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- 2026-04-17 12:22:59
- Policy
- Tarlige, pain reliever & Smyraf, RA treatment approved
- by Lee, Tak-Sun Jan 28, 2020 06:13am
- New drugs such as Tarlige (Mirogabalin besylate by Daiichi Sankyo, Korea) used for the treatment of peripheral neuropathic pain and Smyraf (Peficitinib hydrobromide, Korea Astellas Pharmaceutical) for rheumatoid arthritis received domestic permission at the same time . They are expected to compete with existing products of the same family. The Ministry of Food and Drug Safety approved two new drugs on the 23rd, including 2.5mg, 5mg, 10mg, 15mg and 50mg of Tarlige, & 100mg of Smyraf. Both drugs were made by Japanese global pharmaceutical companies. Tarlige has the efficacy(indication) of treatment of peripheral neuropathic pain. The dosage and dose is usually administered orally 5mg/day twice daily for adults. Multi-national trials showed that 824 patients with diabetic peripheral neuropathy (DPNP) had double-blind, phase III trials performed in Asia for 14 weeks (1 to 2 weeks of dosing and 12 to 13 weeks of fixed dose). In the clinical trials, the group of 30 mg of Mirogabalin/day (15mg twice daily) showed a statistically significant improvement in the pain score at week 14 compared to the placebo group. The main ingredient, Mirogabalin, is a Gabapentinoid-based drug that acts on the calcium channel apa2-delta ligand and reduces the secretion of neurotransmitters involved in pain. Pfizer's Neurontin capsules (Gabapentin) and Lyrica capsules (Pregabalin) have the same mechanism. As a result, Mirogabalin is likely to compete with them. However, it is expected in the medical field for new drugs, since both Neurontin and Lyrica are patent expired drugs. According to the drug market researcher UBIST, in 2019, Neurotin recorded ₩ 19.5 billion and Lyrica recorded ₩62.7 billion in outpatient prescriptions. Smyraf is a JAK inhibitor, such as Pfizer's Xeljanz (Tofacitinib). JAK inhibitor is a drug that blocks the arthritis molecule and improves symptoms by inhibiting the enzyme neurons, Januskinase (JAK), and it is an oral rather than injection as a treatment for rheumatoid arthritis. Currently, there are two items in the same category, including Xeljanz and Lilly's Olumiant (Baricitinib). Smyraf is used to treat moderate to severe active rheumatoid arthritis in adults who do not adequately respond or tolerate one or more anti-rheumatic agents (DMARDs) and may be co-administered with Methotrexate or other abiotic rheumatic agents (DMARDs). However, it should not be combined with potent immunosuppressive agents (except topical therapies) such as biological antirheumatic agents or other Janukinase (JAK) inhibitors. It has a recommended dose of 100mg once a day after meals, and it seems to be more competitive than Xeljanz administered twice a day. However, Lilly's Olumiantis is also once daily use. In a multi-regional phase III trial in 500 patients with rheumatoid arthritis that did not respond properly to existing anti-rheumatic (cDMARDs) formulations including Methotrexate, Smyraf had a higher treatment rate compared to placebo and a statistically significant difference. According to last year's JAK inhibitors, Xeljanz recorded outpatient prescriptions of ₩4.3 billion based on UBIST and ₩500 million of Olumiantis. However, due to the rapid growth of this category of drugs, the market size is expected to expand further with the emergence of Smyraf.
