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- 2025-12-23 12:44:13
- Policy
- Competition intensifies in Forsteo market with 4 latecomers
- by Lee, Tak-Sun Nov 19, 2021 05:51am
- Teriparatide products Fosteo and TeriboneProducts with the same ingredient as the world’s first bone anabolic agent 'Forsteo(Teriparatide),' which was finally able to receive reimbursement in Korea 10 years after its approval, are rapidly entering the market. Domestic pharmaceutical companies are occupying the follow-on market with their Forsteo latecomers. Already 4 teriparatide products have entered the market. On the 16th, the MFDS approved Pharmbio Korea’s teriparatide biosimilar. The product contains the same teriparatide ingredient as Forster and is indicated for the treatment of osteoporosis in women and men. The drug was approved as a biosimilar after demonstrating its bioequivalence to Forsteo. Forsteo is Lilly Korea’s osteoporosis treatment that was approved in 2002. As the first bone anabolic(bone-forming) agent, Forsteo received much attention for its different treatment mechanism from existing antiresorptive agents. Previous bone resorption inhibitors had inhibited the release of calcium from the bone into the bloodstream, however, Forsteo, as an anabolic agent, promoted proliferation and activity of osteoblasts that are involved in new bone formation. It took 10 years for the drug after being approved in 2006 to receive reimbursement. Forsteo was approved for reimbursement as second-line treatment in 2016. However, patients who showed no effect or are unable to use one or more of the existing bone resorption inhibitors are allowed reimbursement for Forsteo. Since receiving reimbursement, Forsteo defeated the then-leading bisphosphonate products in the market and become the top leader in the market. Domestic pharmaceutical companies quickly followed on its course with their biosimilars. Dong-A ST was the first to be approved for its more convenient, single, once-weekly injection formulation of the same ingredient, ‘Teribone subcutaneous inj.’ in 2015. In 2019, Daewon Pharm was the first to be approved for Forsteo’s biosimilar, ‘Terrosa Cartridge.’ And last year, BMI Korea was approved for Teribone’s biosimilar, ‘Teria inj,’ sparking full competition in the market. And the recent introduction of PharmBio’s second Forsteo biosimilar increases the count of teriparatide products to 4. Based on IQVIA, Forsteo sold ₩17.1 billion, Teribone ₩2 billion, Terossa ₩0.8 billion last year. Forsteo continued to show strength as the original by ranking second in the osteoporosis treatment market, but the latecomers still have a long way to catch up due to their late entry. However, this does not mean that Forsteo’s has a solid lead over its competitors because of the large gap between Forsteo and the market leader 'Prolia (₩75.1 billion).' Prolia is a biologic bone resorption inhibitor that is administered once every 6 months and is considered to have upgraded the effect and convenience in administration over existing osteoporosis treatments. In particular, Prolia’s reimbursement was extended to first-line from April 2019, showing an advantage over Forsteo in market competitiveness as it is still only reimbursed in the second-line. This is why there are some negative outlooks on the market performance of Forsteo latecomers. However, there is also analysis that the drugs will show strength in the market if reimbursement is expanded to first-line.
- Policy
- A law, proposed to prohibit overuse of drug price reduction
- by Lee, Jeong-Hwan Nov 19, 2021 05:51am
- The ruling party has proposed an additional bill to regulate the abuse of lawsuits by some pharmaceutical companies, including an injunction to suspend execution of the government's drug price cut. Following Rep. Kim Woni of the Democratic Party of Korea, Rep. Nam In-soon also proposed a partial amendment to the National Health Insurance Act on the 17th. The key point of the bill submitted by Rep. Nam In-soon is to allow the NHIS to collect a significant portion of health insurance losses from drug companies and others if it is confirmed that it is not illegal depending on the outcome of the drug price reduction lawsuit. If the suspension of execution is rejected and the ruling is confirmed to be illegal, the NHIS will pay the losses suffered by pharmaceutical companies. Rep. Nam In-soon explained, "There have been 46 cases of administrative trial claims and administrative litigation over the past 10 years against the reduction in drug prices under the current law. Administrative litigation to benefit from the suspension of execution is on the rise." Rep. Nam said, "As most of the suspension of pharmaceutical companies' applications is cited by the Administrative Appeals Committee or courts, drug price cuts are not executed during the trial or litigation period." She pointed out, "The problem is that even if it is confirmed that the disposition is not illegal in the trial or lawsuit on the merits in the future, pharmaceutical companies enjoy the economic benefits of not being executed during the lawsuit." Rep. Nam said, "The financial loss of health insurance due to abuse of lawsuits reached 160 billion won as of June this year, which was also pointed out in last year and this year's parliamentary audits." She said, "We have pushed for a revision of the law to prevent financial losses in health insurance due to abuse of administrative trials and administrative litigation related to drug prices and compensate for losses from manufacturers and others for illegal dispositions."
