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- 2026-05-11 11:24:42
- Company
- Betmiga generics’ market share rises to 49%...
- by Kim, Jin-Gu May 09, 2023 05:38am
- Miragegron original Betmiga (left) and its generic versions Mirabek and Selebeta (right) Generic versions of mirabegron have increased their influence in Korea’s overactive bladder market. The overall market share of the generic products in Q1 was 49%, chasing sales of the original drug, ‘Betmiga,’ right under the nose. In particular, sales of Hanmi Pharmaceuticals ‘Mirabek’ and Chong Kun Dang’s ‘Selebeta’ have shown rapid growth. On the other hand, the prescription performance of the original product, Astellas Betmiga, dropped to less than half in 3 years after the release of its generics. Betmiga’s generics increase market share to 49%...Sales of original continue to decline According to the market research institution UBSIT on the 6th, the OAB market for the mirabegron ingredient had been KRW 15.6 billion in Q1, which is a 21% increase from the KRW 12.9 billion in Q1 2022. The market expansion was led by mirabegron generics. The overall prescription performance of the 22 Betmiga generics currently released in Korea reached KRW 7.7 billion, which is a 64% increase from the KRW 4.7 billion in Q1 last year. On the other hand, the decline in the prescription of the original mirabegron drug, Betmiga, is evident. In Q1, its prescriptions had fallen 3% from KRW 8.2 billion in Q1 2022 to KRW 8 billion this year. The amount is less than half of what it had made in Q1 2020, immediately before the release of its generics. Astellas had been delaying the execution of the price cut disposition on Betmiga that follows the release of generics by filing administrative suits and suspension of disposition execution requests, but had lost the final suit early last year and received price cuts. The increasing influence of its generics aggravated the decline in the prescription performance of the original drug. At this pace, sales of generics will exceed the original’s and take over the majority of market share in Q2 at the earliest. Mirabek and Selebeta’s sales grow rapidly... Domestic pharmaceutical companies’ new OAD drugs remain a variable in the market By product, sales of Hanmi Pharmaceuticals ‘Mirabek’ and Chong Kun Dang’s ‘Selebeta’ have shown rapid growth. In the case of Mirabek, its sales had increased 18% from KRW 3.2 billion in Q1 last year to KRW 3.8 billion in Q1 this year. In the same period, Selebeta’s sales have also risen from KRW 1.3 billion to KRW 1.7 billion. Sales of generics produced by the other 20 companies have raised less than KRW 0.5 billion in quarterly sales. Hanmi Pharmaceutical and Chong Kun Dang released their generics one after another after winning the patent dispute with Astellas in June 2020. In February last year, 20 additional companies released their generics after the generic exclusivity period expired for the two companies. The quarterly prescriptions of 20 companies that released products after the generic exclusivity period were all less than KRW 0.5 billion, but their growth rate is also quite steep. Therefore, the new OAD drugs released by domestic pharmaceutical companies are expected to act as the variable in this market. Jeil Pharmaceutical Jeil Pharmaceutical received approval for its new OAD drug, ‘Beova (vibegron)', in November last year. Jeil Pharm plans to supply this product, which was developed by Kyorin Pharmaceutical in Japan, within the year. Recently, it held a symposium for doctors, indicating its imminent entry into the market. By selectively acting on β3-adrenoceptor agonists, Beova relaxes the bladder and enhances urine collection. Its mechanism of action is similar to mirabegron, but Beova is known to have a higher response rate to β3 receptors and a low risk of cardiovascular side effects Dong-A ST is also in the final stages of developing a new OAD treatment. Dong-A ST has been conducting a Phase III trial in Korea for its OAD drug candidate 'DA-8010' since January last year. This drug is an antimuscarinic drug developed by Donga. Antimuscarinic drugs act primarily in the urine storage phase when the parasympathetic nerve is not activated, suppressing involuntary contraction of the bladder, reducing urinary urgency, and increasing bladder volume. In terms of mechanism, it is similar to another overactive bladder treatment, 'Veshcare (Solifenacin)'. DA-8010 is a new antimuscarinic being developed by Dong-A ST. Antimuscarinics inhibit involuntary contraction of the bladder and reduce urinary urgency to increase bladder capacity by primarily acting in the urinary storage phase where parasympathetic nerves are not activated. its mechanism of action is similar to that of ‘VESIcare (solifenacin),’ another OAD treatment.