- Company
- Repatha’s options for ultra high risk patients extended
- by Eo, Yun-Ho Jan 28, 2020 06:13am
- Professor Hyeon Cheol Gwon Since statins, the coverage of the PCK9 inhibitor Repatha, an option for managing dyslipidemia, is expected to increase utilization. Amgen Korea(the CEO Noh) held a press conference at the Westin Chosun Hotel in Seoul on the 22nd to commemorate the reinforcement of health insurance benefits for Repatha’s atherosclerotic cardiovascular disease (ASCVD). Repatha has been applied to the treatment of patients with atherosclerotic cardiovascular disease at very high risk and patients with heterozygous familial hypercholesterolemia with hypercholesterolemia and statin intolerance patients from January 1 this year. The press conference centered on atherosclerotic cardiovascular disease among them. Professor Hyeon Cheol Gwon, Director of circulatory internal medicine dept., Samsung Medical Center, who presented as the first speaker at the meeting, announced the theme of 'the latest knowledge on the treatment of atherosclerotic cardiovascular disease with ultra high risk group using PCSK9 inhibitor'. Atherosclerotic cardiovascular disease, known as myocardial infarction, stroke, or peripheral artery disease, is a type of atherosclerosis caused by the accumulation of cholesterol in the vascular lining. Patients who have experienced at least one atherosclerotic cardiovascular disease have a high risk of clinical recurrence and a poor prognosis, with a mortality rate of up to 85%. Professor Hyeon Cheol Gwon said, "A patient who has experienced atherosclerotic cardiovascular disease is a serious disease whose mortality rate increases rapidly with the second and third recurrences, and LDL-C, a major risk factor for the ultra high risk group, must be thoroughly managed". He said, “Statin and Ezetimibe are already standard treatment regimens, but some patients with ultra high risk group are still unable to reach their treatment goals because the LDL-C baseline is high and the target is low in the ultra high risk group. We look forward to lowering LDL-C to prevent recurrence of cardiovascular disease in more patients. And, the indication expansion is expected to lower the LDL-C in the high-risk group to prevent recurrence of cardiovascular disease in more patients”. Meanwhile, domestic treatment guidelines recommend that patients with atherosclerotic cardiovascular disease should be adjusted to less than 70 mg / dL of LDL-C to prevent recurrence of cardiovascular disease. However, in 2019, the European Heart Association lowered the target LDL-C level of the ultrahigh risk group to less than 55 mg/dL. Accordingly, there is increasing interest in the field of PCSK9 inhibitors that are useful for patients at very high risk who do not reach target levels with existing treatment regimens.
- Company
- Last year, Tamiflu sales fell by half
- by Jung, Hye-Jin Jan 28, 2020 06:13am
- Last year, the flu treatment Tamiflu market dropped sharply. The size of the market has shrunk as the number of flu patients has decreased significantly from 2018. The share of generics in the market has been expanding. Outpatient prescription performance of Oseltamivir were down ₩17.2 billion, down 50.4% from last year, according to UBIST, a drug research agency. This is the result of a survey of 37 products with recent prescriptions. Oseltamivir is a drug used to treat flu, and Roche's Tamiflu is the original medicine. Prescriptions for 37 items from 2017 to 2018 rose 103% from ₩17 billion to ₩34.6 billion, but fell back to ₩17.2 billion last year. In the winter of 2018, the flu was a very common epidemic. According to the KCDC(Korea Centers for Disease Control & Prevention), the number of influenza patients per 1,000 outpatients last year were 19.5 at 49 weeks, 28.5 at 50 weeks, 37.8 at 51 weeks, and decreased by more than 30% less than 49.8 at 52 weeks. 34.1, 48.7, 71.9, and 73.3 in the week 49-52 of 2018. In the prescriptions for Oseltamivir ingredients, Tamiflu, the original drug, was still ranked first last year. Tamiflu's prescription amount was ₩5.2 billion. Hanmiflu followed with ₩4.1 billion. After that, Comyflu came in third with ₩1.5 billion in earnings. Tamiflu and Hanmiflu, both of which ranked top in prescription performance, also saw a sharp decline. Both original and generic prescriptions declined, but Tamiflu was the largest among the top five. Tamiflu's prescriptions for 2019 decreased 58.4% year-on-year, while Hanmiflu also decreased 54.2%. Kolon's Comyflu decreased 31%, Yuhan's Yuhan N Flu decreased 50.6%, and Arlico's Tamipro decreased 20.8%. In particular, Tamiflu's share in the overall market of Oseltamivir is decreasing. Tamiflu's 2017 market share continued to decline from 51.3% to 36.2% in 2018 and 30.4% in 2019. The share of generics in the Oseltamivir market soared to around 70%. Generics such as Hanmiflu are interpreted as a competitive effect. However, as this winter is not over yet, it is necessary to observe the first quarter 2020 results. In 2018, the most common cases of influenza were in December, while in 2019, the number of patients has increased since the end of December, and the number of patients continues in January. The KCDC announced that the number of suspected influenza patients increased sharply in late December and January this year after the influenza watch warning was issued on last November 15. Last year, the number of suspected influenza patients per 1,000 outpatients fell 53.1 per week, down sharply from last December, but this week increased to 49.1 per week.
