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- 2025-12-21 03:31:50
- Policy
- Reassessing the comparison of foreign drug pricing is 'idle'
- by Lee, Tak-Sun Jul 08, 2024 05:46am
- The 10th public-private meeting has been held to reassess the comparative methods of foreign drug pricing. However, they exchanged different opinions without reaching a concrete decision. Pharmaceutical industry has particularly opposed to the use of drug pricing references from Germany and Canada. It remains to be seen how the two parties will continue the discussion regarding this matter. According to industry sources, the 10th meeting to reassess the comparative methods of referencing foreign drug pricing was held on the morning of July 5th. The government initially planned to convene the meeting in June, planning to complete gathering opinions, but due to schedule delays, the meeting took place in July. This indicates that the government has considered the current meeting as the final round of gathering opinions. However, the pharmaceutical industry, the attendee of the meeting, argues that further discussion is needed. The differences in opinions are in the reference drug pricing in Germany and Canada, which the government compares drug prices to. The Korean government advocates public reimbursement prices as the reference, while the pharmaceutical industry argues for sales prices. They argued strongly about this matter during the current meeting. The industry argues that comparing Korean drug prices by referencing the public reimbursement price in Germany and Canada, which are also implementing reference-pricing systems, will distort the differences in drug pricing. Under those countries’ reference-pricing systems, China and India’s low-priced generics are frequently reimbursed. The industry argues that the government’s current comparison method works against its aim to set a reasonable drug price by making comparisons to advanced countries (A8). The meeting confirmed the differences in opinions of the government and the industry. Therefore, it remains to be seen whether there will be a next meeting. Since the government claims to have gathered enough feedback, it will likely maintain its current position. Drug pricing is anticipated to be set this year by implementing a weighted mean price comparison method, excluding the highest and lowest drug prices of A8 countries, every three years. It will be applied to pharmaceuticals for chronic diseases that expect patent expirations. The government is likely to pursue the current drug pricing reference sources. However, the two parties are likely to communicate privately until the government makes an official announcement. As a result, the final proposal may change.
- Policy
- 10th external reference pricing reeval meeting is held
- by Lee, Tak-Sun Jul 05, 2024 05:48am
- The 10th meeting for the external reference pricing reevaluations is scheduled to be held this Friday (July 5). The meeting, which was scheduled to be held on June 27th, has been postponed to this week. The meeting between the government and the pharmaceutical industry, which has been held since November last year, is being held for the 10th time this time. It will be interesting to see if the two sides will be able to conclude their talks through this 10th meeting. According to industry sources on the 3rd, the 10th meeting on the reevaluation of foreign drug prices is scheduled for the 5th. The government and the pharmaceutical industry will be meeting after a month since the 9th round of talks that was held on the 10th of last month. At the 9th meeting, the government reportedly expressed its intention to end the discussions. It said that it had gathered enough opinions over the 8 months of talks. However, the pharmaceutical industry believes that the matter requires further discussion, as well as the postponement of the external reference pricing reevaluations. On how to compare the price, which was the most controversial issue, the plan to compare the weighted average of the A8 (Japan, France, Germany, Italy, Switzerland, the United Kingdom, Canada, and the United States) countries’ insurance ceiling price after excluding the highest and lowest price with Korea’s insurance ceiling price, is likely to become the set option. The government notified the industry of this approach at the 8th meeting, and a similar approach was used in the recently concluded research service as well. The industry is concerned that the domestic price ceiling will be higher than that of the external reference price if the formula excludes the U.S., where generic prices are high, resulting in a large price cut. They are opposing the government's proposal due to this, but since it is unlikely that the plan will be withdrawn, they are focusing on revising the remaining details. In particular, the government and the industry have different opinions on the sources of referencing the drug price. The government is using publicly available drug prices in Germany and Canada, but the industry is arguing to base the pharmaceutical manufacturer’s selling price. Also, the industry requested the sum price of the single drugs be ensured for combination drugs. However, the government holds all the cards in the discussion. The industry believes that the government is likely to hasten the external reference pricing reevaluations as a way to save money, as it has recently invested additional health insurance finances to expand medical school admissions. A pharmaceutical industry official said, “I don't understand the government's logic for reducing domestic generic drug prices through the external reference pricing system when even Switzerland, a pharmaceutical powerhouse, has recently raised generic drug prices due to supply instability.”
