some improvement in bone mineral density will be able to continue receiving reimbursement. As such, JW Pharmaceuticals' iron injection Ferinject will also be reimbursed. On the 19th, the Ministry of Health and Welfare issued an administrative notice of the 'Partial Amendment to the Details on the Standards and Methods for Applying Medical Benefits (Pharmaceuticals)' that contained the contents above. It will collect opinions until the 23rd for its implementation on the 1st of next month. The new drugs covered by the reimbursement through the administrative notice are Adtralza, a drug for atopic dermatitis, and Ferinject, an iron injection. Adtralza is a humanized monoclonal antibody that binds to interleukin-13. It controls atopic dermatitis by inhibiting downstream interleukin receptor signaling that triggers the inflammatory response. Adtralza is reimbursable for the treatment of chronic severe atopic dermatitis in adults (18 years and older) and adolescent patients (12 years to 17 years of age) whose condition has remained symptomatic for at least 3 years. Patients must have received at least 4 weeks of topical therapy (at least moderate-potency corticosteroids or calcineurin inhibitors) as a first-line treatment but were unable to adequately control their condition, followed by at least 3 months of systemic immunosuppressive agents (cyclosporine or methotrexate) that did not result in a 50% or greater reduction in Eczema Area and Severity Index (EASI) or were unable to continue their use due to side effects. Patients with an EASI of 23 or greater prior to Adtralza use are recognized as eligible for reimbursement. However, the patient should be able to confirm a history of topical and systemic immunosuppressive therapy within 6 months before initiating treatment with Adtralza for reimbursement. After 14 weeks of Adtralza treatment, if a patient’s EASI is reduced by 75% or greater at the 16th-week assessment, the patient may continue to use Adtralza with reimbursement for 6 additional months. Patients will continue to be evaluated every 6 months thereafter and may maintain their reimbursed status if they maintain their initial results. Inpatient prescriptions are required in principle, and a maximum of 4 weeks’ supply is allowed to be prescribed per single prescription upon discharge for outpatient use. However, a maximum of 8 to 12 weeks' supply is allowed for patients with stable disease activity and no adverse events after 24 weeks from the initial dose, and switching between Adtralza and the JAK inhibitor Dupixent is not allowed. The reimbursement standards for osteoporosis treatments have been extended to allow borderline patients who have reached their T-score treatment goal to continue to be eligible for reimbursement. As a result of clinicians and academic society input, patients who have been recognized to be eligible for reimbursement for a T-score of -2.5 or less (T-score≤-2.5) when measuring bone mineral density using Dual-Energy X-ray Absorptiometry (DXA) of the central bone, will be eligible for an additional year of reimbursement if their T-score improves during treatment to a T-score greater than -2.5 but less than or equal to -2.0. If the T-score remains greater than -2.5 but less than or equal to -2.0 thereafter, reimbursement will be allowed for another year. In the additionally approved period, patients will be allowed to switch between raloxifene, bazedoxifene, bisphosphonate, and denosumab. The patients may also switch to zoledronic acid injections. Lastly, the MOHW added the iron injection Ferinject to the reimbursement standards. However, it excluded Ferinject’s use in patients with chronic kidney disease on dialysis from the reimbursement standards.