- Policy
- Insurance price ceiling reeval results to be notified soon
- by Lee, Tak-Sun May 09, 2023 05:38am
- The Health Insurance Review and Assessment Service completed its first review on drugs subject to primary pricing ceiling reevaluations and will be notifying companies of the results soon. A 30-day objection period will follow HIRA’s result notification. According to HIRA on the 8th, HIRA’s Drug Reimbursement Evaluation Committee completed its first review of drugs subject to pricing ceiling reevaluations and will notify companies of the results within the week. About 14,000 items from about 200 companies were subject to primary evaluations. According to the original schedule, HIRA was supposed to complete the first evaluation and DREC review in April, but the period was delayed by a month due to the large amount of data the companies submitted in February, the last month of the data submission deadline. As a result, the plan for the results to be applied to the reimbursement list in July after negotiations is also likely to be delayed by a month. The re-evaluation of the upper limit amount of drugs includes the decision of whether to maintain or lower the upper limit after examining whether listed drugs met the self-bioequivalence testing and DMF listing requirements. Drugs that satisfy both the self-bioequivalence testing and DMF listing requirements are allowed to maintain their previous upper limit, and the price ceiling for drugs that satisfy only one of the two requirements is reduced to 85%, and those that satisfy none are reduced to 72.25%. In July 2020, the government applied the differentiated drug pricing system based on the standard requirements such as self-bioequivalence testing and DMF to new drugs and then started to reevaluate existing drugs (items listed as of August 1, 2020) after a grace period. The reevaluations were conducted in two groups in consideration of the pharmaceutical companies’ schedules. Companies that were subject to submit bioequivalence test results last year for their items (5,905 items) submitted data by July 31, and for other drugs, the standard requirements data were submitted from October of last year to February of this year. The items that will be notified of the first results are those whose data has been submitted by February. Once the first results are notified to each pharmaceutical company, a 30-day objection period will be available for the companies’ appeal. After the appeal process is concluded, the final result will be announced through DREC’s second review. According to the current schedule, it is highly likely that the final evaluation results will be deliberated at the second DREC meeting held at the end of June. Then, the results are expected to be reflected in the reimbursement list in August after the companies undergo main negotiations with the NHIS in July. The NHIS is currently forging preliminary discussions with pharmaceutical companies to complete the main negotiations in one month.
- Company
- Ildong’s diabetes combi Qtern registered for reimbursement
- by Kim, Jin-Gu May 08, 2023 05:41am
- Ildong Pharmaceutical announced on the 3rd that its type 2 diabetes combination drug 'Qtern 5/10mg' was registered as an item subject to medical care benefit as of May 1st. As a result, Qtern is covered by insurance as a three-drug therapy drug that can be used in combination with metformin when HbA1c is 7% or higher even if the two-drug therapy is administered for more than 2 to 4 months. 'Qtern 5/10mg' is a combination drug that combines ▲DPP-4 inhibitor Saxagliptin 5mg and ▲SGLT2 inhibitor Dapagliflozin 10mg. In 2016 and 2017, it obtained new drug approval in Europe and the United States, respectively, and in Korea, it was launched in 2021 after item approval from the Ministry of Food and Drug Safety in 2017. According to Ildong Pharmaceutical, as a result of phase 3 clinical trials, HbA1c decreased significantly in the three-drug combination therapy of metformin and Saxagliptin·Dapagliflozin compared to the two-drug combination therapy of metformin and Saxagliptin or metformin and Dapagliflozin. Ildong Pharmaceutical emphasized that Qtern is the only combination drug of dapagliflozin and DPP-4 inhibitor that both active ingredients are based on the original. In addition, the combination of three drugs, including metformin, has an economic advantage in that the drug cost is cheaper than prescribing a DPP-4 inhibitor and an SGLT2 inhibitor as single-component preparations, respectively. An official from Ildong Pharmaceutical said, "We plan to continue conducting academic marketing, including delivery of medical information, in consideration of newly changed standards such as the expansion of insurance benefits related to prescriptions for diabetes medications."
