- LOGIN
- MemberShip
- 2026-05-20 14:21:57
- Policy
- Court dismisses request to revoke Galvus IMD approval
- by Lee, Tak-Sun Jun 08, 2020 06:11am
- Novartis’ request to revoke Korea’s Ministry of Food and Drug Safety (MFDS) approving Hanmi Pharmaceutical’s Vildagle (vildagliptin hydrochloride) has reportedly been dismissed. In May, Novartis has filed a litigation to cancel a drug approval on Vildagle 50 mg tablet, claiming the Korean-made drug did not fulfill the duty to notify the patent owner when processing the item approval. On June 4, the industry reported Seoul Administrative Court has dismissed Novartis’ request to nullify the drug approval. Although the court did not disclose the reason behind the decision, the industry suspects the lack of precedent canceling the ministry’s approval has played a part. Novartis As a result, MFDS’ approval on Vildagle 50 mg tablet would be sustained. Hanmi Pharmaceutical’s Vildagle has been approved by MFDS on Jan. 21 as an incrementally modified version of Novartis’ DPP-4 antidiabetic drug Galvus tablet (vildagliptin). Hanmi Pharmaceutical received the approval except on the indication that Galvus extended the original’s substance patent for. The Korean company argues the drug has evaded the substance patent to be expired on Mar. 4, 2022. Currently, the Intellectual Property Trial and Appeal Board is reviewing the case. Novartis, on the other hand, states the approval on Vildagle was not fairly process, as Hanmi Pharmaceutical disregarded the duty to notify the patentee according to the drug approval-patent linkage system. However, Hanmi Pharmaceutical and MFDS refute the Korean company was not required to notify the multinational company as the item did not infringe the original’s patent. Regardless of the court dismissing the request, Novartis plans to continue addressing the dispute during the litigation. After receiving a pricing of 403 won per tablet in April, Hanmi Pharmaceutical is contemplating on the launch of Vildagle. And Novartis has already filed litigation on patent infringement and injunction against Vildagle before the launch.
- Company
- Celltrion, begins development of Insulin pen biosimilar
- by An, Kyung-Jin Jun 08, 2020 06:11am
- View of CelltrionCelltrion is working with a domestic medical device company to develop an insulin biosimilar. The goal is to secure cost competitiveness and lower dependence on imports by developing a pen-type insulin injection for the first time in Korea. Celltrion’s insulin pipeline was selected as a state-designated project by the Korea Evaluation Institute of Industrial Technology (KEIT). The four-year development will require a total budget of ₩4 billion, of which ₩3 billion will be supported by the government. The two companies focused on developing a pen-type injection that can be automatically administered up to 80 units once. The intention is to commercialize domestic insulin pen-type injections using domestic materials. Celltrion is in charge of insulin biosimilar development and clinical trials, and Poonglim Pharmatech plays a role in charge of developing an auto pre-filled pen type injector that can be used by filling in biopharmaceuticals developed by Celltrion. It will be commercialized by 2025 through four years of research and development. Currently, 96 percent of the global insulin market is taken by Sanofi, Eli Lilly and Novo Nordisk. Biosimilar products are also sold only by Sanofi and Lilly. In the domestic insulin market, there were many opinions that the localization of the product was urgent as Novonordisk occupied 45%. The national assignment project evaluation committee is also known to give a high score to reduce the dependence on imports if 'Korea's No. 1' product with quality and cost competitiveness is released in consideration of such market conditions. Half out of an estimated 463 million global diabetic patients use pen injectors, Celltrion said, adding that the market is annually growing by 9 percent. By 2023, the pen insulin market size is predicted to hit ₩37 trillion. An official from Celltrion said, “The selection of the target for this national project is the result of the recognition of the technological development innovation of both companies and the know-how and development of the market in the future.” "We expect diabetic patients around the world to benefit from more convenient treatments at lower cost."
