BIOSIMILARS : SHAPING THE FUTURE IN HAEMATOLOGY This satellite symposium took place on 10 th June 2016 , as a part of the 21 st Congress of the European Hematology Association ( EHA ) 2016 in Copenhagen , Denmark

Disclosure: Prof Foà has received honoraria for advisory boards and has sat on speakers’ bureaux for Roche, Genentech, Janssen Pharmaceuticals, Gilead, Sandoz Biopharmaceuticals, Pfizer, Amgen, BristolMyers Squibb, and Celgene. Dr López-Guillermo has received honoraria for advisory boards and has sat on speakers’ bureaux for Roche, Janssen Pharmaceuticals, Gilead, Sandoz Biopharmaceuticals, Celgene, and Mundipharma. Dr Schiestl is a full-time employee of Sandoz International GmbH. Prof Thirstrup is a full-time employee of NDA Advisory Services Ltd. Acknowledgements: Writing assistance was provided by Dr Blair Hesp CMPP of ApotheCom. Support: The symposium was jointly sponsored by Hexal AG and Sandoz International. Authors received honoraria for preparation and delivery of their presentations. The views and opinions expressed are those of the authors and not necessarily of Hexal AG or Sandoz International GmbH. Citation: EMJ Hematol. 2016;4[1]:30-37.

[1]  H. Rugo,et al.  A clinician's guide to biosimilars in oncology. , 2016, Cancer treatment reviews.

[2]  Grey Giddins,et al.  Statistics , 2016, The Journal of hand surgery, European volume.

[3]  J. Buchner,et al.  Multi-Angle Effector Function Analysis of Human Monoclonal IgG Glycovariants , 2015, PloS one.

[4]  Aaron S Kesselheim,et al.  Progress and Hurdles for Follow-on Biologics. , 2015, The New England journal of medicine.

[5]  G. Salles,et al.  Biosimilar monoclonal antibodies in lymphoma: a critical appraisal , 2015, Expert review of anticancer therapy.

[6]  Martina Weise,et al.  Biosimilars: the science of extrapolation. , 2014, Blood.

[7]  I. Hwang Efficacy and safety of growth hormone treatment for children born small for gestational age , 2014, Korean journal of pediatrics.

[8]  I. Jacobs,et al.  Barriers to the Access and Use of Rituximab in Patients with Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia: A Physician Survey , 2014, Pharmaceuticals.

[9]  H. Ebbers Biosimilars: in support of extrapolation of indications. , 2014, Journal of Crohn's & colitis.

[10]  M. Orme,et al.  Systematic review, network meta-analysis and economic evaluation of biological therapy for the management of active psoriatic arthritis , 2014, BMC Musculoskeletal Disorders.

[11]  Laure Gossec,et al.  Efficacy of biological disease-modifying antirheumatic drugs: a systematic literature review informing the 2013 update of the EULAR recommendations for the management of rheumatoid arthritis , 2014, Annals of the rheumatic diseases.

[12]  F. d'Amore,et al.  Real world data on primary treatment for mantle cell lymphoma: a Nordic Lymphoma Group observational study. , 2013, Blood.

[13]  R. Foà,et al.  Lessons for the clinic from rituximab pharmacokinetics and pharmacodynamics , 2013, mAbs.

[14]  S. Danese,et al.  ECCO position statement: the use of biosimilar medicines in the treatment of inflammatory bowel disease (IBD). , 2013, Journal of Crohn's & colitis.

[15]  C. Schneider,et al.  Biosimilars in rheumatology: the wind of change , 2013, Annals of the rheumatic diseases.

[16]  F. Carballo,et al.  Joint position statement by “Sociedad Española de Patología Digestiva” (Spanish Society of Gastroenterology) and “Sociedad Española de Farmacología” (Spanish Society of Pharmacology) on biosimilar therapy for inflammatory bowel disease. , 2013, Revista espanola de enfermedades digestivas : organo oficial de la Sociedad Espanola de Patologia Digestiva.

[17]  M. Wadhwa,et al.  Biosimilars: what clinicians should know. , 2012, Blood.