- Policy
- MFDS reviews emergency use of Merck’s oral COVID-19 pill
- by Lee, Tak-Sun Nov 18, 2021 05:54am
- The Ministry of Food and Drug Safety announced that it has started review for the Emergency Use Authorization of US Merck’s oral COVID-19 treatment, ‘Lagebvrio (molnupiravir).’ Also, the ministry added that a preliminary review is also in progress for US Pfizer’s ‘Paxlovid.’ On the 17th, the Korea Disease Control and Prevention Agency requested an emergency use authorization for US Merck’s oral COVID-19 treatment ‘Lagebvrio’ to the MFDS. Lagebvrio is a ribonucleoside analog that is inserted in place of the normal RNA needed in the viral replication process to induce lethal mutagenesis. The MFDS plans to carefully review the clinical and quality data submitted by the company, conduct an expert advisory meeting, and hold deliberations with the ‘Committee for the Safe Management and Supply of Medical Products for Public Health Crisis Response’ to verify the product’s safety and efficacy before deciding whether to authorize emergency use. On the 10th, Pfizer Korea applied for the preliminary review of quality and nonclinical data on ‘Paxlovid,’ an oral COVID-19 treatment developed by Pfizer US. The MFDS is conducting a preliminary review on Paxlovid upon the company's request. ‘Paxlovid’ inhibits 3CL protease, which plays an essential role in viral replication, to inhibit the multiplication of the coronavirus. The MFDS plans to carefully review the non-clinical and quality data submitted by the company, and promptly conduct required processes if the KDCA requests an emergency use authorization for Paxlovid as well.
- Policy
- Major bills have been piled up
- by Lee, Jeong-Hwan Nov 18, 2021 05:54am
- Review site of the first bill of the Welfare Committee The National Assembly's Health and Welfare Committee held the first subcommittee on bills on the 23rd and 24th and agreed between the ruling and opposition parties to review the medical law and the Pharmaceutical Affairs Act. The second subcommittee on the bill will be held for two days on the 24th and 25th, and both subcommittees are still before the agreement. The problem is that there are many major bills to be reviewed in preparation for the two-day schedule. The bill, which was not reviewed by the subcommittee, is likely to not be reviewed until the presidential election in March next year. On the 16th, Kim Min-seok, chairman of the Welfare Committee, and the secretaries between the ruling and opposition parties confirmed the schedule of the subcommittee on the bill. The secretariat will go through a consultation process on the 17th to finalize the list of bills to be reviewed by the subcommittee. The Welfare Committee completed next year's budget review by the relevant government department by the 12th. There are 272 new bills and bills that have not been reviewed earlier. As the government has decided to implement with COVID-19, restrictive telemedicine allowances are pending in the National Assembly. In addition, eradication of illegal hospital support, CSO government reporting system, regulation of health functional food note prescription, regulation of suspension of drug price reduction avoidance, and bill to revitalize Generic Substitution are waiting for review. The bill, which will not be reviewed this time, is likely to not be resolved until the 20th presidential election scheduled for March 9 next year. For this reason, the ruling and opposition parties have scheduled consultations on the direction of handling or discussing bills that are highly urgent or highly controversial during the With COVID-19 outbreak. This is because the National Assembly must set the direction of the bill review to some extent so that discussions and consultations on related matters can be carried out. Even so, the schedule of the bill subcommittee, which has been confirmed immediately, is too short, so there is no time for hundreds of bills to be reviewed enough or it is difficult to even present them at all. This means that many of the bills waiting for review will soon be in a situation that will not proceed until the end of next year's presidential election without obtaining a chance to review at the subcommittee on bills. An official from the ruling party's secretariat, Kim Sung-joo, said, "The schedule of the subcommittee on the bill has been agreed, but the agenda has yet to go through an agreement process between the ruling and opposition parties." He explained, "We believe that controversial bills will be introduced due to consultations scheduled on the 17th, but the screening schedule is tight." The official said, "Important bills that will affect the health's weaknesses are waiting," adding, "The problem is that if they are not reviewed by the subcommittee this month, it will be difficult to get a chance to review them until next year's presidential election. This month's subcommittee on legislation is the last of this year, he added.
