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- 2025-12-18 16:03:14
- Policy
- MOHW to 'carefully review' post-dispensing notification law
- by Lee, Jeong-Hwan Jan 22, 2025 05:54am
- A bill to add the Health Insurance Review and Assessment Service to the post-notification subjects for dispensing substitute drugs by pharmacists is scheduled to be reviewed on the 21st, but the government's cautious stance is expected to be a hurdle. The Ministry of Health and Welfare has not changed its stance on the bill, saying it should be carefully reviewed considering the scope of the HIRA’s work and concerns about the safety of drug use caused by the increased notification term. Physicians and hospital organizations are also opposed to the expansion of post-notification, citing concerns that it would undermine the doctors' prescription rights and delay the time of notification to doctors. There are a total of three bills related to dispensing substitute drugs pending in the National Assembly as of the 19th. Rep Byung-Deok Min, Young-seok Seo, and Sujin Lee of the Democratic Party of Korea have separately introduced the 3 bills. The bills are to change the “dispensing substitute drugs” clause in the Pharmaceutical Affairs Act to “same-ingredient drugs” (Young-Seok Seo, Sujin Lee) and to expand the subjects for post-notification of substitute drug dispensing to include HIRA (Byung-deok Min, Young-Seok Seo, and Sujin Lee). MOHW-HIRA “Drug safety concerns arise due to increased notification period of dispensing substitute drugs” The MOHW has been showing a cautious stance on both the provisions to change the ‘dispensing substitute drugs’ clause and the post-notification to HIRA clause. This is a reversal of the opinion as the MOHW had expressed plans to accept the post-notification provision for the same Act mentioned in the bill introduced by Rep. Young-Seok Seo in the 21st National Assembly. The MOHW explained, “Changing the phrase to same-ingredient drug dispensing may be misunderstood as being able to substitute will all drugs that contain the same ingredients,” adding, “There are differences in perceptions and positions between the medical and pharmaceutical communities on dispensing substitute drugs, so careful review is necessary.” “We agree on the need to improve the convenience of the post-notification system, which is currently conducted via phone or fax.” It added, “However, stipulating that the review committee should receive the results of the dispensing substitute drugs and renotify the prescribing physician should be carefully reviewed considering the purpose of the organization's establishment, the scope of its work, and concerns about drug safety due to the increased notification period.” HIRA also expressed a cautious view. “The notification period would inevitably increase when post-notification is made through the review committee. If a weakening incident occurs in a situation without the doctor’s awareness, patient safety issues can also arise as a concern. Since HIRA can only perform the tasks entrusted by law, separate grounds for entrusting alternative notification-related tasks is necessary.” “A unique identification number in accordance with the Personal Information Protection Act, regulations based on handling sensitive information, and provisions on granting immunity for HIRA in the event of a weakening incident would also be necessary.” Doctors and hospitals oppose the revisions...only pharmacists are in favor In addition to the cautious stance expressed by MOHW and HIRA, there are many other expected legislative hurdles. The opposition of doctors and hospital organizations is one of them. In addition, legislation to promote dispensing substitute drugs is expected to be more difficult in the 22nd National Assembly. This is because the NA Health and Welfare Committee is composed of a large number of doctors. In the 21st National Assembly, the bill to promote dispensing substitute drugs failed to pass due to the strong opposition of a single lawmaker who was a physician, although a number of lawmakers, including 3 pharmacists (Young-Seok Seo, Jeong-sook Seo, and Hye-sook Jeon), emphasized the need for legislation. The ratio of doctors and pharmacists in the 22nd National Assembly's Welfare Committee was 5 (Yoon Kim, Myung-ok Seo, Jia Han, Sun-min Kim, Joo-young Lee) to 1 (Young-Seok Seo), which is a great increase in the cap compared to the 21st National Assembly. Just in the 1st Subcommittee of the Legislative and Judiciary Committee alone there are 3 physicians (Yoon Kim, Myung-ok Seo, and Joo-young Lee). Of course, it cannot be assumed that physicians will necessarily oppose the bill to enable dispensing of substitute drugs. However, it is widely believed that the majority of doctors will serve as a major obstacle to the bill's passage. The Korean Medical Association and the Korean Hospital Association also opposed the bill. The KMA said, “If the details of the dispensing substitute drugs are first sent to HIRA, pharmacists can arbitrarily change the drug without the consent of the doctor, which may undermine the doctor's prescription right. It will be difficult to respond quickly to the patient’s drug side effects and may cause liability problems for the prescriptions and side effects.” The KHA also said, “It may be difficult to share information on dispensing substitute drugs between doctors and pharmacists, which may delay the doctors' recognition of inappropriate substitutions and further actions required by the patients. Frequent changes to doctors’ prescriptions may affect treatment outcomes.” Only the Korean Pharmaceutical Association is in favor. “It is often difficult to notify the prescribing doctors and dentists due to lack of fax numbers or telephone connection failures,” said the KPA, ”Improving the process to electronically notify HIRA will eliminate administrative inconveniences and streamline the process to facilitate dispensing substitute drugs.”