- Policy
- Abbvie’s Rinvoq was approved
- by Lee, Tak-Sun Jun 05, 2020 06:10am
- Another oral rheumatoid arthritis drug has been approved in Korea. It is Abbvie’s Rinvoq sustained-release tablet 15mg (Upadacitinib). The competing drugs include Pfizer’s Xeljanz (Topacitinib), Lilly' Olumiant (Baricitinib), and Astellas' Smyraf (Peficitinib). On the 4th, the MFDS approved Abbvie’s Rinvoq 15mg as a new drug. It is used to treat moderate to severe active rheumatoid arthritis in adults who do not respond appropriately to one or more anti-rheumatic agents (DMARDs) or who are intolerant. It can also be administered alone or in combination with Methotrexate or other non-biological anti-rheumatic agents (DMARDs), but not with biological anti-rheumatic agents (DMARDs) or other Januskinase (JAK) inhibitors. It is a drug that is administered orally 15 mg once a day regardless of meals. It is more convenient to use than the TNF alpha-blocking injection that is commonly used in rheumatoid arthritis patients. In five cases of Phase III trial, Rinvoq proved effective in rheumatoid arthritis patients. In addition, the response rate was higher than that of the control drug such as MTX monotherapy or placebo group. In Korea, there are a lot of oral drugs of the JAK inhibitor series, such as Rinvoq, Pfizer's Xeljanz, Lilly's Olumiant, and Astellas' Smyraf. They have been approved in Korea and are on the market. Xeljanz recorded sales of ₩14.7 billion based on IQVIA last year, and is competing with TNF alpha blocker in the antirheumatic arthritis market. Olumiant recorded ₩2.2 billion in the market last year. Sales of oral JAK inhibitors are expected to increase significantly if Astellas' Smyraf which was approved in January and Abbvie’s Rinvoq are released in the domestic market.
- Company
- Unpredictable Cancer Committee make all kinds of decisions
- by Eo, Yun-Ho Jun 05, 2020 06:10am
- The expression on all the pharmaceutical companies accepting the final outcome varied as the meeting concluded. But for sure, no one had a perfect game. On June 3, Health Insurance Review and Assessment Service (HIRA) Cancer Deliberation Committee was convened to discuss two immunotherapies, two poly ADP-ribose polymerase (PARP) inhibiting targeted therapies and two multiple myeloma treatments. ◆ Keytruda and Opdivo The decision on MDS’s Keytruda (pembrolizumab) has been deferred yet again. The Committee reviewed granting reimbursement on Keytruda’s five indications, including first-line treatment (monotherapy and combination therapy) for non-small cell lung cancer (NSCLC), monotherapy for second or later-line treatment in bladder cancer, and monotherapy for third or later-line treatment in or refractory classical Hodgkin lymphoma. In the April meeting finally convened after being postponed twice due to COVID-19, the Cancer Committee deferred the decision on the immunotherapy. Although not required, the multinational company submitted an economic evaluation data and financial impact solution plan on using the immunotherapy as a first-line treatment (mono and combination therapy) in patients with non-small cell lung cancer (NSCLC) to better express its commitment to receive the extended reimbursement. Regardless, the committee did not give a satisfying answer, explaining that they did not have sufficient time to review properly. Bristol Myers Squibb (BMS) and Ono’s Opdivo (nivolumab), on the contrary, gave up on the lung cancer indication and won the benefit in Yervoy (ipilimumab) combination therapy. Apparently, BMS and Ono have also submitted an economic evaluation data to secure the coverage on Opdivo plus Yervoy combination therapy. In April, the Cancer Committee cleared the reimbursement on Opdivo for a second-line therapy for relapsed or metastatic head and neck squamous cell carcinoma (HNSCC) and a second-line therapy for classical Hodgkin lymphoma (CHL), but denied the indication on second-line renal cell carcinoma therapy and third-line stomach cancer therapy. And at the latest meeting, the committee gave a nod to Opdivo’s indication to treat renal cell carcinoma as a first-line therapy. After receiving the first reimbursement as a second-line therapy in patients with NSCLC in September 2017, Opdivo has taken three years to pass the Cancer Committee. ◆Lynparza and Zejula Without a surprise, the Cancer Committee’s answer to PARP inhibitor’s indication on BRCA-negative patients was ‘no.’ AstraZeneca’s Lynparza (olaparib) and Takeda Pharmaceutical’s Zejula (niraparib) were half-successful in the end. The Cancer Committee reviewed Lynparza’s tablet indicated to as a maintenance therapy following a first-line therapy in patients with BRCA-mutated advanced ovarian cancer, second or later-line treatment in platinum-sensitive patients with relapsed high grade serous epithelial ovarian, treatment in patients with HER2-negative metastatic breast cancer. The committee recognized the need for first and second-line maintenance therapy in BRCA-mutated ovarian cancer, but ruled out mBRCA-negative patients included in the second-line therapy indication. Also, the committee seemed skeptical of the breast cancer indication. Zejula also had a similar outcome. The review was on using the drug as maintenance therapy of patients with gBRCA-negative high-grade serous relapsed ovarian cancer who showed complete or partial response in platinum-based chemotherapy, and as monotherapy in patients with relapsed ovarian cancer who previously received fourth-line or later chemotherapy. Ultimately, only the fourth-line monotherapy indication was approved, while the gBRCA-negative indication failed. The government is still conservative about an anticancer treatment indicated to treat ‘all comers.’ ◆ Revlimid and Pomalyst Multiple myeloma treatments seem to be struggling with maintenance therapy. Deferred by the Cancer Committee last September, Revlimid (lenalidomide) once again requested a review on extended coverage on a maintenance therapy to prevent relapse in patients who had stem cell transplantation, which was not granted. The combined company of Bristol Myers Squibb (BMS) and Celgene offered a financial impact solution plan for the coverage on the maintenance therapy indication, but the committee did not change its mind. However, the committee green-lit the reimbursement on Pomalyst (pomalidomide) as a second-line therapy, extended from the current coverage on third-line therapy. Specifically, the approval was granted on the Pomalyst, Velcade (bortezomib) and dexamethasone combination therapy in patients with multiple myeloma, who have previously received one or more treatment including Revlimid. With the latest approvals, BMS and Celgene combined have received approval on two out of three items in the first Cancer Committee meeting held since their merge.
- Company
- General Hospitals to prescribe AbbVie Skyrizi with coverage
- by Eo, Yun-Ho Jun 05, 2020 06:10am
- General hospitals are ready to prescribe now listed Skyrizi, the fourth interleukin inhibitor in the Korean market. Pharmaceutical industry sources reported drug committees (DC) at Korea University Ansan Hospital, Soonchunhyang University Bucheon Hospital, Design Hospital, Gangnam Severance Hospital, Dankook University Hospital, Hallym University Kangnam Sacred Heart Hospital and Korea University Guro Hospital have cleared interleukin-23 (IL-23) inhibitor Skyrizi (risankizumab) for the treatment of patients with severe psoriasis. Skyrizi has been listed for National Health Insurance (NHI) reimbursement from June 1. The coverage would be granted to patients with chronic psoriasis at a severe level expressed for over six months, who show symptoms of plague psoriasis on 10 percent and more of their body surface area, score 10 or higher on Psoriasis Area and Severity Index (PASI) and demonstrate no reaction to three months of or longer administration of methotrexate (MTX) or cyclosporine or cannot maintain the therapy due to adverse reaction, or demonstrate no reaction despite receiving UVB phototherapy for over three months or cannot maintain the therapy due to adverse reaction. From now on, Korea’s interleukin inhibitor drug market would be divided among four competitors including Novartis’ IL-17A inhibitor Cosentyx (secukinumab), Lilly’s IL-17 inhibitor Taltz (ixekizumab) and Janssen’s IL-23 inhibitor Tremfya (guselkumab), as well as Skyrizi. All four drugs have been first approved as a psoriasis treatment, but they are respectively expanding their indications in autoimmune disease sector. Professor Youn Sang Woong of Department of Dermatology at Seoul National University Bundang Hospital said, “Skyrizi has outstanding benefit in skin condition improvement, safety and convenience, which would greatly help patients to achieve their most wanted goal of maintaining clean skin for a long time.” Skyrizi has confirmed efficacy and safety in treatment through four clinical trials including UltIMMa-1, UltIMMa-2, IMMvent and IMMhance studies. The UltIMMa-1 and UltIMMa-2 studies found 75 percent of patients using Skyrizi have reached 90 percent skin improvement (PASI 90) at week 16, and 36 percent and 51 percent of patient groups in respective studies have shown 100 percent skin improvement (PASI 100). Analyzing the patients who received Skyrizi during the two trials, the treatment effect in most of the patients who demonstrated PASI 90 and PASI 100 has been maintained even after a year.