- Policy
- Will impurities again in losartan trigger full recalls?
- by Lee, Tak-Sun Nov 17, 2021 05:45am
- Once again, impurity was detected in ‘losartan,’ an ingredient used in hypertension treatments. The impurity in issue was detected during self-inspections conducted by the individual pharmaceutical companies under the direction of the Ministry of Food and Drug Safety, upon which some companies have been discontinuing the lot release of their products. In particular, the companies are concerned that a large number of the drugs will be subject to recall, as they believe the raw materials imported from India and China that are used by most generic companies may be the cause of the problem. The MFDS plans to take additional measures after receiving the companys’ test results by the end of this month. According to the industry on the 16th, azido impurities were detected in their hypertension drugs containing losartan. The azido impurity detected this time is known to be a different substance from the AZBT(5-(4'-(azidomethyl)-[1,1'-biphenyl]-2yl)-1H-tetrazole) that was detected in losartan last September. At the time, excessive amounts of AZBT were found, and 22 lot numbers of 12 products in 11 companies were recalled. The ministry's measures then were applied not only to losartan but also to other sartan drugs such as valsartan and irbesartan that were used to treat hypertension. However, the impurity detected this time was only found in losartan. Based on information overseas in late September, the MFDS ordered companies producing ingredients and finished products containing losartan to conduct individual tests for azido impurities, and submit their inspection results by the 30th of this month. Pharmaceutical companies that detected excess impurities before submitting the results to the Ministry of Food and Drug Safety had stopped lot releases of their products as a precautionary measure. A pharmaceutical company official said, “We have CMO agreements with 3 places, and all 3 places have told us that they will stop supplying their products due to impurity detection. The word is that the ingredients from India and China that most generic companies use may be the cause of the problem.” Another company official said, “The impurity is presumed to be caused in the course of synthesizing raw materials. Pharmaceutical companies that finished inspections reported their results to the Ministry of Food and Drug Safety last week and are preparing voluntary recalls." However, the MFDS has not made any statements yet. The industry expects the ministry to make an official statement in early December after all the test results are submitted and the authorities prepare measures based on the results. The industry has also requested an extension of the deadline for data submission, claiming that there was not enough time to derive results. If the ministry accepts the deadline extension, the MFDS announcement is also expected to be delayed further. Upon news of the impurities, the pharmaceutical sales market has been intent on finding alternatives. The companies have been encouraging healthcare professionals to prescribe alternatives with a list of other sartan drugs that could replace losartan. Currently, 376 drugs containing losartan are approved by the MFDS. Depending on the magnitude of the recall, the impact on the pharmaceutical industry may also be significant. Depending on the situation, there is also the possibility that pharmacies will also suffer from conducting the recalls.
