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- 2026-03-11 12:50:48
- Policy
- Pharmbio releases first generic Revolade with reimb in OCT
- by Lee, Tak-Sun Sep 24, 2024 05:46am
- The first generic version of the immune thrombocytopenia treatment ‘Revolade (eltrombopag olamine)’ will be released into the market in October. Pharmbio Korea’s Revolade generic has succeeded in receiving reimbursement listing 1 year after its approval in Korea. The company had been delaying its launch due to the burden of patent infringement, but its recent success in avoiding the patent prompted it to launch the product in full force. According to industry sources on the 23rd, Pharmbio Korea’s Elpag Tab. 25 mg and 50 mg will be listed for reimbursement from October 1st. The items were approved in March last year. As a rare disease drug used for thrombopenia, Elpag Tab is a generic version of Novartis’s Revolade. Although Revolade's product patent has expired, 3 composition patents are listed on MFDS’s green list, making it difficult for latecomer generics to enter the market. Pharmbio Korea and SK Plasma sought to evade Revolade ‘s substance patent by filing for a passive trial to confirm the scope of the patent. The Intellectual Property Trial and Appeal Board ruled in favor of the generic companies’ claims in the first half of this year, clearing the patent hurdle. However, the patent dispute is not completely resolved as Novartis immediately filed a following suit to cancel the decision. In this situation, Pharmbio has decided to preemptively launch its product through reimbursement listing. Revolade treats immune thrombocytopenia (ITP), a type of bleeding disorder, by stimulating platelet production. ITP is an autoimmune disease in which the immune system mistakes the body’s platelets as foreign and attacks them. According to IQVIA, Revolade’s domestic sales amounted to KRW 9 billion last year. Pharmbio is challenging the original drug with a lower price. It has applied for a drug price lower than the calculated price, setting the price at KRW 22,849 for Elpag Tab 25 mg and KRW 44,405 for Elpag Tab 50 mg. This is 30% lower than the price of the original Revolade 25mg, which is priced at KRW 32,641, and Revolade 50mg at KRW 63,435. In the case of orphan drugs, the price is set at the same level as previously listed drugs. Pharmbio seems to have adopted a strategy to increase its market share through a relatively low price.
- Policy
- AZ's bispecific ab 'Rilvegostomig' vs Keytruda trial
- by Lee, Hye-Kyung Sep 20, 2024 05:51am
- A Phase 3 trial comparing a combination therapy containing 'Rilvegostomig (Trial name: AZD2936),' AstraZeneca's bispecific antibody gathering attention as the next-generation medicine, to 'Keytruda (pembrolizumab),' a type of immunotherapy drug used to treat cancer, will be conducted in South Korea. The Ministry of Food and Drug Safety (MFDS) has approved a Phase 3, randomized, double-blind, multicenter, and global ARTEMIDE-Lung03 study, evaluating Rilvegostomig or pembrolizumab in combination with platinum-based chemotherapy as first-line treatment for patients with metastatic non-squamous PD-L1-positive metastatic non-small cell lung cancer (NSCLC). Rilvegostomig is a PD-1/TIGIT targeting bispecific antibody that AstraZeneca acquired from Compugen, a company specializing in developing bispecific antibodies. The drug targets PD-1 and TIGIT, which are receptors that inhibit anti-cancer T-cell activities. The Phase 3 trial is being conducted worldwide, enrolling 858 patients. In South Korea, the MFDS approval grants the study to enroll 50 patients at Seoul National University, Severance Hospital, Seoul Asan Medical Center, Samsung Medical Center, Seoul St. Mary's Hospital, Seoul National University Bundang Hospital, and Seoul Boramae Hospital. The current clinical trial is a follow-up study of 'ARTEMIDE-Lung01' and 'ARTEMIDE-Lung02' to evaluate the safety of Rilvegostomig. Keytruda will be used as a control drug to Rilvegostomig, and platinum-based chemotherapy (carboplatin, paclitaxel, and lead-paclitaxel) will be used in combination. Participants will use Rilvegostomig 750 mg or Keytruda 200 mg in combination with the participant's choice of a platinum doublet chemotherapy for the first 4th cycle, administering a single dose infusion every 3 weeks. When the patients do not show clinically significant infusion response within 21 days after the second blinded trial treatment, the investigator will choose to immediately administer pemetrexed upon the completion of the blinded trial treatment, followed by administration of cisplatin and carboplatin in all other cycles. AstraZeneca has been conducting the global Phase 3 trial of Rilvegostomig in South Korea for bile duct cancer and NSCLC. Meanwhile, the data from Rilvegostomig's Phase 1/2 ARTEMIDE-01 study (NCT04995523), presented at the 2024 IASLC International Lung Cancer Summit, have shown that the drug induces continual responses and favorable drug tolerance in patients with metastatic NSCLC. When the patients were given a dose of Rilvegostomig 750 mg every 3 weeks in those with PD-L1 tumor proportion score (TPS) of 1%-49% (n=31), it resulted in an overall response (ORR) of 29%, with 38.7% continuing treatment at the time of data cutoff.