- Policy
- KMPG ‘We ask for the prompt reimbursement of Xpovio’
- by Kim, Jung-Ju Apr 22, 2024 05:45am
- Patients’ demand for the reimbursement listing of ‘Xpovio 20mg (selinexor),’ a new drug for multiple myeloma that was developed by the Chinese pharmaceutical company Antengene, is growing. The patients are claiming that they are becoming ‘medical poor’ due to the delay in the reimbursement of the only option available in the area. Xpovio’s reimbursement agenda has been stuck at the reimbursement stage for more than 3 years since it was approved in Korea and is being delayed without a viable alternative. The Korea Multiple Myeloma Patient Group issued a statement on the 19th and strongly urged the authorities to consider the patients’ situations. The KMPG chairman said, "We strongly urge the Drug Reimbursement Evaluation Committee, which will meet in May, to expedite the reimbursement of Xpovio, the only light of hope remaining for the fading flickers of life for our multiple myeloma patients.” Multiple myeloma is a blood cancer caused by the abnormal differentiation and proliferation of plasma cells, a type of white blood cells responsible for the immune system, in the bone marrow. Xpovio Tab 20mg, which was developed to treat the disease, was approved by the MFDS and introduced to Korea on July 29, 2021. On June 14, 2023, the drug’s reimbursement application passed HIRA’s Cancer Disease Review Committee but suffered a setback right before its reimbursements when it was deemed non-reimbursable by DREC in November of the same year. Min-Hwan Baek, Chairman of KMPG, said, “Xpovio is currently being reimbursed in not only the A8 countries but A9 countries, being granted reimbursement in the United States, Germany, Canada, the United Kingdom, and Australia. But in Korea, patients are dying due to the drug’s non-reimbursement. I lay awake night after night as chairman of KMPG, worrying about the patients who are dying needless deaths due to lack of other options than the non-reimbursed, unaffordable Xpovio.” "It has come to the point where many patients who turned medical poor due to Xpovio’s non-coverage are giving up on treatment," said KMPG, urging for the prompt reimbursement of Xpovio.
- Policy
- Will the 37th new drug in Korea receive approval?
- by Lee, Hye-Kyung Apr 22, 2024 05:45am
- Jeil Pharmaceutical. The approval for the 37th new drug in Korea is approaching. According to industry sources on the 22th, the Ministry of Food and Drug Safety (MFDS) completed the safety and efficacy assessment of the three zastaprazan-containing products from Onconic Therapeutic, Jeil Healthscience, and Jeil Pharmaceutical. The completion of the safety and efficacy assessments by MFDS indicates that approval is nearing. Jeil Pharmaceutical simultaneously applied for new drug approvals from three affiliated companies, including Jeil Healthscience, which manufactures over-the-counter drugs, and its subsidiary, Onconic Therapeutic, which specializes in new drug R&D. These three products contain the active ingredient of zastaprazan. Upon completion of the safety and efficacy assessment by MFDS, approval for these three products is anticipated. In June last year, Onconic Therapeutic submitted the New Drug Application (NDA) to the MFDS for domestic launch. The NDA was based on the Phase 3 clinical trial, which evaluated 298 patients with gastroesophageal reflux disease (GERD) in 28 medical facilities in South Korea. Notably, there has not been a single case of MFDS-designated new drug in South Korea following the 36th new drug in Korea, 'Envlo,' in November 2022. Therefore, approval of zastaprazan would lead to approval of new drugs in South Korea. Zastaprazan is a new drug that belongs to the class of novel potassium-competitive acid blocker (P-CAB). P-CAB is expected to replace the proton pump inhibitors (PPI) in the anti-peptic ulcer drug market, including the treatment for gastroesophageal reflux disease (GERD). P-CAB class products in Korea include HK inno.N’s 'K-CAB,' the 30th new drug in Korea, and Daewoong Pharmaceutical’s 'Fexuclue,' the 35th new drug in Korea. According to medical market research firm UBIST, K-CAB recorded prescription sales of KRW 30.4 billion in 2019. Sales grew rapidly to generate KRW 77.1 billion in 2020, KRW 110.7 billion in 2021, and KRW 132.1 billion in 2022. Since its launch in July 2022, Fexuclue has recorded cumulative prescription sales of KRW 61 billion up to November 2023, changing the market paradigm for gastroesophageal reflux disease.