- Policy
- No companies have won suits on Gov's price cut dispositions
- by Lee, Hye-Kyung Nov 16, 2021 05:53am
- The National Health Insurance Service said it needs to be granted the authority to urge or dispose of arrears in order to efficiently collect the losses that were caused by the non-price cuts that occurred during the stay of execution when preparing a bill to recover and refund the drug price cut amount. The NHIS delivered its opinion on modifying and accepting the ‘Partial Amendment of the National Health Insurance Act (bill No.12727) that NA member Woni Kim presented as representative for the recovery and refund of drug price cuts after adding the request stated above. The bill allows the NHIS to collect the loss incurred due to the drug price not being discounted during the suspended period if the company loses the original case after the suspension of execution is applied in the administrative suit. On the other hand, if the pharmaceutical company wins the trial regarding the disposition of drug price reduction, the bill allows the pharmaceutical company to compensate for its loss. According to the analysis data disclosed by NHIS on the status of drug price cut lawsuits filed by pharmaceutical companies, 40 out of the total 58 cases have been ruled upon in the first or subsequent trials since 2011. Among these, pharmaceutical companies have partially won 17 cases (42.5%). The NHIS said, “One thing to note is that there had been no cases in which the pharmaceutical company won the suits regarding price cut dispositions of original drugs. The stay of execution has only become a means of delaying the price cuts by pharmaceutical companies.” Data on the suspension of execution of drug price cuts and the status its original lawsuits since 2018 showed that the court accepted the suspension of execution in 38 out of 39 administrative lawsuits. The court’s acceptance rate of the stay in execution is 100% as the pharmaceutical company did not apply for suspension of execution for the 1 remaining case. On the other hand, the government won 15 of the 20 cases (75%) that have been ruled upon in the first or subsequent trials after the suspension of execution was applied. The NHIS explained, “Pharmaceutical companies have only won 25% of the suits filed regarding the price cut dispositions. However, as the suspension of execution on the price cut dispositions is accepted 100%, this has been causing losses in NHI finances. In this context, we fully agree with the purpose of the proposed bill.” The reimbursement expense is the actual transaction price of a drug that does not exceed the price cap (as notified by the MOHW). However, in reality, drug transactions are being made at the set upper limit, so the decision to suspend execution of the disposition that lowers this upper limit allows the companies to maintain the previous drug price during the period set by the decision. The NHIS said, “ It may seem excessive that the company needs to bear the loss when the court decides on the stay of execution. However, on the other hand, the NHIS will also be allowing pharmaceutical companies to preserve their loss if the companies win. In this sense, the bill is not disadvantageous to any parties and can be implemented." However, the NHIS added that the scope of the legal provisions, the location of the provisions, and the accepted provisions need to be more specifically stipulated.
- Policy
- Chong Kun Dang is approved for its Jardiance Duo latecomer
- by Lee, Tak-Sun Nov 16, 2021 05:52am
- Chong Kun Dang became the first to receive approval for its latecomer of the SGLT-2 inhibitor combination drug for diabetes, ‘Jardiance Duo (empagliflozin-metformin hydrochloride). In addition, the company received the first generic exclusivity provided to companies that succeed challenging the original patent and be the first to apply for approval. On the 12th, the Ministry of Food and Drug Safety approved three doses of the ‘Chong Kun Dang Empagliflozin Metformin Tablet.’ The product is a combination of metformin hydrochloride and empagliflozin L-proline. Unlike the existing Jardiance Duo, Chong Kun Dang’s product has added an amino acid, L-proline to its Empagliflozin. Chong Kun Dang has also used empagliflozin L-proline in its single-agent Jardiance latecomer, ‘Chong Kun Dang Empagliflozin Tablet.’ The company received generic exclusivity for both its combination and single-agent drug. Chong Kun Dang succeeded in challenging the crystalline form patent of Jardiance and Jardiance Duo that is set to expire on December 14th, 2026. The company was the first to file a negative patent scope declaration trial in January 2018, and a partially valid decision in May, and the court confirmed the decision in June. Like for the single agent, the company was the first to apply for approval of the combination. However, the company’s acquisition of the first generic exclusivity does not mean that the company monopolized the market, as many domestic companies are seeking to enter the first latecomer market for Jardiance and Jardiance Duo. Jardiance DuoMany other companies have also succeeded in avoiding the original’s patent through salt modification. 94 products were approved for generic exclusivity with latecomers of the single-agent Jardiance. The generic exclusivity for Chong Kun Dang’s Empagliflozin Metformin Tablet applies only to products that use the same ingredient, empagliflozin L-proline, and therefore the drugs subject to sales prohibition are limited. However, the possibility that the company may enter the market before other companies through patent strategies remains. Jardiance and Jardiance Duo’s substance patient will expire on March 11th, 2025. Therefore, the companies may release their latecomers from March 12th, 2025 when the patent expires. Jardiance and Jardiance Duo sold 35.4 billion and 15.8 billion each in outpatient prescription sales last year (UBIST).
