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- 2026-03-17 19:30:53
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- 'Vyndamax' fails reimbursement listing once again
- by Eo, Yun-Ho Oct 27, 2021 05:49am
- The new transthyretin amyloid cardiomyopathy (ATTR-CM) drug, 'Vyndamax,’ is suffering hardships in its process of being listed for insurance benefit. According to industry sources, the application Pfizer Korea submitted for the reimbursement of its new ATTR-CM drug, Vyndamax (tafamidis 61mg), was unable to pass the insurance benefit standard subcommittee. After the company failed to receive designation as an essential drug earlier this year, the company had applied for reimbursement once again through the Risk Sharing Agreement (RSA) scheme. Being deemed inappropriate after submitting data for PE evaluation, reimbursement of Vyndamax is facing difficulties. The problem is that this delay in reimbursement is affecting the patients. ATTR-CM is a fatal condition with a poor treatment outcome due to a lack of specific treatment and is often mistaken for simple heart failure. If not treated properly, patients with ATTR-CM have a survival period of only 2 to 3.5 years. Vyndamax is the only drug that demonstrated its survival benefit in ATTR-CM (ATTR amyloidosis with cardiomyopathy) and is virtually the only drug available as there are no alternatives. The subcommittee’s decision left much room for disappointment as experts have submitted a consistent opinion on the clinical benefit of Vyndamax at the government’s inquiry on the need to apply reimbursement to Vyndamax. Usually, another reason would have to exist for a drug that demonstrated clinical efficacy, has no alternative, and received a positive opinion from the academic society to not pass the insurance benefit standard subcommittee, and for Vyndamax, the reason is assumed to be its fiscal impact. However, separate subcommittees such as the economic evaluation subcommittee and the fiscal impact subcommittee do exist to assess the economic feasibility and fiscal impact of a drug. Therefore, the industry has been voicing complaints about the redundancy of the subcommittee reviews, by the insurance benefit standard subcommittee that is in charge of reviewing the insurance benefit standards conducting assessments on a drug’s fiscal impact. Jungwoo Son, Professor of Cardiology at Wonju Severance Christian Hospital said, “Early diagnosis and continued treatment is important for patients with the progressive ATTR-CM disease. Last year, the domestic ATTR-CM treatment environment has made rapid progress with the approval of Vyndamax, the only drug that provides practical survival benefit to ATTR-CM patients, however, the continued non-reimbursement of the drug has brought on the unfortunate situation where patients cannot start treatment even after being diagnosed.” Son stressed, “The insurance reimbursement system needs to be operated in a flexible manner for drugs like Vyndamax that has clear clinical benefit and no alternatives in consideration of the characteristics of rare diseases so that the patients’ right to treatment is not obscured by economic logic.”
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- The supply of 8 GSK vaccines will be suspended until Feb
- by Oct 27, 2021 05:49am
- The supply of eight GSK vaccines, including Rotarix, is temporarily suspended, which is expected to disrupt the inoculation schedule. According to the pharmaceutical industry on the 26th, GSK announced a temporary suspension of supply of its vaccines to clinics and hospitals. Discontinued vaccines are ▲Rotarix (Human Rotavirus Live Attenuated), ▲Synflorix (Pneumococcal Vaccine), ▲Menveo, ▲Havrix, ▲Priorix (MMR Vaccine), ▲Boostrix (Tdap Vaccine), and▲Infanrix-IPV, IPV/Hib(DTaP vaccine). GSK said, "Some errors were found in the process of checking the registration details of its vaccines supplied to Korea, so we stopped importing and shipping additional products altogether." And GSK added, "This is a documentary error that does not affect product safety, quality, characteristics, purity, and efficacy, but this measure is expected to disrupt supply." Vaccines suspended from shipment are expected to be released by February next year. All products except Rotarix are included in the NIP. Most alternative generics exist, but some are multiple doses vaccinations and cross-vaccination with other products is not recommended, which is expected to disrupt the inoculation schedule.