- Policy
- Finally a complete revision of PE guideline after 8 years?
- by Lee, Hye-Kyung Jan 28, 2020 06:12am
- After long eight years, the Korean health authority seems to finally accept the pharmaceutical industry’s demand to amend the pharmacoeconomic analysis guideline. Health Insurance Review and Assessment Service (HIRA) recently unveiled a final report on the cosigned research regarding ‘Pharmacoeconomic (PE) Analysis Guideline Revision Plan (Principal investigator: Professor Lee Tae-jin of Seoul National University Health Science Department and Professor Bae Eun Young of Gyeongsang National University College of Pharmacy).’ Aiming for a ‘complete revision’ of the PE analysis, HIRA has started the research from last year. The research report, disclosed on Jan. 22, found countries the Korean PE analysis guideline refers to, such as the U.K., Australia and Canada, have entirely amended their guidelines after 2011. And it claimed the Korean PE analysis guideline should also reflect the developed PE analysis methodology and precedents that the other countries have based since 2011. The research team conducted a survey on stakeholders like pharmaceutical industry organization, patient and civic group, and related scholars, from July to September last year. The team convened consultative meeting with Korean Research-based Pharmaceutical Industry Association (KRPIA), Korea Pharmaceutical and Bio-pharma Manufacturers Association (KPBMA), Korea Biomedicine Industry Association (KoBIA), Korea National Council of Consumer Organization, National Council of the Green Consumers Network, Korea Consumer Agency, National Health Insurance Policyholder Forum, Korean Association of Health Technology Assessment (KAHTA) and other experts. The survey helped the research team to limit the scope of guideline revision down to perspective of revision, analysis period, analysis subject and population group, analytic techniques, comparison subject selection, data source (indirect comparison), items of cost, utility (health related quality of life), discount rate, model construction, and uncertainty. The team recommended the guideline to remove ‘financial impact’ article, but to add ‘statistical consideration (estimated long-term effect, treatment switching (cross over) and etc.)’ and ‘analysis guideline for laboratory test drug.’ ◆ Cost: As the article of cost in PE analysis depends on the perspective, the researchers recommended using healthcare perspective instead of the existing limited societal perspective, as well as only including direct medical expense and excluding non-medical expense (transportation cost, time cost, nursing guardian cost and etc.) for the basic analysis. In the PE analysis material submitted to this date, expert’s opinion takes up the majority of data source with seven cases (14 percent) in diagnostic cost and five cases (ten percent) in treatment cost. Compared to data-focused referential material, expert opinion or cost and resource use quoted from hospital investigation have limited credibility or consistency. Therefore, referencing expert opinion should require official statement of an academic society, or stipulated minimum number of expert panel to improve credibility and consistency. Although the existing guideline does not mention drug wastage, the researchers suggested stating the cost of wastage volume, because it generates noticeable amount of expense. ◆ Utility, the healthcare related quality of life: Rounding up the recommendations made by HIRA, pharmaceutical companies, and civic groups, the researchers said following articles in the guideline about ‘utility’ should be revised; prioritization of utility measuring techniques; Health-related quality of life (HRQL) indicating tool and reviewing tariff selection; detailed guideline on mapping; detailed guideline of direct measuring; and additional review on minimal clinically important difference of utility. Recommending the revised guideline to clarify preference of indirect measurement based on the Health Technology Assessment (HTA) of many other countries, the researchers also suggested using health state vignette-based direct measuring, calculating weighted value of quality of life via mapping, or quoting a value proposed in a published literature, as an option when lacking or having limited data quoted from preference-based measuring tool. About reviewing and selecting HRQL tool and tariff, they argued the health authority should select a single set of tool and tariff to ensure consistency in policy-making process. ‘Tariff’ means the value that converts utility value in foreign country to fit the Korean landscape. The primary recommendation is to select EQ-5D-3L, a tool used the most home and abroad so far, as a single tool and to select tariff developed in the most recent study ‘Lee et al. (2009)’ with the largest sample as a standard tariff. However, the team also proposed keeping the existing guideline as a secondary option, because a proper comparison study or qualitative evaluation on HRQL tool and tariff in Korea has not been conducted, yet, and related empirical data are insufficient. ◆ Discount rate: According to 50 cases of PE analysis material submitted to HIRA, 45 cases (90 percent) have been discounted and five cases (10 percent) have not been discounted. The analysis period of the five cases was apparently under a year. The researchers stated the discount rate for PE analysis should be reduced as well, because the social discount rate continues to descend due to changes in socio-economic conditions. Hence, the report suggested the revised guideline should set 4.5 