- Policy
- Reimb expansions of Keytruda have failed the 4th CDRC
- by Lee, Tak-Sun Apr 19, 2024 06:24am
- MSD Korea’s cancer immunotherapy drug Keytruda’s reimbursement expansion item did not cross the Cancer Disease Review Committee (CDRC) threshold for the fourth time following its expansion in June last year. The analysis is that this attempt is particularly significant as all 15 indications were reviewed by the CDRC, and MSD’s financial contribution proposal was discussed for the first time. During the 3rd CDRC in 2024, held on April 17th, the reimbursement expansion of MSD Korea’s cancer immunotherapy drug 'Keytruda (pembrolizumab)' was reviewed but failed in securing reimbursement expansion. The CDRC announced during the meeting, it decided to postpone setting reimbursement criteria for 15 indications, including endometrial cancer. It was decided that the setting of reimbursement criteria would be reconsidered upon the additional submission of financial contribution proposal. All 15 indications included in the reimbursement expansion application were reviewed. In June of last year, MSD Korea submitted Keytruda’s reimbursement expansion application to the Health Insurance Review and Assessment Service (HIRA) for 13 indications with high unmet needs in medical fields in Korea. MSD's application includes 13 indications: ▲ Early-stage triple-negative breast cancer ▲ Metastatic or recurrent triple-negative breast cancer ▲ Metastatic or recurrent head and neck cancer ▲ Advanced or metastatic esophageal cancer ▲ Adjuvant therapy after renal cell carcinoma surgery ▲ Non-invasive bladder cancer ▲ Persistent, recurrent, or metastatic cervical cancer ▲ Advanced endometrial cancer ▲ Metastatic endometrial cancer with MSI-H or dMMR ▲ Metastatic rectal cancer with MSI-H or dMMR that cannot be removed with surgery ▲ Metastatic small intestine cancer with MSI-H or dMMR ▲ Metastatic ovarian cancer with MSI-H or dMMR ▲ Metastatic pancreatic cancer with MSI-H or dMMR. The company recently added two additional indications. It was reported that MSD applied for the reimbursement expansion of two indications last December: gastric cancer with MSI-H and bile duct cancer with MSI-H. Three indications were assessed at the CDRC meeting in October last year, where Keytruda's reimbursement expansion was first discussed. Then, 4 indications were assessed in November of the same year, and 6 indications were assessed in January of this year. The CDRC said at each review, “We will prioritize reviewing the medical validity and clinical necessity of multiple indications for reimbursement expansion. Upon receiving the pharmaceutical companies' financial contribution proposal towards proven indications, we have decided to analyze its impacts to establish reimbursement criteria.” Furthermore, during this CDRC review, 15 indications, including the previously discussed 13 and the two additional indications applied for in December, were all brought to the review table. This indicates that the CDRC prioritized reviewing the medical validity and clinical necessity of multiple indications for reimbursement expansion. In other words, the initial assessment of indication has been completed. The committee will discuss establishing final reimbursement criteria for the next step after reviewing the pharmaceutical companies' financial contribution proposal. It was reported that the financial contribution proposal submitted by MSD Korea was added as an additional agenda item just two days before the CDRC review. This suggests that pharmaceutical companies deliberated on their financial contribution proposals until the last minute. However, it has been reported that members of the CDRC were not satisfied with the financial contribution proposal submitted by MSD. Keytruda's reimbursement expansion in the future depends on how much MSD is willing to compromise in their financial proposal. “Keytruda is reimbursed for 7 indications, and its domestic sales reach KRW 400 billion,” an industry expert explained. He added, “If the pharmaceutical company does not submit a new financial contribution proposal, it may not be possible to reimburse all 15 indications at once.”
