Clinical considerations for biosimilar antibodies
Tóm tắt
Từ khóa
Tài liệu tham khảo
Revers, 2010, An introduction to biologics and biosimilars. Part II: Subsequent entry biologics: biosame or biodifferent?, Can Pharmacists J, 143, 184, 10.3821/1913-701X-143.4.184
2012
2013
2013
European Medicines Agency, 2005
European Medicines Agency
Schneider, 2008, Toward biosimilar monoclonal antibodies, Nat Biotechnol, 26, 985, 10.1038/nbt0908-985
Schellekens, 2005, Follow-on biologics: Challenges of the ‘next generation’, Nephrol Dial Transplant, 20, iv31, 10.1093/ndt/gfh1085
Revers, 2010, An introduction to biologics and biosimilars. Part I: Biologics: What are they and where do they come from?, Can Pharmacists J, 143, 134, 10.3821/1913-701X-143.3.134
Hu, 2002, Capillary electrophoresis for the analysis of biopolymers, Anal Chem, 74, 2833, 10.1021/ac0202379
Visser, 2013, Physiochemical and functional comparability between the proposed biosimilar rituximab GP2013 and originator rituximab, BioDrugs, 27, 495, 10.1007/s40259-013-0036-3
López Garcia, 2000, NMR structure of the bovine prion protein, Proc Natl Acad Sci U S A, 97, 8334, 10.1073/pnas.97.15.8334
European Medicines Agency
Celltrion Healthcare
EU Clinical Trials Register
Young-Hyuck, 2013, Double-blind, randomized, parallel group, phase III study to demonstrate equivalent efficacy and comparable safety of CT-P6 and trastuzumab, both in combination with paclitaxel, in patients with metastatic breast cancer (MBC) as first-line treatment, J Clin Oncol, 31
Schneider, 2012, Setting the stage for biosimilar monoclonal antibodies, Nat Biotechnol, 30, 1179, 10.1038/nbt.2447
Park, 2013, A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: The PLANETAS study, Ann Rheum Dis, 72, 1605, 10.1136/annrheumdis-2012-203091
Yoo, 2013, A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: The PLANETRA study, Ann Rheum Dis, 72, 1613, 10.1136/annrheumdis-2012-203090
Siegel JP. EMEA Workshop on Biosimilar Monoclonal Antibodies session 3: Clinical issues. Presented at EMEA Workshop on Biosimilar Monoclonal Antibodies, July 2, 2009, London, United Kingdom.
2013
Weise, 2012, Biosimilars: What clinicians should know, Blood, 120, 5111, 10.1182/blood-2012-04-425744
Shaw, 2011, Concerns about the use of biosimilar granulocyte colony-stimulating factors for the mobilization of stem cells in normal donors: Position of the World Marrow Donor Association, Haematologica, 96, 942, 10.3324/haematol.2011.045740
Dumoutier, 2004, Role of the interleukin (IL)-28 receptor tyrosine residues for antiviral and antiproliferative activity of IL-29/interferon-λ1, J Biol Chem, 279, 32269, 10.1074/jbc.M404789200
Smith, 2012, Mouse model recapitulating human Fcγ receptor structural and functional diversity, Proc Natl Acad Sci U S A, 109, 6181, 10.1073/pnas.1203954109
Cohen, 2006, Rituximab for rheumatoid arthritis refractory to anti-tumor necrosis factor therapy: Results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial evaluating primary efficacy and safety at twenty-four weeks, Arthritis Rheum, 54, 2793, 10.1002/art.22025
Delarue, 2013, Dose-dense rituximab-CHOP compared with standard rituximab-CHOP in elderly patients with diffuse large B-cell lymphoma (the LNH03-6B study): A randomised phase 3 trial, Lancet Oncol, 14, 525, 10.1016/S1470-2045(13)70122-0
Cunningham, 2013, Rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisolone in patients with newly diagnosed diffuse large B-cell non-Hodgkin lymphoma: A phase 3 comparison of dose intensification with 14-day versus 21-day cycles, Lancet, 381, 1817, 10.1016/S0140-6736(13)60313-X