percent as an adequate level of discount rate, equivalent to the discount rate applied on preliminary feasibility assessment. About applying the same discount rate on the cost and result, the report tried to persuade applying the unchanged rate, but applying either zero percent for no discount or three percent discount rate to analyze sensitivity. Applying the discount rate of 4.5 percent for the entire period of basic analysis was suggested in case the period of PE analysis for the healthcare sector is longer than three decades. But also as a sensitivity analysis, 3.5 percent could be applied after 30 years in case the applicant drug is essential for pediatric treatment. ◆ Perspective: Taking in account the state and realistic environment of reimbursement decision making, the researchers argued the analytic perspective should be amended. Keeping in mind the interest of reimbursement listing reviewer is on the impact on the healthcare sector, the research team first recommended shifting the perspective from limited societal perspective to healthcare perspective and excluding items applicable for direct medical cost from the basic analysis. So the cost should cover items centering the direct medical expense, but it should include nursing if the cost is reimbursed from long-term nursing insurance, whereas the effect should reflect benefit of health on the patient. The secondary proposal suggested was maintaining the current guideline. ◆ Analysis period: The current guideline recommends the analysis to be conducted long enough to confirm major clinical endpoints. The research team studied deliberation cases of similar diseases and contemplated on patient age (cohort joining age), expected life expectancy of general population group, patient’s survival rate, analysis period of similar drugs, clinical trial outcome (median OS), monitoring period, clinical consulting, and uncertainty for calculating analysis period. The team advised to maintain the principal approach of the existing guideline, but to consider validity of calculated analysis period. Also the team elaborated the revision, when comparing with other countries’ guidelines, should take in account the age of applicable population, life expectancy, survival rate based on epidemiological data, median OS observed from clinical trial, difference in survival rate between cohorts, monitoring period, numerous uncertainties inserted in model, similar drug evaluation case or cases in referential countries and expert consulting. ◆ Analytic techniques: The current guideline recommends using cost-utility analysis when quality of life is a crucial aspect or the health outcome is demonstrated in various indicators. But the research team claims the guideline should provide more specific standard or analytic techniques to distinguish equivalence of effect. They first advised offering more detailed guideline on selecting subject for cost-minimization analysis, expense item and submission data to be considered when conducting the cost-minimization analysis. Regarding subject for cost-minimization analysis, the researchers recommended clarifying the cases of the drug effect is non-inferior (or superior) and recognizing the non-inferiority of the applicant drug in safety profile. As for the cost estimation, the guideline should set equi-effective doses and provide cost of comparing options’, as well as other costs estimated from monitoring, adverse reaction relief, and others. The secondary recommendation is to exclude cost-minimization analysis from the analytic techniques. The researchers explained it would theoretically eliminate the issues of effect equivalence and uncertainty. ◆ Subject of comparison: The existing guideline stipulates selecting alternative treatment option with the highest market share as a reference. When there are multiple drugs with similar market share, multiple options can be selected for comparison, and other therapy and surgery can be used as reference if there is no other alternative option. The referential option selection has been an issue raised by the pharmaceutical industry for a long while. The Korean guideline clearly states to select a substitutable option with the highest market share, but many of other countries’ guideline does not specify “the highest market share.” As a primary recommendation, the researchers suggested keeping the basic principal of selecting the ‘most used’ drug for comparison, but to loosen the description of ‘highest market share’ to prioritize replaceability when selecting a referential treatment option. The majority of the researchers were negative about providing a range of options like in Australia or limiting the option to reimbursed treatment, but they agreed on having government committee to discuss or negotiate with pharmaceutical companies based on submitted PE analysis material and market status. However, the team put down a precondition that comparing with existing treatment option, which fails to treat health condition but has no other option, is ‘not automatically neglected from referential candidate list.’ ◆ Data source: The HIRA’s guideline barely mentions of indirect comparison, but a separate indirect comparison guideline is used to accommodate, and the government agency has already opened up about possibly accepting simple comparison of drugs as they reflected stakeholders’ demands, since the 2014 revision. The researchers elaborated “It could be seen that it was actually more lenient than other countries’ guidelines,” and advised that the revised guideline should edit the detailed guideline and supplementary explanation in a wider sense.
