- LOGIN
- MemberShip
- 2026-04-17 00:26:10
- Policy
- There are 17 cases of COVID-19 tx with stem cells worldwide
- by 박상준 May 21, 2020 06:01am
- As world-renowned pharmaceutical bio companies such as Gilead Sciences Korea, Novartis, and Pfizer have announced the development of COVID-19 treatment and vaccines, domestic pharmaceutical companies are also revealing their intentions through various mechanisms and strategies. In particular, it has attracted attention by offering various possibilities from cytokine anti-inflammatory drug candidates through stem cells to drug repositioning and therapeutics that directly target the RNA genome of COVID-19 using RNA interference technology. On the 20th, Bio Korea set up a special session on the development trend of COVID-19 treatment, and provided a place to promote the development of new drugs by sharing precautions for clinical and non-clinical development for treatment development and sharing cases of treatment development by domestic companies. Six sessions of industry-academia, including academic research institutes such as the Institut Pasteur Korea and the Korea Research institute of Chemical Technology (KRICT), and Cellivery, which received attention as an in vivo transport technology for pharmacological substances, participated in this online session. .Soon-wook Song, vice president of SCM Life Sciences, which first published a case study on the development of a stem cell therapy for treatment of COVID-19 (SCM-AGH), explored the possibility that stem cells could be used for COVID-19 treatment through anti-inflammatory functions .▲Stop cytokines, Stem cell anti-inflammatory mechanism "There is a worldwide search for ways to use stem cells for the treatment of COVID-19," said vice president Song ."Currently, clinical trials registered with stem cells called Mesenchymal Stem Cells (MSCs) have been registered worldwide." The number of cases reached 17," he said .Soon-Wook Song Vice President, SCM Life Sciences#"In the first clinical trial of stem cell therapy in China, 10 COVID-19 confirmed patients participated, 7 were included in the stem cell treatment group, and 3 were included in the control group." "Patients who participated in this trial received 1x106 cells / kg stem cells once, and usually started to respond after 2-4 days," he said .It has been found in animal experimental models that stem cell administration reduces inflammatory cytokines that cause cytokine storms and activates immune T cells that are effective in suppressing viruses .COVID-19 confirmed patients are exposed to the immune system's cytokine when the virus penetrates the human body, and the 'cytokine storm' phenomenon that attacks normal cells is expressed ."We have our own original technology for separating stem cells with high purity, and we are producing high-efficiency and low-cost stem cell therapies based on this technology," said Song ."We have already demonstrated its effectiveness in animal models of mild and severe acute pancreatitis with these high-efficiency stem cell therapies," he explained .He said, "In particular, stem cells reduce the inflammatory cytokines TNF-alpha, INF-gamma, IL-1beta, and IL-6, which cause cytokine storms, and increase the anti-inflammatory cytokines IL-4 and IL-10 .And activated T cells ." Also he said, "The expected therapeutic effects of SCM-AGH stem cell therapy are also cytokine storm control," In addition, "regulatory T cells are activated to increase IL-10 secretion, so immune cells such as abnormally activated T- and B-cells can also be regulated." It is expected to induce efficacy .Stem cell therapy is expected to induce the long-term treatment efficacy by rapidly normalizing the patient's immune system," he added .Cellivery, which has recently emerged as a technology for in vivo transport of pharmacological substances, is also developing therapeutic agents with a focus on anti-inflammatory properties .▲Regulate the signal of nuclear location in cells, Possible to suppress hyperinflammatory reaction Dae-Woong Cho, CEO of Cellivery, who announced 'Development of iCP-NI treatment for acute inflammation suppression', said, "Intracellular transmission of a nuclear localization signal can suppress inflammation by regulating the expression of cytokines / chemokines." "COVID-19 induces a cytokine storm, leading to death, and excessive inflammatory cytokines and chemokines can lead to destruction of bronchial and alveolar tissue, leading to permanent lung damage, such as lung fibrosis," he said .Dae-Woong Cho, CEO of Cellivery#"The iCP-NI, which we are developing, aims to regulate the expression of excessive inflammatory cytokines and chemokines," he said ."The nuclear location signal transmitted into the cell prevents stress-responsive transcription factors (SRTFs) from moving from the cytoplasm to the nucleus .It is a mechanism to limit and suppress the inflammatory response." As a result of animal experiments, iCP-NI showed the effect of regulating the expression of chemokines (MCP-1: -89%) and a cytokine (TNF-α: -79%, IL-6: -91%, IL-12: -110% & IL) in bronchial-alveolar fluid in an inhaled pneumonia model similar to RNA virus infection .