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- 2025-12-26 12:27:06
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- Yuhan distributed gold rings to all employees
- by Kim, Jin-Gu Apr 12, 2021 05:55am
- A gold ring recently issued by Yuhan to all employees. LECLAZA is engraved on the outside of the ringYuhan recently handed out gold rings to former employees, showing Leclaza (Lazertinib)'s commitment to success. According to the industry on the 11th, Yuhan provided a gold ring with LECLAZA to all employees at the end of last February. It was only a month after receiving Conditional Marketing Authorization (CMA) as the 31st Korean drug on January 18th. Yuhan's officials congratulated Leclaza for permission and wished for success in the future. An official from Yuhan said, "A ring was distributed in commemoration of the achievement of the long-aspired work." He wished the success of Leclaza and gave the entire temple a gold ring. Immediately after CMA earlier this year, a gold ring engraved with LECLAZA was delivered. Formation of a marketing team of around 10 people, preparing for full-scale market entry in June Yuhan recently handed out gold rings to former employees, showing Leclaza (Lazertinib)'s commitment to success. According to the industry on the 11th, Yuhan provided a gold ring with LECLAZA in English to all employees at the end of last February. It was only a month after receiving Conditional Marketing Authorization (CMA) as the 31st Korean drug on January 18th. Yuhan officials congratulated Leclaza for permission and wished for success in the future. An official from Yuhan said, "A ring was distributed in commemoration of the achievement of the long-aspired work. I know that the rings have been distributed to all employees as a means of encouraging the R&D department that has struggled with Leclaza permits, and at the same time supporting other departments that will lead Leclaza to success in the future." Another Yuhan official said, "Even though employees who have worked for 10 years or 20 years have received gold as a concept of long-term service, this is first time that all employees have given gold rings." Immediately after CMA earlier this year, a gold ring engraved with LECLAZA was delivered. In addition to this, it is reported that the company is preparing for marketing in earnest by forming a dedicated Leclaza team. Yuhan has formed a marketing team of about 10 people before and after the Leclaza license. It is known that they are already conducting marketing to key doctors in general hospitals and hematologic oncology specialists. The procedure for listing benefits is also going smoothly. As soon as possible, it is expected to enter the market in earnest after being listed on the benefit list in June. Leclaza was evaluated as appropriate as a benefit by the HIRA's Cancer Drugs Benefit Appraisal Committee on February 24, more than a month after CMA. The committee is the first step to benefit. On the 8th, the Pharmaceutical Benefits Advisory Committee recognized the appropriateness of the benefit, and even passed the second step. The only remaining step is actually negotiating drug prices with the NHIS. Yuhan plans to negotiate drug prices with the NHIS within the next 60 days. After that, it is finally listed through the resolution of the Health Insurance Policy Committee of the MOHW. Assuming that the drug price negotiations were successful, Leclaza took only 5 months from application to registration for the MFDS. Other anticancer drugs took an average of 34 months from approval. Leclaza was first approved as a second-line therapy for lung cancer in patients with EGFR T790M mutation-positive locally advanced or metastatic non-small cell lung cancer who had previously been treated with EGFR-TKI. Based on the results of a phase 2 clinical trial (therapeutic exploratory clinical trial) conducted in Korea, it was approved under the condition that a phase 3 clinical trial should be conducted after marketing. Currently, in Korea, the first-generation drug AstraZeneca's Iressa (Gefitinib), Roche's Tarceva (Erlotinib), and the second-generation drug Giotrif (Afatinib )and Vizimpro (Dacomitinib), and EGFR TKI such asTagrisso (Osimertinib) of AstraZeneca, a third-generation drug such as Leclaza, are being prescribed.
