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- 2026-05-06 15:22:55
- Policy
- AstraZeneca Xigduo’s latecomers consecutively approved
- by Lee, Tak-Sun Dec 27, 2021 05:57am
- AstraZeneca’s SGLT-2 inhibitor diabetes combination, Latecomers of AstraZeneca’s SGLR-2 antidiabetic combination therapy ‘Xigduo XR (dapagliflozin propanediol/metformin) are receiving approval. Due to the patent period set for the original’s substance patent, the latecomers will only be available for sale from April 2023, however, due to its commerciality and patent issues, companies are racing to commercialize their latecomers. According to the industry on the 24th, four companies including KyungDong Pharm have recently received approval for their Xigduo latecomers. The approved drugs are fixed combinations of dapagliflozin L-proline and metformin hydrochloride. The latecomers contain a different active ingredient solvate from the original Xigduo XR tab. With the addition of the 4 companies, a total of 24 companies have now received approval for Xigduo XR latecomers. However, only three companies will be manufacturing the drugs. Richwood Pharmaceutical, the first company to receive approval in October, Chong Kun Dang that completed independent development in November, and KyungDong Pharm will be manufacturing the latecomers. Richwood Pharmaceutical’s latecomer is a combination of dapagliflozin citric acid and metformin hydrochloride and Chong Kun Dang’s is a combination of dapagliflozin and metformin hydrochloride, all of which use a different solvate from the original drug. The drugs decided to use a different solvate to evade the solvate patent. The patent was set to expire on June 21st, 2027, but the invalidation claims filed by latecomers in Korea have been accepted and therefore invalidated. Latecomer companies have also filed and won the first and second trials to invalidate Xigduo’s second substance patent that is to expire on January 8th, 2024. Therefore, the possibility of invalidating the patent is rising, raising the probability of latecomers being sold from April 7th, 2023 after the expiry of the first substance patent. Even if this becomes a reality, around 2 years are still left until the companies may release the latecomers. However, the companies have initiated their development early as Xigduo’s outpatient prescription last year amounted to 28.6 billion won (UBIST), and the PMS expiry date for latecomers was due November 26th, 2019. If some companies obtain generic exclusivity, the release date of the other companies' products could be further delayed. At the time of development, there were no restrictions regarding consigned bioequivalence studies, therefore many companies have made CMO agreements to outsource their products. Richwood Pharmaceutical has orders from18 companies and KyungDong Pharm from 3 companies to produce Xigduo latecomers.
- Policy
- Roche applies for approval of its new drug faricimab
- by Lee, Tak-Sun Dec 27, 2021 05:56am
- The global pharmaceutical company Roche has applied for the approval of its newly developed treatment for macular degeneration, ‘faricimab.’ The company had submitted an application for faricimab in the US, Europe, and Japan. If approved, the drug will be competing with Bayer’s ‘Eylea (aflibercept)’ and Novartis’ ‘Beovu (brolucizumab-dbl)’ in the next-generation treatment market for macular degeneration. According to the industry on the 24th, Roche applied for the marketing authorization of ‘faricimab’ to the Ministry of Food and Drug Safety. Faricimab was registered under the brand name ‘Bavismo inj.’ in Korea. Faricimab is the first bispecific antibody treatment developed for ophthalmologic diseases. It simultaneously blocks both pathways involving the Ang-2 that causes various retina conditions and VEGF-A and promotes vascular stability and improves the vision outcome of patients in the long term. A Phase III study that was disclosed earlier this year showed that faricimab was well tolerated with a consistent safety profile in four studies that assessed faricimab on age-related macular degeneration (nAMD) and diabetic macular edema (DME) under a dosing schedule that administers the drug at a maximum of 48 weeks apart. Macular degeneration is a major cause of vision loss in adults over the age of 60. With the aging society, the size of the treatment market has also been growing exponentially. Last year, the market size recorded 37 billion won, with the global market recording 13 trillion won. According to global data announced by a market research institution, the market size of the macular degeneration market is expected to spike to record 21 trillion won by 2028. The market is currently led by ‘Eylea (aflibercept)’ and ‘Lucentis (ranibizumab ).’ Also, the development of biosimilars for the two drugs is speeding up upon the imminent expiry of Eylea and Lucentis’s patents. Novartis has released Beovu in preparation for the Lucentis biosimilars. The prefilled syringe formulation of Beovu was approved in Korea last year, and reimbursed and sold since April this year. Beovu’s strengths lay in the improved patient convenience and compliance provided with its 12-weekly dosing schedule. On the other hand, Lucentis is administered every 4 weeks. Faricimab is administered every 16 weeks at most and therefore is expected to further improve patients’ convenience in administration. Roche had completed applying for the marketing euroization of farcical in Japan in June, and in Europe and the US in July, and is awaiting authorization from the respective authorities.