-10: + 574%) .In addition, Bleomycin-induced pulmonary fibrosis in animal models reduced pulmonary fibrosis by 50% and iCP-NI protects leukocytes in staphylococcal enterotoxin B and acute pneumonia animal models (CD3+ T cell: 100%, CD4+/CD3+ T cell: 96%, B220+ B cell: 85%, CD45+ macrophage: 100%), and splenocyte cell apoptosis was reduced by 97% .These results indicate that iCP-NI is a potential as a new treatment for inflammation of various infectious diseases such as COVID-19, which is accompanied by cytokine storms and severe sepsis .▲Mutable RNA virus, solved by RNA interference Dong-ki Lee, CEO of Olix, announced the current status of COVID-19 RNA interference treatment .The challenge for COVID-19 is the high rate of RNA-based mutations .This is because vaccine development is not easy due to the possibility of mutation as well as resistance to therapeutic agents ."We are developing treatments for various diseases through our own RNA interference technology .Among domestic companies, only Olix is entering clinical trials with RNA interference technology." said CEO Lee .He explained that RNA viruses have a high variability, so they can easily develop resistance to therapeutic agents, but RNA technology can be used to directly target the viral RNA genome .RNA interference technology has advantages such as targeting a region that is not prone to mutation, or minimizing the possibility of mutation by allowing multiple asymmetric small-interference ribonucleic acids (siRNA) to target the genome at once .In addition, the Institut Pasteur Korea focused on 'Drug Repositioning' that utilize existing treatments in COVID-19 ."There are currently no vaccines or treatments available for COVID-19, and drug repositioning is the only alternative," said Dr .Seung-Tak Kim, researcher at the Institut Pasteur Korea ."To discover, we first screened about 3,000 antiviral drugs against the SARS coronavirus, which was prevalent in 2002 to 2003." He said that 48 FDA-approved drugs were selected and the drugs were tested for SARS coronavirus-2 antiviral activity again .As a result, a total of 24 drugs with significant antiviral efficacy against SARS coronavirus-2 were found.
- Product
- Hospitals ready to prescribe another CDK inhibitor Kisqali
- by Eo, Yun-Ho May 21, 2020 06:01am
- Following after Ibrance and Verzenio, a third cyclin-dependent kinase 4 and 6 (CDK 4/6) inhibitor is landing its prescription code in Korean general hospitals. Pharmaceutical industry sources reported drug committees at eight major general hospitals like Seoul National University Hospital, Seoul Asan Medical Center, National Cancer Center, Korea University Anam Hospital and Konkuk University Hospital have recently cleared Novartis’ Kisqali (ribociclib). While awaiting Drug Reimbursement Evaluation Committee’s (DREC) nod after passing Health Insurance Review and Assessment Service (HIRA) Cancer Deliberation Committee in last January, Kisqali is preparing for prescription code-in process at major hospitals. Unlike Ibrance (palbociclib) and Verzenio (abemaciclib), Kisqali can be prescribed to premenopausal and postmenopausal patients who have not had an oophorectomy. Phase III MONALEESA-7 study evaluated Kisqali plus endocrine therapy (either an aromatase inhibitor or ovarian function suppression) against existing endocrine single therapy as first-line treatment for pre and perimenopausal women with HR+/HER2- advanced or metastatic breast cancer. The result found that the combination therapy significantly extended patient’s overall survival (OS). Specifically, the study confirmed the patient group receiving Kisqali combination therapy had median progression free survival (mPFS) of 23.8 months, whereas the group receiving endocrine therapy alone had mPFS of 13 months. In an Asian subgroup analysis, Kisqali combination therapy group reached mPFS of 24.7 months, about 14 months longer than endocrine therapy only group. Moreover, MONALEESA-3 study confirmed Kisqali extending the OS of pre and postmenopausal women. At 42 months, estimated rates of survival were 58 percent for Kisqali combination therapy group and 46 percent for fulvestrant alone. Professor Im Seock-ah of Hemato-oncology Department at Seoul National University Hospital elaborated, “MONALEESA-7 was actively proposed and led by Asian researchers. The fact that 30 percent of patients registered for the clinical study were Asians reflects the demand for new breast cancer treatment option for premenopausal patients is high in the Asian region.”