- Company
- Price hike of ‘Rotarix’ after ‘RotaTeq’ adds burden
- by Apr 12, 2021 05:54am
- The price of rotavirus vaccines for newborns is expected to increase altogether, with GSK also deciding to increase its supply price of ‘Rotarix’ after MSD’s price hike on ‘RotaTeq.’ Kwang Dong Pharmaceutical, the company in charge of the domestic supply of GSK’s Rotarix, recently sent a notice to clinics and hospitals on the decision to increase Rotarix’s supply price. The price will increase approximately 12% from the current late-70,000 won range to reach the mid-80,000 won range per dose (VAT included). The change in Rotarix’s supply price will be applied from May 1st. Prior to GSK, MSD had also raised the price of its rotavirus vaccine RotaTeq by 17%. With the price hike, RotaTeq is being supplied at a 50,000 won range starting this month. With both rotavirus vaccines increasing their supply price simultaneously, the price paid by consumers for each vaccination is also expected to increase. The current vaccination price at first-line hospitals is around 70,000-100,000 won for RotaTeq and 100,000-130,000 won for Rotarix. As Rotateq is administered 3 times and Rotarix 2 times, the total cost of vaccination would range around 210,000-300,000 won for RotaTeq and 200,000-260,000 won for Rotarix. GSK had already increased the price of Rotarix by 20% in 2019. The company explained that the price increase was inevitable due to the increased production cost. MSD also cited the rising input cost as the reason for its price hike. However, such an increase in the price of non-reimbursed drugs is expected to increase the financial burden borne by parents, as the rotavirus vaccine is regarded as an essential vaccine for infants aged 2 months. Rotavirus, a major cause of acute gastroenteritis in infants and toddlers, is a common virus that 95% of children around the globe are infected with before the age of 5. Symptoms include vomiting, fever, diarrhea, stomachache, etc. It is very contagious, therefore the World Health Organization recommends rotavirus vaccines to be included in all national immunization programs (NIPs). However, as rotavirus vaccines are not included in Korea’s NIP, they are administered as non-reimbursement in Korea.
- Company
- Local companies in panic over ‘Eliquis’ patent suit result
- by Kim, Jin-Gu Apr 09, 2021 05:56am
- The winner and loser of the long patent suit were reversed in the end. After losing the first and second trial, BMS finally got the upper hand in the fight with the generic manufacturers with a favorable ruling by the supreme court. On the other side, the generic companies are in hot water due to the unexpected result. In addition to immediately discontinuing the sale of its generics, the companies are expecting a massive damages claim will be filed by the original drug’s company. The ruling will also affect the price cut that was previously ordered for Eliquis. If the ruling is finalized, the price cut disposition will be pushed back to the patent expiry date. ◆Case remanded to Patent Court… Attention on whether the final ruling sides with the Supreme Court's decision On the 8th, the Supreme Court’s Special 3rd Division reversed and remanded the original ruling of the patent invalidation suit in the appeal filed by BMS against Navipharm, Huons, Intron Biotechnology, and Alvogen Korea. The lawsuit is linked to multiple other suits filed by BMS including the patent infringement suit as well as the administrative suit filed in objection to the disposition to reduce the ceiling price of Eliquis. Considering the gravity of the issue, the Supreme Court rendered an en banc decision. The Supreme Court’s ruling is not final. As the Supreme Court reversed the original judgment, the case will once again be tried by the Patent Court. However, as most trials for remanded cases follow the higher court’s decision, which would be the Supreme Court’s decision in this case, expectations are leaning towards BMS’s victory. ◆Patent infringement suit to pace up… generic sales highly likely to be discontinued With the victory, BMS expects to be able to achieve three goals. First is the discontinued sale of generics. The prescription of Eliquis has been dwindling with the release of its generics. According to