- Policy
- The suspension of execution for Legalon has been extended
- by Kim, Jung-Ju Dec 27, 2021 05:56am
- It is an extension of the grace period for deleting insurance drug benefits due to prolonged lawsuits. Abbott's Cholib, which item license has been revoked by the licensing authority, is automatically removed from the list according to the company's decision to withdraw from the market. The MOHW announced the court's decision to extend the suspension of execution of the drugs currently being sued and follow-up measures on insurance drugs following the cancellation of the MFDS' item license.12th division of the Seoul Administrative Court decided to extend the deadline for suspension of the execution of Bukwang Pharmaceutical, which was scheduled for the 17th, as the lawsuit was prolonged. The government previously conducted a re-evaluation of this year's benefit for a total of five ingredients, Vitis Vinifera, Avocado-Soya, Ginko X, Bilberry Gunjo X, and Silymarin. Milk-thistle Fruit Dry Extract, to which Bukwang Pharmaceutical products belong, was confirmed to be withdrawn, and the government deleted the list after three months of action (deferred). Accordingly, the company decided to file a lawsuit and applied for a suspension of execution to the court at the same time, and the suspension was extended this time. The period of suspension of execution is 30 days from the date of the sentence of the judgment, and during this period, the deletion of benefits is suspended. However, since the government suspended it for three months at the time of the announcement, medical institutions are not expected to undergo significant changes in prices for the time being. The insurance price of Legalon cap 70 is 137 won per capsule and 242 won per capsule for Legalon cap 140. Abbott's Cholib 145/20 mg and 145/40 mg products are removed from thel list according to the withdrawal of the company's market. Earlier on June 10, the MFDS suspended sales for six months (June 24th to December 23rd) due to a lack of the number of survey subjects required for the reexamination PMS. The disposition period has been extended due to the second violation, and if the reexamination data is not submitted again, the item permission will be automatically revoked. As a result, the insurance drug benefit list will also be deleted. The deletion period is on the 24th.
- Policy
- What are the variables for the release of Forxiga+ Januvia?
- by Lee, Tak-Sun Dec 24, 2021 05:49am
- MSD Januvia and AZ Forxiga Daewon Pharmaceutical and Dongkoo Bio's combination of Dapagliflozin (Forxiga) and Sitaglipin (Januvia) is approved. Since both ingredients are widely used in the diabetes treatment market, attention is being paid to whether there will be a change in the market due to the emergence of complex drugs. However, there are still steps to overcome, such as patents and benefits. On the 21st, Daewon Pharmaceutical was approved for "Dapacombi 10/100mg," a combination that combines Dapagliplozin and Sitaglipin. On the 23rd, Dongkoo was then approved for Sitagliptin 10/100mg, which combines Papaglipozin and Sitagliptin. The salt and solubilizing materials are slightly different, but the active ingredients are the same. Both drugs are administered as supplements to diet and exercise therapy to improve blood sugar control in patients with type 2 diabetes whose combined administration of Sitagliptin and Dapagliplozin is suitable. The original brands of Sitagliptin and Dabagliplozin are leading the domestic diabetes treatment market. According to UBIST's outpatient prescriptions, MSD's Januvia recorded 21.2 billion won in the first half of this year and AZ Forxiga recorded 18.3 billion won. It was also known that the proportion of combined prescriptions for the two drugs was also high. Therefore, it is analyzed that the emergence of a Forxiga+Januvia complex with convenience of use will have significant market value. However, the Forxiga+Januvia complex developed by a domestic pharmaceutical company has to wait until next year to be released in Korea. This is because Januvia's material patent will not end until September 1, 2023. Forxiga's material patent expires on April 7, 2023, ahead of that. Along with this, it is a variable for applying benefits. This is because the SGLT-2+DPP-4 complex, which was approved in Korea before the Forxiga+Januvia complex, has not yet obtained insurance benefits. Domestic approved SGLT-2+DPP-4 complexes are AZ "Qtern" (Dapagliflozin+Saxagliptin), Beringer Ingelheim Esglito (Empagliflozin+Linaglipin), and MSD "Stegluzan(Ertugliflozin L-pyroglutamic acid). Qtern was first released in November as a non-reimbursment. Recently, insurance authorities are discussing the improvement of benefit standards for the combined prescription of SGLT-2 and DPP-4 drugs. A growing number of domestic pharmaceutical companies are also developing SGLT-2+DPP-4 combination due to the possibility of entering the reimbursed market. Recently, SK Chemicas, Donghwa, and GL Pharm Tech have begun clinical trials for Dapagliflozin+Sitaglipin combinations.