- Policy
- Remdesivir's special import was decided
- by Lee, Tak-Sun Jun 05, 2020 06:10am
- RemdesivirThe special import of Gilead’s Remdesivir was decided. It will be used in severely hospitalized patients infected with the COVID-19. The MFDS (Minister Lee Eui-kyung) decided to import special cases for Remdesivir, which is being developed as a treatment for COVID-19, and accordingly, the KCDC (Director Eun-Kyung Jung), announced on the 3rd that it is planning to negotiate with the MFDS and Gilead science Korea as soon as possible In the special drug import system, the MFDS imports unlicensed drugs from the country through importers at the request of the relevant ministries in order to deal with the public health crisis, such as pandemic of infectious diseases. The KCDC requested the special import from the MFDS, as the 'Clinical Committee for Infectious Diseases' proposed the introduction of 'Remdesivir' as a treatment for COVID-19 in Korea. As a result, the MFDS announced that it had decided to import special cases after deliberation by the National Stabilization and Supply Council for Essential Drugs (Disease Management Subcommittee). The MFDS judged that the shortening of the treatment period in severe patients due to the use of Remdesivir was clinically meaningful and that it was necessary to secure additional therapeutic agents. In addition, the US, Japan, and the United Kingdom are also considering the fact that the use of Remdesivir in the COVID-19 Pandemic situation was also considered. The government announced that it will support as much as possible to ensure that the medicines are imported as soon as possible, along with domestic importer Gilead Sciences Korea. Remdesivir is used for COVID-19 confirmed patients through PCR tests, in case of ▲Patients who have 94% or less of oxygen saturation (SpO2) in room air ▲Patients who need supplemental oxygen treatment ▲Non-invasive or invasive machines. It is used for severely hospitalized patients, such as those requiring ventilation or extracorporeal membrane oxygen therapy (ECMO). The total administration period is within 10 days.
- Policy
- COVID-19 vaccine by Inovio was first approved in Korea
- by Lee, Tak-Sun Jun 05, 2020 06:09am
- COVID-19 vaccine is the first clinical trial approved in Korea. It is a vaccine candidate developed by Inovio of the United States and is conducted by theInternational Vaccine Institute (IVI). On the 2nd, the MFDS approved phase I/IIa of IN0-4800, a candidate for COVID-19 vaccine, applied by the IVI. In clinical trials, the safety, tolerability and immunogenicity of COVID-19 preventive vaccine INO-4800 using electroporation after intradermal inoculation in healthy adults will be evaluated. It will be administered to 160 healthy adults in Korea and will be administered at Seoul National University Hospital. Inovio began clinical trials of INO-4800, a candidate for COVID-19 vaccine, in 40 healthy adults since last April. It is expected that the results of Phase I clinical trial will be released soon, and antibodies have been successfully generated in animal studies. INO-4800 is a DNA vaccine that activates immune T cells in the body by inserting a part of COVID-19 gene into the plasmid and a 'transcription factor' to express it as an antigen. It is different from the existing fertilized egg or cell culture vaccine. Currently, the fastest clinical candidate for COVID-19 vaccine in Moderna, the United States, is also a DNA vaccine. The vaccine candidate developed by Genexine in Korea is also a DNA vaccine.