- Policy
- Yuyu seeks to expand the scope of its fexofenadine to ETC
- by Lee, Tak-Sun Jan 21, 2025 05:54am
- Yuyu Yuyu Pharma, which developed a 60mg OTC drug containing the antihistamine fexofenadine, is now seeking to enter the specialty drug market. Currently, only Handok, the original drugmaker, and Hanmi Pharm own a 180 mg fexofenadine product, but Yuyu Pharma is expected to barge in and pave its way into the two-drug market with its new product. According to industry sources on the 20th, Yuyu Pharma’s Fexoone Tab. 180mg (fexofenadine hydrochloride) will be reimbursed as of the 1st of next month. The upper insurance price ceiling was set at KRW 309 per tablet, which is cheaper than Handok’s Allegra Tab 180 mg (KRW 310) and Hanmi Pharmaceutical’s Fexonadine Tab 180 mg (KRW 314). Since there are two other drugs containing the same ingredient, and Yuyu Pharma met all the criteria for pricing premiums the company was able to receive the highest price of KRW 314, but Yuyu lowered its price to KRW 309 to become the lowest-priced drug in the market. Fexofenadine hydrochloride is a 2nd generation antihistamine. Depending on the dose, it is divided into over-the-counter and ethical-the-counter (specialty) drugs, with 60mg and 120mg classified as OTC and 30mg and 180mg classified as ETC drugs. However, Yuyu’s 60mg formulation recently received approval as an ETC drug. The 60mg dose, which was developed by Yuyu, has never been available before. The 120mg version is usually taken as a single pill before bed, but the effects do not last until the next day. In contrast, the company said that the 60mg version can as two pills a day to remain effective throughout the day. With Yuyu receiving approval for the 60mg formulation as an OTC, ETC, fexofenadine 60mg became an OTC/ETC drug. With the addition of Fexoone Tab 180 mg, Yuyu now has 4 fexofenadine products on Korea’s reimbursement list. The four items include Fexogien 60mg, an OTC drug, Fexogien 60mg, an ETC drug, and Alesta 120mg, a general drug. Of these, Fexozien 60mg and Fexoone 180mg have been or will be reimbursed. Yuyu’s focus on fexofenadine is likely influenced by the fact that the second-generation antihistamines olopatadine and bepotastine are undergoing reimbursement reevaluations this year. The company focused on developing fexofenadine as an alternative to these drugs. The original fexofenadine, Allegra, generated KRW 7.2 billion in outpatient prescription sales (UBIST) last year. It has the advantage of having steady market sales. It will be interesting to see if Yuyu’s fexofenadine expansion strategy will gain success.
