悪性リンパ腫におけるフィルグラスチムバイオ後続品「モチダ」と先行バイオ医薬品の前向きランダム化クロスオーバー比較試験
「緒言」Granulocyte colony-stimulating factor (G-CSF)は, 好中球前駆細胞に作用してその増殖を促進させるほか, 骨髄からの成熟好中球の放出促進, 好中球機能亢進することが知られている. G-CSF製剤はがん化学療法において好中球減少期間の短縮, 発熱性好中球減少症(FN)発現率の減少, 入院期間の短縮などに寄与している. G-CSFなどのバイオ医薬品は, 化学合成医薬品と比べて分子量が非常に大きく, また複雑な構造を有している. そのためバイオ後続品はアミノ酸配列が先行バイオ医薬品と同一でも, 医薬品として分子レベルで同一であることを証明することは困...
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| Published in | 医療薬学 Vol. 41; no. 11; pp. 793 - 798 |
|---|---|
| Main Authors | , , , , , , , , , |
| Format | Journal Article |
| Language | Japanese |
| Published |
一般社団法人日本医療薬学会
10.11.2015
日本医療薬学会 |
| Online Access | Get full text |
| ISSN | 1346-342X 1882-1499 |
| DOI | 10.5649/jjphcs.41.793 |
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| Abstract | 「緒言」Granulocyte colony-stimulating factor (G-CSF)は, 好中球前駆細胞に作用してその増殖を促進させるほか, 骨髄からの成熟好中球の放出促進, 好中球機能亢進することが知られている. G-CSF製剤はがん化学療法において好中球減少期間の短縮, 発熱性好中球減少症(FN)発現率の減少, 入院期間の短縮などに寄与している. G-CSFなどのバイオ医薬品は, 化学合成医薬品と比べて分子量が非常に大きく, また複雑な構造を有している. そのためバイオ後続品はアミノ酸配列が先行バイオ医薬品と同一でも, 医薬品として分子レベルで同一であることを証明することは困難である. また, 品質特性において先行バイオ医薬品と類似性が高く, かつ, 品質特性に何らかの差異があっても最終製品の有効性, 安全性に有害な影響を及ぼさないことを非臨床試験, 臨床薬理試験, 品質に関する試験によって証明することで医薬品として承認されている. |
|---|---|
| AbstractList | 「緒言」Granulocyte colony-stimulating factor (G-CSF)は, 好中球前駆細胞に作用してその増殖を促進させるほか, 骨髄からの成熟好中球の放出促進, 好中球機能亢進することが知られている. G-CSF製剤はがん化学療法において好中球減少期間の短縮, 発熱性好中球減少症(FN)発現率の減少, 入院期間の短縮などに寄与している. G-CSFなどのバイオ医薬品は, 化学合成医薬品と比べて分子量が非常に大きく, また複雑な構造を有している. そのためバイオ後続品はアミノ酸配列が先行バイオ医薬品と同一でも, 医薬品として分子レベルで同一であることを証明することは困難である. また, 品質特性において先行バイオ医薬品と類似性が高く, かつ, 品質特性に何らかの差異があっても最終製品の有効性, 安全性に有害な影響を及ぼさないことを非臨床試験, 臨床薬理試験, 品質に関する試験によって証明することで医薬品として承認されている. |
| Author | 友金, 幹視 小林, 裕 魚嶋, 伸彦 藤田, 将輝 澤田, 真嗣 石田, 曜子 藤田, 敦夫 中川, ゆかり 三上, 正 大坪, 達弥 |
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| References | 4) Morstyn G, Campbell L, Souza LM, Alton NK, Keech J, Green M, Sheridan W, Metcalf D, Effect of granulocyte colony stimulating factor on neutropenia induced by cytotoxic chemotherapy, The Lancet, 1988, 1, 667-672. 9) Aapro MS, Cameron DA, Pettengell R, Bohlius J, Crawford J, Ellis M, Kearney N, Lyman GH, Tjan-Heijnen VC, Walewski J, Weber DC, Zielinski C, EORTC guidelines for the use of granulocyte-colony stimulating factor to reduce the incidence of chemotherapy-induced febrile neutropenia in adult patients, Eur J Cancer, 2006, 42, 2433-2453. 1) Gabrilove JL, Jakubowski A, Scher H, Sternberg C, Wong G, Grous J, Yagoda A, Fain K, Moore MAS, Clarkson B, Herbert F, Oettgen, Alton K, Welte K, Souza L, Effect of granulocyte colony-stimulating factor on neutropenia and associated morbidity due to chemotherapy for transitional-cell carcinoma of the urothelium, N Engl J Med, 1998, 318, 1414-1422. 7) Matsuguma K, Matsuki S, sakamoto K, shiramoto M, Nakagawa M, Kimura M, Irie S, Kaneko D, Ohnishi A, A comparative pharmacokinetic and pharmacodynamics study of FSK0808 versus reference filgrastim after repeated subcutaneous administration in healthy Japanese, Men, Clinical Pharmacology in Drug Development, 2015, 4, 99-104. 14) Gershon SK, Luksenburg H, Coté TR, Braun MM, Pure red-cell aplasia and recombinant erythropoietin, N Eng J Med, 2002, 346, 1584-1586. 3) Sheridan WP, Morstyn G, Wolf M, Dodds A, Lusk J, Maher D, Layton JE, Green MD, Souza L, Fox RM, Granulocyte colony-stimulating factor and neutrophil recovery after high-dose chemotherapy and autologous bone marrow transplantation, The Lancet, 1989, 2, 891-895. 