- Company
- Promising shingles vaccine market halved by COVID-19
- by Chon, Seung-Hyun May 21, 2020 06:01am
- Product images of Sky Zoster (left) and Zostavax The Korean shingles prevention vaccine market has halved this year. SK Bioscience' Sky Zoster has been maintaining high growth since its launch in 2018, but the market itself plummeted recently due to the COVID-19 outbreak. According to pharmaceutical market research firm IQVIA, this year’s first quarter shingles vaccine market marked 12.2 billion won taking a 37.8-percent fall from last year’s first quarter generating 19.7 billion won. Compared to last year’s fourth quarter making 27.9 billion won, the overall shingles vaccine market shrunk by 56.1 percent. Currently, Zostavax by MSD and Sky Zoster by SK Bioscience are the only two shingles preventive vaccines in Korea. Zostavax was dominating the market initially, until Sky Zoster came about in the market in late 2017. The first quarter shingles vaccine market has hit a historic low since Sky Zoster was launched. Quarterly review on shingles vaccine market (Unit: KRW 1 million) Source: IQVIA Apparently, the spread of COVID-19 has significantly impacted the preventive vaccine market. First, the vaccine recipients refrained from visiting healthcare institutes and lowered the number of vaccination. And the fact that it was not an urgent treatment, but a preventive vaccine could have influenced the users avoiding the vaccination. After Sky Zoster was introduced, the shingles vaccine market continued to grow. The market volume skyrocketed by 16.3 percent in merely two years from 24 billion won in the fourth quarter of 2017 to 27.9 billion won in the fourth quarter of 2019. As Sky Zoster is priced about 10 percent lower than Zostavax, the market had even bigger surge in use. But the volume plunged when COVID-19 started disturbing the market. Quarterly review on Zostavax and Sky Zoster sales (Unit: KRW 1 million) Source: IQVIA The research firm reported both Zostavax and Sky Zoster took a steep fall in sales volume. Zostavax made 7.3 billion won in the first quarter, which was 39.3 percent less than last year first quarter and 56.9 percent less than the last fourth quarter. Sky Zoster made 4.9 billion won, generating 35.5 percent less than last year. From the last fourth quarter, the Korean-made vaccine took a sharp 55.0 percent dip. Taking the steep fall together, Zostavax and Sky Zoster respectively maintained about the same market share as previous quarter. Sky Zoster’s first quarter market share marked 40.3 percent, when the previous quarter marked 39.3 percent.
- Policy
- Lilly’s Baricitinib begins clinical trial of COVID-19
- by Lee, Tak-Sun May 21, 2020 06:00am
- Global pharmaceutical company Eli Lilly's rheumatoid arthritis treatment, 'Baricitinib' (Olumiant) is conducting sponsor-investigator trials on COVID-19 patients. So far, 10 drugs have been approved for clinical trials in COVID-19 patients, including Baricitinib. The MFDS approved a sponsor-investigator trials investigating COVID-19 for Baricitinib submitted by Seoul National University Hospital on the 18th. The trial will be conducted from May 2020 to March 2023, and will target 1032 COVID-19 confirmed patients worldwide. In Korea, it will be held at Seoul National University Hospital and Bundang Seoul National University Hospital for 100 patients. Baricitinib is the ingredient name of rheumatoid arthritis treatment drug 'Olumiant', which was released in December 2017 by Lilly Korea. Baricitinib is expected to be a potential COVID-19 treatment and is being tested in clinical trials worldwide. The anti-inflammatory effect of Baricitinib may help to suppress the COVID-19's reaction in the human body, Lilly said. In addition, the National Institutes of Health (NIH) recently launched sponsor-investigator trials to see if Gilead's Remdesivir and Baricitinib can be used to treat COVID-19 infection. With the clinical approval of Baricitinib, the number of drugs that have been approved for clinical trials in COVID-19 patients has increased to 10. In Korea, starting with Remdesivir, Abbvie's AIDS treatment Kaletra, Hydroxychloroquine praised by US President Trump, asthma treatment Alvesco inhaler, Shinpoong's malaria drug Pyramax, EC-18 by Enzychem, SK Chemicals' Futhan, Young Poong’s Ferodil, and Bukwang’s Levovir are conducting clinical trials on COVID-19 confirmed patients. However, no treatment has been proven to be effective in Korea.