U-BIST, outpatient prescription sales of Eliquis had increased annually from 19.5 billion won in 2016 to 49 billion won in 2019. However, its sales dropped 3% to 47.7 billion won last year. On the other hand, prescription sales of generics of Eliquis have been rapidly increasing, from 1.2 billion won accrued from July to December in 2019 to the 8.3 billion won last year. The numbers suggest that the release of generics had some effect in reducing Eliquis prescriptions. BMS also plans to speed up the patent infringement suits filed against each generic company. Around 10 relevant suits are currently in progress. The cases were waiting for the Supreme Court's judgment on this case to determine whether the generic drugs infringed upon BMS Korea's patent right. If BMs wins the patent infringement suit, BMS will also be able to enjoy reflective benefits from the discontinuation of its generics. ◆ Full-fledged claim for damages deemed inevitable.…calculation of the compensation amount is key BMS's second purpose is to file claims for damages against the generic companies. The Supreme Court's ruling recognized the validity of the drug substance patent. If the court recognizes the patent infringement of the generic companies in subsequent infringement lawsuits, BMS will meet all the requirements to claim compensation for damages. Eliquis generics that were released since June 2019 include ▲Chong Kun Dang’s ‘Liquisia’ ▲Samjin Pharm’s ‘Elxaban’ ▲Yuhan Corp’s ‘Yuhan Apixaban’ ▲Hanmi Pharm’s ‘Apixban’ ▲Aju Pharm’s ‘Eliban’, and ▲Yooyoung Pharm’s ‘Yupix.’ Last year, prescription sales of Liquisia were 2.6 billion won, and 1.1 billion won for Yuhan Apixaban. The key lies in the reinforced standards used for the calculation of compensation for damages since last December. Last year, the National Assembly passed an amendment to the Patent Act that would strengthen the standards used to calculate damages caused by patent infringement. Previously, the compensation was calculated by multiplying the 'range of production capacity' by the 'profit per unit.' However, the newly amended act that took effect in December last year adds an amount calculated by multiplying the 'amount exceeding range of the production capacity' by the 'reasonable royalty.' For instance, under the previous law, if the patent holder's production capacity was 100 but the infringer sold 1000, the patent holder was unable to receive compensation for the 900 that exceeds the patent holder's production capacity. However, the amended act allows for the company to receive compensation for the exceeding 900 products as well. At first sight, the prescription amount of the original Eliquis overwhelms the amount of generics prescribed. However, experts believe the result may differ depending on how 'production capacity' is interpreted. Nevertheless, faced with potential claims for damages by BMS, generic companies are now moving to voluntarily discontinue sales of their generic products. An unnamed official of one company that sells a generic of Eliquis stated, "After the ruling, we are considering whether we should voluntarily stop selling our product." ◆Price cut disposition for Eliquis may be suspended until September 2024 The third is to nullify the drug price cut disposition. In July 2019, the government had notified BMS that it would lower the price ceiling of Eliquis by 30% with the reason being the release of its generics. However, BMS had filed a suit with the Administrative Court to suspend the price cut as the final ruling has not been made on its substance patent suit. BMS's request was to suspend the execution of the price cut disposition until the Supreme Court's ruling. The court accepted the company's request, therefore Eliquis is currently being sold at the same price, at 1,185 won per tablet. With the Supreme Court's ruling adding support, the government's justification to execute price cuts based on the introduction of generics will not be able to stand. The substance patent of Eliquis will expire on September 9th, 2024. If the Patent Court ruling is in line with the Supreme Court ruling, the launch of Elquis's generics will be postponed to September 2024. Also, in that case, it is highly likely that the price of Eliquis will be lowered in October 2024.