- Policy
- Daewoong·Ildong late entries to the dapagliflozin market
- by Lee, Tak-Sun Jul 04, 2024 05:52am
- Daewoong Pharmaceutical and Ildong Pharmaceutical have made late entries in the market for diabetes treatment containing 'dapagliflozin.' Although the door to the biosimilar market for dapagliflozin opened in April last year, these two companies did not join the market immediately. It was presumed because of the contract binding with AstraZeneca, which owns the original product. After resolving the binding contract and with Forxiga’s imminent withdrawal from the Korean market, two companies have likely entered the competition for the market. According to industry sources on July 3rd, Daewoong Pharmaceutical’s 'Forxilo Tab 10 mg (dapagliflozin propanediol hydrate)' and Ildong Pharmaceutical’s two products of 'Daformet SR Tab (dapagliflozin bis L-proline/metformin hydrochloride)' became listed for reimbursement as of July 1st. Forxilo Tab is a generic version of Forxiga (AstraZeneca), the original monotherapy, and Daformet SR Tab is a biosimilar referencing Xigduo XR tab (AstraZeneca) with a change to the salt form. As the substance patent for dapagliflozin expired on April 7th, most pharmaceutical companies in South Korea have released either generics or biosimilars, such as salt-form-changed products. However, Daewoong and Ildong were the exceptions. At the time, Daewoong was in a joint agreement with AstraZeneca to sell Forxiga and Xigduo. Ildong was preparing to launch reimbursed 'Qtern,' a combination therapy containing dapagliflozin plus saxagliptin. Because of the joint-sales agreement with AstraZeneca for Qtern, Ildong could not release biosimilar referencing Forxiga and Xigduo. Two companies entered the market for biosimilars as Forxiga was set to withdraw from South Korea after the canceling approval in April, and Xigduo’s joint-sales agreement was transferred to HK inno.N instead of Daewoong Pharmaceutical from January. Daewoong Pharmaceutical listed 'Forxilo Tab 5 mg,' acquired through a transfer and acquisition deal, for reimbursement in April. This month, Daewoong Pharmaceutical joined the competition in the market with reimbursed Forxilo Tab 10 mg, acquired through a transfer and acquisition deal. Daewoong Pharmaceutical and Ildong Pharmaceutical join the market for biosimilars referencing Forxiga or Xigduo. Daewoong Pharmaceutical has six years of experience selling the original Forxiga, from 2018 until last year. Its generic drug is expected to settle in the market quickly. Furthermore, Daewoong Pharmaceutical is also preparing to obtain reimbursement for its biosimilar, “Forxilomat SR tab (dapagliflozin·metformin hydrochloride).” The company is expected to launch biosimilars soon. Ildong Pharmaceutical launched the reimbursable 'Dafor Tab 10 mg (dapagliflozin bis L-proline),' a biosimilar containing a salt form change, and secured reimbursement for its combination therapy. The company is expected to pursue sales and marketing of its products. As major pharmaceutical companies, Daewoong Pharmaceutical and Ildong Pharmaceutical, enter the market despite their one-year delay, the competition among biosimilars is expected to intensify.