- Policy
- Govn’t to prepurchase 10 mil of SK Bio’s COVID-19 vaccine
- by Kim, Jung-Ju Dec 24, 2021 05:49am
- The government plans to purchase 10 million courses of domestic COVID-19 vaccine in advance this year. Also, the government will support a total of ₩545.7 billion on overcoming COVID-19 next year - ₩321 billion in the development of vaccines and treatments, ₩119.3 billion in the establishment of research and manufacturing infrastructure, ₩36.4 billion in the advancement of disease control and prevention material and devices, ₩69 billion in the advancement of basic research. On the 23rd, the government held the 12th meeting of the Pan-Government Committee for COVID-19 Treatment and Vaccine Development to review the progress and discuss ▲COVID-19 treatment and vaccine development status and support, ▲reinforcing R&D support for the development of COVID-19 treatment and vaccine, ▲budget allocation for COVID-19 treatment and vaccine development support. At the meeting, Minister of Science and ICT (co-chair) Hyesook Lim, Second Vice Minister of Health and Welfare Ryu Geun-hyuk, and other relevant ministries and domestic experts in the field of treatments and vaccines participated in the meeting. ◆ COVID-19 treatment and vaccine development status and support = Other than the COVID-19 antiviral treatment that was officially approved on September 17th, 16 companies are currently conducting clinical trials on 17 local COVID-19 treatment candidates. The government has been increasing the number of residential treatment centers, short-term·outpatient treatment centers, and long-term care facilities while conducting efficacy assessments of the antivirals developed on COVID-19 variants. The government has also prepared measures to improve clinical trials on COVID-19 treatments so that latecomer COVID-19 treatments can continue to be developed. Also, with the increased at-home COVID-19 treatment cases for trials, the government prepared measures to more easily accommodate these patients into clinical trials. Eligible patients who are treated from home may participate in clinical trials through outpatient care or researcher visits from research nurses or other researchers. The government will also pursue the advance purchase of 10 million courses of the local COVID-19 vaccine developed by SK Bioscience to support local COVID-19 vaccine development. SK Bioscience’s vaccine has met the pre-purchase requirements set by the government at the 10th Pan-Government Support Committee (announcement of Phase II trial at interim results and approval of Phase III trial protocol). After a comprehensive review of the safety, immunogenicity, and utilization of the vaccine based on the interim results of the Phase II clinical trial, the government decided to purchase the vaccine in advance. The advance purchase agreement will be made as soon as possible after the details on the practical terms of the agreement are discussed. ◆ Reinforcing R&D support for the development of COVID-19 treatment and vaccine = To government also plans to support clinical trials of COVID-19 treatments and vaccines to the end and reinforce R&D support of clinical trials to accelerate development and improve the probability of success. Also, in consideration of the public interest and potential of succeeding in the R&D of COVID-19 treatment/vaccine, the government also plans to strategically review measures to reduce corporate out-of-pocket expenses for clinical trial R&D projects. Companies that participate in the COVID-19 treatment·vaccine clinical trial support project need to cover a fixed proportion of the R&D expense (50-25% of the total R&D expense) themselves. The government plans to review measures to reduce the clinical expenses borne by small-and-mid sized companies by easing regulations made to support the rate borne by private companies in cash, but only for ▲(vaccine) Phase I-III trials and ▲(treatment) Phase II-III trial and new drugs (excluding repurposed drugs) ◆ budget allocation for COVID-19 treatment and vaccine development support= The government will be supporting a total of ₩545.7 billion for the development of COVId-19 treatments and vaccines. This is a 107.7% (₩283 billion) increase from the main budget that was set for COVID-19 in 2021. The government plans to reinforce research support at clinical and non-clinical