- Company
- Tagrisso’s 1st-line reimbursement rejected once again
- by Eo, Yun-Ho Apr 09, 2021 05:55am
- With ‘Tagrisso’ once again failing to expand its reimbursement, it seems that it may take a while for 3rd generation EGFR TKIs to be prescribed as 1st-line in Korea. According to industry sources, the Cancer Disease Review Committee of the Health Insurance Review and Assessment Service (HIRA) decided it was inappropriate to expand the reimbursement of Tagrisso to first-line in non-small cell lung cancer (NSCLC). After receiving approval to extend its indication to first-line treatment in December 2018, AstraZeneca first applied for the expanded reimbursement in 2019. However, the Cancer Disease Review Committee in October that year decided to defer the decision until full data from the Phase 3 FLAURA trial, which studied the overall survival (OS) of NSCLC patients treated first-line, is disclosed. AstraZeneca then submitted the full FLAURA data and expressed the will to accept most of the budget sharing plan proposed by the government. However, faced with strong opposition from committee members (specialists), the company failed to expand Tagrisso's reimbursement to first-line last May. AstraZeneca had attempted to reverse the decision once more by submitting OS data from FLAURA China that confirmed Tagrisso’s OS benefit in Asian patients, but the committee’s response was, once again, a ‘No.’ In the FLAURA China trial that studied a cohort of Chinese patients, 71 patients were randomly assigned to the Tagrisso-treated group, and 65 patients in the control group. Patients in the control group were allowed to cross over to 2nd-line Tagrisso when their disease progressed with T790M mutation. Among the 65 patients, 22 continued their treatment with Tagrisso. In the trial, the median OS of the Tagrisso-treated group was 33.1 months, which was 7.4 months longer than the 25.7 months of the control group. Also, Tagrisso reduced the risk of death by 15.2%.
- Company
- Qsimia's sales exceeded ₩200 billion
- by An, Kyung-Jin Apr 09, 2021 05:55am
- Alvogen Korea surpassed ₩200 billion in annual sales for the first time since its launch in Korea. Qsymia, an obesity treatment drug released at the beginning of last year, and the obesity treatment Qsymia, which was released earlier last year, produced the largest sales. According to the Financial Supervisory Service on the 7th, Alvogen Korea's sales last year reached ₩211.1 billion, up 11.3% from the previous year. For the first time since the establishment of the branch, annual sales exceeded the ₩200 billion. Operating profit was ₩17.3 billion, up 19.3% from the previous year. Sales and operating profit of Aalvogen Korea by year (Unit: ₩100 million, Source: the FSS) The predecessor of Alvogen Korea is KEUNWHA, founded in 1958. Alvogen Group, a foreign company, entered the domestic market with the acquisition of KEUNWHA in 2012. Alvogen acquired Dream Pharma, which was owned by Hanwha Group with funds raised through KEUNWHA in 2014, and changed its name to Alvogen Korea by merging the two companies the following year. The product with the highest performance ever is Qsymia. Alvogen Korea was launched from Vivus in the US in 2017. After securing the domestic copyright of Qsymia, a combination of Phentermine and Topiramate, it launched in partnership with Chong Kun Dang at the beginning of last year. After its release, Immediately after its release, Qsymia shook the domestic obesity treatment market with Saxenda by NovoNordisk. In the first quarter of last year, it ranked second in domestic obesity treatment sales with sales of ₩4.3 billion, and sales increased to ₩5.8 billion in the second quarter and ₩6.5 billion in the third quarter. Last year's cumulative sales of Qsymia reached ₩22.5 billion, and the market share reached 15.7%. Alvogen Korea’s sales declined slightly for the first time in 2019. However, both sales and operating profit have rebounded after a year due to the success of the new product. Alvogen Korea posted a net profit of ₩6.9 billion last year. This is a 49.3% increase from the previous year. The company is paying a cash dividend of ₩8.5 billion in 7 years since 2014. The largest shareholder of Alvogen Korea is Alvogen Korea Holdings Co., Ltd. (100% stake).
