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- 2026-07-01 12:03:09
- Policy
- Why is price different btw patent-expired original/generic
- by Lee, Tak-Sun Aug 18, 2022 05:47am
- The drug price will be lowered to 53.55% of the existing upper limit from the 22nd after losing an administrative lawsuit against the drug price lowered by the anticoagulant Xarelto with the government. As a result, it will be the same as the highest price of generics registered last year. However, the drug price of Xarelto 10mg is expected to be about 20 won higher than the original. What is the reason? First, Xarelto 10mg immediately before generic registration was higher in drug price than Xarelto 15mg or Xarelto 20mg. The original three dosages were the same at 2,626 won at the time of initial registration, but just before the generic registration in July last year, the price of Xarelto 10mg was 2,487 won for Xarelto 15mg and Xarelto 20mg was 2,450. This seems to be a strategy to increase the main capacity of 10mg more. However, as the original low dosage exceeded the high-capacity drug price, the generic drug price needed to be adjusted. This is because the upper limit of low-doset products is calculated to be below the upper limit of high-content products if products with the same company, administration path, ingredients, and formulations are already listed. For this reason, the highest price of Xarelto's generic 10mg was registered at 1,312 won which is the same as Xarelto's generic 15mg and 20mg. The original Xarelto is reduced to 53.55% by calculation formula, making 15mg and 20mg the same as the generic high at 1,312 won, while 10mg becomes Xarelto 1,332 won. In 2012, the principle of patent expiration original-generic identification collapsed due to changes in drug price policy. Since the price difference between the original and generic is not large, the impact on the market is expected to be insignificant. In addition, if a generic that meets the standard requirements and registers only 10mg of Xarelto alone is released, the original upper limit is expected to be the same.
- Product
- Settlement of Xarelto price difference
- by Jung, Heung-Jun Aug 18, 2022 05:47am
- Some wholesalers are complaining at pharmacies as they demand that Xarelto, which will be lowered in drug prices, be returned by this week. This is because if the physical return is closed a week ago, there is no inventory to be prepared next week. In the case of Xarelto, wholesale companies seem to avoid returning on paper because the drug price reduction is large and the frequency is also an item. A pharmacist in Gyeongsangbuk-do said, "Large-sized products are intended to receive physical returns. "In fact, they don't believe in drugstore inventories, if so, I think we should provide the deadline for actual return as much as possible until just before the drug price cut." In online malls exclusively for pharmacies, many wholesalers have designated the deadline for actual returns until this week and are announcing it. Some pharmacies have already returned all the goods in accordance with the deadline guided by the wholesale company's manager. If a prescription comes next week, it will guide the patient to revisit. Pharmacist B in Seoul said, "I was told to return the actual product by this week, so I sent it all. "Only the full package is possible, and we proceeded according to the demand that all the divided cases should be filled," he said. " I think we should guide patients to revisit." Still, I can't help feeling anxious," he said. The situation was the same at a pharmacy in front of a general hospital with high frequency of prescriptions. Pharmacists have also contacted pharmaceutical companies to protest, but it is pointed out that the return problem has not been resolved. Pharmacy C, located in front of the general hospital, said, "We were informed that we could not request a physical return until this week and receive compensation for the individual pills. Next week, he also called the pharmaceutical company to protest because it was impossible to manufacture. We haven't received a response yet. Bayer said it was preparing to receive compensation for the drug price, but explained that it had never set a return deadline until this week and informed wholesaler by this week. Bayer said, "We are preparing to compensate for drug prices. Individual compensation is also possible. We did not inform wholesalers of the return deadline until this week.