stages and seek advance purchase of locally developed COVId-19 vaccines by investing ₩321 billion in the development of COVID-19 treatment and vaccines and the success of their clinical trials. More specifically, the Ministry of Health and Welfare is investing ₩89.3 billion in the clinical support of COVID-19 treatments and vaccines and ₩10.5 billion in the clinical support of mRNA vaccines; the Ministry of Science and ICT investing ₩10 billion in bio and medical technology development; and the Korea Disease Control and Prevention Agency investing ₩192 billion on the advance purchase of local vaccines. Also, the authorities plan to support ₩119.3 billion on the development of test methods for COVID-19 treatments and vaccines while establishing testing facilities and devices to lay the foundation for manufacturing. Specifically, the MOHW will invest ₩4.8 billion to establish a system for clinical trial support, KDCA ₩8.2 billion to establish a national healthcare research infrastructure, the MFDS ₩22.7 billion to strengthen the international competitiveness of biopharmaceuticals, the MSTI ₩12.2 billion to the Center for National Preclinical Trial Support, and the MOTIE ₩16.7 billion to support companies that promote the industrialization of vaccines using the vaccine demonstration support center. Ryu Geun-hyuk, Second Vice Minister of Health and Welfare, said, “We will reinforce support on clinical trials to provide support for vaccine and treatments to the end. Through this, we will establish a development system for biopharmaceuticals that can rapidly respond not only to COVID-19 but also to other infectious diseases that may arise in the future.”
- Policy
- Domestic approval of EU-approved Novavax is imminent
- by Lee, Tak-Sun Dec 24, 2021 05:48am
- As the European Union (EU) approved the conditional sale of the NovaVax COVID-19 vaccine, attention is being paid to when it will be approved in Korea. As the MFDS is known to be preparing for Novavax's approval for national lot release, analysts say that approval is imminent in Korea. On the 20th, the European Commission (EMA) approved the conditional sale of the COVID-19 vaccine developed by Novavax. A few hours ago, the European Medicines Agency (EMA) recommended conditional sales approval. The EMA recommended approval for the use of the vaccine to prevent COVID-19 over the age of 18. Novavax was found to have a preventive effect of 90% in clinical trials of about 45,000 people in the United States, Mexico, and the United Kingdom. Side effects are also mostly mild symptoms such as pain in the inoculation site, muscle pain, and fatigue.On the 17th, Novavax, which is produced in India, was approved for emergency use by the WHO. Approval screening is currently underway in Korea. On the 15th of last month, SK Bioscience, a consignment producer in Korea, applied for permission to manufacture and sell items to the MFDS. However, while EU-approved products are multi-use vials, domestic products have different methods which is PFS type. As it has been approved by the WHO and the EMA, the MFDS is also expected to speed up approval. The MFDS has established a policy to process the COVID-19 vaccine as soon as possible. Existing licensed AstraZeneca and Pfizer vaccines were approved within 40 days of application. Therefore, it is predicted that permission can be obtained at the end of this month, around 40 days after application. Some analysts say that the MFDS has recently set up a major test item for Nuvaxovid PFS, and that approval may be imminent. This is because the national lot release is the last quality inspection for the market after approval of biological products such as vaccines. The MFDS is planning to proceed with the national lot release of the COVID-19 vaccine within 20 days of approval as soon as possible. Even if it is approved at the end of the year, it will be difficult to use it immediately in Korea. It is interpreted that it will only be available at the end of the third inoculation because the third vaccination is being conducted with Pfizer or Moderna. Hong Jung-ik, head of the COVID-19 vaccination response vaccination management team, also said in a media briefing on the 21st, "The entire amount of Novavax vaccines signed this year will be carried over," adding, "If approved by the MFDS, we will apply for supply next year."