- Company
- Betadine, disposes of 3 months of advertising suspension
- by Nho, Byung Chul Apr 08, 2021 05:55am
- Mundipharma's Betadine Throat Spray (Povidone Iodine) was suspended from advertising by the MFDS. Mundipharma recently sent a notice regarding administrative disposition to pharmacies that handle the product, and requested cooperation in the removal of Betadine advertising installations in pharmacies. The advertisement business suspension period is from the 29th of this month to the 28th of June. Betadine's suspension of advertising business is a result of the recognition of inappropriate advertisements due to the lack of ad review in the press release posted on the Betadine Throat Spray product website in December of last year. Mundipharma's Betadine was controversial about false hype around October last year. Sales representatives of Kwang Dong, who are in charge of sales, provided small billboards (POPs) with contents such as 'Povidone = 99.9% death of COVID-19' to pharmacies at the end of 2019, and the MFDS launched an investigation of false hype. According to pharmaies, the POP at the time contained contents such that Povidone kills 99.9% of COVID-19, inactivating within 30 seconds, Povidone was recommended as an interim guideline for the World Health Organization, and the content that gargle solution mixed with Povidone is effective in suppressing COVID-19 was included. Povidone's recently announced anti-COVID-19 inhibitory effect is a cell experiment conducted in a laboratory. According to Article 68(5) of The Pharmaceutical Affairs Law, advertisements on the name, manufacturing method, efficacy or performance of pharmaceuticals, etc. are not allowed unless permission has been obtained or a report has been filed. Povidone Throat Spray obtained only indications for sore throat. However, no punitive administrative measures were taken by the health authorities, and it was replaced by retraining sales staff, collecting and disposing of POP promotional materials, promising to prevent recurrence, and posting an apology. Mundipharma said, "Sales of Betadine are the same as before. However, it is impossible to display advertisements and promotional materials in the pharmacy for the product for the next three months. We will sincerely answer inquiries through the sales representative in charge."
- Company
- Zytiga listed as a prostate cancer selective benefit
- by Apr 08, 2021 05:55am
- Janssen announced on the 7th that it will be applied as a first-line treatment for patients with high-risk metastatic prostate cancer with hormone-responsiveness from the 1st. Zytiga, as a CYP17 inhibitor, was approved by the MFDS in July 2012 as a treatment for metastatic castration-resistant prostate cancer, and added hormone-responsive high-risk metastatic prostate cancer treatment indications in June 2018. With this amendment, Zytiga can be used in patients newly diagnosed with hormone-responsive high-risk metastatic prostate cancer (mHSPC). If two or more of the three conditions are satisfied, such as visceral metastasis (excluding lymph node metastasis), which can be confirmed by imaging tests such as MRI, Prednisolone and Androgen blockade therapy (ADT) are applied in combination. Metastatic hormone-sensitive prostate cancer (mHSPC) is a stage that still shows a therapeutic response to hormone therapy or androgen blockade (ADT) among stage 4 prostate cancers that cannot be operated because metastases to other organs have already been confirmed. After this stage, if it progresses to the stage of metastatic castration-resistant prostate cancer that no longer responds to hormone therapy, it is difficult to cure it and the survival period is only 1-2 years. Zytiga significantly improved overall survival (OS) in a newly diagnosed hormone-responsive high-risk metastatic prostate cancer (mHSPC). Accordingly, the National Cancer Network (NCCN) recommended Zytiga as a treatment option first. Seong-il Seo, a professor of urology at Samsung Medical Center, said, "Through the application of Zytiga's insurance benefits, hormone-responsive high-risk metastatic prostate cancer (mHSPC) patients can receive treatment while reducing the economic burden. We look forward to improving our quality of life.”