- Company
- Celltrion's self-test kit has been approved for EUA
- by Chon, Seung-Hyun Oct 27, 2021 05:49am
- Celltrion announced on the 25th that the COVID-19 antigen rapid self-test kit DiaTrust COVID-19 Ag Home Test, jointly developed with Humasis recently acquired Emergency Use Authorization from the U.S. Food and Drug Administration (FDA). Celltrion received the EUA of Celltrion DiaTrust™ COVID-19 Ag Rapid Test for Professionals from the FDA in April, and the rapid self-test kit was also approved this time. The DiaTrust Home Test conducted clinical trials on 490 patients with COVID-19 symptoms in the United States from March to July, and showed 86.7% and 99.8% accuracy in sensitivity and specificity, respectively. Third-party products that have already been approved by the FDA and are in circulation in the U.S. require consecutive tests that require at least two tests regardless of symptoms. The company explains that this product requires the same continuous itest for asymptomatic patients, but for symptomatic patients, it is possible to check for infection with just one test. This product is available for those aged 14 or older and can be purchased online or offline without a separate prescription. Celltrion is planning to supply DiaTrust Home Test in the U.S. through its subsidiary Celltrion USA. For rapid supply, last-minute consultations are underway with local governments, online distributors, and offline distributors. The home test kits are handled by Humasis, a co-developer. Celltrion won a contract from DLA in the U.S. last month to supply DiaTrust for experts worth up to 738.2 billion won. An official from Celltrion said, "This EUA is based on the high reliability of Celltrion diagnostic kit products, and we will make efforts to prevent the spread of COVID-19 through early supply of products."
- Company
- Sales of choline alfoscerate rise despite controversy
- by Chon, Seung-Hyun Oct 26, 2021 05:53am
- Sales of brain function enhancer ‘choline alfoscerate’ are on the rise in the prescription drug market. The drug recorded growth for 3 consecutive quarters despite controversy over its efficacy, reduced scope of reimbursement, and the restitution of insurance benefits. Also, with many CA products withdrawing from the market after giving up clinical re-evaluations, the market dominion has fluctuated. According to the market research institution on the 25th, the outpatient prescriptions in Q3 recorded ₩127.3 billion. This was a 5.4% decrease YOY, however, also a 3-quarter consecutive rise from the ₩116.7 billion in Q4 last year. The cumulative prescription of choline alfoscerate products was ₩368.7 billion by Q3 this year, which was a 2.3% increase from the previous year. Choline alfoscerate is currently approved for the following three indications: ▲ Secondary symptom caused by cerebrovascular defects or degenerative brain-organic psychiatric syndrome by cerebrovascular deficiency; ▲ Emotional and behavioral change; and▲ Senile pseudo depression.’ Despite the recent flood of issues from clinical reevaluations, reduced scope of reimbursement, and negotiations for restitution of insurance benefits, sales of choline alfoscerate have stayed strong in the prescription market. The amount of choline alfoscerate prescriptions in Q3 nearly doubled from Q3 2017, 4 years ago. The safety and efficacy of choline alfoscerate are currently on the testbed, and the governments’ pressure to reduce the drug's insurance benefits is still ongoing. Choline alfoscerate became the first subject of the unprecedented restitution negotiations. At the end of last year, the Ministry of Health and Welfare ordered the National Health Insurance Service to sign an insurance benefits agreement ‘to return the prescription amount if the clinical trial fails.’ 8 months after the negotiation order, the companies have comprehensively agreed on the restitution rate of 20%. What is noteworthy is that the overall market size showed growth even though some of the choline alfoscerate products withdrew from the market after giving up re-evaluations. The MFDS had first ordered clinical re-evaluations to 134 companies, and 57, less than half, of the companies received approval for their clinical reevaluations. In other words, 77 companies have given up reevaluations and decided to withdraw from the market. Some of the companies have officially withdrawn from the market by voluntarily withdrawing their licenses. The interpretation is that these products were replaced by other choline alfoscerate products. The market dominion for each product had also been fluctuating. Some products showed a sudden surge in sales by absorbing prescriptions of products that withdrew from the market. Sales from market leaders, Daewoong Bio and Chong Kun Dang, recorded sales at a similar level to previous years. Sales of Daewoong Bio’s Gliatamine fell 1.6% from the previous year to record ₩28.1 billion in Q3, and Chong Kun Dang’s Gliatilin recorded ₩23.4 billion, a 3.3% decrease from Q3 of the previous year. Mid-sized pharmaceutical companies including Korea Prime Pharm, Hutecs Korea Pharmaceutical, Dongkoo&Pharma, HLB Pharma showed high growth.