- Policy
- Cushing’s syndrome drug Isturisa is approved in Korea
- by Lee, Hye-Kyung Sep 20, 2024 05:51am
- Various doses of ‘Isturisa’ (osilodrostat), a treatment for Cushing's syndrome, are expected to be approved in Korea soon. According to industry sources on the 19th, the Ministry of Food and Drug Safety concluded the safety and efficacy review of Recordati Korea's Isturisa Film Coated Tab 1mg earlier this month and recently completed the safety and efficacy review of the 5mg dose as well. Isturisa was previously approved by the US Food and Drug Administration (FDA) on March 6, 2020, the European Medicines Agency (EMA) on January 9, 2020, and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) on March 23, 2021. Among the three dosage forms available – 1, 5, and 10 mg – the MFDS has completed a safety and efficacy review for the 1 and 5 mg doses. Isturisa has been under review for approval in Korea since November last year after being designated as a Global Innovative products on Fast Track (GIFT) by the MFDS. As the safety and efficacy review is the final step in the approval process, the drug’s approval is expected soon. Isturisa inhibits CYP1181, an enzyme responsible for the final step of the cortisol pathway in the adrenal glands, and was designated as a GIFT product in April 2022, when Novartis' ‘Signifor Inj’ was withdrawn from the market and the only existing treatment option was eliminated. The drug is indicated for the treatment of adult patients with Cushing’s disease for whom pituitary surgery is not an option or has not been curative and is taken orally twice a day. Cushing's syndrome occurs when the body is exposed to excessive amounts of a hormone called glucocorticoids. Glucocorticoids are produced by an endocrine organ called the adrenal glands, which are located on top of the kidneys and can occur when the adrenal glands produce more glucocorticoids than necessary, or when excessive amounts of glucocorticoids enter the body from the outside for various reasons. Cushing's syndrome is characterized by a rounded, moon-shaped face and excessive subcutaneous fat deposits on the back of the neck and shoulders, and is most common in adults between the ages of 30 and 50. It affects women three times more often than men. It can cause health issues such as hypertension, obesity, type 2 diabetes, blood clots in the legs and feet, fractures, a weakened immune system, and depression, and can be diagnosed through a blood test and a 24-hour urine test. Isturisa is also the first FDA-approved drug to work directly on cortisol overproduction by blocking an enzyme known as 11-beta-hydroxylase and preventing cortisol synthesis. The safety and effectiveness of Isturisa were demonstrated in a clinical study involving 137 adult patients, where approximately half of the patients reached cortisol levels within normal limits at Week 24. After Week 24, 71 patients who did not require further dose escalation and tolerated the drug participated in an 8-week double-blind, randomized withdrawal study in which withdrawals were treated with either Isturisa or placebo. Results showed that 86% of the patients in the Isturisa arm maintained cortisol levels within normal limits. On the other hand, only 30% of the placebo arm reached the same result.