- Company
- Yuhan talks plans after lazertinib L/O at JPM Conference
- by Jung, Hye-Jin Jan 28, 2020 06:12am
- Yuhan announced on Jan. 22, the company has participated in J.P. Morgan Healthcare Conference 2020 to talk about plans following the out-licensing lazertinib and to hold R&D recruiting event. Since 2018, Yuhan has signed 3.5 trillion won worth of out-licensing deals including lazertinib. And at the event in the U.S., the company representatives met with partner companies to share the details of this year’s scheduled plan and discussed about further research topics. Meetings were convened with global pharmaceutical giants to talk about possible licensing deals on Yuhan’s candidate medicine in clinical and preclinical phases, and also the Korean company had a partnering opportunity to reinforce pipeline by adopting anticancer treatments and NASH sector. Moreover, the company held a special event to recruit outstanding global R&D experts. The members of ‘Korean Life Scientists in the Bay Area (KOLIS)’ from three universities—UCSF, UC Berkeley and Stanford)—were invited for networking. Besides, the company also visited the university campuses to show the company introduction video, introduce its R&D facility and ImmuneOncia and provide a Q&A session. Head of Global Business Development Yoon Taejin participating in the conference explained “The J.P. Morgan Conference was our time to fine-tune Yuhan’s focus on achieving the ultimate vision, ‘Global Yuhan.’” He added, “Yuhan aims to leap as a global company by stepping out of simple notion of open innovation based on pipeline license-in deals, but by taking a step further in open innovation, where it covers not only technology and substance, but extends out to incorporate exceptional specialists of the field.” In this year, overall 25 representatives of Yuhan’s R&D, Global BD and Development departments and other corporate subsidiary and global offices participated in the event.
- Company
- Sanofi firing employee for playing golf is unfair dismissal
- by Eo, Yun-Ho Jan 23, 2020 06:16am
- A government organization has decided a salesperson fired by Sanofi Pasteur for playing golf with his colleagues during their working time was unfair dismissal. Following the decision made by Chungnam Regional Labor Relations Commission in 2019, National Labor Relations Commission (NLRC) has accepted “Manager A”’s request for unfair dismissal remedy claim on Jan. 20 regarding Sanofi Pasteur dismissing the employee for violating the Compliance Program. The Commission ordered, “Sanofi should immediately reinstate the employee as it was an unfair dismissal.” Manager A, who used to work at Chungcheong and Honam regional team of Sanofi Pasteur, went out to play golf with his colleagues as proposed by then sales executive director for two days in September 2018. And on the day of the rounding, the employee submitted a call report and received a daily pay of 36,000 won. In July 2019, Sanofi Pasteur sent a notice of termination to Manager A for violating the Global Code of Ethics. But Manager A argued the disciplinary action of termination was excessive and requested for unfair dismissal remedy to Regional Labor Relations Commission. The Labor Commission acknowledged the claim and accepted the remedy request. Although Sanofi Pasteur filed an appeal for the decision, NLRC also sided with Manager A. In the ruling, NLRC stated “Sanofi Pasteur’s Code of Ethics regulates disciplinary actions vastly ranging from training, verbal warning, written warning, change of assignment, termination of employment, and civil and criminal law suit. However, dismissing Manager A for violating the Code of Ethics and not considering other disciplinary actions is an abuse of power.” “The reason for termination is understandable, but it is difficult to say his action was intentional or ill-intended, and as he had good attitude at work, the company’s decision was abnormally unfair in the standard of social norm. Therefore, the Commission decided the company’s action was out of their discretionary power of human resource management,” the Commission elaborated.
