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Fulphila, INN-Pegfilgrastim 20 September 2018 EMA/724003/2018 Committee for Medicinal Products for Human Use (CHMP) Assessment report Fulphila International non-proprietary name: pegfilgrastim Procedure No. EMEA/H/C/004915/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact An agency of the European Union © European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged. Table of contents 1. Background information on the procedure .............................................. 7 1.1. Submission of the dossier ...................................................................................... 7 1.2. Steps taken for the assessment of the product ......................................................... 8 2. Scientific discussion ................................................................................ 9 2.1. Problem statement ............................................................................................... 9 2.1.1. Disease or condition ........................................................................................... 9 2.1.2. Epidemiology and risk factors, screening tools/prevention ...................................... 9 2.1.3. Biologic features, aetiology and pathogenesis........................................................ 9 2.1.4. Clinical presentation, diagnosis and stage/prognosis ............................................ 10 2.1.5. Management ................................................................................................... 10 2.2. Quality aspects .................................................................................................. 11 2.2.1. Introduction .................................................................................................... 11 2.2.2. Active Substance ............................................................................................. 12 2.2.3. Finished Medicinal Product ................................................................................ 16 2.2.4. Discussion on chemical, pharmaceutical and biological aspects .............................. 23 2.2.1. Conclusions on the chemical, pharmaceutical and biological aspects ...................... 24 2.2.2. Recommendation for future quality development ................................................. 24 2.3. Non-clinical aspects ............................................................................................ 24 2.3.1. Introduction .................................................................................................... 24 2.3.2. Pharmacology ................................................................................................. 25 2.3.3. Pharmacokinetics............................................................................................. 27 2.3.4. Toxicology ...................................................................................................... 28 2.3.5. Ecotoxicity/environmental risk assessment ......................................................... 32 2.3.6. Discussion on non-clinical aspects...................................................................... 33 2.3.7. Conclusion on the non-clinical aspects ................................................................ 33 2.4. Clinical aspects .................................................................................................. 34 2.4.1. Introduction .................................................................................................... 34 2.4.2. Pharmacokinetics............................................................................................. 35 2.4.3. Pharmacodynamics .......................................................................................... 42 2.4.4. Discussion on clinical pharmacology ................................................................... 50 2.4.5. Conclusions on clinical pharmacology ................................................................. 51 2.5. Clinical efficacy .................................................................................................. 51 2.5.1. Dose response study(ies) ................................................................................. 51 2.5.2. Main study(ies) ............................................................................................... 51 2.5.3. Discussion on clinical efficacy ............................................................................ 66 2.5.4. Conclusions on the clinical efficacy ..................................................................... 67 2.6. Clinical safety .................................................................................................... 67 2.6.1. Discussion on clinical safety .............................................................................. 79 2.6.2. Conclusions on the clinical safety ....................................................................... 80 2.7. Risk Management Plan ........................................................................................ 80 2.8. Pharmacovigilance .............................................................................................. 83 2.9. Product information ............................................................................................ 83 2.9.1. User consultation ............................................................................................. 83 Assessment report EMA/724003/2018 Page 2/88 2.9.2. Additional monitoring ....................................................................................... 83 3. Biosimilarity assessment ....................................................................... 84 3.1. Comparability exercise and indications claimed ...................................................... 84 3.2. Results supporting biosimilarity ............................................................................ 85 3.3. Uncertainties and limitations about biosimilarity ..................................................... 86 3.4. Discussion on biosimilarity ................................................................................... 86 3.5. Extrapolation of safety and efficacy ...................................................................... 86 3.6. Additional considerations ..................................................................................... 86 3.7. Conclusions on biosimilarity and benefit risk balance .............................................. 87 4. Recommendations ................................................................................. 87 Assessment report EMA/724003/2018 Page 3/88 List of abbreviations a.u Absorbance units ADA anti-drug antibodies AE adverse event AET Analytical evaluation threshold AIEX anionic exchange chromatography ANC AUC0-t above baseline levels of the subject’s absolute neutrophil count ANC Cmax maximum absolute neutrophil count ANC Tmax time of maximum change from baseline of absolute neutrophil count ANC absolute neutrophil count ANOVA analysis of variance ANS 1-anilinonaphthalene-8-sulfonate APQR Annual Product Quality Review AR Analytical Reagent AS active substance ATR Attenuated Total Reflectance AUC analytical ultracentrifugation AUC0-∞ area under the curve extrapolated to infinity AUC0-t area under the curve from time zero to t BPI Brief Pain Inventory BRL Biocon Research Limited BSC/LAF Bio Safety Cabinet / Laminar Air Flow CAS Chemical Abstract Service CD Circular dichroism CD34+ Cmax maximum concentration change from baseline for CD34+ cell counts CD34+ Tmax time of maximum change from baseline for CD34+ cell counts CD34+ hematopoietic progenitor antigen positive cells CD34+AUC0-t area under the curve from time zero to t from baseline for CD34+ cell counts CDS Coding DNA Sequence CE-SDS Capillary electrophoresis sodium dodecyl sulfate method CHR Chromatography CI confidence interval cIEF iso- electric focusing CIEX cation exchange chromatography CIEX-HPLC Cation-exchange-High performance liquid chromatography Cmax maximum concentration CPP Critical Process Parameter CQA Critical quality attribute CSR clinical study report CSS clinical summary of safety CTCAE common terminology criteria for adverse events CV coefficient of variation Da Daltons DF diafiltration DLS Dynamic light scattering DP Drug Product DS Drug Substance DSC Differential Scanning Calorimetry DSN duration of severe neutropenia ECG electrocardiogram ECOG Eastern Cooperative Oncology Group EDTA Ethylenediaminetetraacetic acid ELISA enzyme-linked immunosorbent assay EMA European Medicines Agency EoPCB End of Production Cell Bank EP Elution Pool ESI Electrospray Ionization EU European Union EU European Union EU/ml Endotoxin units/millileter FDA Food and Drug Administration Assessment report EMA/724003/2018 Page 4/88 FMEA Failure Modes Effect Analysis FN Febrile neutropenia FTIR Fourier Transform Infrared Spectroscopy FP finished product GC Gas Chromatography GCSF granulocyte colony-stimulating factor GLM general linear model Glu-C Endoproteinase Glu-C GPP cGMP Pilot Plant HCDNA Host Cell Deoxyribonucleic Acid HCl Hydrochloric acid HCP Host Cell Protein HMW high-molecular-weight HMWP high molecular weight proteins HPLC High Pressure Liquid Chromatography IB Inclusion Body IEX Ion Exchange Chromatography INN international non-proprietary name IPC
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