- Policy
- MFDS approves Hemgenix for Hemophilia B in Korea
- by Lee, Hye-Kyung Sep 19, 2024 05:48am
- The Ministry of Food and Drug Safety (MFDS) announced on the 13th that it has approved the orphan drug ‘Hemgenix Inj (etranacogene dezaparvovec)’ imported by CSL Behring Korea. Hemgenix is used to treat moderate-to-severe hemophilia B (congenital blood clotting factor IX deficiency) in adults without a history of Factor IX inhibitors. The drug is expected to provide new treatment opportunities for hemophilia B patients by offering a long-term, single-shot treatment option, unlike existing treatments. The MFDS explained that the quality, safety and effectiveness, manufacturing and quality control standards of Hemgenixwere thoroughly reviewed and evaluated scientifically in accordance with the review criteria outlined in the “Act on The Safety of and Support for Advanced Regenerative Medicine and Advanced Biological Products (“Advanced Regenerative Bio Act”),” which enabled the product’s expedited review and prompt introduction into the field. Hemgenix will be subject to long-term follow-up under Article 30 of the Advanced Regenerative Bio Act, which requires pharmaceutical companies to follow up on the occurrence of adverse events for 15 years from the date of administration. The MFDS said, "Based on our expertise in regulatory science, we will continue to make our best efforts to ensure that novel therapies for severe and rare diseases are promptly supplied to patients in Korea.”
- Policy
- Moderna’s COVID-19 vaccine is approved in Korea
- by Lee, Hye-Kyung Sep 13, 2024 05:50am
- A new COVID-19 variant vaccine, which is the only mRNA-based COVID-19 vaccine that will be manufactured domestically (by Samsung Biologics) has been approved in Korea. The Ministry of Food and Drug Safety (MFDS, Minister: Yu-Kyoung Oh) announced on the 11th that it has authorized the manufacturing and sale of ‘Spikevax JN.1’ that Moderna Korea applied for. Like Pfizer's COVID-19 vaccine, which was approved on August 30, Spikevax JN.1 is a vaccine that contains an mRNA designed to express the JN.1 variant antigen as the active ingredient. It is indicated for the prevention of COVID-19 in persons 12 years of age and older and is administered as a single intramuscular injection of 0.5mL. Those who have previously received a COVID-19 vaccine should administer Spikevax JN.1 at least 3 months after his or her most recent COVID-19 vaccination. Samsung Biologics will receive the active pharmaceutical ingredient supplied by Moderna and manufacture the finished drug through filling and labeling, and its domestic manufacture is expected to ensure a smooth supply of the vaccine. The Ministry of Food and Drug Safety said, ‘While strictly examining the safety, effectiveness, and quality of this vaccine, we worked to promptly approve the drug in 2 months so that there would be no disruption to the National Immunization Program for high-risk groups that are scheduled to begin next month.”
- Policy
- Price of Pristiq original and IMDs cut with generic release
- by Lee, Tak-Sun Sep 11, 2024 05:54am
- PfizerThe release of generic versions of Pfizer's antidepressant ‘Pristiq ER Tab,’ has hit not only the sales of the original drug but also the salt-modified version. Korea Pharma launched the first generic version of Pristiq in Korea last month, and the release has also affected the salt-modified drug that was released 4 years ago. According to industry sources on the 9th, the upper insurance price limit of the original Pristiq ER Tab and the salt-modified drug received ex officio adjustments upon the entry of the generic version. The insurance price of the items will remain at 70% of the maximum price for 1 year but then be reduced to 53.55% like the generic’s price. Desvenlafaxine is a serotonin-norepinephrine reuptake inhibitor (SNRI), which is characterized by its low risk of drug interactions and a low risk of side effects such as hypertension and sexual dysfunction. Due to such advantages, the drug has become a popular choice in the antidepressant market. According to IQVIA sales, the original Pristiq generated sales of KRW 7.2 billion last year. With the listing of the generic drug, its upper insurance price limit will be reduced to 70% from September. As a result, the price of Pristiq 50mg ER Tab will be reduced from KRW 1,002 to KRW 702, and Pristiq 100mg ER Tab will be adjusted to KRW 873. This was an ex officio adjustment of the upper limit upon the reimbursement listing of Korea Pharma’s generic drug. The upper limit of the original drug is adjusted to 53.55% of the initial price when a product with the same route of administration, ingredients, and dosage form is introduced for the first time, but then is set at 70% of the original price for one