- Company
- Merck will actively support Korea to become one of the top 5
- by Oct 26, 2021 05:53am
- Korea M Lab Collaboration CenterM Lab has promised to actively invest and expand cooperation with domestic companies to expand its capabilities in Korean vaccine production and bio-process. In an online press conference hosted to commemorate the 5th anniversary of its establishment on the 21st, M Lab said, "We will support Korea to leap into one of the top five global vaccine production powerhouses." M Lab explores pharmaceutical bio companies' ideas for developing new drugs and provides solutions to solve important process development and production problems. It is located in eight countries around the world, including the United States, France, China, and Singapore, and was located in Songdo, Incheon in 2016. Merck Life Sciences invested a total of 10 million euros (about 12 billion won) for the 1865㎡ M Lab Center. M Lab supports professional education and skills in a wide range of fields, including drug development, manufacturing, and guarantee. Non-GMP research facilities allow customers to improve their R&D processes through the M Lab simulation system without being affected by the actual production line. M Lab has provided more than 540 customized training programs over five years and has helped practice more than 240 state-of-the-art facilities. It has formed a technology strategy partnership with more than 100 domestic pharmaceutical bio companies such as Samsung Biologics, Chong Kun Dang, and SK Bioscience. As large-scale biopharmaceutical production facilities have been established in Korea over the past decade and the need for vaccine and cell gene therapy has been increasing, M Lab also plans to expand cooperation in this field. Kim Yong-seok, general manager of process solution business, said, "Global is also paying attention to the growth potential of the Korean biotech industry. In particular, we expect biopharmaceutical production facilities to achieve the largest growth after the U.S. and China, he explained. He said, "In the past, we mainly collaborated with large pharmaceutical companies, but in the future, we will also cooperate with growing bio ventures to contribute to the construction of Korea's bio-eco system." In particular, bio ventures are rich in R&D ideas, but they are having difficulty in concrete demonstration methods. M Lab predicts that it will be able to educate them on scale-up technologies necessary in the initial process development and commercialization process and provide services for development optimization. It also expressed its intention to actively contribute to Korea's leap into the world's top five vaccine producers. Merck is also affiliated with a consultative body of vaccine companies composed of the Korean government and domestic pharmaceutical bio companies. It is determined to invest to support vaccine production and expand bio-processing capabilities. The domestic pharmaceutical bio industry has grown rapidly for 10 years, but it is difficult to recruit talent. The government, Incheon, and Yonsei University are establishing a K-NIBRT consortium to foster professionals in the vaccine and bio sectors. Merck will also participate in the consortium to support training programs and dispatch of experts. On November 4, the "Virtual M Lab Open House" will be held to guide bio-process education, job consulting, and recruitment information for college students majoring in life science. As national expectations for the biopharmaceutical industry grow after the COVID-19 incident, we will contribute to the growth of the industry by providing customized solutions and services through M Lab and sharing expertise and know-how, he said. "We will establish ourselves as a win-win partner that grows together through collaboration with Korea, which has unlimited potential," he said.
- Company
- ‘Brilinta’ generic to be released next month
- by Kim, Jin-Gu Oct 25, 2021 05:50am
- Pic. of Brilinta Generics of AstraZeneca’s oral antiplatelet therapy Brilinta will be released next month. However, only 6 of the 25 companies that received first generic exclusivity will be releasing actual products. The small number of releases is interpreted to be caused by the domestic companies' declining interest in Brilintagenerics. According to industry sources on the 22nd, the substance patent for Brilinta will expire on the 20th next month. In other words, generics that had avoided the formulation patent of Brilintawill be allowed to be released from the 21st next month. Currently, 25 companies have successfully avoided Brillinta’s formulation patent and acquired first generic exclusivity. However, only 6 of these companies will be releasing actual generics. The companies are Chong Kun Dang, Samjin Pharm, Genuone Sciences, Alvogen Korea, and Hana Pharm. The other 19 companies including Hanmi Pharmaceutical and Boryung Pharmaceutical are adjusting their schedules for its release. The companies, which already own other antiplatelet therapies with different ingredients are in no rush to release the generics. This is in stark contrast to 2015 when generic companies competitively challenged Brillinta’s patent. At that time, the ticagrelor market showed promise to expand significantly. This was why around 30 companies in Korea had challenged the substance, formulation, and crystalline form patent of Brilinta. According to the market research institution UBIST, outpatient prescriptions for Brilinta, which recorded 4.8 billion won in 2014, then rose to 7 billion won in 2015. The market continued to grow until 2019 when it peaked at 10.8 billion won. However, sales fell to 9.8 billion won last year. And 4.3 billion won’s worth was prescribed in the first half of this year. At this trend, it is likely that outpatient prescriptions of Brilintamay see a decline for 2 consecutive years. The industry pointed to the existence of strong competitors such as aspirin, clopidogrel, sarpogrelate, and the introduction of new oral anticoagulants (NOACs) that have coinciding indications that quickly gained popularity, as the reason why Brilintais performing less than expected. Also, the relatively high price of ticagrelor APIs is one reason why generics are hesitant to produce their generics. An official from a company that postponed their generics’ release said, “The bottom line is, marketability is low and the price of its API is high, so the generic is not very profitable. That is why we decided to wait and see how the companies that first enter the Brilinta market do then enter the market as latecomers.”