- Policy
- GSK will discontinue supply of Infanrix IPV
- by Lee, Tak-Sun Jul 02, 2024 05:48am
- GlaxoSmithKline has decided to discontinue supply of its ‘Infanrix IPV’ vaccine, which protects against diphtheria, tetanus, pertussis, and polio in children, in South Korea. Infanrix IPV and Sanofi Pasteur's ‘Tetraxim’ are the only DTaP-IPV vaccines used in the National Immunization Program (NIP), raising concerns about the shortage of vaccines and the shortage of vaccinations that will follow. GSK reported to the MFDS that it will discontinue the supply of Infanrix IPV Prefilled Syringe as of July 1. The reason for the suspension is low domestic demand. The company said, "It is difficult to import additional supply, and it will not be possible for the company to participate in future NIPs after the stock is exhausted. The remaining stock is expected to run out in January next year. In fact, sales of Infanrix IPV on IQVIA last year were not captured. Tetraxim, on the other hand, generated sales of $3.1 billion. The vaccine is used to prevent diphtheria, tetanus, pertussis (whooping cough), and polio in infants and children from 2 months of age. It is administered as 3 intramuscular injections of 0.5 mL at 2, 4, and 6 months of age, followed by a booster dose of 0.5 mL at 4 to 6 years of age. Infanrix IPV has experienced pediatric immunization shortages in the past. In 2016, the global DTaP vaccine shortage disrupted pediatric immunizations due to domestic supply disruptions. In 2016, a global shortage of the DTaP vaccine disrupted pediatric immunization schedules, and when the domestic supply of Infanrix IPV was temporarily suspended, Tetraxim’s stock also ran out due to high demand. In 2021, GSK’s vaccine was also suspended due to a paperwork error, and the MFDS allowed cross-immunization with an alternative vaccine. Such history suggests that the discontinuation of Infanrix IPV in the Korean market will inevitably cause disruptions on-site. A fundamental solution for this is localizing pediatric vaccines. Recently, LG Chem has begun localizing a hexavalent combination vaccine for infants and young children, but it will take time for the product to be commercialized in Korea. An industry official said, “Vaccines for nationally mandated vaccinations such as DTaP are entirely imported from foreign countries. Localization of vaccines required for nationally mandated vaccinations is urgently needed to protect people's health and improve national competitivity as seen during the COVID-19 crisis." .
- Policy
- Expenses for the major four severe diseases tops KRW 7T
- by Lee, Tak-Sun Jul 01, 2024 05:47am
- Pharmaceutical expenses for the four major severe diseases exceeded KRW 7 trillion last year. The four major severe diseases refer to cancer diseases, cerebrovascular disease, and rare·severe incurable diseases. Pharmaceutical expenses for this category have risen due to high-cost pharamceuticals. Consequently, an analysis suggests that managing pharmaceuticals in this category is crucial for continuing the National Health Insurance. The Health Insurance Review and Assessment Service (HIRA) published the '2023 Report on Reimbursement Claims for Pharmaceuticals Expenses' on June 27th. It indicates that the claim amount for the four major severe diseases last year was KRW 7.348 trillion, a 20% increase from KRW 5.8495 trillion in 2022. Pharmaceutical expenses for the four major severe diseases (unit: 1,000 cases, KRW 1 million). Notably, pharmaceutical expenses for cancer disease and rare·severe incurable diseases are increasing rapidly. Anticancer drug expenses have reached KRW 4 trillion. Last year’s expense was KRW 3.8506 trillion, up 23.5% Year-over-Year (YOY). Pharmaceutical expenses for rare·severe incurable diseases topped KRW 3 trillion. It was KRW 3.337 trillion for 2023, up 16.2% YoY. Pharmaceutical expenses for cerebrovascular and cardiac diseases were KRW 803.5 billion and KRW 700.5 billion, respectively, and they have maintained an increasing trend. In contrast, the percentage of pharmaceutical expenses out of the total medical fees for the National Health Insurance has remained at 23% for the past two years. Last year’s figure was 23.86%, an increase from 23.34% in 2022 but still at around 23%. From 2019 to 2021, pharmaceutical expense was at around 24%. However, last year’s rate of increase in pharmaceutical expenses showed the highest figure in the past five years. The rate of increase for pharmaceutical expenses was 12%, recording a double-digit figure. This seems to be relevant to the rapid increase in pharmaceutical expenses for the four major severe diseases. Last year’s total pharmaceutical expense was KRW 25.6446 trillion. The percentage of pharmaceutical expense for the major four severe diseases out of the total expense amounted to 27.4%. The government is in the process of improving the post-management system and re-assessment for pharmaceutical expense management. Specifically, it plans to establish a system to post-manage high-cost pharmaceuticals after reimbursement and re-assess the pricing, such as lowering the pricing after comparing to foreign drugs or patent-expired drug costs.