- Company
- Immunotherapy Keytruda faces Cancer Committee once again
- by Eo, Yun-Ho Jun 05, 2020 06:09am
- An immunotherapy Keytruda would be standing before the Cancer Deliberation Committee once again. On June 3, Keytruda (pembrolizumab) would be deliberated by Health Insurance Review and Assessment Service (HIRA) Cancer Deliberation Committee again, although the committee deferred the decision in a meeting finally held on Apr. 29 after COVID-19 postponing the schedule twice. The Cancer Deliberation Committee reviewed granting reimbursement on Keytruda’s five indications, including as a first-line treatment (monotherapy and combination therapy) for non-small cell lung cancer (NSCLC), monotherapy for second or later-line treatment in bladder cancer, and monotherapy for third or later-line treatment in or refractory classical Hodgkin lymphoma. In March 2017, Keytruda monotherapy has been approved as a first-line treatment in patients with NSCLC. And the MSD Korea has submitted an application for reimbursement approval on the monotherapy indication to be used as a first-line treatment in September 2017, and continued the talk with the government for over two years. Regardless of the effort, the talks fell through in September last year. Considering the health authority’s decision, MSD showed its commitment by submitting unasked-for economic evaluation data on the first-line treatment in NSCLC to seek for the reimbursement expansion. But the Cancer Deliberation Committee rather demanded additional data on reducing the cost and deferred the decision. Accordingly, MSD has revised the financial impact resolution plan once again for technically the last negotiation. If Keytruda fails to pass the Cancer Committee this time, the coverage extension discussion on the immunotherapy would highly likely to get pushed aside indefinitely. Keytruda was listed for the first time in August 2017 through a combination of refund and expenditure cap type risk sharing agreement (RSA) based on the PD-L1 expression rate as a standard. The drug is even trying to replace existing first-line chemotherapy option with the immunotherapy as a monotherapy. This holds a significant meaning. If the coverage expansion is granted, then a patient diagnosed with stage IV lung cancer, not subject for targeted therapy with EGFR mutation, could be prescribed with Keytruda.
- Policy
- Permission is increasing prior to the end of PMS
- by Lee, Tak-Sun Jun 04, 2020 10:41pm
- Hanmi's RosuzetEven before the end of PMS (Post marketing surveillance), a lot of new items have been approved through a contract production contract with the original company. Since PMS system in Korea is also provided with the data protection function of the original drug, it is possible to apply for a license for the same ingredient after PMS expires. However, as more and more original companies share item data in order to expand commissioned production, market competition is intensifying even before PMS. According to the industry on the 3rd, 18 new drugs (6 companies) were approved for the hyperlipidemic complex (Rosuvastatin and Ezetimibe) on the 29th of last month. New products have been released in about 3 years since December 2017. The first licensed item for this formulation is Hanmi's Rosuzet. Rosuzet was approved in June 2015. Subsequently, by December 2017, 84 additional drugs with the same ingredients were approved. All of these items, including Rosuzet, are drug for data-based re-evaluation, and were granted PMS until June 7, 2021, in recognition of the new combination of the two ingredients. During this period, the vendor of the item should conduct a post-marketing investigation on a certain patient. If post-marketing investigation is mandatory, data protection rights are also granted to prevent the generic drug of the same ingredient from applying for permission during the PMS period. As expected, until June 7, 2021, the same ingredient generic cannot apply for permission. However, 18 items that received this new license were commissioned and produced by the original PMS-granted original company and shared data, making it possible to enter the market. In 2016, it was approved through Ajou Pharm, which has been approved for Cretrol. Imported original companies do not increase their competitors. However, these days, domestic companies