References
- Declerck PJ. Biologicals and biosimilars: a review of the science and its implications. GaBI J 2012;1:13-16
- Wang J, Chow SC. On the regulatory approval pathway of biosimilar products. Pharmaceuticals (Basel) 2012;5:353-68
- Abraham J. Developing oncology biosimilars: an essential approach for the future. Semin Oncol 2013;40(Suppl 1):S5-24
- Rinaudo-Gaujous M, Paul S, Tedesco ED, et al. Review article: biosimilars are the next generation of drugs for liver and gastrointestinal diseases. Aliment Pharmacol Ther 2013;38:914-24
- Grabowski H, Guha R, Salgado M. Biosimilar competition: lessons from Europe. Nat Rev Drug Discov 2014;13:99-100
- Chow S-C, Liu J-P. Introduction. In: Design and analysis of bioavailability and bioequivalence studies. Chapman and Hall/CRC, Boca Raton, FL, USA; 2008
- Ahmed I, Kaspar B, Sharma U. Biosimilars: impact of biologic product life cycle and European experience on the regulatory trajectory in the United States. Clin Ther 2012;34:400-19
- Seo JS, Kim YJ, Cho JM, et al. Effect of culture pH on recombinant antibody production by a new human cell line, F2N78, grown in suspension at 33.0 degrees C and 37.0 degrees C. Appl Microbiol Biotechnol 2013;97:5283-91
- Seo JS, Min BS, Kim YJ, et al. Effect of glucose feeding on the glycosylation quality of antibody produced by a human cell line, F2N78, in fed-batch culture. Appl Microbiol Biotechnol 2014;98:3509-15
- European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). Assessment report: Remsima (infliximab) 2013. Available from: www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002576/WC500151486.pdf [Last accessed 16 March 2015]
- Schneider CK. Biosimilars in rheumatology: the wind of change. Ann Rheum Dis 2013;72:315-18
- Schiestl M, Stangler T, Torella C, et al. Acceptable changes in quality attributes of glycosylated biopharmaceuticals. Nat Biotechnol 2011;29:310-12
- Weise M, Kurki P, Wolff-Holz E, et al. Biosimilars: the science of extrapolation. Blood 2014;124:3191-6
- International Conference on Harmonisation (ICH). ICH Harmonised tripartite guideline. comparability of biotechnological/biological products subject to changes in their manufacturing process Q5E 2004. Available from: www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q5E/Step4/Q5E_Guideline.pdf [Last accessed 16 March 2015]
- European medicines agency. Guideline on similar biological medicinal products 2014. Available from: www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf [Last accessed 16 March 2015]
- Zuniga L, Calvo B. Biosimilars: pharmacovigilance and risk management. Pharmacoepidemiol Drug Saf 2010;19:661-9
- Giezen TJ, Mantel-Teeuwisse AK, Leufkens HG. Pharmacovigilance of biopharmaceuticals: challenges remain. Drug Saf 2009;32:811-17
- McCamish M, Moskal Gallagher A, Orloff J. Biosimilar by name and biosimilar by nature. RPM Report 2013
- Covic A, Cannata-Andia J, Cancarini G, et al. Biosimilars and biopharmaceuticals: what the nephrologists need to know–a position paper by the ERA-EDTA Council. Nephrol Dial Transplant 2008;23:3731-7
- Ebbers HC, Crow SA, Vulto AG, et al. Interchangeability, immunogenicity and biosimilars. Nat Biotechnol 2012;30:1186-90
- Ebbers HC, Muenzberg M, Schellekens H. The safety of switching between therapeutic proteins. Expert Opin Biol Ther 2012;12:1473-85
- Narayanan S. SAT0094 Relationship between the duration of rheumatology practice experience and likelihood of use and perception towards biosimilars in rheumatoid arthritis Arena. Ann Rheum Dis 2014;73:624
- Berghea F, Popescu C, Ionescu R, et al. AB1052 biosimilars use in rheumatology - the patient perspective. Ann Rheum Dis 2014;73:1148
- European medicines agency. Guidelines on similar medicinal products containing monoclonal antibodies - non-clinical and clinical issues 2010. Available from: www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500128686.pdf [Last accessed 20 February 2015]
- European Medicines Agency. Remicade (infliximab). summary of product characteristics 2014. Available from: www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000240/WC500050888.pdf [Last accessed 23 February 2015]
- European medicines agency. Remsima (infliximab). Summary of product characteristics 2014. Available from: www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002576/WC500150871.pdf [Last accessed 23 February 2015]
- Jung SK, Lee KH, Jeon JW, et al. Physicochemical characterization of Remsima. MAbs 2014;6:1163-77
- Park W, Hrycaj P, Jeka S, et al. 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 2013;72:1605-12
- Yoo DH, Hrycaj P, Miranda P, et al. 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 2013;72:1613-20
- Shields RL, Lai J, Keck R, et al. Lack of fucose on human IgG1 N-linked oligosaccharide improves binding to human Fcgamma RIII and antibody-dependent cellular toxicity. J Biol Chem 2002;277:26733-40
- Shealy DJ, Cai A, Staquet K, et al. Characterization of golimumab, a human monoclonal antibody specific for human tumor necrosis factor alpha. MAbs 2010;2:428-39
- Park W, Jaworski J, Brzezicki J, et al. A randomised, double-blind, parallel-group, phase 1 study comparing the pharmacokinetics, safety and efficacy of CT-P13 and infliximab in patients with active ankylosing spondylitis: 54 week results from the PLANETAS study. Ann Rheum Dis 2013;72(Suppl 3):516 [FRI0421]
- Yoo DH, Racewicz A, Brzezicki J, et al. A phase 3 randomised controlled trial to compare CT-P13 with infliximab in patients with active rheumatoid arthritis: 54 week results from the PLANETRA study. Ann Rheum Dis 2013;72(Suppl 3):73; [OP0068]
- Park W, Miranda P, Brzosko M, et al. Efficacy and safety of CT-P13 (infliximab biosimilar) over two years in patients with ankylosing spondylitis: comparison between continuing with CT-P13 and switching from infliximab to CT-P13. Arthritis Rheum 2013;65:3326 (L15)
- Yoo DH, Prodanovic N, Jaworski J, et al. Efficacy and safety of CT-P13 (infliximab biosimlar) over two years in patients with rheumatoid arthritis: comparison between continued CT-P13 and switching from infliximab to CT-P13. Arthritis Rheum 2013;65:3319 (L1)