- Company
- Boryung Pharmaceutical acquired Zyprexa's domestic rights
- by Kim, Jin-Gu Oct 25, 2021 05:49am
- Boryung announced on the 21st that it has signed an asset transfer contract with Eli Lilly for the schizophrenia treatment "Zyprexa (Olanzapine)." Through this contract, Boryung will take over all rights from Eli Lilly, including domestic copyrights and permits for Zyprexa. Zyprexa is the world's most prescribed treatment for schizophrenia since its launch in 1996. It is a drug used for schizophrenia and bipolar disorder and controls the imbalance of Dopamine in the brain. According to IQVIA, a pharmaceutical market research firm, Zyprexa generated 14 billion won in sales in Korea last year. It occupies about 50% of the domestic Olanzapine market. Boryung plans to further strengthen its central nervous system (CNS) treatment business through the acquisition of Zyprexa. Boryung has CNS drugs such as Buspar (mental inhibitor), Prozac (central stimulant), and Strattera (behavioral disorder). Boryung's goal is to add Zyprexa to achieve 50 billion won in annual sales in the CNS sector by 2025. The contract was made as part of the Legacy Brands Acquisition (LBA) strategy announced by Boryung in July. LBA refers to the acquisition of original medicines that maintain a certain level of sales and market share even after patent expires. It acquired the domestic rights of the anticancer drug Gemzar (Gemcitabine) from Lilly in May last year. CEO of Boryung Jang Doo-hyun said, "The acquisition of Zyprexa has provided an opportunity for a new leap forward in the CNS treatment business." "In order to continue to acquire products that can contribute to Boryung's growth in the future, we are considering a number of products that are leading the domestic and foreign treatment markets," he said.
- Company
- Supreme court to finally rule on ‘Galvus’ patent dispute
- by Kim, Jin-Gu Oct 22, 2021 05:45am
- The 4-year long patent dispute over the patent of the anti-diabetic DPP-4 inhibitor ‘Galvus (vildagliptin)’ will finally come to an end at the Supreme Court on the 28th. Industry officials believe that the Supreme Court’s decision may affect and modify the overall patent strategies of generic companies in the coming future. If the Supreme Court rules in favor of Ahn-Gook Pharmaceuticals, this will greatly increase the number of challenges filed on substance patents of original drugs, which have been considered impregnable. ◆Will the first ‘invalidation of substant patent extension’ case be born? According to industry sources on the 20th, the Supreme Court issued a notice that it will rule on the Galvus patent dispute between Ahn-Gook Pharmaceutical and Novartis on the 28th. The issue, in this case, is how much of the "extended duration" of the drug substance patent will be considered invalid. The industry anticipates that the Supreme Court’s decision may affect and modify the overall patent strategies of generic companies that will be made. Until now, there has never been a case in which a generic company has overcome the extended term of a drug substance patent.” If the supreme court rules in favor of the generic company and renders even one day of the extended patent term invalid, this will may trigger a series of challenges on substance patents of original drugs, an area that has been considered impregnable. On the other hand, if the Supreme Court accepts Novartis’ claim and recognizes the entire extended period as is, generic companies are expected to maintain their current patent strategy. ◆Mixed rulings at 1st and 2nd trial… what will the Supreme Court’s ruling be? Patent rights are usually protected for 20 years from the filing date. For pharmaceutical products, the time taken for clinical trials and regulatory approval is added to the term. Depending on the recognized period, patent protection for a drug can last 21 years or even 22 years. The same applied to Novartis when applying for Galvus’s patent in Korea. The company requested the patent term for Galvus to be extended to make up for the time spent on clinical trials and for the regulatory review by the Ministry of Food and Drugs Safety. The Korean Intellectual Property Office accepted the request and extended the term by 2 years, 2 months, and 23 days (1068 days). Pic. of GalvusAhn-Gook Pharmaceutical claimed that ‘187 days’ of the extended term for Galvus’s substance patent was invalid. Hanmi Pharmaceutical later joined in the fight. The court ruled in favor of Ahn-Gook Pharmaceutical in the first trial. The Patent Court of Korea accepted Ahn-Gook’s claim and ruled the 187 days invalid. With the ruling, Ahn-Gook Pharmaceutical received the right to release its generic 187 before the expiry of Galvus’s substance patent. Novartis got a partial win in the second trial. The