- Company
- Anti-smoking treatment at public health centers was stopped
- by 박상준 May 20, 2020 06:12am
- From this year, the provision of smoking cessation treatments, such as Champix, through smoking cessation clinics in public health centers will disappear. The MOHW recently removed the provision of anti-smoking treatment Bupropion and Varenicline services from smoking cessation clinics in public health centers by revising the guidelines for the '2020 Community Integrated Health Promotion Project' (Non-Smoking). This is to prevent confusion and prescription of smoking cessation drugs through hospitals and clinics. #The MOHW established a new nicotine supplement policy through smoking cessation clinics in the public health center. However, if the target patient was prescribed a non-smoking treatment drug at a health center or clinics, the prescription of nicotine supplements was restricted. It is a policy to establish a system linkage to check whether smoking treatment has been prescribed before supplements are prescribed. .An official from the Health Promotion Section ( Section chief Young-Ki Jeong) said, "The guidelines have been revised because there has been confusion about the provision of smoking cessation drugs at smoking cessation clinics and health centers registered in the hospital's smoking cessation treatment business can prescribe smoking cessation treatments by doctors." However, the number of non-smoking patients who visited medical institutions due to the COVID-19 crisis has plummeted .As a result of the Medical Times coverage, the number of patients who quit smoking in hospitals in February and March this year has dropped by nearly 40% .Of the 14,000 hospitals registered for the NHIS' smoking cessation treatment business, 18, 811 patients registered in February, and 15,683 in March .#This is a decrease of 26.2% and 39.7%, respectively, compared to 25,496 in February and 25,972 in March from the previous year (2019) The prescription of anti-smoking drugs for Bupropion and Varenicline prescribed by the hospital should be reduced .According to data released by National Assembly Auditor Seung-hee Kim of the United Future Party in September of last year, the prescription amount of 'Champix' (Varenicline, Pfizer), the absolute strongest in anti-smoking treatment, In 2016, decreased from ₩39.1 billion to ₩50.7 billion in 2017, ₩37.2 billion in 2018, and ₩9.9 billion in January-June 2019 .Combined prescription amount of 'Wellbutrin SR 150mg' (GSK, Bupropion) and 'Nicopion SR 150mg' (Hanmi, Bupropion), another cessation treatment drugs are ₩1.2 billion in 2016, ₩680 million in 2017 , ₩810 million in 2018, and ₩3.3 billion in January-June 2019 .Patches, gums, etc .were only ₩350 million in 2016, ₩280 million in 2017, ₩240 million in 2018, and ₩100 million in January-June 2019 .An official from the Insurance Benefits Division (Section chief Jung-gyu Lee) said that patients who quit smoking in hospitals have decreased due to the unexpected COVID-19 situation, and it is expected that the amount of prescription for smoking cessation treatment will also be reduced .also he added that the exact numbers will need to be calculated .The MOHW is currently in the process of researching the smoking cessation treatment business as the NHIS as research director .An official in charge of the Insurance Benefits Division added, "The research service project is struggling due to the decrease in the number of non-smoking patients .We will decide the policy direction based on the research results such as improving the success rate of smoking cessation and improving patient incentives." It is pointed out that in the medical community, in order to improve the effectiveness of the smoking cessation treatment business, the treatment consultations fee needs to be improved, and various measures should be taken, such as expanding the scope of prescriptions for anti-smoking treatments such as patches .