- Policy
- CKD completes acquisition of diabetes drug 'Januvia'
- by Lee, Tak-Sun Jan 21, 2025 05:54am
- Chong Kun Dang has completed the sale transfer and takeover of 'Januvia (sitagliptin phosphate hydrate),' a diabetes drug that generates annual sales of KRW 23 billion in South Korea. Conseqently, what was previously labelled as MSD's is now labelled as Chong Kun Dang's in South Korea. According to industry sources on January 20, the pharmaceutical company label for three Januvia items (25 mg, 50 mg, 100 mg) registered in the National Health Insurance Service's reimbursement list will be changed from MSD Korea to Chong Kun Dang. The change is due to adjustments following the sale transfer and takeover. The insurance authority allows the final ceiling price to be the same as the transferred item if the acquired item holds the production rights. As a result, the prices will remain the same: KRW 200 for Januvia Tab 25 mg, KRW 301 for Januvia Tab 50 mg, and KRW 453 for Januvia Tab 100 mg. In 2023, Chong Kun Dang signed an agreement with the MSD headquarters to acquire all domestic rights for three items: Januvia, Janumet, and Janumet XR. Chong Kun Dang will acquire domestic sales and distribution rights, as well as approval, trademark, and production rights. The contract period is from July 15, 2025, to August 31, 2038. Chong Kun Dang has been selling the Januvia series since 2016 through joint promotion with MSD Korea. Now that Chong Kun Dang wholly owns Januvia's domestic rights, it has secured a stable cash cow. Januva recorded outpatient sales of KRW 23 billion in 20224, according to UBIST. The annual sales performance of Januvia, Janumet, and Janumet XR exceeds KRW 100 billion. Currently, Chong Kun Dang has completed the process for Januvia's permit and is expected to takeover the reimbursement permit soon. The company is proceeding with the sale transfer and takeover of Janumet XR Tab. Chong Kun Dang explained on the sale transfer and takeover of the Januvia series as "By securing the Januvia series in addition to previously acquiring Duvie, new drug for diabetes, we have stably expanded treatment options for patients."
- Policy
- MFDS approves Vyvgart for severe myasthenia gravis
- by Lee, Hye-Kyung Jan 21, 2025 05:54am
- The Ministry of Food and Drug Safety (MFDS, Minister Yu-Kyoung Oh) announced on the 20th that it has approved the orphan drug Vyvgart(efgartigimod alfa) for the treatment of adult patients with general myasthenia gravis (gMG) who are anti-AChR antibody positive. Myasthenia gravis is an autoimmune disease characterized by decreased neuromuscular signaling and generalized muscle weakness caused by IgG (Immunoglobulin G) autoantibodies that target components of the neuromuscular junction. Vyvgart Inj works by preventing the binding of autoantibody IgG to the neonatal Fc receptor (FcRn)*, which promotes the degradation of autoantibodies, bringing therapeutic benefit in patients with autoantibody-mediated myasthenia gravis. The neonatal Fc Receptor (FcRn) is specific for antibody IgG homeostasis in the body and prevents IgG from being degraded by lysosomes. This is the first drug to be approved in Korea with a new mechanism of action that binds to FcRn, and the approval is expected to broaden the treatment options for adult patients with myasthenia gravis. For reference, the MFDS designated the drug as the 22nd Global Innovative product on Fast Tracking (GIFT) (November 2023) and announced it would expedite its review so that it could be quickly introduced into the field for myasthenia gravis patients in Korea. “Based on our regulatory science expertise, we will continue to do our best to ensure that new therapies are quickly supplied to patients with rare diseases to expand treatment opportunities,” said the MFDS.