16) Iki S, Yoshinaga K, Ohbayashi Y, Urabe A, Cytotoxic drug-induced pneumonia and possible augmentation by G-CSF–clinical attention, Ann Hematol, 1993, 66, 217-218. 15) Locatelli F, Del Vecchio L, Pozzoni P, Pure red-cell aplasia “epidemic”–mystery completely revealed? Perit Dial Int, 2006, 27, S303-S307. 17) Yokose N, Ogata K, Tamura H, An E, Nakamura K, Kamikubo K, Kudoh S, Dan K, Nomura T, Pulmonary toxicity after granulocyte colony-stimulating factor-combined chemotherapy for non-Hodgkin's lymphoma, Br J Cancer, 1998, 77, 2286-2290. 8) Sagara Y, Sato K, Fukuma E, Higaki K, Mizutani M, Osaki A, Takano T, Tokuda Y, Ohno S, Masuda N, Suzuki M, Saeki T, The Efficacy and Safety of FSK0808, Filgrastim Biosimilar, A Multicenter, Non-randomized Study in Japanese patients with Breast Cancer, JPn J Clin Oncol, 2013, 43, 865-873. 10) Lyman GH, Kuderer NM, Epidemiology of febrile neutropenia, Support Cancer Ther, 2003, 1, 23-35. 11) Sorensen PS, Tscherning T, Mathiesen HK, Langkilde AR, Ross C, Ravnborg M, Bendtzen K, Neutralizing antibodies hamper IFNbeta bioactivity and treatment effect on MRI in Patients with MS, Neurology, 2006, 67, 1681-1683. 13) Casadevall N, Nataf J, Viron B, Kolta A, Kiladjian JJ, Martin-DuPont P, Michaud P, Papo T, Ugo V, Teyssandier I, Varet B, Mayeux P, Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin, N Engl J Med, 2002, 346, 469-475. 2) Bronchud MH, Scarffe JH, Thatcher N, Crowther D, Souza LM, Alton NK, Teata NG, Dexter TM, Phase I/II study of recombinant human granulocyte colony-stimulating factor in patients receiving intensive chemotherapy for small cell lung cancer, Br J Cancer, 1987, 56, 809-813. 6) Matsuguma K, Matsuki S, Eunhee C, Watanabe A, Tanaka A, Sakamoto K, Takeshita H, Hitaka A, Shigetome K, Kimura M, Miyamoto A, Irie S, Kaneko D, Ohnishi A, pharmacokinetics and pharmacodynamics of FSK0808 and Gran after single intravenous drip administration or single subcutaneous administration: comparative study in healthy Japanese adult male subjects, Drug Dev Ind Pharm, 2014, 41, 470-475. 12) Hesse D, Sørensen PS, Using measurements of neutralizing antibodies: the challenge of IFN-beta therapy, Eur J Neurol, 2007, 14, 850-859. 5）平成21年3月4日, 薬食審査発第0304007号, バイオ後続品の品質・安全性・有効性確保のための指針（厚生労働省 |
| References_xml | – reference: 2) Bronchud MH, Scarffe JH, Thatcher N, Crowther D, Souza LM, Alton NK, Teata NG, Dexter TM, Phase I/II study of recombinant human granulocyte colony-stimulating factor in patients receiving intensive chemotherapy for small cell lung cancer, Br J Cancer, 1987, 56, 809-813. – reference: 10) Lyman GH, Kuderer NM, Epidemiology of febrile neutropenia, Support Cancer Ther, 2003, 1, 23-35. – reference: 13) Casadevall N, Nataf J, Viron B, Kolta A, Kiladjian JJ, Martin-DuPont P, Michaud P, Papo T, Ugo V, Teyssandier I, Varet B, Mayeux P, Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin, N Engl J Med, 2002, 346, 469-475. – reference: 11) Sorensen PS, Tscherning T, Mathiesen HK, Langkilde AR, Ross C, Ravnborg M, Bendtzen K, Neutralizing antibodies hamper IFNbeta bioactivity and treatment effect on MRI in Patients with MS, Neurology, 2006, 67, 1681-1683. – reference: 7) Matsuguma K, Matsuki S, sakamoto K, shiramoto M, Nakagawa M, Kimura M, Irie S, Kaneko D, Ohnishi A, A comparative pharmacokinetic and pharmacodynamics study of FSK0808 versus