- Company
- Yuhan, sell anticancer drug 'Glivec' with Novartis
- by Chon, Seung-Hyun May 20, 2020 06:11am
- Yuhan jointly sells anti-cancer drug 'Glivec' with Novartis. While Glivec's patent expired seven years ago, its growth slowed, but it intends to secure stable sales and overcome its recent sluggish earnings. On the 19th, Yuhan announced that it had signed a domestic exclusive sales and joint promotion agreement for Glivec with Novartis. Glivec is an anticancer drug used to treat chronic myelogenous leukemia and gastrointestinal stromal tumors. Yuhan is responsible for joint sales of Glivec with Novartis under this agreement. Glivec had annual sales of ₩80 billion. However, since generics entered after patent expiration in 2013, sales have been somewhat reduced. Glivec Sales Trend by Year (Unit: ₩100 million, Source: IQVIA) According to drug research firm IQVIA, Glivec's sales last year recorded ₩46.9 billion. It has consistently generated sales of ₩40 billion, including ₩43.3 billion in 2015, ₩45.8 billion in 2016, ₩45.9 billion in 2017, and ₩43.3 billion in 2018. Currently, six companies including Hanmi, Chong Kun Dang, Boryung, and Dong-A ST are selling Glivec's generics. Yuhan is expected to benefit from Glivec's domestic copyright. Yuhan has recently performed poorly in the prescription market. Sales amount in the first quarter were ₩303.3 billion, down 11.3% from the previous year. The prescription drug division, which accounts for more than 60% of total sales, is showing a severe slump. In the first quarter, Yuhan's prescription drug sales fell 13.3% YoY to ₩193.7 billion. Compared to the previous quarter (₩255.3 billion), prescription drug sales fell 24.1%. It means that about a quarter of sales of prescription drugs disappeared in three months. As sales of Glivec amounted to about ₩50 billion a year, Yuhan could overcome the sluggish prescription drug sales. It is also evaluated that the sales of Glivec also provided an opportunity to accumulate anti-cancer drug sales know-how. Yuhan has some anticancer drugs, but has no experience in handling anticancer drugs with a large sales volume. Yuhan is conducting a clinical trial for commercialization of 'Lazertinib', an anticancer drug that has been transferred to Janssen. The company expects that after Yuhan boosts its anticancer drug sales capabilities, it will be able to create synergies if Lazertinib gets domestic approval.
- Opinion
- [Reporter’s View]Raising the voice of rare disease patients
- by Eo, Yun-Ho May 20, 2020 06:11am
- Seems like rare diseases put patients in utmost pain, because of its ‘rarity.’ Rare disease treatments can hardly prove cost-effectiveness and predictability with limited patient size for the reimbursement listing approval. Regardless, the Korean government is aware of the struggle. The revised drug pricing system the Ministry of Health and Welfare (MOHW) unveiled is in process of legislative preannouncement until June 11. The key revision in the new drug pricing system is to expand eligibility in pharmacoeconomic evaluation (PE) exemption and RSA. The revision would stipulate the Korean government to sign risk sharing agreement (RSA) not only with first-in-class drugs, but also with follow-on drugs. And also the revision would expand subjects for PE exemption and coverage with phase III clinical evidence in development. Even the PE exemption, previously restricted to anticancer and rare disease treatments, would be applicable on National Essential Drugs, such as tuberculosis treatment, antibiotics and emergency antidotes. However, many of the public claim rare disease treatments would still face various obstacles before receiving RSA and PE exemption benefits. In Korea, rare disease is defined as a disease with patient size less than 20,000 with difficulties in diagnosis to survey accurate number of patients. The affected patients are desperate to get access to life-saving treatment as the diseases are difficult to diagnose and treat, but many of the diseases cannot even start a clinical study with barely sufficient number of patients. Pharmaceutical companies are hesitant to develop a novel drug for rare disease, as the limited number of patients means limited marketability, while the chances of successfully proving the cost-effectiveness of the drug through PE would be thin. Many countries around the world are introducing regulatory exceptions in legislation, special approval or reimbursement listing for better access to rare disease treatments. Korea has also provided regulatory exceptions like medically essential drug management, PE exemption system and RSA in reimbursement listing or drug pricing. Regardless, the limitations to treatment access still exist. In fact, data comparing listing rate by each drug type before and after implementing RSA and PE exemption systems for bettering the