- Policy
- MFDS' pharma policy keyword, 'shorten time'
- by Lee, Hye-Kyung Jan 21, 2025 05:54am
- According to the business plan announced by the Ministry of Food and Drug Safety (MFDS) this year, support policy to facilitate quick market entry for new drugs and innovative products stands out. The 'Ministry of Food and Drug Safety's Major Policy Implementation Plan for 2025' announced on January 21 by the MFDS contains its aim to shorten the duration of development to commercialization using various systems. First, the MFDS will newly establish a dedicated review team this year to provide expert consultation services at each approval stage. Improvement of panel·process for approval·review. The new drug approval fee increased to KRW 410 million. The MFDS will prioritize document review and GMP site monitoring and plan to shorten the approval duration from 420 to 295 days. The MFDS will implement a priority review policy to expand the number of interview consultations (3→10) and prioritize the review of a document that requires supplementation as soon as it is completed. Additionally, the MFDS will improve the expetise of the review panel and regulatory capacity by continuosly expanding the percentage of experts within the review panel, including doctors and pharmacists, developing educational programs for the latest technologies, and conducting training programs customized to the panel's work experience (basic·core·intensive). Notably, companies can apply for a single pre-registration consultation session before applying for a new drug marketing authorization. It has been reported that two consultation sessions have been held to date. Kim Sang Bong, Director of the Pharmaceutical Safety Bureau, stated during the briefing held on January 20, "We have held two pre-registration consultation sessions until today." Kim added, "Yet, we do not have a record of the new drug application that was submitted." "The MFDS announced a documented plan for a procedure that is equivalent to the level of new drug assessment in advanced pharmaceuticals countries such as the U.S. and Europe," Kim said. "To efficiently run the annouced process, we will assign review panels and expand expert personnel with a strong background." Starting in April, the MFDS will implement a regulatory suitability review system where innovative product R&D research as part of government R&D projects will be selected and provide regulatory requirements, process, and commercialization strategy. The The MFDS will run a 'Path Program,' providing approval guidelines to support new technology-based product development, including gene diagnosis and antibody-drug conjugate technologies, and facilitating prior-registration consultation for each stage, such as clinical trials·approval, and expedited review. "The MFDS will implement a 'Path Program' linking the With-U prior-registration consultation, clinical trial review, and GIFT expedited review," Kim said. "Previously, we received a review that each program runs without smooth transition, so we designed a program to overlook the transition." The 'Path Program' is projected to shorten the time for innovative product development to commercialization. Kim stated, "We cannot guarantee that the time will greatly reduce, but the program has the advantage in terms of predictability and transparency." Kim Sang Bong, Director of the Pharmaceutical Safety BureauThe MFDS also plans to establish a stable pharmaceutical supply network this year. Starting in April, to prepare for the pharmaceutical supply shortage, the MFDS will set a preliminary report date of 180 days before the supply discontinuation of production and imports by pharmaceutical production·import companies and mandate reporting of supply shortage. "The government is in the process of establishing a safety network for efficient transaction between various policies, including national essential drugs, private-public committee for supply shortage, and consignment production·production by orders," Kim said. "Reporting of supply shortage is one of the advanced measures." "The pharmaceutical industry may take these updates as another regulatory measure, but the intent of these policies is to predict supply shortage in advance and to secure time for each policy measure to run smoothly," Kim said. "The MFDS aims to prevent supply shortage in advance and allow companies to receive administrative support."