- Company
- One-on-one briefing sessions with doctors are not allowed
- by Apr 08, 2021 05:55am
- It is expected that MSD Korea will in principle ban one-on-one product presentations for individual doctors from May. Business restrictions are much stronger than the industry's 'fair competition rules'. According to the pharmaceutical industry on the 7th, MSD Korea announced plans to improve CP to its employees on the 5th. From May, it will prohibit one-on-one product presentations between doctors and sales staff. This is a measure according to the global headquarters' criticism that the cost used for one-on-one product presentations is excessive and the cost-effectiveness is low. MSD Korea emphasized that one-on-one product presentations are not allowed in principle, but they gathered the opinions of each sales team, saying that special exceptions can be considered. The company will review the opinions gathered by mid-April and finalize the new regulations, and it is expected to take effect from May. However, employees point out that the company's claim that one-on-one product presentations are not allowed in principle does not comply with not only the Pharmaceutical Affairs Act but also the industry's voluntary fair competition regulations. Under the current the pharmaceutical affairs law, food and beverages can be provided within ₩100,000 at product presentations. In addition, in Article 10 of the 'Fair Competition Regulations and Detailed Operation Standards for Pharmaceutical Transactions' published by the KRPIA, which MSD Korea belongs to, in the case of a product briefing session that explains its own medicines by visiting individual nursing institutions, member companies provide food and beverage and A small amount of promotional materials can be provided with the company name or product name entered, and in this case, it must be ₩100,000 per day for food and beverages (limited to 4 times a month) and less than ₩10,000 for promotional materials.' The '2021 CP Guidebook' published by the KRPIA on the 1st also contained the same content. Multinational and domestic pharmaceutical companies are conducting one-on-one product presentations within the limit of ₩100,000 per person for food and beverage in accordance with these CP regulations. The CP regulation of MSD Korea follows Article 10 of the KRPIA regulation, and the explanation for one-to-one product-related explanation (PRE) is also clearly stated. 'One-on-one PRE is not included in small meetings (product presentations for 2 to 25 people), but must comply with the KRPIA rules.' Considering that the average cost per person for a one-on-one product presentation at MSD Korea is about ₩60,000, the evidence that the cost is excessive is insufficient. Some employees criticized the company's decision as a one-sided measure that did not take into account the business environment. The competition situation with other pharmaceutical companies and the sales target suggested by the company remain unchanged. However, it is argued that limiting meetings, which are allowed by other pharmaceutical companies, is overpressing the business environment. One MSD Korea employee said, "It is also said that the regulations will be strengthened in the so-called Simple PRE, in which an employee eats light meals of less than ₩10,000, such as coffee or sandwiches, with a doctor." He said, "There is a lot of anxiety that the company is in the process of changing its business to online rather than offline and further reducing the organization drastically." In response, MSD Korea said, "MSD always prioritizes transparent and legitimate business execution based on high ethical standards. Current issues are closely monitored internally and externally, this is a part of reflecting them in internal regulations, and there is no clear decision yet."
- Company
- Tumor-agnostic ‘Rozlytrek’ seeks PE exemption
- by Eo, Yun-Ho Apr 07, 2021 06:03am
- Discussions will begin for the listing of Roche's anticancer drug ‘Rozlytrek,’ which may be prescribed regardless of cancer type if specific conditions are met. According to industry sources, 2 types of anticancer drugs by Roche Korea – Rozlytrek (entrectinib) and Polivy (polatuzumba) – will be up for deliberation by the Review Committee for Cancer Disease of the Health Insurance Reimbursement and Assessment Service (HIRA) tomorrow on the 7th. Among the two drugs, Rozyltrek, which targets the neurotrophic tyrosine receptor kinase (NTRK), is expected to take the pharmacoeconomic evaluation (PE) exemption track. Rozlytrek’s approval was based on a single-arm study that did not involve a control group. As it already meets subparagraph 2 of the PE exemption criteria, it is likely that the drug will have not much difficulty in receiving the exemption once the committee deems the remaining conditions to be met. Rozlytrek, which was approved as an orphan drug in April last year, is currently indicated for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have an NTRK gene fusion without a known acquired resistance mutation, and for adult patients with locally advanced ROS1-positive or metastatic NSCLC. This means Rozlyterk may be used in virtually all cancer types confirmed with an NTRK gene. In addition, the listing of ‘Polivy,’ an antibody-drug conjugate(ADC) used in combination with the standard BR therapy (rituximab-cyclophosphamide) for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL), will also be first discussed by the committee on the same day. Considering the fact that Roche submitted the application for Polivy's reimbursement listing this year, the schedule for deliberation by the Review Committee for Cancer Disease has been set relatively quickly. Diffuse large B-cell lymphoma (DLBCL), the most common form of non-Hodgkin lymphoma (NHL), is an aggressive (fast-growing) type of lymphoma that requires immediate treatment. Although DLBCL is generally responsive to treatment and over half of the patients reach remission, 30% to 40% of the patients do not respond to the standard-of-care, R-CHOP, or experience relapse after first-line treatment. Polivy, the first ADC that targets CD79b, a protein expressed in B-cells, binds to the CD79b to induce apoptosis. This drug was also designated as an orphan drug last October. Meanwhile, Roche has been continuously expanding its rare disease pipeline. Last year, it had received approval for ‘Evrysdi (Risdiplam),’ for the treatment of spinal muscular atrophy (SMA). Also, the approval process for Roche’s ‘Enspryng (satralizumab),’ a competitor of ‘Soliris (eculizumab)’ is also currently underway.