Intellectual Property Trial and Appeal Board had overturned the first instance judgment and ruled that only 55 of the 187 days are invalid. Despite the reduced period, the ruling still rendered a part of the period invalid. As a result, Ahn-Gook did lose the suit but reaped the rewards. Novartis once again appealed, and the case is now being reviewed by the Supreme Court. Novartis is claiming that not a single day should be rendered invalid. The Supreme Court's ruling is expected to be one of the three – recognizing the ‘187 days invalid’ by accepting the ruling of the first trial; recognizing the ’55 days invalid’ by accepting the ruling of the second trial, or accepting Novartis’ claim and not recognizing any part of the term invalid.
- Company
- COVID antibody kits are entering the market of clinics
- by Kim, Jin-Gu Oct 22, 2021 05:44am
- Although the sale of COVID-19 antibody diagnostic kits to pharmacies has been banned, diagnostic kit companies are speeding up into the market, especially in hospitals and clinics. It is explained that the industry's impact from the government's measures is not significant because it has focused on the hospital and clinic markets rather than pharmacies in the first place. Although it is said that there is a limit to accurately confirming the effectiveness of the COVID-19 vaccine, related companies are expecting to expand the market in the future due to the increase in vaccination rates. ◆The impact of banning the sale of pharmacies will be limited to some companies According to the diagnostic kit industry on the 20th, the government's ban on selling antibody diagnostic kits at pharmacies is not expected to have a significant impact on the entire antibody diagnostic kit market. This is because most companies have focused on the hospital and hospital markets, not pharmacies. Industry officials say that only a small number of companies have supplied products to pharmacies. According to the MFDS, 14 products from 11 companies were approved as antibody diagnostic kits as of the end of last month. However, about two of them were distributed to pharmacies. ◆The vaccination rate is close to 70%. The demand for antibody diagnostic kits is increasing On the contrary, some companies are expressing expectations in that demand for on-site is expanding as the vaccination rate increases. As of midnight on the 20th, the complete COVID-19 vaccination rate in Korea reached 66.7%. It is expected to exceed 70% within this month. In particular, it is reported that the demand for the vaccine effect has increased further recently as the effect of the COVID-19 vaccine has dropped sharply within two to six months. It is confirmed that front-line hospitals are using antibody diagnosis kits as non-reimbursed items for confirmation of vaccine effects. ◆Pharmaceutical companies are expressing regret over the government's position of "not being able to confirm the vaccine effect" However, the fact that the government reiterated that "there is a lack of medical evidence for the purpose of confirming the vaccine effect" is a common concern among diagnostic kit companies. The diagnostic kit industry has focused on exploring related markets around the time when the domestic complete vaccination rate exceeded 10%. They expected the market for neutralizing antibody diagnostic kits to confirm vaccine effects to grow explosively. However, in July, the government said, there was a lack of medical evidence for the purpose of confirming the effectiveness of the vaccine. The government reaffirmed its position by banning the sale of pharmacies. ◆It is impossible to determine the vaccine effect by simply producing neutralizing antibodies There are three types of domestic approved diagnostic kits. It is a PCR, antigen, and antibody diagnostic kit. PCR and antigen diagnostic kits are used to confirm suspected COVID-19 patients. Antibody diagnostic kits are used to determine if people have been infected with COVID-19. People who have been infected with COVID-19 develop binding antibodies, which is the principle that antibody diagnosis kits check whether or not binding antibodies are produced. The diagnostic kit industry focused on the fact that it can also check whether neutralizing antibodies are produced with antibody diagnostic kits. Neutralizing antibodies are antibodies that occur after vaccination. They have argued that their own clinical results can determine whether neutralizing antibodies are produced with 90% accuracy. The government is in a position that it is difficult to determine the effectiveness of the vaccine simply by producing neutralizing neutralizing antibodies are produced. This is because in order to check the vaccine effect, it is necessary to determine how much neutralizing antibodies are formed in the body.