- Policy
- Gov't releases generic drug price comparison study results
- by Lee, Tak-Sun Jun 27, 2024 05:47am
- The government's decision to fully disclose the 'Study on Measures to Improve the Generic Drug Pricing System,' which ended in April, ahead of the final meeting for the external reference pricing reevaluations, is being analyzed as a sign that the authorities intend to push ahead its plan to cut generic drug price through reevaluations. In particular, the industry believes the government is using media to publicize the study findings that the generic drug price is up to 10 times more expensive in Korea than in other countries, excluding the U.S., as a means to justify the reevaluation. According to industry sources on the 25th, the 10th meeting on the external reference pricing reevaluations is scheduled for the 27th. The government is reportedly planning to finalize the process of collecting opinions from the pharmaceutical industry within this month. Therefore, the 10th meeting is expected to be the final meeting between the government and the industry. In this situation, there are voices that the recently released study on how to improve the generic drug pricing system is just the government’s means to justify its plan for external reference pricing reevaluations. The study compared drug prices with the A7 countries (Canada, France, Germany, Italy, Japan, Switzerland, and the United Kingdom), excluding the United States, where generic prices are relatively high. As a result, as of 2022, the price of hyperlipidemia generics in most countries was 0.09 to 0.41 times cheaper than those in Korea. However, the study concluded that the comparison of Korean generic drug prices with those of A8 countries showed differences by efficacy group and API and that there is a limit to unilaterally applying price cuts to generic drugs. The pharmaceutical industry analyzes that the comparison of drug prices excluding the U.S. used in the study is similar to the recent government's proposed external reference pricing reevaluation, which suggested using an adjusted average price that excludes the highest and lowest prices among the A8 countries. This is because excluding the highest price removes the U.S. price, which has the highest generic drug prices, from the comparison. As shown in the study, excluding the U.S. price will lead to Korea having relatively high prices for hyperlipidemia drugs, and domestic pharmaceutical companies are concerned that the performance of related generic drugs will suffer from the price cuts that may follow. An industry official said, "Off-patent drugs can become cheaper abroad than in Korea over time. In foreign countries, generics occupy a higher market share than the original over time, so they can maintain sales even at the lowered price." On the other hand, the industry official explained that there is no difference between Korea and the A8 countries when comparing generics that newly entered the market upon patent expiry. "It is problematic to compare overall prices based on only one aspect when generic prices vary depending on the time of launch or disease. We should be giving incentives to increase the generic drugs’ market share and grow the market pie like foreign countries." The study also proposed the creation of a market structure that allows generic drugs to gain competitiveness. For example, in order to create a drug pricing structure where drug prices can be reduced over time after generics enter the market, it is necessary to strengthen not only the pricing policies used at the time of drug listing but also policies to encourage the use of low-priced products in the field. However, the government will likely first focus on lowering domestic generic prices through external reference pricing system.
- Policy
- Some Akynzeo products recalled due to insufficient API
- by Lee, Hye-Kyung Jun 27, 2024 05:47am
- The Ministry of Food and Drug Safety (MFDS) recalled some lot numbers of HK Inno.N's antiemetic ‘Akynzeo Cap’ after confirming the possibility that the drug may not contain enough active pharmaceutical ingredient (API). On the 21st, the MFDS issued a recall order for Akynzeo batch number '43000563 [2026-11-30].’ The reason for the recall was the possibility of the drug lacking some of its API (palonosetron hydrochloride). HK Inno.N also informed wholesalers of the voluntary recall of Akynzeo and asked them to send the drug back to the warehouses of companies that have the affected product. HK Inno.N imported Akynzeo from the Swiss pharmaceutical company Helsinn. It is indicated for the prevention of initial nausea and vomiting or the prevention of acute and delayed nausea and vomiting induced by repeated treatment in adults receiving moderate emetogenic cancer chemotherapy. It contains fosnetupitant (as chloride hydrochloride) and palonosetron hydrochloride, which work by inhibiting neural pathways involved in nausea and vomiting. Both ingredients have a long plasma half-life, making them effective antiemetic agents.