year. In addition to the ‘Pharma Desvenlafaxine ER Tab 100mg’ that Korea Pharma received reimbursement listing last month, the company has listed ‘Pharma Desvenlafaxine ER Tab 50mg’ with reimbursement this month. Both are generic drugs that contain the same active ingredient (desvenlafaxine succinate monohydrate) as Pristiq. The generic listing also affected the price of salt-modified versions of the drug that were released 4 years ago. The price of Whan In Pharm (desvenlafaxine), Myeongin Pharm, Hallim Pharmaceutical, and Nexpharm Korea (desvenlafaxine benzoate) was also reduced to 70% of the initial price. This is because when the price of the development target product (original Pristiq ER Tab) is adjusted, the price of the salt-modified drugs is also reduced together. No price adjustments had been made until now as only salt-modified versions with different ingredient names were listed, with no generic versions. The price of the salt-modified versions was set at 90% of the target product's price upon initial listing. However, generic products were introduced 4 years after the launch of the salt-modified drugs, rendering price adjustments of all the previously introduced drugs inevitable. The salt-modified drugs were developed to avoid patent infringement and introduced to the market in 2020. The patent for the original Pristiq ER Tab expired in October 2022. The price of the original and the salt-modified versions will be reduced to 53.55% after 1 year. An industry official said, “With the launch of the generic, the 4-year coexistence between the original and the salt-modified drug has come to an end. Due to the price cut, sales of the existing drugs will inevitably decline.”
- Policy
- MFDS announces EUA application of new COVID-19 vaccine
- by Lee, Hye-Kyung Sep 09, 2024 05:49am
- An emergency use authorization process is in progress for new COVID-19 vaccines so that the disease control authorities can inoculate using the vaccines in October. On the 6th, the Ministry of Food and Drug Safety announced an application for emergency use approval of the ‘JN.1 variant-response recombinant protein vaccine for the prevention of COVID-19 caused by SARS-CoV-2 virus’. The EUA system allows vaccines requested by the Commissioner of the Korea Disease Control and Prevention Agency to be manufactured and sold for a limited time if there is no approved product in Korea. With the frequent reemergence of infectious diseases that threaten mankind, such as the swine flu and COVID-19, the U.S. Food and Drug Administration (FDA) established the Emergency Use Authorization (EUA) system to exempt the authorization process of medical devices that are in urgent need due to infectious disease pandemics. In Korea, the EUA was first introduced in 2016 for MERS, and during the COVID-19 outbreak, many vaccines and treatments were actively approved using the EUA system. The EUA application notification this time is for 320,000 doses of a new COVID-19 vaccine, which is believed to be Novavax's JN.1 COVID-19 vaccine, which the KDCA signed an agreement for in July. The KCDA said it has secured 5.23 million doses of Pfizer’s vaccine, 2 million doses of Moderna, and 320,000 doses of Novavax’s vaccine, as new COVID-19 vaccines to be used in the 2024-2025 season starting in October. Two of the vaccines that the KDCA procured the most – Pfizer's Comirnaty JN.1 COVID-19 Inj (bretovameran) (Sars-coronavirus-2 mRNA vaccine) and Comirnaty JN.1 Inj (single-dose vial) - have already been granted marketing authorization in Korea. Pfizer had first applied for marketing authorization of ‘Comirnaty Bivalent Inj,’ which is used for the existing pandemic variant, to expedite the approval of the new vaccine, by leaving a GMP review history in place. To receive formal approval for their COVID-19 vaccines, the companies need to submit data on non-clinical trials, clinical trials, quality and risk management plans, and manufacturing and quality control for marketing authorization and review. On the other hand, for EUA, the following requirements need to be satisfied: ▲ the applicant needs to be a drug manufacturer or importer; ▲ demonstrate that the drug is effective against the JN.1 variant of COVID-19 caused by the SARS-CoV2 virus; ▲ demonstrate that the safety and quality of the drug is ensured; ▲ and, in the case of imported products, the products need to have received measures equivalent to approval in a foreign country that conducts drug safety control at a level equal to or higher than that of Korea. During the last COVID-19 outbreak, the EUA system was used to shorten the document preparation period from 30 days to 7 days, the protocol approval and clinical trial period from 90 days to 22 days, and the final review and approval period from 80 days to 30 days.