- Policy
- Unfair profit of orphan drugs will be readjusted
- by Lee, Jeong-Hwan Jan 23, 2020 06:15am
- The KOEDC (Korea Orphan & Essential Drug Center) took the first step toward improving the 'profit for difference' of urgently imported drugs, which had been disputed for over 20 years. The KOEDC will soon discuss the detailed procedures for drug price adjustments with the Ministry of Health and Welfare & the HIRA, for the purpose of permanently eliminating the profits from urgently imported drugs. In particular, The KOEDC are considering not only one-time drug price adjustment, but also regularizing the re-adjustment system every six months or one year. An official of the KOEDC said on the 20th, “We are currently selecting drugs that need to adjust the price due to the large difference in profits, and apply for collective price adjustment by next month after meeting with the Ministry of Welfare and the HIRA”. The problem of unfair profit of orphan drugs is regarded as chronic disease. If the KOEDC unveils the policy of price restructuring, the illegal disputed earnings will soon disappear. In last year's National Assembly audit, many members of the parliament have pointed out that the KOEDC spent about ₩6.5 billion on unfair profits for the past five years and spent it on institutional expenses. In response, Young-mi Yoon, the president of the KOEDC, embarked on a discussion on rebalancing of drug costs with the HIRA to fundamentally solve the problem of drug price gaps and delivered a plan to eliminate the proceeds. Proceeds will be generated when the center purchases insurance contracts of emergency drugs from abroad and imports them into Korea. For example, the profit generated when the center buy ₩10,000 abroad for a orphan drug with a domestic insurance price of ₩20,000 is ₩10,000. Indeed, the difference between the import price of a drug and the high insurance price is the profit, but there is a problem that the national budget and national tax, the cost of health and pharmaceutical drugs, are unnecessarily wasted. There are a total of 17 insurance-listed items in Korea. The KOEDC will select the item with the largest drug price difference, apply for the drug price adjustment to the Ministry of Health and Welfare and is to eliminate controversial proceeds. In detail, the center plans to complete the request for price re-adjustment next month after a selection of drug price-adjusted items reflecting the changes in the total price of drugs and the VAT for each item through the meeting with the HIRA related officials. Drug rebalancing is the process by which the KOEDC re-adjust urgent import drug prices that is out of the range. In addition, the center also planned to regularize the drug price adjustment system. It is a policy to enforce the price adjustment repeatedly for all of the urgent imported drugs handled every six months or one year. The center official said, "We will re-adjust drug prices sequentially from items with large difference in profits as discussed with the Ministry of Health and Welfare, and currently reorganizing the entire 17 listed urgent imported drugs, as well as planning regular realignment procedures for 6 months or 1 year".
- Company
- Lilly Korea, certified as a family-friendly company
- by Eo, Yun-Ho Jan 23, 2020 06:15am
- Lilly Korea (CEO Alberto Riva) said it has succeeded for receiving the family-friendly company certification, which is given to companies that run family-friendly models, for 10 consecutive years by the Ministry of Gender Equality and Family. The Family-Friendly Certification System, through the screening of the Ministry of Gender Equality and Family, provides certification to companies and public institutions that run family-friendly models to balance work and family with workers, including childbirth and nurturing of children, flexible working hours, and the creation of a family-friendly workplace culture. Lilly has been certified as a family-friendly company for 10 consecutive years, beginning with the first certification in 2011 and continuously receiving excellent evaluations every three years. In last December, the recertification audit was conducted to receive family scores for management awareness of the family-friendly culture, high scores for childbirth and childcare, and to continue to be certified as a family-friendly company. On the other hand, Lilly Korea is operating various in-house systems that provide a flexible working environment such as ▲family day, ▲male parental leave, and ▲at-home job. Alberto Riva, the CEO said, “Korea Lilly will continue to lead the creation of a healthy working environment where employees' work and life are balanced, as has been practiced for the past 10 years. Furthermore, it will be an example of a family-friendly company that strives for healthy living and happiness of community members".