- Policy
- Boryung’s Pomalyst generic first to be reimbursed in Korea
- by Lee, Tak-Sun Jan 20, 2025 05:54am
- Boryung will be the first in Korea to receive reimbursement for its generic version of Pomalyst (pomalidomide, BMS), a multiple myeloma treatment. As a product from an innovative pharmaceutical company, the drug also receives premium pricing. According to industry sources on the 17th, four dosage forms (1, 2, 3, and 4 mg) of Boryung's ‘Pomalikin Cap’ that contains pomalidomide will be listed for reimbursement on February 1. The insurance price ceiling was set at KRW 132,184 for the 1mg, KRW 132,493 for the 2mg, KRW 134,140 for the 3mg, and KRW 135,271 for the 4mg formulation. This is 53.55% of the highest list price, plus a 68% premium granted as a product by an innovative pharmaceutical company. Pomalikin Cap is the first generic version of the original Pomalyst Cap. This month, the cap was adjusted due to the termination of the reimbursement risk-sharing agreement for Pomalikin Cap. Before the adjustment, the ceiling price of the 1mg product was KRW 356,691, while the adjusted price was KRW 194,389, a 44.6% price adjustment. Compared to Pomalikin Cap 1mg, the adjusted price of the original product is around KRW 60,000 higher. So Boryung’s first generic can be seen as competitive in terms of price. The premium pricing markup for Pomalikin Cap will end in February 2026, and the price will fall to 53.55% of the highest price thereafter. Meanwhile, Pomalyst is a blockbuster product that posted sales of KRW 22.8 billion as of 2023 according to IQVIA data. It is indicated ▲for the treatment of multiple myeloma patients who have received at least one prior therapy, including lenalidomide, in combination with bortezomib and dexamethasone; and ▲for the treatment of relapsed or refractory multiple myeloma patients who have received at least two prior therapies, including lenalidomide and bortezomib, in combination with dexamethasone. By securing a pomalidomide-based treatment in addition to lenalidomide, Boryung is expected to strengthen its position in the multiple myeloma treatment market,
- Policy
- Drug expenditures surge due to the use of high-priced drugs
- by Lee, Tak-Sun Jan 17, 2025 05:53am
- Drug expenditures have risen significantly in 2023 due to the rising cost of high-priced anticancer drugs and rare disease treatments. Due to the aging population increasing the expenditures spent on treating chronic diseases, an urgent need has arisen to come up with a measure to reduce drug expenditures. According to the National Health Insurance Service (NHIS, President: Ki-suk Jung), the total drug expenditure in 2023 was KRW 26.196 trillion, an 8.5% increase from the previous year (KRW 24.1542 trillion). This is twice as high as the 4.7% year-on-year increase in total medical expenses (KRW 110.8029 trillion) in 2023. The proportion of drug expenses in medical expenses also increased by 0.8 percentage points year-on-year to 23.6%, which indicates that the increase in drug expenditures has exceeded the critical level. As of 2022, the proportion of drug expenditures in Korea's current health expenditures was 18.0%, 3.8 percentage points higher than the OECD average of 14.2%, and ranked 7th among OECD countries. One factor contributing to the rapid increase in drug expenditures is the recent increase in reimbursement expenditures for high-priced anticancer drugs and rare disease treatments. Under the Comprehensive National Health Insurance Plan, the government has been expanding health insurance reimbursement coverage for cancer and rare diseases with high drug costs and promoting drug reimbursement for essential drugs needed for treatment in comprehensive consideration of the social and clinical needs, cost-effectiveness, public acceptance, and financial condition. In 2022, 22 drugs, including the acute lymphocytic leukemia drug Kymriah, were covered, and the scope of use was expanded for 7 drugs, including immuno-oncology drugs such as Keytruda. In 2023, 24 drugs, including the spinal muscular atrophy drug Evrysdi, were covered, and the scope of use was expanded for 8 drugs, including those for severe atopic dermatitis. As a result, as of 2023, the cost of reimbursed drugs used to treat cancer and rare and difficult diseases increased by 10.8% and 9.7% year-on-year to KRW 3.8402 trillion and KRW 2.5492 trillion, respectively, outpacing the growth rate of overall drug expenditures (8.5%). By age group, patients in their 60s accounted for the highest proportion (25.2%) of drug expenses at KRW 6.6 trillion, followed by those in their 70s (KRW 5.2 trillion), 50s (KRW 4.4 trillion), then 80s (KRW 3.1 trillion). Those aged 60 and over accounted for 58.1% of all drug expenses. By type of