- Opinion
- [Reporter’s View] Industry sullen over revised PE exemption
- by Eo, Yun-Ho Aug 17, 2022 05:52am
- The pharmaceutical industry is sullen despite the government's announcement of a measure to expand drug coverage, as the so-called measures for expanded coverage are closer to reductions from the industry’s point of view. The main issue lies in the improvement of the pharmacoeconomic evaluation (PE) exemption system that was included in the “Measure to improve patient access and reinforce reimbursement management for high-priced severe disease treatments” that was recently presented by the government. The goal of the improvement is to expand coverage for the pediatric patients. The government added a clause allowing PE exemption for "drugs used to treat pediatric patients that are therapeutically equivalent or has no available treatment option, and demonstrates improvement in quality of life or is otherwise approved by the committee." The added clause excluded the “life-threatening disease” condition required for PE exemptions in pediatric patients. In other words, if drugs used for pediatric patients satisfy the remaining conditions, the PE exemption may be applied even if the condition is not life-threatening. On the surface, it seems like an encouraging improvement. Many multinational pharmaceutical companies and the Korean Research-based Pharmaceutical Industry Association have been requesting the ‘life-threatening’ condition be removed from the eligibility criteria for PE exemptions. In this sense, this exclusion, although limited to pediatric patients, is a valuable step forward. However, a major premise for PE exemptions had also been revised. The government had added the phrase “a small number of eligible patients ” in the revision. This condition had previously been an “OR clause" included in Article 2c of eligibility for PE exemption regulations, along with other clauses such as ‘if a single-arm study was conducted,’ etc. In other words, if the amendment is applied in the current state, all drugs that wish to take the PE exemption track would have to have a small number of patients (as defined as 200 in the current criteria) and receive recognition from the committee for its difficulty in producing evidence to satisfy Article 2c of the regulation. Multinational pharmaceutical companies have been criticizing that this has narrowed the pathway for PE exemptions rather than expanding it. In fact, the KRPIA had issued a statement immediately after the government announced the revision, criticizing that the amended measure “overlooks the fact that it can demotivate companies from developing innovative new drugs and impede access to severe rare disease treatments.” Although such industry complaints are common following government policy announcements, considering the fact that the new government promised prompt listing of anticancer and rare disease drugs upon inauguration, and the non-reimbursed blind spots still exist for drugs that apply for special exemptions, the government needs to consider whether this revision is achieving its original purpose.
- Policy
- KDCA will announce its plan to inoculate bivalent vaccine
- by Lee, Jeong-Hwan Aug 17, 2022 05:52am
- The domestic quarantine authorities plan to announce vaccination plans at the end of this month, including the subject and use of Moderna's bivalent vaccine for COVID-19 omicron. Moderna bivalent vaccine is still in the pre-application stage, and the intention is to make a plan for use in consideration of the effectiveness and safety of vaccines as well as the quarantine situation and the amount introduced in Korea. Baek Kyung-ran, head of the Korea Centers for Disease Control and Prevention, answered reporters' questions at a regular briefing on COVID-19 on the 16th. Moderna's bivalent vaccine "Moderna COVID-19 Spikevax," called the Omicron vaccine, has been officially approved by British health authorities for the first time in the world on the 15th (local time). Specifically, MHRA conditionally approved the use of Moderna bivalent vaccine for additional inoculations (booster shots) for adults. This is the first time that the Omicron variant COVID-19 vaccine has been officially approved by a government agency. The vaccine is effective in preventing both the early round virus that caused the COVID-19 pandemic. Korea is conducting a preliminary evaluation of Moderna bivalent vaccine, and plans to announce a domestic vaccination plan as soon as the official approval review is conducted. Director Baek Kyung-ran said, "We are currently conducting a preliminary evaluation at the request of Moderna regarding Moderna bivalent vaccine. We haven't started any formal deliberations yet," she said. As soon as the review application proceeds, we will announce the use plan at the end of August, considering the effectiveness and safety of the improved vaccine, as well as the quarantine situation, introduction schedule, and quantity.
- Company
- Sanofi to supply flu vaccine Vaxigrip Tetra Nationwide
- by Aug 17, 2022 05:52am
- Sanofi's Korean subsidiary announced on the 16th that it has supplied its flu vaccine Vaxigrip Tetra nationwide on the 10th to mark this year's flu vaccination season. Sanofi supplied its flu vaccine earlier than usual so that those who need vaccinations can be vaccinated safely and effectively in preparation for the 2022-2023 seasonal flu epidemic. Accordingly, Vaxigrip Tetra can be inoculated at public health centers, consignment medical institutions, and major hospitals and clinics nationwide. Vaxigrip Tetra confirmed immunity and safety profiles through a total of six large-scale global clinical trials (four continents including Europe, Asia, South America, and Oceania) involving more than 13,000 people at all ages, including high-risk groups for influenza such as children, pregnant women, underlying diseases, and the elderly. It is the only quadrivalent flu vaccine that has a vaccination efficacy and safety profile targeting only infants, cardiovascular disease patients, and pregnant women. "With the flu epidemic becoming a reality in southern hemisphere countries such as Australia, the flu epidemic is also feared in Korea," said Woo Jae-kyung, general manager of the Korean company's influenza division. "As the COVID-19 pandemic has not spread over the past two years, natural immunity is likely to be reduced and the flu-sensitive population is more important this season."