- Policy
- Retevmo passes DREC review and undergoes negotiations
- by Lee, Tak-Sun May 08, 2023 05:41am
- The anticancer drug ‘Retevmo Cap (selpercatinib, Lilly Korea)’ has passed redeliberations by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee (DREC). Therefore, the drug is expected to be smoothly listed for reimbursement if it passes drug pricing negotiations with the National Health Insurance Service. On the 4th, HIRA announced that it had recognized the reimbursement adequacy of Retevmo Cap after deliberations at the 5th 2023 DREC meeting. Although the agenda had been discussed at the 4th DREC meeting held in April, a conclusion had not been made for Retevmo Cap, and was set to be rediscussed at a further meeting. Retevmo is indicated for ▲RET fusion-positive non-small cell lung cancer (NSCLC); ▲ RET-mutated medullary thyroid cancer; ▲ RET-fusion benign thyroid cancer. Although the number of patients is small, it is used in the RET mutation patient group with poor prognosis Along with Retevmo Cap the chronic kidney disease treatment ‘Verquvo Tab’ was also determined to be adequate for reimbursement. On the other hand, the Breztri Aerosphere inhaler and the Hemophilia A treatment Jivi Injection were determined to have reimbursement adequacy if they accept a price lower than DREC’s assessed amount. In other words, the two drugs will be able to pass DREC review and proceed further to receive pricing negotiations with the NHIS only if they accept the price presented by DREC.
- Company
- Xospata passed the first hurdle to increasing benefits
- by Eo, Yun-Ho May 08, 2023 05:41am
- After submitting the application for expansion of Xospata's benefits, the Health Insurance Review and Assessment Service's Cancer Disease Review Committee succeeded in setting the reimbursement standard. As a result, attention is focused on future procedures such as the schedule for submission to the Pharmaceutical Reimbursement Evaluation Committee. As Xospata is a PE drug, in the case of insurance coverage expansion, it is necessary to go through the drug price negotiation process with the Health Insurance Corporation. Xospata has been approved as monotherapy for patients with FLT3 mutation-positive relapse or Acute Myeloid Leukemia, but the current reimbursement standard allows up to four cycles only for patients eligible for allogeneic hematopoietic stem cell transplantation. There are no specific reasons to limit the dosing cycle of Xospata except for financial issues. Looking at the ADMIRAL clinical study of this drug, it was designed with no restriction on the administration period, and it is recommended as 'Category 1' in the NCCN Guidelines without any limitation on the period. The best treatment for patients with acute myeloid leukemia is hematopoietic stem cell transplantation, but there is a high risk of recurrence, and transplantation is difficult in many cases because there are many elderly patients. In the case of patients who cannot undergo hematopoietic stem cell transplantation, which is excluded from the current reimbursement standard, there is no suitable treatment alternative other than Xospata, so they remain on chemotherapy developed over 40 years ago. The Korea Leukemia Patients Association commented immediately after the review committee, "There are many patients with acute myeloid leukemia aged 70 years or older who are unable to undergo transplantation due to lack of physical strength or high non-insured hematopoietic stem cell transplantation costs. Such allogeneic hematopoietic stem cell transplantation is impossible. FLT3 Xospata is used in patients with mutation-positive relapsed or refractory acute myeloid leukemia." "The government authorities and the relevant pharmaceutical companies should expeditiously carry out follow-up procedures such as scheduled deliberation committee, drug price negotiation, and deliberation by the Health Insurance Policy Deliberation Committee so that the reimbursement standard for Xospata, a treatment for acute myeloid leukemia, can be expanded as soon as possible," he urged.