- Policy
- ‘Hypertension·hyperlipidemia generics are pricier in KOR'
- by Lee, Jeong-Hwan Jun 26, 2024 05:46am
- According to a government study, generic drugs for some indications, such as those for the gastrointestinal system, hypertension, and hyperlipidemia, are more expensive in Korea than in major overseas countries other than the United States, such as the United Kingdom, Switzerland, and Japan. As of 2022, Korean generic hyperlipidemia drugs were more than 10 times more expensive than those in the UK and 3 times more expensive than those in Japan, while those for hypertension were 2 times more expensive than those in the UK and 3 times more expensive than those in Japan. Based on such findings, the study concluded that the government may directly reduce the price of hypertension and hyperlipidemia drugs with more than 20 generic listings. The researchers proposed the government consider a policy that collectively reduces the price of hypertension and hyperlipidemia drugs to 85% of the lowest price when 20 or more items are listed at the same time. In addition, it was suggested that the domestic generic drug price system should be converted to an indirect price reduction structure, in which the drug price is reduced when the number of listed items increases above a certain level. "Domestic generic drugs for gastrointestinal system-hypertension-hyperlipidemia are more expensive than in overseas" The Ministry of Health and Welfare compared the generic drug prices in South Korea with the "A8" countries (the United States, the United Kingdom, Germany, France, Japan, Italy, Canada, and Switzerland) for 323 ingredient-dose drugs that contain 160 ingredients in 5 efficacy groups Specifically, the study compared the Price-to-Consumer (PTC) price rather than the Price-to-Pharmacists (PTP) price as PTPs in countries abroad include pharmacy dispensing fees and are not comparable to domestic prices. When comparing the PTC price based on the buying power index, the A8 countries' drug price index in 2022 ranged between 0.52 to 0.86 and was lower than Korea's index except for diabetes drugs and antibiotics which were 1.66 times and 1.81 times higher, respectively. Excluding diabetes drugs and antibiotics, generics for gastrointestinal drugs, hypertension drugs, and hyperlipidemia drugs were about 14% to 48% more expensive in Korea than in the A8 countries. In particular, the study looked at the drug prices of the 7 individual countries other than the U.S., given that the U.S. has a relatively high drug price among the A8 countries. Results showed that generics in 3 out of 5 therapeutic classes in Canada were more expensive than in South Korea, while in Germany antibiotics, in Switzerland antibiotics, and UK gastrointestinal drugs and antibiotics were more expensive than in South Korea. Except for these, the price of hyperlipidemia drugs in most countries was 0.09 to 0.41 times less expensive than those in Korea. This means that hyperlipidemia drugs were priced at 9% to 41% of the price of the same in Korea. In addition, the ratio of original to generic drug prices was below 0.5 in most countries, whereas it was closer to 1 in Korea. "20 product criteria for differential pricing of generic drugs is adequate" The study analyzed the market share of the top products by drug market segment and found that the top 20 products accounted for more than 90% of the market in most cases, and 60% in the lowest cases, indicating that the top 20 products dominate the market. This means that the current threshold of 20 products set for differential pricing of generics is sufficient to motivate companies to enter the generic market and to maintain the generic market within an ingredient. In addition, the researchers added that the market share of the top 10 products ranges from 50% to 80%, which accounts for a significant portion of the market but is not considered sufficient to maintain the market. Therefore, according to market logic, the price of ingredients with multiple products should be allowed to be reduced, and policy mechanisms should be put in place to compensate for the market failure of ingredients that no longer enter the market. "For drugs that have 20 or more generics listed simultaneously, setting its price at 85% of the lowest drug price should be reviewed" The study concluded that the comparison of domestic generic prices with those of A8 countries showed price differences by drug class and ingredient and that there are limitations to applying a one-size-fits-all approach. Since the domestic generic drug price level is not unilaterally higher or lower than foreign countries across all efficacy groups and varies by efficacy group, the research diagnosed that the generic policy currently in place should be observed so it could show effect, then be reviewed again and modified. Nevertheless, in terms of maintaining the appropriateness of the generic drugs’ price level, the study suggested the government introduce price-reducing measures for multiple listed ingredients. In particular, the study pointed out that hypertension and hyperlipidemia drugs have many products listed and are expensive compared to foreign countries, so the price of items with more than 20 listed products can be directly reduced. The study suggested the government consider a policy that unilaterally reduces the price of hypertension and hyperlipidemia drugs to 85% of the lowest price when “20 or more products are listed at the same time.”