medical institution, pharmacies accounted for the highest amount of KRW 18 trillion (68.9%), followed by tertiary hospitals (KRW 3.8 trillion), general hospitals (KRW 2.2 trillion), and general clinics (KRW 1.1 trillion). By efficacy group, arteriosclerosis drugs (hyperlipidemia drugs) accounted for the largest expenditure of KRW 2.849 trillion, followed by anticancer drugs (KRW 2.7336 trillion), blood pressure lowering drugs (KRW 2 trillion), peptic ulcer drugs (KRW 1.3904 trillion), then diabetes combination drugs (KRW 1.3667 trillion). Due to the aging population and westernized dietary habits, hyperlipidemia drugs have taken the top spot in recent years, followed by drugs for chronic diseases (hypertension, diabetes, and hyperlipidemia). By ingredient group, the top-ranked drug was the combination of ezetimibe + rosuvastatin for hyperlipidemia, an atherosclerosis drug, posting KRW 605.8 billion. This was followed by choline alfoscerate (brain function enhancer, KRW 563 billion) > atorvastatin (hyperlipidemia drug, KRW 558.7 billion) > clopidogrel (antithrombotic drug, KRW 417.9 billion) > rosuvastatin (hyperlipidemia drug, KRW 337.7 billion). The second-ranked drug, choline alfoscerate, has seen a 104.3% increase in spending over the past 5 years (KRW 275.6 billion in 2018 → KRW 563 billion in 2023). The drug is undergoing clinical reevaluation by the Ministry of Food and Drug Safety to prove its therapeutic effectiveness through clinical trials, and for proper prescription management of the drug, HIRA has recommended institutions refrain from prescribing it for diseases other than dementia as a screened item from 2022, but expenditures on the ingredient have not decreased. “Drug expenditures are steadily increasing due to the inclusion of new drugs such as high-priced anti-cancer drugs and gene therapies in the reimbursement list and expansion of reimbursement standards, as well as the increase in chronic diseases caused by the aging population,” said an NHIS official. ”We will continue to increase coverage so that people can use the drugs they need for medical treatment on time, but will expand the analysis of drugs that are misused or unnecessarily prescribed to prepare management measures to protect health insurance finances while promoting public health.”
- Policy
- Pulmonary fibrosis drug 'Ofev' under consideration for reimb
- by Lee, Tak-Sun Jan 17, 2025 05:53am
- As 'Ofev Soft cap (nintedanib),' a treatment for pulmonary fibrosis, has been approved for reimbursement appropriateness, latecomer drugs are projected to enter the market quickly. Following the expiration of Ofev's usage patent, latecomer companies are anticipated to prepare for launching their drugs. According to industry sources on January 16, Daewoong's "Ofevvia tab 150 mg,' containing the same active ingredient as Ofev Soft Cap, was approved by the Ministry of Food and Drug Safety (MFDS). Last month, Yungjin Pharm's 'Nintebro Tab 150mg,' containing the same active ingredient, was approved. These companies aim to join the market early by changing the capsule formation of the original drug to tablets. They have successfully avoided the usage patent not registered as a patent in the MFDS. Therefore, latecomer drugs are projected to launch following the patent expiration of the substance patent, which is set to expire on January 25. However, latecomer companies are concerned that 'Ofev' has not been introduced the reimbursement list after it was approved in South Korea in October 2016. If Ofeb becomes introduced to the list, latecomer drugs that are considered products of development can be introduced to the list in three months after applying for reimbursement through the estimated course. Fortunately, Ofev received the green light from the Drug Reimbursement Evaluation Committee (DREC) of the Health Insurance Review and Assessment Service (HIRA). Both the original company and the generic company desire this outcome. The DREC committee determined Ofev's reimbursement appropriateness for the following indications: ▲ Systemic sclerosis-associated interstitial lung disease (SSc-ILD) ▲Treatment of chronic fibrosing interstitial lung diseases with a progressive phenotype. When the pharmaceutical company accepts the result, Ofev will be considered for the reimbursement list after undergoing drug price negotiations with the National Health Insurance Service (NHIS). Yet, the DREC excluded Ofev's first indication, idiopathic pulmonary fibrosis (IPF), for the reimbursement appropriates decision. IPF is a condition characterized by persistent and irreversible deterioration of lung function, leading to progressive scarring of the lungs and symptoms such as shortness of breath. As the disease progresses, lung function gradually and irreversibly declines. 