- Policy
- First reimbursement of Yuhan Pregabalin 75mg CR
- by Lee, Tak-Sun May 08, 2023 05:41am
- Yuhan Pregabalin SR 300mgYuhan Corporation became the first company in Korea to list Pregabalin 75mg SR tablets for benefit. This drug is used as an initial dose for patients with moderate renal impairment. According to the industry on the 6th, Yuhan Pregabalin SR 75mg has been listed at 513 won per tab since May. Various doses of Pregabalin, such as 25 mg, 50 mg, 150 mg, and 300 mg, as well as 75 mg for neuropathic pain, were registered for reimbursement. Pregabalin is usually administered at a starting dose of 150 mg per day for neuropathic pain. However, in patients with renal impairment, lower doses are used first. Pregabalin 75 mg is used as a starting dose for patients with moderate renal impairment. In the meantime, only 150mg and 300mg, which are the main doses, have been developed for SR. Pregabalin 75mg extended-release tablet is the first time for Yuhan. This drug is intended for use in low doses in patients with moderate renal impairment. As it is SR, it is taken once a day. Considering that the existing 75mg fast-acting tablet was taken 2-3 times a day, it is expected that the convenience of taking it will increase for patients. Although there is no 75mg sustained-release tablet, Original Viatris is offering Lyrica CR extended-release 82.5mg for patients with moderate renal dysfunction. It is analyzed that Pregabalin 75mg was developed targeting Lyrica CR 82.5mg. In terms of price, Pregabalin 75mg is cheaper than Lyrica CR 82.5mg. Yuhan products are priced at 513 won, while Viatris products are priced at 732 won, which is more than 200 won higher. Lyrica is a blockbuster product that recorded 69 billion won in outpatient prescriptions (UBIST) last year. However, the SR market is small. Lyrica CR's outpatient prescriptions last year were only 900 million won. As such, the extended-release tablet market, which is highly convenient to take, has great potential for growth, and generics are also launching products one after another targeting this. Yuhan was the first to receive approval and is evaluated as having established an unrivaled area in the domestic Pregabalin 75mg market. Yuhan is already rolling out Pregabalin 50mg and 300mg SR through reimbursement. In the pregabalin market, in the Pregabalin market, attention is focused on whether Yuhan's efforts to develop SR will bear fruit.
- Opinion
- [Reporter's View] Suspension of drug price cut
- by Kim, Jin-Gu May 08, 2023 05:41am
- The price of Forxiga, an SGLT-2 diabetes drug, remains unchanged despite the release of a generic version. AstraZeneca applied for suspension of drug price cut execution along with an administrative lawsuit, and the court accepted it. AstraZeneca cited the reason that Forxiga's indications include not only diabetes but also heart failure and kidney disease. A generic Forxiga was released as a treatment for diabetes, and the government's price cuts that affect other indications are unreasonable. Unlike the US, Switzerland, and Australia, Korea does not differentiate drug prices by indication. In other words, unless the current drug pricing system changes in a broader framework, it is very likely that the administrative lawsuit filed by AstraZeneca will not be accepted by the courts. There is no way that AstraZeneca did not know about this situation. Nevertheless, AstraZeneca applied for a suspension of execution of Forxiga's drug price cut. It is a very clever decision from AstraZeneca's point of view. Considering that it usually takes more than three years for the Supreme Court to make a final decision, it can prevent expected losses of tens of billions of won every year for more than three years. However, at the same time, it cannot be free from criticism that it abused the suspension system. Coincidentally, the day Forxiga's drug price cut enforcement suspension was cited was the day the 'Drug Price Cut Refund and Refund Act' passed the National Assembly. This law is about the collection and refund of pharmaceutical expenses paid or unpaid during the period of suspension or execution of drug price cuts. The government has emphasized the necessity of this bill. Biopharmaceutical companies complained that the judiciary's decision to suspend the execution of drug price cuts caused a loss in health insurance finances. The biopharmaceutical industry criticized that it was concerned about violating the constitutional right to sue. Regarding the government's claim that the pharmaceutical industry abuses the judiciary's suspension of execution, he protested that it was only a "partial problem." The face of the biopharmaceutical industry, claiming the injustice of the drug price reduction/refund law, has become meaningless. Rather, it has strengthened the government's argument that has emphasized the necessity of the bill. According to the government's logic, health insurance financial losses of tens of billions of won are expected over the next few years. Neither the government nor the biopharmaceutical industry can view this positively. On the day the bill to correct the problem was passed, he did that very problematic act. Criticism comes from the pharmaceutical industry that the degree of cleverness is too much. The bill will come into effect six months after promulgation. After 6 months, such an application for suspension of execution is burdensome. If the Forxiga drug price cut had been six months later, would AstraZeneca have made the same decision as it is now?