- Policy
- Fasenra·Idelvion, Ajovy·Emgality receive reimb in KOR
- by Lee, Jeong-Hwan Jun 25, 2024 05:47am
- AstraZeneca's severe eosinophilic asthma treatment Fasenra (benralizumab) and CSL Behring's hemophilia B drug Idelvion (albutrepenonacog alfa) will be reimbursed by the national health insurance starting on the 1st of next month. Also, the anti-malignant tumor agent rituximab (original brand name: MabThera) and the migraine drug Ajovy (fremanezumab) and Emgality(galcanezumab) will receive expanded reimbursement coverage. In addition, the reimbursement standards for psoriasis and macular degeneration treatments will be improved. The Ministry of Health and Welfare recently issued a pre-announcement of an administrative notice on the ’Partial Amendment of Details Regarding the Standards and Methods for Applying Medical Care Benefits (drugs)’ that contained the details stated above. The MOHW plans to collect opinions until the 25th and implement the amended standards from the 1st of next month. New reimbursement standards set for Fasenra·Idelvion Fasenra, a severe eosinophilic asthma drug that contains benralizumab, and Idelvion, a hemophilia B treatment that contains albutrepenonacog alfa, will be newly granted reimbursement in July. Fasenra will be granted reimbursement for use in adult patients with severe eosinophilic asthma who are not adequately controlled despite the use of high-dose inhaled corticosteroids-long-acting inhaled beta2-agonists (ICS-LABAs) and long-acting muscarinic antagonists (LAMA). More specifically, ▲ patients with a baseline blood eosinophil count of 300 cells/μL or greater and have experienced four or more acute asthma exacerbations requiring systemic corticosteroids within 12 months prior to treatment initiation, or received continuous use of oral corticosteroids at a dose equivalent to prednisolone 5 mg/day or greater for 6 months prior to starting treatment; or ▲patients with a blood eosinophil counts of 400 cells/㎕ or greater who have experienced 3 or more acute asthma exacerbations requiring systemic corticosteroids within 12 months prior to starting treatment, will be eligible for reimbursement. Patients will be evaluated every year before and after Fasenra’s use, and those who showed overall asthma control, such as ▲ those who showed a 50% or greater reduction in the frequency of acute asthma exacerbations from baseline, and ▲those requiring ongoing oral corticosteroid therapy who showed a 50% or greater reduction in the oral corticosteroid dose from baseline while improving or maintaining asthma symptom control, that submit a doctor’s note will be eligible for continued use of Fasenra with reimbursement. However, in patients for whom the drug’s effect is deemed insufficient based on clinical symptoms, the effectiveness of the treatment can be evaluated before one year. Patients who co-administer biological agents for severe asthma will not be granted reimbursement. Also, reimbursement will not be granted for patients switching between Nucala, Fasenra, and Cinqair, or switching from Fasenra to Xolair. However, patients switching to Fasenra after Xolair may be reimbursed on a case-by-case basis if the patient has been on Xolair for at least 3-6 months and is unable to continue taking Xolair due to inadequate efficacy, side effects, or the need to improve adherence. Such patients would need to submit a doctor’s note and satisfy the Fasenra reimbursement eligibility standards to receive reimbursement. Idelvion will be granted reimbursement as a routine prophylactic therapy for the control and prevention of bleeding, pre-and post-operative management, and reduction in the frequency of bleeding episodes in patients with hemophilia B, at 23 IU/kg (30 IU/kg in children) per dose. However, for patients with moderate or severe bleeding, up to 39 IU/kg (up to 50 IU/kg for children) may be reimbursable, based on the physician's medical judgment. For patients who need to be hospitalized but receive outpatient treatment and require dose escalation, their use of the increased dose can be reimbursed with the submission of a doctor’s note. In terms of dosing interval, up to 2 doses at the first visit and 1 dose (2 doses for severe patients) at the second visit every 4 weeks will be granted reimbursement, which totals to 3 doses every 4 weeks (up to 4 doses for severe patients with a coagulation factor activity of less than 1%). If the patient's condition is stable, up to a total of 3 doses per visit every 4 weeks (4 doses for severe patients) may be reimbursed at the doctor’s discretion, and if bleeding occurs after being administered 3 doses every 4 weeks (4 doses for severe patients), up to 1 dose per visit is granted reimbursement, and a doctor's note must be attached. If the dose is administered in the hospital, the administered dose is included in the calculation of the allowable number of reimbursed doses. Reimbursement expanded for Ajovy-Emgality Reimbursement for the migraine drugs Ajovy and Emgality had been previously limited to patients who had failed treatment with three or more migraine prevention drugs within one year, but the period limit has been lifted, expanding coverage. The anti-malignant tumor agent rituximab will additionally be reimbursable as maintenance therapy for patients with severe refractory pemphigus vulgaris and pemphigus foliaceus. Two doses of 500 mg/day every 6 months, 12 months after initiation will be granted reimbursement. In addition, the reimbursement exclusion phrase for macular degeneration treatments such as abatacept (original brand name: Eylea), brolucizumab (original brand name: Beovu), faricimab (original brand name: Vabysmo), and ranibizumab (original brand name: Lucentis) has been clarified. Also, the expected adverse events in the psoriasis-specific reimbursement standards for dimethyl fumarate (original brand name: Skilarence), guselkumab (original brand name: Tremfya), ixekizumab (original brand name: Taltz), Risankizumab (original brand name: Skyrizi), secukinumab (original brand name: Cosentyx), ustekinumab (original brand name: Stelara), adalimumab(original brand name: Humira), etanercept (original brand name: Enbrel), Infliximab (original brand name: Remicade) have been further specified.