- Company
- Beovu heats up the AMD treatment market with its ease of use
- by Apr 07, 2021 06:01am
- Novartis has jumped into the competition in the macular degeneration treatment market with ‘Beovu.’ Emphasizing its longer treatment interval, the new drug is fiercely chasing the market leader ‘Eylea.’ Beovu (brolucizumab) is a treatment for wet (neovascular) age-related macular degeneration (AMD) launched by Novartis as a successor to its ophthalmology drug ‘Lucentis.’ The prefilled syringe formulation of Beovu was approved in Korea last July and is being reimbursed from this month. The biggest benefit of Beovu is its longer treatment interval. Beovu is administered once every 4 weeks for the first three doses, followed by once every 12 weeks. Bayer’s Eylea is also administered monthly like Beovu for the first 3 doses, however, the following doses for Eylea are administered every 8 weeks. In other words, patients who had to visit the hospital every 2 months will be able to increase the interval to every 3 months with Beovu, which may improve convenience and the possibility of patient compliance. At the Beovu press conference held by Novartis Korea on the 5th, Sang-jin Kim, a professor of ophthalmology at Samsung Medical Center, said, “ In macular degeneration, the number of injections administered is highly correlated to vision maintenance. However, many AMD patients fail to continue treatment due to that burden of treatment, which results in reduced vision improvement effects. Therefore, the unmet need that existed for a treatment that can maintain its efficacy while reducing the number of injections and hospital visits may be satisfied with the introduction of Beovu." Beovu demonstrated its non-inferiority in head-to-head clinical trials with Eylea. In the Beovu HAWK and HARRIER clinical trials conducted by Novartis, the Beovu-treated group showed non-inferiority in the best-corrected visual activity (BCVA), the primary endpoint, compared to the Eylea-treated group at week 48. The therapeutic effect lasted until week 96. Also, the Beovu-treated group showed superior improvement in intra-retinal fluid and sub-retinal fluid compared to the Eylea-treated group. The reason Beovu produces a similar effect despite the longer dosing interval is due to its molecular characteristics. Beovu’s single-chain antibody fragment (ScFv) is engineered to deliver a higher concentration of molecules compared to other treatments with multiple chains. With the higher molar concentration, the agent potently inhibits vascular endothelial growth factor A (VEGF-A) isoforms, has better tissue penetration, and clears more rapidly from systemic circulation. However, why vision gains with Beovu at week 96 is similar to that of Eylea even with stronger effects may be yet questionable. “Opinions have been divided among doctors on the reason behind the matter. Personally, I would say that anatomical changes such as exudates often precede functional changes. However, it is true that in the long-term, the possibility of degeneration happening in photoreceptor cells, etc. is high as the period exudate remains is prolonged.” Kim added, “Although there was no difference in vision gains during the 96-week study period, I believe there will be a difference in the long-term.” Also, another hidden competitor to note is the anticancer drug ‘Avastin,.' Since Avastin has the same mechanism as Lucentis but is relatively cheaper than Lucentis or Eylea, off-label prescription of Avastin for the treatment of AMD is known to be quite active in the treatment of macular degeneration. The price of the newly reimbursed Beovu is similar to that of Eylea, and this higher price compared to Avastin is an obstacle. On this, the company stated that "Beovu was approved for the same indication as with other macular degeneration treatments, so we do not foresee big changes in the current market. We would have to wait and see in the long run as patients who have a lot of remaining exudate, or those who wish to reduce more exudate may choose Beovu over other competitors.” According to data from IQIVA, Eylea made 63.6 billion won, and Lucentis 36.9 billion won in sales last year.