- Policy
- Novavax vaccine approved for use for 12+ years in Korea
- by Lee, Hye-Kyung Aug 17, 2022 05:52am
- The age eligibility of Novavax’s COVID-19 vaccine will be extended. The Ministry of Food and Drug Safety (Minister: Yu-Kyung Oh) announced that it had approved the Post Approval Change Application for the COVID-19 vaccine ‘Nuvaxovid Prefilled Syringe,’ developed by Novavax and manufactured by SK Bioscience, to change the vaccination age from the previous 18 years older to 12 years or older. Nuvaxovid in teens aged 12 to 17 years will be administered as two 0.5ml doses three weeks apart, the same as the dosage and administration approved for those aged 18 years and older. The MFDS determined it was appropriate to extend the allowed age of administration for Nuvaxovid based on clinical data from a trial conducted on adolescents aged 12 through 17 years. Trial results showed that adverse events observed in those aged 12-17 after receiving Nuvaxovid were generally similar to those in people aged 18 years and older, and were well-tolerated. The most common adverse reactions observed were injection site tenderness/pain, headache, myalgia, fatigue, malaise, nausea, arthralgia, etc. The symptoms were mostly mild or moderate and disappeared within a few days after vaccination. Nuvaxovid showed a 79.5% preventive effect on 1799 subjects (1,205 in the vaccine group, 594 in the placebo group), 6 of which in the vaccine group and 14 in the placebo group were confirmed with COVID-19, 7 days after the second vaccination. Also, the neutralizing antibody titer in 400 subjects who were not infected with COVID-19 two weeks after the second vaccination showed that the neutralizing antibody titer of those aged 12 to 17 (390 people) was 1.46 times that of those aged 18-25 (416 people), meeting the required standard. The MFDS said, “We will continue making our best efforts to provide safe and effective vaccines to our people.”
- Policy
- Generic exclusivity of Ticagrelor terminated but no benefits
- by Lee, Tak-Sun Aug 16, 2022 05:47am
- Brilinta, original for Ticagrelor Anti-thrombotic Ticagrelor have disappeared, but no news of generic benefit has been heard. Since the expiration of material patents in November last year, six pharmaceutical companies, including Chong Kun Dang, have registered their benefits, but pharmaceutical companies that have obtained generic exclusivity or later approved have been hesitant to register their benefits. This is because manufacturing costs are high and marketability is insufficient. According to the industry on the 13th, the general exclusivity period of Ticagrelor's generic will end on the 20th.No pharmaceutical company has applied for benefits on the premise of sales since that day. Ticagrelor's original drug is Brilinta of AstraZeneca. The drug expired its material patent on November 20 last year, allowing generics to enter the market after succeeding in subsequent patent challenges. Contrary to expectations, only six pharmaceutical companies registered their benefits at the time. They include Chong Kun Dang, Genuonescience, Samjin, Hana, Alvogen, and Hutecs. Like them, there were 18 more pharmaceutical companies that succeeded in subsequent patent challenges and obtained generic for exclusivity, but they did not register their benefits. This is because raw material prices are expensive and marketability is insufficient. They were also excluded from the generic for exclusivity list. An industry official said, "It is analyzed that the growth potential is not high as existing anti-thrombotic drugs competing with Ticagrelor are in good shape." "There are many companies that are worried about the balance of payments due to the high cost of raw materials," he said. Last year, the original Brilinta recorded 9.7 billion won in outpatient prescriptions based on UBIST. Pharmaceutical companies that failed to acquire generic for exclusivity have also received permission, but there is no movement to register their benefits. Even after the generic for exclusivity period is over, products can be sold only when the original drug patent challenge is successful, but few companies are active. Currently, 41 Ticagrelor generic companies are licensed, but none of them are seen in pharmaceutical companies that are considering entering the market except Chong Kun Dang, which is licensed for salt change drugs. Even Hanmi Pharmaceutical, Yooyoung and Korea Prime dropped their licenses this year. Some companies are said to have applied for and withdrawn their benefits.