Shitara, 2013, Correlation between overall survival and other endpoints in clinical trials of second-line chemotherapy for patients with advanced gastric cancer, Gastric Cancer
2013
Danese, 2013, ECCO position statement: The use of biosimilar medicines in the treatment of inflammatory bowel disease (IBD), J Crohns Colitis, 7, 586, 10.1016/j.crohns.2013.03.011
2013
McCamish, 2013, The continuum of comparability extends to biosimilarity: How much is enough and what clinical data are necessary?, Clin Pharmacol Ther, 93, 315, 10.1038/clpt.2013.17
Schiestl, 2011, Acceptable changes in quality attributes of glycosylated biopharmaceuticals, Nat Biotechnol, 29, 310, 10.1038/nbt.1839
Sundaram, 2011, An innovative approach for the characterization of the isoforms of a monoclonal antibody product, MAbs, 3, 505, 10.4161/mabs.3.6.18090
2012
Xie, 2010, Rapid comparison of a candidate biosimilar to an innovator monoclonal antibody with advanced liquid chromatography and mass spectrometry technologies, MAbs, 2, 379, 10.4161/mabs.11986
Schellekens, 2004, Biosimilar epoetins: how similar are they?, Eur J Hosp Pharm, 3, 243
Sburlati, 1998, Synthesis of bisected glycoforms of recombinant IFN-β by overexpression of β-1,4-N-acetylglucosaminyltransferase III in Chinese hamster ovary cells, Biotechnol Prog, 14, 189, 10.1021/bp970118s
Liu, 2008, Human IgG2 antibody disulfide rearrangement in vivo, J Biol Chem, 283, 29266, 10.1074/jbc.M804787200
Schmelzer, 2002, Hyperosmotic stress and elevated pCO2 alter monoclonal antibody charge distribution and monosaccharide content, Biotechnol Prog, 18, 346, 10.1021/bp010187d
van den Hamer, 1970, Physical and chemical studies on ceruloplasmin: IX. The role of galactosyl residues in the clearance of ceruloplasmin from the circulation, J Biol Chem, 245, 4397, 10.1016/S0021-9258(19)63808-1
Li, 2001, Thrombocytopenia caused by the development of antibodies to thrombopoietin, Blood, 98, 3241, 10.1182/blood.V98.12.3241
Casadevall, 2002, Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin, N Engl J Med, 346, 469, 10.1056/NEJMoa011931
Casadevall, 2005, Epoetin-induced autoimmune pure red cell aplasia, J Am Soc Nephrol, 16, S67, 10.1681/ASN.2004110959
Jahn, 2009, How to systematically evaluate immunogenicity of therapeutic proteins – regulatory considerations, N Biotechnol, 25, 280, 10.1016/j.nbt.2009.03.012
Remicade® (infliximab)
2006
2013
2012
2008
Medicines and Healthcare Products Regulatory Agency
2006
Medicines and Healthcare Products Regulatory Agency, 2008, Biosimilar products, Drug Saf Update, 1, 8
Niederwieser, 2011, Biosimilar agents in oncology/haematology: From approval to practice, Eur J Haematol, 86, 277, 10.1111/j.1600-0609.2010.01566.x
Kermani
Generics and Biosimilars Initiative
Czech Society of Oncology
Baumgartel, 2013, Austria increases dialogue in order to involve physicians more with biosimilars, GaBI Journal, 2, 8, 10.5639/gabij.2013.0201.003
Cohen, 2006, Managing the expanded use of biologics across therapeutic areas: An example from B-cell targeted therapies, Am J Manage Care, 12, S24
Simoens, 2011, Biosimilar medicines and cost-effectiveness, Clinicoeconom Outcomes Res, 3, 29, 10.2147/CEOR.S12494
2010
Grabowski, 2006, The market for follow-on biologics: How will it evolve?, Health Aff (Millwood), 25, 1291, 10.1377/hlthaff.25.5.1291
King, 2002, Encouraging the use of generic medicines: Implications for transition economies, Croatian Med J, 43, 462
Morelli