- Policy
- LG Chem and Samsung Bioepis's biosimilars are reimbursed
- by Lee, Tak-Sun Jun 25, 2024 05:46am
- LG Chem and Samsung Bioepis’ biosimilar products will be listed for reimbursement in July. LG Chem is launching a biosimilar of the autoimmune disease treatment Humira, and Samsung Bioepis is launching a biosimilar of Stelara. Both are aiming to list at the lowest price to compete with their respective original products. According to industry sources on the 23rd, LG Chem's Humira biosimilar Xelenka Autoinjector Inj 40mg/0.4L and Xelenka Prefilled Syringe Inj 40mg/0.4mL will be listed at KRW 220,390 from month. Samsung Bioepis' Stelara biosimilars Epyztek Prefilled Inj and Epyztek Intravenous Inj will also be listed the same month at KRW 1,292,890 and KRW 1,355,393, respectively. These are the first Stelara biosimilars to be reimbursed in Korea. Humira is a TNF-a inhibitor used for 13 autoimmune diseases, including rheumatoid arthritis, ankylosing spondylitis, psoriasis, psoriatic arthritis, ulcerative colitis, and adult Crohn's disease. The drug confirmed an effect in various diseases through its mechanism of action that inhibits TNF-α (tumor necrosis factor-alpha), which affects immune diseases. As of last year, its sales amounted to KRW 86.6 billion based on IQVIA. The domestic market for Humira biosimilars opened in earnest with Samsung Bioepis launching Adaloce with reimbursement in May 2021 and Celltrion launching Yuflyma in March 2022. According to IQVIA sales, Adaloce sold KRW 13.1 billion and Yuflyma sold KRW 1.8 billion last year. Sales of the biosimilars are fiercely chasing the original. LG Chem’s Xelenka was approved in December last year. It took 7 months for the drug to be listed for reimbursement after approval. Like other biosimilars, it is a high-concentration formulation that offers improved patient convenience. As a latecomer to the market, the company also paid attention to the price of Xelenka. Currently, for the 40mg/0.4mL dose, the original Humira is priced at KRW 280,891, and the biosimilars Adaloce and Yuflyma at KRW 248,877. LG Chem’s Xelenka is priced lower than these and will be listed at KRW 223,900. It is about KRW 20,000 cheaper than other biosimilars and KRW 60,000 cheaper than the original. Samsung Bioepis, the first company to introduce a Stelara biosimilar, also significantly reduced its product’s price from the estimated price. While biosimilars are usually priced at 80 percent of the original, Samsung Bioepis’s product will be listed at 50 to 60% of the original price. Stelara Prefilled Syringe Inj is priced at KRW 2,182,000, while Epyztek Prefilled Inj is priced at about KRW 900,000 cheaper at KRW 1,298,290. Also, when comparing the IV injection versions, Stelara IV Inj is priced at KRW 2,261,500, compared with EpyztekIV, which is priced at KRW 1,345,593. Stelara generated sales of KRW 47.4 billion last year based on IQVIA. Stelara is indicated and reimbursed for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years and older, active psoriatic arthritis in adults, active Crohn's disease in adults, and moderate-to-severe ulcerative colitis in adults. Following Samsung Bioepis’s footsteps, Celltrion received approval for Steqeyma PFS on March 12. Samsung Bioepis is believed to have adopted a lowest-price strategy to occupy the market before Celltrion's product is listed. Biosimilars are products approved after demonstrating equivalence and effectiveness to the original product. As biosimilar companies sell their products at a significantly reduced price compared with the original product, the financial burden borne by patients is greatly reduced upon the introduction of biosimilars.