- Opinion
- [Reporter’s View] MFDS opens up, discloses contact info
- by Lee, Hye-Kyung Aug 16, 2022 05:46am
- The Ministry of Food and Drug Safety is changing. The ministry's efforts to transform into an ‘Open MFDS’ as emphasized by Minister Yu-Kyoung Oh since her day of appointment on May 27th, is showing results. After holding 7 ‘ultimate debate’ sessions in June this year, the MFDS also held 16 roundtable meetings and discussion sessions with the industry, associations, and academia, as well as 2 separate public debates for the medical and food sector to prepare '100 tasks for regulatory innovation.' Based on the feedback accrued, the MFDS announced the final 100 tasks for regulatory innovation on the 11th. The Korea Chamber of Commerce and Industry and the Korea National Council Consumer Organization attended the announcement, signifying the deep public-private communication that had been made in its process. A bigger change is that the contact information for each department in the organizational chart on the MFDS’s webpage that had been hidden since February 22nd last year was disclosed again. At the time, the MFDS deleted the contact information of the officials in charge, deciding that regular business was difficult due to the flood of inquiries and complaints made by the general public regarding COVID-19 vaccines and treatments. Complaints followed this deletion of contact information, but the MFDS only repeated its response that it has prepared a main representative number system for inquiries to resolve the difficulty of making contacts arising from the absence of officials in charge and to increase focus on the ministry's review work. Therefore, the inconvenience caused by the lack of communication was entirely borne by the complainant. The introduction of the ‘core time system’ to allow officials to focus on their regular work, had further caused hardships in reaching MFDS officials. However, the contact information for each department in the organizational chart on the MFDS’s webpage has been disclosed since the 8th. Although the core time system will still be in place, the MFDS decided to reduce its period from the previous 7 hours (10:00 a.m.-5:00 p.m.) to 4 hours (11:00 a.m.-3:00 p.m.). On the day of her appointment, Minister Oh said, “The MFDS needs to become a science and technology expert, crisis management expert, and public communications expert. Communications between ministries, departments, and various stakeholders, as well as internal inter-field and inter-function communication, must be encouraged for growth. I will create an open MFDS in which employees can actively communicate, and one that encourages public-private communication and cooperation." Minister Oh had constantly emphasized communication during her official appearances. She said she will listen to various opinions in the process of preparing and implementing the 100 tasks for regulatory innovation. In 100 days after her appointment, Oh’s determination for communication is coming to fruition in various ways. The reporter hopes that the MFDS’s efforts for ‘open communication’ continue.
- Policy
- Why AZ’s vaccine was used as comparator for SKY Covione
- by Lee, Hye-Kyung Aug 16, 2022 05:46am
- The minutes of the Central Pharmaceutical Affairs Council’s meeting that reviewed the first homegrown COVID-19 vaccine - SK Bioscience’s 'hasCovione multi inj.’ – have now been disclosed. The minutes contained discussions on the reason why a vaccine from a different platform was selected as the control vaccine for SKY Covione, whether its safety is acceptable, and on the adequacy of post-approval safety assurance measures. The CPAC meeting that was held on June 26th, whose minutes were disclosed by the MFDS recently, sought counsel on the safety and efficacy of the homegrown COVID-19 vaccine SKY Covione, which applied for manufacture, sale, and marketing authorization in Korea. An employee from SK Biosience’s Andong L House is filling the Sky Covione formulation (Pic: SK Bioscience) On why a vaccine from a different platform was selected as a control vaccine for SKY Covione, the MFDS explained, “Although it is best to use a comparator from the same platform, a recombinant vaccine using the same platform had only been approved in January this year in Korea, and at a similar period in Europe as well.” “The clinical trial for SKY Covione had been approved in August last year, and no approved vaccines were using the same platform at the time. Therfore, the company had to find the most appropriate control vaccine among available vaccines, all of which were being supplied by the state. The multinational pharmaceutical companies have not approved the use of their vaccines as control vaccines, therefore, AstraZeneca’s vaccine was used as control vaccine in consideration of the approval status and availability of vaccines.” The World Health Organization also states that although using vaccines from the same platformas a control vaccine is advisable if the company cannot secure a vaccine from the same platform, it may use other vaccines as control as long it can demonstrate clear immunogenicity compared to that control vaccine. The MFDS said, “Unlike in the past, all of the vaccines for COVID-19 are being contracted and used by the state. This was why it was difficult for latecomers to obtain a control vaccine, and only AZ’s vaccine was available for use as a control vaccine." Explaining how vaccines based on bridging immunogenicity data are approved under the condition that it submits efficacy evaluations, the MFDS added, “The Ministry will add a condition for the drug’s approval to follow-up for a certain period post-approval to evaluate how much infection is prevented after actual vaccination."