access to high-cost treatments showed a significant improvement in general drug (79.6 percent to 98.6 percent) and anticancer treatment (77.1 percent to 91.7 percent), but the improvement in rare disease treatment (71.1 percent to 71.4 percent) was rather unnoticeable. As a solution to the much needed access to rare disease treatment, some argue the PE exemption eligibility should be expanded for the rare disease treatment. They say the reimbursement review system should be flexible to exempt PE or adjust the number of PE sample patients similar to the special case reimbursement standard, when a drug has no other alternative option or has been approved with placebo-controlled study results. For instance, the U.S. Food and Drug Administration’s (FDA) Breakthrough Therapy Designation (BTD) or European Medicines Agency’s (EMA) Priority Medicine (PRIME) designation could be referred as a review standard. The PE exemption system aims to provide patients the access to rare disease and anticancer treatments unable to produce PE data, while protecting the initial purpose of positive listing system. So to serve its purpose, the Korean health authority should contemplate on the flexibility of the healthcare reimbursement listing procedure. Same goes for RSA. Compared to numerous anticancer treatments that received coverage through RSA, many of rare disease treatments have failed in passing the barrier to RSA due to lack of PE data. As far as quality-adjusted life-year (QALY) goes, the majority of rare diseases results in severe physical damage in patient’s body, lowers quality of life, and shortens life expectancy. And because of extremely small number of users, rare disease treatments are inevitably high-priced and show poor cost-effectiveness. The rare disease treatments can hardly prove cost-effectiveness, when applied with incremental cost-effectiveness ratio (ICER) thresholds on par with other general drugs. The regulation stipulates the health authorities to flexibly set ICER thresholds on rare disease treatments, but the drugs are challenged with PE barriers higher than that of anticancer treatments due to their practices so far. This is why many urge more adaptable ICER thresholds should be given to rare disease treatments for their PE. When the Rare Disease Management Act came in effect in 2015, the Korean government designated May 23 as the Rare Disease Day to raise awareness and understanding of patients fighting against rare diseases. Rare diseases have a handful of treatments for a handful of patients, which is why the voice to demand their healthcare benefit is so easily lost. Hopefully in the near future, the government and pharmaceutical companies would pay a closer attention to those patients, as much as they do for cancer patients.
- Company
- Daewon launches bone forming biosimilar Terrosa
- by Nho, Byung Chul May 20, 2020 06:11am
- On May 18, Daewon Pharmaceutical (CEO Baek Seung Ryel) announced the launch of a biosimilar treating patients with osteoporosis, Terrosa cartridge injection,. Richter-Helm BioTec, a joint venture between a German-based company Helm and a Hungarian-based company Gedeon Richter, has developed biosimilar Terrosa with an active ingredient teriparatide. Eli Lilly’s Forsteo (U.S. brand name Forteo) is the originator of the product. A recombinant human parathyroid hormone (PTH) drug, Terrosa is indicated to treat both postmenopausal women and men with osteoporosis in high risk of fracture. By increasing the number of osteoblasts in bones, the biosimilar forms bones and demonstrates outstanding effect of reducing risk in osteoporotic fracture. Phase 1 and 3 clinical studies conducted in Europe and Japan have confirmed the drug’s significant effect of increasing bone mineral density in lumbar, femoral neck and total hip. As a bone builder, the drug has effect of increasing bone mass superior than other bone absorption inhibitors and it received four years of post-marketing survey period after being listed as a bioequivalent biologic confirmed via bioequivalence test. The self-injected once-daily injection pen can be reused with replaceable cartridge. The sturdy aluminum body of the injection pen is intricately designed to protect the product from external damage. Daewon Pharmaceutical official stated, “Terrosa is a meaningful addition to Daewon Pharmaceutical’s line up not only as the company’s first bio drug, but also as the first teriparatide biosimilar to be released in the Korean market,” and “besides confirmed efficacy and safety, the biosimilar is expected to lessen the financial burden on patients with its competitive pricing.” With the approximate patient size of one million in Korea only, the osteoporosis treatment market in Korea is projected to be worth around 200 billion won and specifically the injectable market is worth about 70 billion won.