- Company
- New polycythemia vera drug Besremi may be prescribed
- by Eo, Yun-Ho May 08, 2023 05:40am
- The Taiwanese pharmaceutical company PharmaEssentia’s first new drug ‘Besremi’ can now be prescribed in general hospitals in Korea. According to industry sources, PharmaEssentia’s polycythemia vera treatment, Besremi (Ropeginterferon alfa-2b) passed drug committee reviews of tertiary hospitals in Korea including Seoul National University Hospital and Asan Medical Center. The company submitted an application for the reimbursement of its drug on March 28 and is undergoing the reimbursement process in Korea. If listed, the drug is expected to quickly lead to actual prescriptions in the field. Polycythemia vera is a rare blood disorder where a somatic cell mutation in the bone marrow abnormally activates bone marrow function and produces excessive red blood cells. It has a short survival period and is so fatal that 10~15% of patients with polycythemia vera develop myelofibrosis or leukemia within 10 years. Although hydroxyurea had been used as the standard of care, it was difficult to fundamentally cure the disease with hydroxyurea, and patients who could not be treated with hydroxyurea had limitations as there were practically no drugs available for them in Korea’s domestic reimbursement environment. Besremi is an interferon treatment that selectively removes JAK2 mutations that cause polycythemia vera. In Korea, the drug received approval in October 2020 to treat low-risk and high-risk patients with polycythemia vera without symptomatic splenomegaly. The drug demonstrated its potential as a radical treatment for polycythemia vera in patients who had not received cytoreduction therapy or received less than 3 years of treatment with hydroxyurea. Therefore, whether the only interferon treatment option approved for polycythemia vera will be born in Korea is receiving attention. Besremi demonstrated its efficacy and safety in the Phase III PROUD/CONTINUATION-PV trial that was conducted on polycythemia vera patients. Trial results showed that 53% of the patients in the Besremi arm achieved a complete hematological response, an improvement compared with the hydroxyurea patient arm (38%). The hematologic and molecular response rates at 72 months were also high, at 80.4% and 65.3% in low-risk and high-risk patients, respectively. Regardless of their risk, patients treated with Besremi did not require phlebotomy even 6 years after administration. Sung-Soo Yoon, Professor of Hemato-Oncology at Seoul National University Hospital, said, “Polycythemia vera is currently left unattended in the blind area of reimbursement in Korea. Patients that show no response to hydroxyurea, the current standard of care, had no appropriate treatment and had no option but to wait for their condition to progress further.” He added, “Korea’s clinical practice guidelines recommend interferon and ruxolitinib as second-line treatment for patients who show intolerance or are refractory to hydroxyurea, but both drugs are currently unreimbursed, and other interferon treatments have withdrawn from the Korean market. Therefore, as the only treatment option available, Besremi is in urgent need of reimbursement.” Besremi is recommended as a first-line or second-line treatment for polycythemia vera in the National Comprehensive Cancer Network (NCCN) and European Leukemia Network (ELN) guidelines, regardless of previous treatment experience.