18-32% of patients with IPF are known to progress to 'advanced pulmonary fibrosis,' where the lungs become stiffened, and fibrosis continues. The industry draws attention to whether Ofev's Boehringer Ingelheim will accept the reimbursement appropriateness decision for the rest of the indications, excluding the first indication for IPF. Even if Ofev gets introduced to the reimbursement list without the first indication, it will not pose a problem for latecomer companies. This is because the drug's use for IPF is patented, and IPF usage is not included in the currently approved efficacy and effectiveness. The efficacy and effectiveness of drugs from Yungjin Pharm and Daewoong are ▲Delay of pulmonary function decline in patients with SSc-ILD ▲Treatment of chronic fibrosing interstitial lung diseases with a progressive phenotype, excluding IPF. Analysis suggests that these companies could have avoided the usage patent if IPF is excluded from the efficacy·effectiveness section. Consequently, latecomer companies will likely determine the date to apply for reimbursement following Boehringer Ingelheim's next step. If Boehringer Ingelheim undergoes a negotiation process, companies are projected to aim for reimbursement listing as estimated drugs once the origunal drug is introduced to the list. Analysis indicates that companies must apply for reimbursement after negotiations if the original drug's reimbursement listing fails. Despite the non-reimbursement status in the domestic market, Ofev's sales have steadily increased. Based on IQVIA, Ofev generated KRW 1.8 billion in 2020, KRW 3.3 billion in 2021, KRW 5.6 billion in 2022, and KRW 5.7 billion in 2023. Ofev is projected to generate even higher sales when covered by national health insurance reimbursement.
- Policy
- Innovative Pharmaceutical Company certification to change
- by Lee, Jeong-Hwan Jan 17, 2025 05:53am
- The Ministry of Health and Welfare will improve the certification system for innovative pharmaceutical companies to a 'certification evaluation score system' that will increase the proportion of new drug research and development (R&D) and change the disqualification criteria to a point-based score system. The MOHW plans to issue an administrative notice next month after deliberations by the Pharmaceutical Industry Fostering and Support Committee. It will be interesting to see if the final notice will reflect the pharmaceutical industry's opinion that it is too harsh or unreasonable to cancel the certification of innovative pharmaceutical companies that encourage the creation of homegrown drugs and the development of the pharmaceutical industry based on illegal rebates in the past, etc. An MOHW official who requested anonymity made such remarks on the 15th, during a meeting with reporters from the Korea Special Press Association on Friday. While announcing its major work plan for 2025, the MOHW announced it would improve the core regulations for each industry to make the global leap. The improvement measures include overhauling the certification criteria for innovative pharmaceutical companies. The key is to add criteria for granting extra points for items such as a pharmaceutical company's R&D investment efforts and to allocate points for the disqualifying criteria, such as revoking the certification of innovative pharmaceutical companies based on the number of administrative penalties or the amount of illegal rebates. The industry has claimed that despite investing in R&D to create new drugs and its ethical management efforts, the revocation or decertification as an innovative pharmaceutical company due to rebate cases detected in the past dampens the companies’ will to develop new drugs. The current innovative pharmaceutical company certification system excludes innovative pharmaceutical companies based on the illegal rebate disqualification clause if they have received two or more administrative penalties for violating the Pharmaceutical Affairs Act in the past three years, or if the total amount of rebates exceeds KRW 5 million. A MOHW official said, “Under the current system if a company violates the standards, its innovative pharmaceutical company certification is revoked. We plan to introduce quantitative indicators to the disqualification criteria and add a premium for R&D efforts to allow companies to make up for the lost score” The MOHW is also considering the typification of the certification criteria for multinational pharmaceutical companies. The Korean Research-based Pharmaceutical Industry Association (KRPIA) has previously argued that open innovation collaboration with domestic research centers and companies, in addition to conventional clinical research, plays an important role in building