- Policy
- Consult with PM from the development to post-marketing stage
- by Lee, Tak-Sun May 20, 2020 06:11am
- The MFDS (Minister Eui-kyung Lee) expanded the role of the 'product manager (PM)', which has been limited to the permitting step, from the drug development to the post-marketing cycle, in order to increase the predictability of the approval and review process and safety management expertise. Announced on the 18th that it will switch to a one-stop support and management system Accordingly, the 'Product Manager', established in 2009, will manage the entire drug lifecycle, including pre-examination at the development stage, re-examination and risk management after approval. PM is the general manager of the pharmaceutical products of the MFDS, and it manages the history of each stage, such as permits and reviews, operates communication channels between reviewers and developers, and acts as an early recognition of problems to strengthen permit efficiency and predictability. Regulatory authorities such as the United States and Europe also operate item managers and are expanding their role. PM will be managed by the headquarters of the MFDS and new and orphan drugs or high-risk items will be classified as 'Special Management Items', and designated managers with expertise and experience will be differentially managed. Pharmaceutical companies can receive the necessary consultation from the drug development stage to the post-marketing stage through the designated 'PM', and the person in charge can be found on the website of the MFDS. "The expansion of the role of PM is a policy that the MFDS is pursuing with a strong will to advance to an international level of regulatory authority, so we will try to settle early," said Minister Eui-kyung Lee, while communicating with experts such as doctors and pharmacists, we will create an environment where people can use it more safely. ”
- Company
- Samsung Bioepis' SB11 has equivalence with Lucentis
- by Lee, Seok-Jun May 20, 2020 06:10am
- SB11 (Ranibizumab), Lucentis' Biosimilar by Samsung Bioepis has demonstrated equivalence with the original. This is a global phase III for 705 people. SB11 is Samsung Bioepis' first ophthalmic disease treatment. It is also the sixth antibody biosimilar following three autoimmune disease treatments (SB2, SB4, and SB5) and two tumor disease treatments (SB3, SB8). 'Lucentis', original for SB11 is a treatment for macular degeneration and diabetic macular edema developed by Genentech. Currently, multinational pharmaceutical companies Roche and Novartis are selling it, and last year they made a global sales of about ₩4.6 trillion. Samsung Bioepis conducted a comparative study of clinical efficacy between SB11 and Lucentis in clinical trials for a total of 705 neovascular age-related macular degeneration (nAMD) patients from March 2018 to December 2019. The primary efficacy evaluation index (primary endpoint) was set in two ways to determine whether the previously established equivalence margin was met. After the prescription, the maximum corrected visual acuity (BCVA) improvement value was measured for 8 weeks, and then the 90% confidence interval (CI) was checked. In addition, 95% confidence intervals were observed after 4 weeks of macular center thickness (CST) measurements. According to the study results, the BCVA Least Squares mean improved by 6.2 characters in SB11 and the original 7.0 characters. The 90% confidence interval interval (-1.827 ~ 0.219) of the mutual difference (-0.8) met the pre-established range of equivalence (± 3). The least square mean of the 4 week CST change was observed to be SB11 -108.4 micrometers (μm) and the original -100.1 micrometers. The 95% confidence interval interval (-19.446 ~ 2.747) of the inter-difference (-8.3) was included in the pre-established range of equivalence (± 36). Samsung Bioepis plans to start the product licensing phase by applying for sales authorization of SB11 in the US and Europe as early as this year. Samsung Bioepis is expanding the field of biopharmaceutical development with ophthalmic diseases, rare diseases, etc. along with existing autoimmune and oncology treatments based on its product portfolio expansion strategy. In addition to SB11, SB15 (Eylea’s Biosimilar, Aflibercept) is also being developed.