- Policy
- COVID-19 drug Paxlovid’s price likely to be based on Japan
- by Lee, Tak-Sun Sep 06, 2024 05:48am
- The insurance ceiling price of Pfizer's COVID-19 drug Paxlovid is likely to be set at around KRW 900,000 in Korea. This is similar to its price in Japan. Japan is said to have the lowest price for Paxlovid among the A8 countries. According to industry sources on the 4th, Paxlovid passed the Drug Reimbursement Evaluation Committee (DREC) on the 29th of last month after undergoing economic evaluation. The drug will be registered for health insurance reimbursement benefits after the company negotiates the drug price with the National Health Insurance Service. The key is its price. DREC reportedly deliberated on a price in the KRW 1 million range and approved the drug’s reimbursement as adequate. However, the NHIS is expected to focus on lowering the price further through negotiations, and the final price is likely to be around KRW 900,000. In Japan, which has the lowest price among the A8 countries, 1 set (5-day supply) of Paxlovid is reportedly priced at JPY 99,027. At the current exchange rate, that's about KRW 920,000. It is analyzed that the price, which was initially in the KRW 1 million range, has dropped to KRW 920,000 upon Japan’s yen falling. The NHIS is also expected to negotiate Korea’s drug prices based on Japan’s prices. However, timing is of issue. The NHIS only has about 20 days to negotiate to meet the October deadline set by the Ministry of Health and Welfare. Add to that the Chuseok holiday and the NHIS negotiation team will be under much pressure to lower the price and complete the registration process quickly. Currently, the government purchases the drug, and patients pay KRW 50,000 for the drug. If it is listed for reimbursement at KRW 1 million, at the current co-payment rate of 30%, patients will have to pay KRW 300,000. If this happens, the patients’ out-of-pocket expenses will skyrocket, which will cause a public backlash. This is why the government is pushing to lower the co-insurance rate. On the 3rd, the Ministry of Health and Welfare announced a proposed amendment to the Enforcement Decree of the National Health Insurance Act to reduce the co-insurance rate for patients with infectious diseases. Accordingly, the drug pricing negotiations and the adjustment of the co-insurance rate for Paxlovid will be conducted simultaneously this month. This will determine the final price paid by the patients. “Looking back at the past drug pricing negotiations, I think the price of Paxlovid will be adjusted to a level lower than the price accepted by DREC during the HIRA negotiations,” said a pharmaceutical industry insider, “but unlike the government, Pfizer is not in a hurry, so the NHIS will have a lot to worry about.”
- Policy
- ‘Policy support enabled the prompt approval of Envlo’
- by Lee, Hye-Kyung Sep 04, 2024 05:49am
- The backstory of Daewoong Pharmaceutical's Envlo 0.3mg (enavogliflozin), which is a representative success case of the MFDS’s expedited review process, was introduced recently. The government’s policy support for the commercialization of innovative products was what enabled Envlo’s clinical trial to approval in just 5 years. In general, diabetes drugs that require long-term use take an average of 7 years from clinical trials to approval. However, with MFDS support and Daewoong Pharmaceutical's R&D capabilities, Envlo succeeded in shortening this period to 5 years. The MFDS published the 'Successful Medical Product Commercialization Casebook' and revealed not only Envlo, but also cases such as Roche Korea’s Lunsumio Inj (mosunetuzumab) and Recordati Korea's Qarziba Inj 4.5mg/ml (dinutuximab beta). Envlo Tab= Envlo Tab, the first product to be subject to expedited review, received a quality review in advance through a rolling review process prior to its approval. During the approval review process, the company was able to closely communicate with the reviewer about the submitted data through product briefings and supplementary briefings, and the MFDS ordered data preparation guidance and requested supplementary material in real-time. While the average time to the approval of a new drug in Korea is 314 days, Envlo was approved in 243 days, reducing the time required by 71 days. Based on this, Daewoong Pharmaceutical licensed out Envlo’s technology for KRW 108.2 billion to Mexico and Brazil in February last year and for KRW 77.1 billion to Russia/CIS in December of the same year. The company is currently undergoing approval reviews in 12 countries, including Mexico, Saudi Arabia, and