reference filgrastim after repeated subcutaneous administration in healthy Japanese, Men, Clinical Pharmacology in Drug Development, 2015, 4, 99-104. – reference: 16) Iki S, Yoshinaga K, Ohbayashi Y, Urabe A, Cytotoxic drug-induced pneumonia and possible augmentation by G-CSF–clinical attention, Ann Hematol, 1993, 66, 217-218. – reference: 15) Locatelli F, Del Vecchio L, Pozzoni P, Pure red-cell aplasia “epidemic”–mystery completely revealed? Perit Dial Int, 2006, 27, S303-S307. – reference: 14) Gershon SK, Luksenburg H, Coté TR, Braun MM, Pure red-cell aplasia and recombinant erythropoietin, N Eng J Med, 2002, 346, 1584-1586. – reference: 8) Sagara Y, Sato K, Fukuma E, Higaki K, Mizutani M, Osaki A, Takano T, Tokuda Y, Ohno S, Masuda N, Suzuki M, Saeki T, The Efficacy and Safety of FSK0808, Filgrastim Biosimilar, A Multicenter, Non-randomized Study in Japanese patients with Breast Cancer, JPn J Clin Oncol, 2013, 43, 865-873. – reference: 17) Yokose N, Ogata K, Tamura H, An E, Nakamura K, Kamikubo K, Kudoh S, Dan K, Nomura T, Pulmonary toxicity after granulocyte colony-stimulating factor-combined chemotherapy for non-Hodgkin's lymphoma, Br J Cancer, 1998, 77, 2286-2290. – reference: 5）平成21年3月4日, 薬食審査発第0304007号, バイオ後続品の品質・安全性・有効性確保のための指針（厚生労働省）． – reference: 1) Gabrilove JL, Jakubowski A, Scher H, Sternberg C, Wong G, Grous J, Yagoda A, Fain K, Moore MAS, Clarkson B, Herbert F, Oettgen, Alton K, Welte K, Souza L, Effect of granulocyte colony-stimulating factor on neutropenia and associated morbidity due to chemotherapy for transitional-cell carcinoma of the urothelium, N Engl J Med, 1998, 318, 1414-1422. – reference: 6) Matsuguma K, Matsuki S, Eunhee C, Watanabe A, Tanaka A, Sakamoto K, Takeshita H, Hitaka A, Shigetome K, Kimura M, Miyamoto A, Irie S, Kaneko D, Ohnishi A, pharmacokinetics and pharmacodynamics of FSK0808 and Gran after single intravenous drip administration or single subcutaneous administration: comparative study in healthy Japanese adult male subjects, Drug Dev Ind Pharm, 2014, 41, 470-475. – reference: 4) Morstyn G, Campbell L, Souza LM, Alton NK, Keech J, Green M, Sheridan W, Metcalf D, Effect of granulocyte colony stimulating factor on neutropenia induced by cytotoxic chemotherapy, The Lancet, 1988, 1, 667-672. – reference: 12) Hesse D, Sørensen PS, Using measurements of neutralizing antibodies: the challenge of IFN-beta therapy, Eur J Neurol, 2007, 14, 850-859. – reference: 3) Sheridan WP, Morstyn G, Wolf M, Dodds A, Lusk J, Maher D, Layton JE, Green MD, Souza L, Fox RM, Granulocyte colony-stimulating factor and neutrophil recovery after high-dose chemotherapy and autologous bone marrow transplantation, The Lancet, 1989, 2, 891-895. – reference: 9) Aapro MS, Cameron DA, Pettengell R, Bohlius J, Crawford J, Ellis M, Kearney N, Lyman GH, Tjan-Heijnen VC, Walewski J, Weber DC, Zielinski C, EORTC guidelines for the use of granulocyte-colony stimulating factor to reduce the incidence of chemotherapy-induced febrile neutropenia in adult patients, Eur J Cancer, 2006, 42, 2433-2453. |
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| Snippet | 「緒言」Granulocyte colony-stimulating factor (G-CSF)は, 好中球前駆細胞に作用してその増殖を促進させるほか, 骨髄からの成熟好中球の放出促進, 好中球機能亢... |
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| Title | 悪性リンパ腫におけるフィルグラスチムバイオ後続品「モチダ」と先行バイオ医薬品の前向きランダム化クロスオーバー比較試験 |
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