- Policy
- Impurity detected in single-agent entacapones
- by Kang, Shin-Kook Apr 19, 2024 06:24am
- t has been confirmed that impurities have been detected in entacapone, a single-agent drug used to treat symptoms of Parkinson's disease. According to medical and pharmaceutical organizations on the 18th, the Ministry of Food and Drug Safety began reviewing safety measures, including setting necessary temporary permissible limits based on the submitted test and inspection results, following a company report that nitrosamine impurities (NDEA, N-nitrosodiethylamine) were detected in its entacapone-containing drugs. In other words, if there is a medical need for the drug or there is a concern about supply interruptions (shortage), the government plans to apply a temporary permissible limits for the drugs’ distributions for a certain period of time. For this, the MFDS is collecting opinions from doctors to prepare for the possibility of unstable supply and demand of entacapone-containing drugs if recall measures or suspension of production and import measures are applied due to necessity until impurities are reduced. This is a preliminary investigation into the medical necessity of entacapone, the impact on patient care in the event of a supply interruption (shortage) of entacapone single-agent drugs, the current status of substitute drugs, and the establishment of temporary permissible limits. The entacapone single tablets currently approved in Korea include Comtan Tab 200 mg, Myungin Entacapone Tab 200 mg, and Entapone Tab 200 mg.
- Policy
- Four Otezla generics were authorized simultaneously in Korea
- by Lee, Hye-Kyung Apr 19, 2024 06:24am
- Amgen Four generic versions of Amgen's oral psoriasis drug Otezla (Apremilast) have been approved simultaneously in Korea. With the resolution of Otezla’s 'use patent' issue, which had served as an obstacle to the launch of generics, domestic pharmaceutical companies that have previously succeeded in avoiding the drug’s composition patent seem to have applied for approval of their generic versions at once. On the 17th, the Ministry of Food and Drug Safety approved four apremilast-based formulations, including Dong-A ST's ‘Otelia Tab,’ Daewoong Pharmaceutical's ‘Apsola Tab,’ Dongkoo Biopharm’s ‘Otemila Tab,’ and Chong Kun Dang’s ‘Otebell Tab.’ Otezla, the original apremilast formulation of these generics, was the first oral psoriasis treatment to be approved by the MFDS in November 2017, but the company voluntarily withdrew the drug’s license in June 2022 after failing to cross the reimbursement threshold. In the process, domestic pharmaceutical companies began filing patent suits to launch their generic versions of Otezla. Otezla has 3 registered patents, including a use patent (10-0997001) and two formulation patents (10-2035362 and 10-2232154). In the case of the 2 formulation patents, 7 companies, including Daewoong Pharmaceutical, Dong-A ST, DongKoo Bio&Pharma, Huons, Chong Kun Dang, Mothers Pharm, and Cosmax, filed to confirm the passive scope of rights in May 2021 and November 2022 and succeeded in avoiding the patents. However, the companies still had to overcome the use of patents to launch their generic versions. Otezla’s use patent was set to expire on March 18, 2028. The companies must invalidate the use patent as well to launch their generic versions, and on August 24 last year, the court decided to ‘partially reject and dismiss’ the use patent’s invalidation trial. Despite withdrawing from the Korean market, Amgen appeared to be vigorously defending its patent rights, leading to criticism that it was blocking the entry of generics that were preparing to launch in Korea. And with no further news of the domestic pharmaceutical companies filing appeals to evade the use of patents since August last year, the news of the 4 generic Otezla approvals drew attention to their background. A representative from a relevant Korean pharmaceutical company said, "We have been continuously making an agreement with Amgen regarding the use of the patent. Amgen withdrew its license for Otezla in 2022 and had no intention of launching it in the future, so there was no reason to prevent generics from entering the market." "Amgen said that it didn't want to continue litigating a product that they had no intention of launching in the country. They agreed that the patent would not be a barrier to generic entry in the future, which is why we went through the process." Currently, the legal status of Otezla's use patent, (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione, and methods of synthesis and compositions thereof" is indicated as “revoked," according to Korea’s Intellectual Property Trial and Appeal Board bulletin. An industry official said, "The Otezla generics have not been jointly developed by the companies, but seem to have been approved at the same time upon the resolution of the patent issue. We plan to apply for reimbursement immediately upon approval and start drug price negotiations."