[18]  P. Dutka Erythropoiesis-stimulating agents for the management of anemia of chronic kidney disease: past advancements and current innovations. , 2012, Nephrology nursing journal : journal of the American Nephrology Nurses' Association.

[19]  Dean C Ripple,et al.  Protein particles: what we know and what we do not know. , 2012, Journal of pharmaceutical sciences.

[20]  C. Waller Biosimilars and their use in hematology and oncology , 2012 .

[21]  Hongcheng Liu,et al.  Disulfide bond structures of IgG molecules , 2012, mAbs.

[22]  A. López-Guillermo,et al.  CHOP-like chemotherapy with or without rituximab in young patients with good-prognosis diffuse large-B-cell lymphoma: 6-year results of an open-label randomised study of the MabThera International Trial (MInT) Group. , 2011, The Lancet. Oncology.

[23]  B. Shaw,et al.  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 , 2011, Haematologica.

[24]  Martin Schiestl,et al.  Acceptable changes in quality attributes of glycosylated biopharmaceuticals , 2011, Nature Biotechnology.

[25]  M. Mccamish,et al.  Worldwide experience with biosimilar development , 2011, mAbs.

[26]  M. Hallek,et al.  Interindividual Variability of Response to Rituximab: From Biological Origins to Individualized Therapies , 2011, Clinical Cancer Research.

[27]  A. Berrebi,et al.  Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: a randomised, open-label, phase 3 trial , 2010, The Lancet.

[28]  Andrew M Goetze,et al.  Assessing monoclonal antibody product quality attribute criticality through clinical studies , 2010, mAbs.

[29]  L. Revers,et al.  An Introduction to Biologics and Biosimilars. Part I: Biologics: What are They and Where Do They Come from? , 2010 .

[30]  P. Ganly,et al.  Rituximab plus fludarabine and cyclophosphamide prolongs progression-free survival compared with fludarabine and cyclophosphamide alone in previously treated chronic lymphocytic leukemia. , 2010, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[31]  Harold Willmington,et al.  What You Need to Know About You , 2010 .

[32]  J. Reichert,et al.  European Medicines Agency workshop on biosimilar monoclonal antibodies , 2009, mAbs.

[33]  A. D. De Groot,et al.  T cell epitope: Friend or Foe? Immunogenicity of biologics in context☆ , 2009, Advanced Drug Delivery Reviews.

[34]  A. Hunter,et al.  Host cell proteins in biologics development: Identification, quantitation and risk assessment , 2009, Biotechnology and bioengineering.

[35]  R. Marcus,et al.  Phase III study of R-CVP compared with cyclophosphamide, vincristine, and prednisone alone in patients with previously untreated advanced follicular lymphoma. , 2008, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[36]  S. Misbah,et al.  Cetuximab-induced anaphylaxis and IgE specific for galactose-alpha-1,3-galactose. , 2008, The New England journal of medicine.

[37]  Nitin Rathore,et al.  Current Perspectives on Stability of Protein Drug Products during Formulation, Fill and Finish Operations , 2008, Biotechnology progress.

[38]  Markus Loeffler,et al.  Six versus eight cycles of bi-weekly CHOP-14 with or without rituximab in elderly patients with aggressive CD20+ B-cell lymphomas: a randomised controlled trial (RICOVER-60). , 2008, The Lancet. Oncology.

[39]  Mire Zloh,et al.  Disulfide bridge based PEGylation of proteins. , 2008, Advanced drug delivery reviews.

[40]  I. Markovic Evaluation of safety and quality impact of extractable and leachable substances in therapeutic biologic protein products: a risk-based perspective , 2007, Expert opinion on drug safety.

[41]  Randy D Gascoyne,et al.  Rituximab-CHOP versus CHOP alone or with maintenance rituximab in older patients with diffuse large B-cell lymphoma. , 2006, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[42]  Hervé Watier,et al.  From the bench to the bedside: ways to improve rituximab efficacy. , 2004, Blood.

[43]  D. M. Kennedy,et al.  Glycation of monoclonal antibodies impairs their ability to bind antigen , 1994, Clinical and experimental immunology.

[44]  E. Kabat,et al.  Antibody variable region glycosylation: position effects on antigen binding and carbohydrate structure. , 1991, The EMBO journal.