- Policy
- The PV guideline amendments may not be applied on Jan. 1st
- by Lee, Hye-Kyung Dec 23, 2021 05:42am
- It is believed that the improvement of the detailed guidelines for the Price-Volume agreement negotiations (PV) prepared by the National Health Insurance Service may not be implemented on January 1st of next year. This is in part due to the authorities’ internal affairs including its reorganization schedules, but also due to the strong opposition shown by the industry regarding the amendment. However, the NHIS plans to finish the guideline amendments through discussion with the Ministry of Health and Welfare by February next year when the selection of pharmaceuticals subject to monitoring for PV negotiations begins. The NHIS had presented a plan on improving the PV negotiation reservation (exclusion) system at the 10th public-private consultative meeting that was held on the 2nd. The improvements proposed included the revision of Article 6.1.1 of the guideline that calls for expanding the "same product group with an annual claims amount of less than ₩1.5 billion" to "less than ₩2 billion" and Article 6.1.2 that reduces "items with an upper limit of less than the arithmetic average of the main component code” to “less than 90% of the arithmetic average”. The increase of the claims amount from ₩1.5 billion to ₩2 billion was made based on the reference standards used when legislating the guidelines in 2014. At the time, the average claims amount in 2012 was ₩1.52 billion. Products that are less than 90% of the arithmetic average follow the negotiation conditions set for new drug negotiations Among new drugs, drugs that are listed without pricing negotiations usually accept a price at 90% of the weighted average of alternative drugs, therefore, the standards for PV negotiations were also set in line with this standard to less than 90% of the arithmetic average to be exempt from negotiations when the company voluntarily cuts its drug price by 10%. Upon the announcement, the pharmaceutical industry submitted a statement opposing the PV guideline improvements. The industry conveyed its position that the amount subject to exclusion from PVA that is set for the same product group with an annual claims amount of less than ₩1.5 billion should be set to ₩10 billion or less, and items whose price is less than the arithmetic average should be maintained at the present state. The Korea Pharmaceutical and Bio-Pharma Manufacturers Association said, “In line with the purpose of implementing the price-volume linkage system, the negotiation endeavors need to focused on mid-to-large sized items whose use increased to exceed ₩10 billion and the amount subject to exclusion from PVA be set to all drugs below ₩10 billion. The arithmetic average is a social convention and an absolute standard for judging whether the insurance finances can be saved, and therefore, it is in line with the system to exclude drugs that cost under the arithmetic average from negotiations.” Meanwhile, the NHIS plans to first review the opinion statement submitted by the pharmaceutical industry, then discuss it with the MOHW to prepare a plan for the final PV guidelines. However, it seems that it will take some time for the PV guideline improvements to be prepared and announced as personnel transfers of Deputy Ministers and Director-Generals in HIRA's Drug Price Management Office may occur this week or early next week at the latest.
- Policy
- Kyprolis succeeded in renewing the RSA contract
- by Kim, Jung-Ju Dec 22, 2021 05:56am
- LG Chem's Eutropin Plus 24mg (Human Growth Hormone, Somatropin) and Eutropin Pen are included in the PVA, falling from as little as 1% to as much as 4%. In addition, Amgen Korea's Kyprolis 60mg (Carfilzomib) and Kyprolis 30mg will be adjusted to 4-5% lower prices, respectively, after successfully renewing their RSA contracts. According to the industry, until recently, these companies agreed to cut insurance prices through negotiations with the NHIS and the PVA to renew their contracts with RSA. Based on this, the MOHW is pushing for a revision of the "drug benefit list and upper limit table." If the revision is finalized soon, it will be applied as of January 1. First, the price of Eutropin Plus 24mg and Eutropin Pen falls to PVA type Na. In PVA, type "Na" is used as a mechanism to reduce up to 10% through negotiations if the upper limit has been adjusted by type "Ka," the claim of the same product group, which has been increased by more than 60% or more than 10% from the previous year's claim, or more than 5 billion won. Eutropin Plus 24mg will be reduced by 3.9% to 148,861 won and Eutropin Pen will be reduced by 1.1% to 182,787 won. Two drugs were adjusted to the reduced price after negotiating again with the NHIS after the RSA contract was terminated. Kyprolis 60mg will be reduced by 5.6% to 975,950 won and Kyprolis 30mg to 488,443 won, respectively, by 4.5%.