- Company
- Merck establishes a bio-production facility in Daejeon
- by Jung, Sae-Im May 08, 2023 05:40am
- (From left) Minister of Trade, Industry and Energy Lee Chang-yang, Merck Life Science CEO Matthias Heinzel, Daejeon Metropolitan City Mayor Lee Jang-woo Merck Life Sciences establishes a bio raw material production facility in Korea. Merck Lifesciences announced on the 3rd that it has signed a memorandum of understanding (MOU) with the Ministry of Trade, Industry and Energy and Daejeon Metropolitan City to establish a production facility for raw and subsidiary materials used in the new Asia-Pacific bioprocess in Korea. The bio-process production facility scheduled to be established in Daejeon will support the pharmaceutical/bio ecosystem in the Asia-Pacific region and focus on producing products for biotech and pharmaceutical customers. Along with this, the company and the city of Daejeon will support biotech companies that have moved into the Daedeok Research Complex in Daejeon and will expand research cooperation with leading universities in Korea. Matthias Heinzel, CEO and Member of the Board of Directors of Merck Life Sciences said, "Korea is an emerging world leader in the biotechnology industry, and this MOU is a commitment to actively support our customers in the Asia Pacific region through close cooperation with the government. "The production facility being tested will play an essential role in meeting the demand for bioprocessing in the Asia-Pacific region, while also serving as an important hub for the development of Korea's biopharmaceutical industry." said. Minister of Trade, Industry, and Energy Lee Chang-yang said, "This cooperation is expected to serve as an opportunity for our biopharmaceutical industry to take a leap forward as a national high-tech industry."
- Company
- AbbVie Korea merges with Allergan Korea
- by Jung, Sae-Im May 07, 2023 08:37pm
- AbbVie Korea announced on the 2nd that it will complete the integration of domestic corporations with Allergan Korea on May 1st and launch as a single corporation. The domestic corporation merger is a follow-up to the announcement of the merger and acquisition of Allergan by the global headquarters in May 2020. It plans to integrate the entire business operation management system and take a new leap forward with 'one AbbVie'. As part of the integration process, AbbVie Korea recently expanded its existing office space and renovated it into a smart office to integrate the two companies workspaces. Since the announcement of the global acquisition of Allergan in 2020, the two companies have been operating employee programs such as Culture Week, company-wide training program, and Possibilities Week together every year, integrating corporate culture into a unified AbbVie. With this domestic corporation integration, the total number of AbbVie Korea employees will be about 330 as of May. As a leader in the field of immunology, AbbVie has successfully launched Humira, a treatment for autoimmune diseases, Skyrizi, a treatment for psoriasis, and Rinvoq, which is expanding its treatment to include rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, atopic dermatitis, and ulcerative colitis. introduced domestically. In addition, it is supplying innovative treatments such as Maviret, a treatment for hepatitis C, and Venclexta, a treatment for chronic lymphocytic leukemia and acute myeloid leukemia. The integration will include Allergan's Ozurdex treatment for diabetic macular edema and uveitis, Combigan treatment for glaucoma, Ganfort and XEN Gel implant medical devices for eye diseases, as well as Botox for stroke-related upper extremity spasticity and chronic migraine headache treatment, which will be included in AbbVie's specialty medicines business. widen Allergan esthetic provides differentiated brand programs and educational opportunities in the medical esthetic business, such as botulinum toxin preparation Botox, hyaluronic acid filler Juvedern, and coolsculpting, and provides new growth opportunities. Kang So-young, CEO of AbbVie Korea, said, "We are pleased to have successfully completed the operation management system and corporate integration process of both companies." We expect that we will be able to maximize the synergy effect by integrating each other's professional capabilities and experiences, as well as expanding the treatment area."