- Policy
- Rx drugs,allowed according to CTD starting from next year
- by Lee, Tak-Sun Nov 15, 2021 05:56am
- The MFDS announced on the 11th that it will partially revise the Regulation on Drug Product Authorization, Declaration, & Review to secure the quality reliability of generics in accordance with international standards. The revision includes improving the management of manufacturing methods such as Rx drugs manufacturing processes, deleting some submission data exemption regulations upon approval based on foreign drugs, process documents, and specifications, establishing standards for packaging disposable eye drops, and listing active ingredients in the product name. Accordingly, from November 12 next year, when licensing Rx drugs, it will be improved to describe in detail according to CTD when describing manufacturing methods such as manufacturing processes. Currently, it is summarized mainly in major manufacturing processes. In addition, the manufacturing method of the product submitted by CTD will be changed. Some submission data exemption regulations will be deleted upon permission based on the acceptance of foreign pharmacies, process documents, and specifications (Pharmacopoeia). Some data, such as toxic and pharmacological data, could have been exempted if they were listed in a foreign drugstore, but in the future, they will be required to submit data to examine safety and effectiveness based on scientific evidence. Along with this, a new standard for limiting the packaging unit of disposable eye drops will be established. In order to relieve public anxiety caused by the reuse of disposable eye drops and to provide a safe use environment for medicines, the packaging unit considering the amount of eye drops used once is defined as 0.5ml or less. Only single-component drugs are currently marked with active ingredients in the product name, but in the future, information provision will be expanded by marking active ingredients in the product name of combinations with three or less main ingredients. The revision to the drug equivalence test standards includes the preparation of biological equivalence test evaluation standards reflecting the formulation characteristics of enteric agents, and harmonization of international standards and regulations for biological equivalence test exemption standards according to the BCS. From November 12 next year, criteria for evaluating biological equivalence tests reflecting the characteristics of preparations of Enteric-coated preparations will be prepared. Starting today, the BCS exemption criteria for biological equivalence tests will be met with international standards. In accordance with the enactment of the ICHM9 guidelines, the standards for exemption from biological equivalence tests for drugs will be newly established to align international and domestic regulations equally. The MFDS said it expects the revision to raise the quality of medicines to the next level, and it will strengthen its drug licensing and management system based on Regulatory Science so that doctors, pharmacists, and patients can use quality drugs with confidence. Details can be found on the MFDS' website (mfds.go.kr > statutes/data > statute information > amendment notice, etc.).
- Policy
- More convenient new dementia treatments introduced to market
- by Lee, Tak-Sun Nov 12, 2021 05:54am
- Donepezil patch (Source : Icure PR material) With a series of new dementia treatments being approved in Korea, whether the market dominated by Aricept will falter is gaining attention. Aricept (donepezil hydrochloride, Eisai Korea) has been dominated the market with an 80% share in the Korean prescription market. The Ministry of Food and Safety approved Lundbeck Korea’s ‘Ebixa tablet 20mg’ on the 1st. Although Ebixa’s share in the market is much behind Aricept by performance, it is still the single Alzheimer’s treatment that ranks second after Aricept in the Korean market as a single product. The Ebixa tablet currently in the market is a 10mg formulation and is used to treat moderate-to-severe Alzheimer’s. The maximum daily dose of Ebixa is 20mg, and elderly patients over the age of 65 should take the 10mg dose twice a day. On the other hand, the recently-approved Ebixa 20mg can be taken once a day. This improved convenience in administration is expected to be received with a more positive response in the market. Previously on the 5th, the first donepezil patch was approved in Korea. The patch, which was co-developed by Icure and Celltrion, is expected to outperform oral treatments in terms of patient compliance. Icure’s Doneciv patch and Celltrion’s Donerion patch are used to treat dementia of the Alzheimer’s type and are alternately attached to the shoulder twice a week at 3-day and 4-day intervals. The patch only needs to be attached twice a week, therefore is more convenient than the existing oral formulations. With such products with improved convenience being introduced to the market, whether the products will be able to shake Aricept’s stronghold, which occupies 80% of the market, is also an area of interest. Based on UBIST, Aricept sold ₩83.9 billion in outpatient prescriptions and accounts for 80% of the original dementia treatment market. The runner-up is Ebixa, which recorded ₩13.7 billion. In particular, Ebixa’s sales have continued to increase after Daewoong Pharmaceuticals joined in co-promoting the products since July 2019. The industry expects Daewoong Pharmaceuticals to also conduct joint sales and marketing activities for Ebixa 20mg as well. Daewoong Pharmaceuticals had also pursued the development of a 20mg formulation of memantine, which is the same ingredient used in Ebixa, and received approval for its Phase I study, but did not initiate development. The analysis was that this may be due to the company’s plan to co-promote Ebixa 20mg with its original developer, Eisai. Also, the fact that Celltrion, which has a well-established domestic distribution network in biosimilars, has entered the dementia treatment market with the patch formulation may act as a variable in the market. Like all other drugs, the preference for originals is high for dementia treatments as well. However, as Celltrion has established as much trust as biosimilars in Korea for its biosimilars, this is expected to have a positive effect on its sales of the donepezil patch. The new products that were approved recently will be sole in earnest from next year after going through the reimbursement process. Therefore, the industry is paying keen attention to whether the introduction of these new drugs will shake Aricept’s sole lead in the dementia treatment market.