often share it with competitors even though it is a drug that has been granted exclusive rights. As for the sustained-release tablet of the indigestive drug, Mosapride citrate, PMS expires on June 29th, but 50 items of the same ingredient have already been approved. The original company, Daewoong Pharmaceutical, was granted permission to share data and produce it in consignment. Telmisartan, Amlodipine besylate The hypertensive complex Telmisartan-Amlodipine besylate complex also ends PMS on October 30th, but only 30 items have been approved this year. This is because Ildong Pharmaceutical, one of the original companies, is a consigned product. This trend is accelerating in recent years as the calculation of consignments aimed at rapidly entering the market and pharmaceutical companies seeking to increase profits by expanding commissioned production. However, pharmaceutical companies that maintain the No. 1 market share are not happy with the addition of competitors. These are Hanmi Pharm, which owns Rosuzet, and Yuhan, which has a dominant share of Duowell (Telmisartan-Amlodipine besylate) and Gastin CR (Mosapride citrate sustained release tablet). Industry officials said, "This is a result of a combination of Korean development situations driven by lucrative items."
- Company
- Janssen revs up 2 new global trials on lazertinib
- by An, Kyung-Jin Jun 04, 2020 06:14am
- Janssen’s novel anticancer treatment lazertinib licensed out from Yuhan is initiating a new global clinical trial. Prior to a global phase 2 trial, the multinational company is accelerating the investigational drug’s commercialization process with other phase 1 trials. According to a clinical trial registration website ‘clinicaltrials.gov’ by the U.S. National Institutes of Health (NIH) on June 2, Janssen has registered two global phase 1 trials attached to lazertinib. One is an open-label study to investigate absorption, metabolism and excretion of administered 14C-lazertinib and another is assessing effects of CYP450 3A4 inhibitor itraconazole or CYP450 3A4 inducer rifampin on lazertinib. Both trials are testing the drug in healthy adults. Lazertinib, in development as a non-small cell lung cancer (NSCLC) treatment, aims to evaluate its tolerance, safety and pharmacokinetics. The two trials are scheduled to conclude in coming November, but they have not started calling for participants. In 2018, Yuhan licensed out a third generation epidermal growth factor receptor (EGFR) targeted therapy lazertinib to Janssen Biotech. The novel drug is evaluated to have potency to be a second-line treatment in NSCLC patient who developed T790M mutation after taking existing EGFR targeted therapy or a first-line treatment in NSCLC patient who has EGFR mutation. Janssen is currently focused on investigating the potency of combining lazertinib and a bispecific antibody targeted therapy amivantamab that the company started developing after licensing in lazertinib. A large-scale global clinical trial evaluating the amivantamab plus lazertinib combination therapy has started by calling for participants from September last year. By early this year, the trial participant size increased from 400 to 460 and moved up the end point to June 2022. The trial would proceed to next stage when the recommended phase 2 dose (RP2D) is decided. Johnson & Johnson (J&J) has appointed amivantamab and lazertinib as a promising pipeline of the pharmaceutical sector and drew up a blueprint to complete the U.S. Food and Drug Administration (FDA) New Drug Application (NDA) by 2023. The latest registration of the clinical trials could be interpreted as the company consolidating their commitment to commercialize lazertinib. Yuhan, on the other hand, could receive massive milestone payment again within this year with the combination therapy’s phase 2 trial in full motion. In November 2018, Yuhan has signed lazertinib license-out deal with Janssen Biotech and received an upfront payment of USD 50 million (approximately 55 billion won). The Korean company recently received milestone payment of 35 million dollars for the amivantamab combination therapy phase 2 trial. 18 months into the deal, the company generated 85 million dollars. When lazertinib is successfully commercialized, the Korean company would receive up to 1.25 billion dollars for achieving milestones.
