Quality characteristics and nonclinical/clinical profiles of Etanercept BS SC [MA]
| العنوان: | Quality characteristics and nonclinical/clinical profiles of Etanercept BS SC [MA] |
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| المؤلفون: | Jooncheol Kwon, Jineon So, Hiroshi Kyono, Suyeon Ko, Chulho Jung, Sun Young Kim, Shota Kojima, Kayo Haraguchi, Takumi Ota, Park Sang Woo, Sung Mo Yang, Minae Yun |
| المصدر: | Folia Pharmacologica Japonica. 151:261-272 |
| بيانات النشر: | Japanese Pharmacological Society, 2018. |
| سنة النشر: | 2018 |
| مصطلحات موضوعية: | musculoskeletal diseases, 0301 basic medicine, Arthritis, Pharmacology, Etanercept, Arthritis, Rheumatoid, 03 medical and health sciences, 0302 clinical medicine, Japan, Pharmacokinetics, immune system diseases, Humans, Medicine, skin and connective tissue diseases, Quality characteristics, Biosimilar Pharmaceuticals, Tumor Necrosis Factor-alpha, business.industry, Therapeutic effect, Biosimilar, medicine.disease, 030104 developmental biology, Immunoglobulin G, 030220 oncology & carcinogenesis, Rheumatoid arthritis, Tumor necrosis factor alpha, business, medicine.drug |
| الوصف: | Etanercept is a dimeric genetic recombinant glycoprotein consisting of Fc domain of human Immunoglobulin G1 and the extracellular domain of human tumor necrosis factor (TNF) receptor type II. Etanercept exerts therapeutic effects on inflammatory diseases such as rheumatoid arthritis and juvenile idiopathic arthritis by neutralizing biological activities of TNFα/Lymphotoxin (LT) α. Mochida Pharmaceutical and LG Chem have developed syringe, pen, and vial products of Etanercept BS (biosimilar) as the first biosimilar of Enbrel in Japan. The active ingredient of those products "Etanercept biosimilar 1" has the identical primary structure to that of Enbrel. The development of the Etanercept BS, including evaluations of quality attributes, nonclinical and clinical studies was performed in accordance with "Policies on Assurance of Quality, Safety and Efficacy of Biosimilars". The quality attributes of Etanercept BS were similar to those of Enbrel, and the binding affinities to TNFα/LTα, TNFα neutralizing activity, nonclinical pharmacokinetics and toxicological profiles of Etanercept BS were comparable to Enbrel. Additionally, the pharmacokinetic profile and efficacy of Etanercept BS were equivalent to those of Enbrel and there was no clinically significant difference in safety profiles between them in Phase I and Phase III clinical studies. The marketing approval application of the Etanercept BS with the same indications as Enbrel filed by Mochida Pharmaceutical was approved in January 2018 and the products will be launched by Ayumi Pharmaceutical in the near future. The Etanercept BS, which is as highly effective as Enbrel is expected to make beneficial therapies more easily accessible to patients. |
| تدمد: | 1347-8397 0015-5691 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9b2f116b3d76849efcb3ebd626d72e62Test https://doi.org/10.1254/fpj.151.261Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....9b2f116b3d76849efcb3ebd626d72e62 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 13478397 00155691 |
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