- Policy
- SK Chemicals’ hemophilia drug Afstyla wins MFDS approval
- by Lee, Tak-Sun Jan 23, 2020 06:15am
- Hemophilia treatment Afstyla, developed by SK Chemicals, has won an approval for sales in Korea. The drug has licensed out its technology to Australia-based CSL in 2009. Ministry of Food and Drug Safety (MFDS) has authorized commercialization of Afstyla (lonoctocog Alfa (recombinant Factor VIII)) on Jan. 20. The licenser is Zanovex Korea, a subsidiary of global pharmaceutical distributor Zuellig Pharma. SK Chemicals’ blood product-manufacturing subsidiary, SK Plasma would be in charge of the sales in Korea. The U.S. Food and Drug Administration (FDA) granted approval on Afstyla in May 2015, and European Medicines Agency (EMA) also approved the treatment in January 2017. In Australia, where CSL is based, the treatment received the approval in April 2017. The Korean-developed treatment was approved first in overseas and entering the Korean market later. The drug is a recombinant factor VIII single-chain therapy for hemophilia A, developed by SK Chemicals. After the preclinical phase, the technology was licensed to Australia’s biotechnology firm CSL for all clinical trials. Existing hemophilia A treatments had two separate proteins combined, but Afstyla forms one whole structure with two proteins that improves stability of the treatment significantly and provides an option of twice-weekly dose. Compared to existing treatment options, the treatment apparently has enhanced productivity by ten-fold and doubled the stability. Specifically, Afstyla has doubled the duration of action of alternative options, and shows effect with only administration of twice or three times a week. Most of other hemophilia treatments are administered three to four times a week. However, some say Afstyla’s launch in Korea is late in the game as a once-weekly subcutaneously injected hemophilia treatment was approved in Korea last year and other Korean pharmaceutical companies like GC Pharma are developing investigational drugs. The hemophilia A treatment market in Korea is estimated to be around 150 billion won. While CSL is in charge of Afstyla’s global sales, SK Chemicals receives royalty on global sales and payment for agreed sales milestones. The Korean company is estimated to have earned approximately 6.5 billion won from Afstyla royalty last year.
- Policy
- Pfizer, challenges Velcade’s generic market
- by Lee, Tak-Sun Jan 22, 2020 10:47pm
- Pfizer will show anticancer generics (Pfizer Bortezomib, generic for Velcade) used in multiple myeloma. It is expected to compete with the original drug by Janssen and six domestic generics. The MFDS approved the Pfizer Bortezomib 3.5 mg of Pfizer Korea on the 21st. It is the same ingredient of Janssen Korea’s Velcade (Bortezomib). The difference is that the velcade is attached to the trimer, while the Pfizer’s Bortezomib has monohydrate attached to the main component. In conclusion, the same effectiveness is shown for multiple myeloma and mantle cell lymphoma. The original 'Velcade' is a blockbuster drug that generates about ₩10 billion in sales in Korea. In December 2015, the generic market was opened due to patent expiration, but it has maintained its market share due to the characteristics of the cancer drug market that prefers the original. Moreover, it is licensed as a first-line treatment for patients with multiple myeloma. About 8000 patients with multiple myeloma are known in Korea. Multiple myeloma is a type of blood cancer that occurs in plasma cells, the final stage of maturation of B lymphocytes, a type of white blood cell. Symptoms such as bone pain, and symptoms caused by bone marrow dysfunction. Janssen's Darzalex and Celgene’s Revlimid are available. As Velcade's patent expired in December 2015, generics for Belcade by Chong Kun Dang and Samyang Biofarm launched at a low price. Since then, generics for Boryung, ACE Pharma, Korea United Pharm, and Alvogen Korea have been approved. Seven companies are competing, including the original Janssen. Although there are few competitors, generic sales are still small enough to compete the original. An official of the related company said, "Even if there are few competitors because of the original loyalty in the anticancer drug market, there is no room for generics to enter the market." In this situation, Pfizer has challenged the generic market with imported products. Pfizer is showing a variety of anticancer drugs such as Sutene, Xalkori and Ibrance, and is expected to show its competitiveness as a generic because of the high reliability of domestic medical institutions. It is noteworthy that Pfizer will use the success story as generics in the anticancer market.