- Policy
- Controversy rise over standards used in pricing negotiations
- by Moon, sung-ho Nov 11, 2021 06:00am
- “It may seem cruel for the smaller pharmaceutical companies, but it is important.” The National Health Insurance Services is expected to consider the ‘marketing and sales’ ability of pharmaceutical companies as a major criterion in estimating the ‘expected claims amount’ of the companies, which is an essential part in drug pricing negotiations. In other words, such abilities will be a major consideration in judging the ‘market share rate’ of drugs subject to negotiations. As marketing and sales abilities inevitably correspond to the size of the companies, controversy over this criterion will be inevitable in the future. # The NHIS held an online briefing session on ‘Guidelines for setting the expected claims amount’ for front-line pharmaceutical companies and explained the specifics of its implementation. The NHIS guideline could be considered as the standard used by the NHIS in setting the expected claims amount of a drug during pricing negotiations, a process that is mostly conducted for new drugs. The guideline will serve as a guide that shows what data is used to calculate the expected market size, growth, and share of a drug, depending on whether the drug has an alternative available, and how the expected claims amount is set. In the drug negotiation process, the NHIS had been continuously criticized for conducting ‘negotiations in the dark.’ The guideline is interpreted as the authorities’ groundwork to dispel such concerns and conduct transparent negotiations. The key item of focus among pharmaceutical companies was the method NHIS used to estimate the ‘market share’ of the drug subject to negotiation. This is because the NHIS will be estimating the market size and growth rate with predictable data such as the NHI claims data, claims amount, and the number of patients, but will reflect the characteristics of pharmaceutical companies to estimate the market share of the drug subject to negotiations. The ‘characteristics’ part of the pharmaceutical companies was designed so that the marketing and sales power of the companies will affect the results. In other words, marketing for the subject drugs and the number of sales representatives will be used to judge the expected market share of the drug, and this number could influence the drug pricing negotiations. Therefore, the NHIS said that the pharmaceutical companies will have to submit data on doctor surveys, hospital drug committee (DC) approval status, number of client clinics and hospitals, major pipeline, number of sales representatives, number of marketing PMs, and whether a domestic trial was conducted in the process of drug pricing negotiations. Se Rim Oh, Head of Team in the NHIS’s New Drug Management Division, said, “It may seem brutal for the smaller pharmaceutical companies, but new drug development requires more than just will. We need to be level in this aspect. Developing a new drug and future occupation of the market both require money.” Oh said, “Submitting a survey on doctors or data on the number of PMs or sales representatives at your company will help estimate the claims amount during the negotiation process. Even a small pharmaceutical company that has an excellent pipeline in its field and has enough clients, the aspects will be fully considered in our estimates.” In addition, the NHIS said that data from domestic claims companies may be used as a reference when the authorities estimate the total market size of the drug subject to pricing negotiations. However, this only applies when domestic or foreign data on the drug is virtually nonexistent. Some pharmaceutical companies have been submitting claims data from domestic pharmaceutical research institutions for support during the negotiation process, however, such data is not expected to be much help. Oh said, “NHIS’s claims data is more accurate than UBIST and IQVIA combined. However, we will consider using such data when identifying the market size. We may consider using the data if the domestic data or the NHIS claims data we have is limited.”