- Company
- Will the situation in the Atozet market improve?
- by Kim, Jin-Gu Aug 16, 2022 05:46am
- With the revision of guidelines for treating hyperlipidemia in Korea announced, attention is focused on how it will affect the prescription performance of major drugs. The pharmaceutical industry predicts that the Atorvastatin and Ezetimibe market, which has recently been growing rapidly, will benefit the most from the revision of the guidelines. Domestic pharmaceutical companies that have recently entered this market are also in the midst of preparing marketing and sales strategies with guidelines in mind. ◆ Proactive treatment for patients with high-risk hyperlipidemia According to the pharmaceutical industry on the 9th, The Korean Society of Lipid and Atherosclerosis is planning to officially announce the fifth edition of the "2022 dyslipidemia treatment guidelines" in September. The core of the new guidelines is active treatment for high-risk patients. Patients in stages 1 to 3 of CKD are regarded as high-risk groups and their LDL-C is actively lowered. Currently, the LDL-C level of high-risk patients is lowered to 70, but the revised guidelines lower this target to 50. ◆ The pharmaceutical industry expects Atorvastatin and Ezetimibe to benefit In the case of Ezetimibe, it is expected that its use as a combination therapy with statins will expand in the primary treatment of high-risk patients who are not controlled by Statins alone. In this process, it is predicted that the use of Statin + Ezetimibe will increase. Atorvastatin has a lower burden on the mechanical kidney than other statin drugs such as Rosuvastatin. This is because it is an mechanism of action that is excreted by the liver, not the kidney. Given that the new guidelines see patients with chronic kidney diseases in the first to third stages as high-risk groups, Atorvastatin, which can be used regardless of whether they have kidney disease, is expected to benefit. In the case of Rosuvastatin, as a precaution in use, it is stated in the product manual that do not administer it to patients with severe renal failure. Pitavastatin also includes patients with moderate to severe renal impairment among patients. Atorvastatin and Simvastatin do not include this in the administration indication. ◆Announcement of competitive heating of hyperlipidemia compound, preparing the details that match the guidelines If the guidelines are revised, it is predicted that competition in the Statin+Ezetimibe combination's hyperlipidemia complex market will intensify. According to UBIST, a pharmaceutical market research firm, the performance of Rosuvastatin and Ezetimibe in the first half of the year was 232.9 billion won, up 11.4% from the first half of last year. During the same period, prescription performance of Atorvastatin and Ezetimibe increased 80.6% from 50.3 billion won to 90.8 billion won. The market for Atorvastatin and Ezetimibe is growing explosively with the addition of a large number of generics last year. Until 2020, the Atorvastatin·Ezetimibe combination was one item of Atozet by Organon Korea. Since Chong Kun Dang was approved for Lipilouzet, in October 2020, 113 pharmaceutical companies have entered the Atojet market with generic licenses until June last year. The revision of the guidelines is raising expectations for the growth of the Atorvastatin and Ezetimibe markets. At the same time, it is in the midst of preparing marketing and sales strategies tailored to the revision of guidelines. An official from a pharmaceutical company selling the item said, "We are aware of the revision of the guidelines," adding, "If the guidelines are revised as scheduled, we plan to focus on this part in the second half of the year to further increase prescription performance." Another pharmaceutical company official said, "We expect changes due to the revision of the guidelines to appear first in general hospitals." He explained, "In the local area, we are preparing related details to expand prescriptions tailored to the new guidelines."