- Policy
- The MFDS approved Spikevax on the 13th
- by Lee, Tak-Sun Dec 22, 2021 05:56am
- The MFDS announced on the 13th that Moderna Korea has decided to allow manufacturing and sales items for Spikevax, which was applied on November 8. Spikevax' is a COVID-19 vaccine produced by Samsung Biologics in Korea with vaccines such as Moderna Spikevax developed in Moderna, USA, which was approved for import on May 21. Samsung Biologics receives raw material drugs and produces finished drugs through processes such as filling and marking. Spikevax is the first domestic consignment production vaccine in the mRNA method among COVID-19 vaccines licensed in Korea. The MFDS said it expects the permit to contribute to the stable supply of COVID-19 vaccines in Korea as well as to leap into a global vaccine hub. The MFDS added that it will continue to work with related ministries to strengthen the monitoring system for abnormal cases after inoculation and to provide an environment in which people can be vaccinated with confidence thorough monitoring and prompt response.
- Policy
- MFDS is speeding up the COVID-19 vaccine screening
- by Lee, Tak-Sun Dec 21, 2021 06:06am
- In 2021, the MFDS focused on speeding up the screening of COVID-19 vaccines aimed at 70% of the nation's vaccinations. As a result, the screening period for COVID-19 vaccines and treatments has been significantly advanced, contributing to the achievement of the goal. Unexpected inspections have begun on manufacturers to cope with illegal manufacturing incidents triggered by media reports. In addition, as impurity issues from overseas erupted one after another this year, drugs such as Sartan and Varenicline were recovered by inducing corporate self-inspection. Choline alfoscerate formulations, which have controversy over efficacy, were prepared in June with a clinical re-evaluation plan. ◆COVID-19 vaccine and treatment screening=As the government formalized the vaccination of the COVID-19 vaccine from the first quarter, the MFDS focused on advancing the approval period by mobilizing all personnel for product screening. As a result, vaccines were approved 40 days after receipt, and the National lot release was also completed 20 days after approval. Starting with AstraZeneca in February, Pfizer in March, Janssen in April, and Moderna vaccines in May were approved one after another. Most of them were achieved 40 days after the start of the permit review, and the National Lot Release was immediately carried out, and the vaccination began quickly. The EUA system has been enacted as a law to provide an institutional environment so that it can be urgently introduced even before formal approval. As a result, in October, Moderna vaccines commissioned by Samsung Biologics were able to receive EUA and supply them to the market. ◆Illegal manufacturing= Overseas COVID-19 vaccine confirmed the capabilities of the domestic pharmaceutical industry by selecting a domestic manufacturer as a production source, but it was also revealed that it was manufactured arbitrarily unlike permission. The MFDS, which immediately went into crackdown after hearing media reports, found that BINEX and Vivozon had illegally manufactured them in March. Additives were arbitrarily changed without permission, and some document manipulation appeared in the process. As a result, manufacturing and sales of related items were temporarily suspended and recovered. BINEX was found to have arbitrarily manufactured 32 items, including consignment and consignment manufacturing. Since then, the MFDS has set up a counter for internal complaints with the GMP special planning and inspection team and started unannounced inspections of all manufacturers. As a result, violations such as Hanall Biopharma, Chung Kun Dang, Dongin-dang, Hansol, Samsung, Jeil, and Medicakorea were found. As the MFDS proceeded with administrative measures against the caught companies, some pharmaceutical companies were treated as criminal charges. Illegal random manufacturing cases are currently under investigation by the prosecution, which is expected to have repercussions depending on the situation. ◆Choline alfoscerate, outline of clinical reevaluation= The clinical trial plan for this was finally approved in June when the MFDS issued a clinical re-evaluation order last year due to controversy over the effectiveness of the "Choline alfoscerate" drug raised by the National Assembly and civic groups. Each company decided to participate in consideration of cost and probability of success. As a result, a total of 57 companies expressed their intention to participate in the group led by Daewoong Bio and Chong Kun Dang, which have the highest sales in the market. Daewoong Bio and Chong Kun Dang conduct clinical re-evaluation of the efficacy of Choline alfoscerate's treatment of Alzheimer's dementia for 4 years and 6 months and mild cognitive impairment for 3 years and 9 months. All other indications were deleted as the revaluation effect was limited to Alzheimer's dementia and mild cognitive impairment. With the confirmation of the revaluation plan, each company has since started negotiations with the NHIS to recover benefits in the event of a clinical revaluation failure.