- Company
- Q3 exports of Biopharmas 'Good’ Diagnostic kits ‘Slow'
- by Kim, Jin-Gu Oct 21, 2021 05:13am
- While pharmaceutical exports in Q3 increased slightly compared to the same period of the previous year, the performance of biopharmaceuticals and chemical drugs have shown mixed results. Export of biopharmaceuticals increased 13% YOY and continued on its strong flow from last year, however, export of chemical drugs fell 13%. Also, diagnostic kits, which rose as an export ‘cash cow’ after the COVID-19 outbreak, saw a decline in export value amount despite the large increase in export volume. The analysis is that this may be due to the continued decline in its export unit price. ◆Earned ₩6.8 trillion in Q3 exports….will the industry exceed last year’s ‘largest ever’ record? According to Korea Customs Service on the 15th, the domestic export value of pharmaceuticals in Q3 was $1.86 billion (approx.. ₩2.2 trillion). This is a 6% YOY increase from the $1.76 billion (approx.. ₩2.07 billion) in Q3 last year. The cumulative amount of exports by Q3 has increased 26% from $4.60 billion (approx. ₩5.44 trillion) last year to $5.77 billion (approx. ₩6.82 trillion) this year. If this trend continues, the industry may break the all-time export record that it made last year. The total pharmaceutical exports last year amounted to $6.89 billion (approx. ₩8.15 trillion). However, exports last year were concentrated around Q4. In Q4 last year, the industry earned $2.30 billion (approx. ₩2.71 trillion), accounting for 33% of the total amount of exports of the whole year. ◆Biopharmaceuticals increase 13% · Chemical drugs decrease 13% … shows clear difference between areas In detail, the export between biopharmaceuticals and chemical drugs have shown mixed results. In Q3, export sales of biopharmaceuticals amounted to $1.4485 billion (approx. ₩1.71 trillion) and increased 13% YOY. The analysis is that the export of biopharmaceuticals is continuing to show good flow. The share of biopharmaceuticals contributing to the total pharmaceutical exports also rose 5%p from 73% in Q3 last year to 78% in Q3 this year. Export of biopharmaceuticals has soared over the past 2 years, mainly around biosimilars from Celltrion and Samsung Biologics. Biopharmaceutical exports doubled from $430.17 million (approx. ₩510 trillion) in Q1 2019 to $868.95 million (approx. ₩1.03 trillion) in Q1 2020 and doubled once more to $1.81 billion (approx. ₩2.14 trillion) in Q1 this year. On the other hand, the export of chemical drugs fell 13% from $467.81 million (approx. ₩550 billion) in Q3 last year to $408.8 million (approx. ₩480 billion) in Q3 this year. ◆Export volume of diagnostic kits the greatest-ever… however value earned falls 5% in one year Also, the export performance of diagnostic kits that soared after the COVID-19 outbreak has been slowing down recently. In Q3 this year, exports of domestic diagnostic kits amounted to $570.37 million (approx. ₩670 billion), which is 5% lower than the $600.41 million (approx. ₩710 billion) in Q3 of last year. By each quarter, sales of diagnostic kits increased steadily until Q4 last year, and then was showing signs of stagnation entering this year. This is due to the worldwide COVID-19 vaccinations that began earlier this year, and the falling unit price of the kits due to intensified competition between global diagnostic kit companies. By export volume, quarterly exports of diagnostic kits set a new record of 2,517 tons in Q3 this year. This is much larger than the export volume in Q3 last year - 1,467 tons. In other words, the export value fell 5% despite a 72% increase in exports export volume in the same period.