the Philippines. The MFDS said, “The rapid approval achieved by the collaboration of public and private sectors is expected to lead to the overall growth of the domestic pharmaceutical industry in the long run. The expedited review of Envlo was an opportunity to experience the MFDS’s determination to support domestically developed new drugs.” “After being designated as the first drug subject to expedited review, we communicated with the reviewers frequently through briefings and technical consultations, which helped clarify the direction of our future preparations,” said Jong-won Choi, Executive Director of the Development Division at Daewoong Pharmaceutical. ”The approval period was shorter than expected by two months with the help of the rolling review system.” Lunsumio Inj= Lunsumio Inj, a first-in-class CD20 and CD3 bispecific antibody treatment was designated as the No.1 GIFT drug, which allowed the review to begin immediately upon the submission of the application. In particular, the fast-track designation and approval process fostered the conditions for faster access for patients, as domestic approval was prepared without any time lag from overseas regulatory review. The number of patients with recurrent/refractory vesicular lymphoma in Korea increased from 885 in 2018 to 1,770 in 2022, and the number of patients is still increasing every year, increasing the disease burden on society. “We were able to communicate with the reivewee frequently and quickly prepare the necessary materials for the review,” the MFDS said, adding that ”we were able to grant marketing authorization faster than the usual drug license review period.” Qarziba Inj=Qarziba, which is a treatment for high-risk and relapsed/refractory neuroblastoma was eligible to GIFT and other support benefits in the approval process as the No.1 ‘approval-evaluation-drug pricing negotiation project.’ The reviewers from the Expedited Review Division communicated frequently with the company representatives and actively delivered their inquiries and comments on the submitted data. In particular, one of the benefits of GIFT is the opportunity to share opinions through supplementary briefings and frequent non-face-to-face consultations, which can be utilized through wired and wireless communication such as phone calls and emails, as well as opportunities such as product briefings and supplementary briefings. In the case of safety and efficacy, criteria, and test methods, the first round of supplementation was already made, and the reviewers provided detailed and professional counseling in the video supplementation session requested by the company.
- Policy
- Alvogen voluntarily recalls Comtan Tab due to impurities
- by Lee, Hye-Kyung Sep 03, 2024 05:53am
- Single-agent entacapones, which are used for Parkinson's syndrome, are being recalled due to the detection of excess impurities. The issue of drug impurities continues to arise after MFDS has added nitrosamine impurity testing as a quality control test item to strengthen the management of nitrosamine impurities. On March 30, MFDS announced the recall of Alvogen Korea's Comtan Tab 200mg (entacapone) due to the detection of excess NDEA in the post-market stability test. In April, following the company's report that N-nitrosodiethylamine (NDEA) impurities were detected in its single agent entacapone, the MFDS began reviewing safety measures, including setting necessary temporary permissible standards based on the submitted test and inspection results. The MFD introduced the Carcinogenic Potency Categorization Approach (CPCA), which predicts carcinogenic potential based on the structure-activity correlation of molecules, to set standards for nitrosamine impurities as introduced by the European EMA and the U.S. FDA, and updated the daily intake allowance for nitrosamine impurities in Korea based on the standard-setting method. However, in the case of medicines with medical necessity or supply interruption (shortage), a temporary distribution allowance is applied for a certain period of time to address the supply and demand situation. The item being recalled this time is Comtan Tab 200mg with the lot number (expiration date) '2169627 (2026-07-30).’ Currently, there are only 2 items licensed in Korea as single-agent entacapone: Comtan Tab 200 mg and Myungin Entacapone Tab 200mg by Myung In Pharmaceutical. Single-agent entacapone is indicated as an adjunct to levodopa-dopa decarboxylase inhibitors in patients with Parkinson's syndrome whose symptoms do not improve with standard levodopa-dopa decarboxylase inhibitors therapy.