global-level R&D capabilities. Therefore, the KRPIA has been requesting standards that can recognize and promote such activities. The MOHW has been preparing measures to reflect this. One of the improvements under consideration is to specify the reasons for rejection when notifying pharmaceutical companies of their innovative pharmaceutical company certification results. On the 10th, the 2nd Vice Minister of MOHW, Minsoo Park, said in a Q&A session on the 2025 Major Work Plan, “The most important criterion for selecting innovative pharmacuetical companies will be the R&D criteria, but we are looking at the specific condition and status of the current industry and trying to adjust the criteria accordingly.” He added, “We are considering expanding various quantitative evaluation criteria, creating customized criteria for each type of pharmaceutical company, and rationally improving the disqualification criteria,” he said. Such improvements must be reviewed by the Pharmaceutical Industry Fostering and Support Committee under the ‘Special Act on Fostering and Support of the Pharmaceutical Industry.’ The MOHW is currently preparing committee deliberations and plans to issue an administrative notice in February. Meanwhile, the benefits of being certified as an innovative pharmaceutical company include: (1) points for participating in government R&D; (2) corporate tax deduction for R&D expenses and tax deduction for investment in facilities to improve drug quality control; (3) When building research facilities, they are exempted from local regulations and levies on location; (4) companies that enter the KOSDAQ under the technology special exception or growth special exception are exempted from KOSDAQ listing requirements; and (5) drug prices are preferentially reduced for generic drugs, incrementally modified new drugs, and biosimilars, and reduce the actual transaction price reduction rate.
- Policy
- Boryung’s Pomalyst generic soon to be released
- by Lee, Tak-Sun Jan 14, 2025 05:57am
- Boryung's multiple myeloma drug Pomalikin Cap may soon be released in Korea’s market. The drug is the first generic version of Pomalyst Cap (pomalidomide, BMS). The risk-sharing agreement (RSA) applied to the original drug, Pomalyst Cap, ended this month, and the insurance price cap of the drug had been adjusted following the reimbursement application of its generic drug, Pomalikin Cap. According to industry sources, four dosage forms (1mg, 2mg, 3mg, and 4mg) of Pomalikin Cap, which were approved in August last year, are expected to be listed for reimbursement and be released to the market soon. The insurance price ceiling of the original drug has already been adjusted upon the generic drug’s reimbursement application. According to Article 13, Paragraph 4, Item 5 of the Standard for Medical Care of National Health Insurance, if a drug with the same route of administration, ingredients, and formulation applies for reimbursement approval, the risk-sharing agreement signed by the NHIS for the original drug will be terminated after NHIS evaluations. After Health Insurance Review and Assessment evaluations, BMS underwent negotiations with NHIS for Pomalyst Cap and decided to terminate the RSA and adjust the drug’s upper price limit. The drug was applied the refund type RSA, so there was a difference between the list price and the actual price due to the dual drug pricing system. Upon the termination of the RSA, the actual price was revealed. Before the price adjustment, the upper limit of the 1mg product was KRW 356,691, and the adjusted price was KRW 194,389, a 44.6% price cut. The fact that Boryung’s Pomalikin Cap is the only drug approved with the same route of administration, ingredients, and formulation as Pomalyst Cap indirectly implies that Boryung had applied for the reimbursement of Pomalikin Cap. Boryung succeeded in circumventing the original’s patent last year by filing a trial to confirm the passive scope of the original drug's patent to enter the generic market. Pomalyst Cap is a multiple myeloma treatment that posted sales of KRW 22.8 billion as of 2023, according to IQVIA. It is indicated ▲ in combination with bortezomib and dexamethasone in patients with multiple myeloma who have received at least one prior therapy, including lenalidomide; and ▲in combination with dexamethasone in patients with relapsed or refractory multiple myeloma who have received at least two prior therapies, including lenalidomide and bortezomib. Boryung has been focusing on the multiple myeloma market, recently introducing the lowest-priced lenalidomide to the market. As the only company that has released a pomalidomide generic, it will be interesting to see how Boryung will fare in the market established by the original.
