Considerations in Medicines

Biosimilars already approved and in development



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Developed by CESAS Medical and BMJ Group
This activity is supported by an unrestricted educational grant from Pfizer

Release date: 30 October 2017
Estimated time to complete activity: 1 hour
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TARGET AUDIENCE
This activity is designed for rheumatologists of all levels of seniority, and other healthcare professionals involved in treating patients with chronic inflammatory diseases.

PROGRAM OVERVIEW
Biosimilar clinical trials have used various designs to look at switching between originator and biosimilar products, with some reassuring results for clinical practice. Biosimilars already approved and in development explores the current evidence base, with the results of these trials presented and their implications considered. While not a replacement for definitive data built on long term follow-up, these reviews will at least prepare practicing clinicians with the current state of knowledge in this rapidly evolving area.

EDUCATIONAL OBJECTIVES
By following this programme, the learner will be able to:
  • Use current and emerging data to enhance therapeutic decision-making and optimize outcomes for patients with chronic inflammatory diseases
  • Evaluate the current clinical data relating to biosimilars in inflammation
  • Provide accurate and appropriate counsel as part of the comprehensive treatment team

INSTRUCTIONS FOR PARTICIPATION
Participants must 1) read the activity information; 2) study the educational activity; 3) successfully complete the post-module assessments with a score of 80% or better; 4) and complete the evaluation form. Upon completion of the full activity, your certificate will be made available to download and print.

DISCLOSURE OF CONFLICTS OF INTEREST
CESAS Medical requires faculty, presenters, planners, managers, writers, and any other individuals who are in a position to influence the content of this activity to disclose any real and/or apparent conflict of interest (COI) they may have as related to the content of this activity. All identified COI are thoroughly reviewed and resolved according to CESAS Medical policy.

Module Presenter Video Questions
Biosimilars already approved and in development
Professor Thomas Dörner image
Professor Thomas Dörner

Professor of Rheumatology and Clinical Immunology,
Charité University Hospitals, Germany

Professor Thomas Dörner serves as Professor of Rheumatology and Clinical Immunology at Charité University Hospitals Berlin, Germany and group leader of the “B cell memory group” at the German Research Centre of Rheumatology Berlin.

Since 1998, Professor Dörner has participated in various clinical trials of rheumatic diseases, including SLE, Sjögren's syndrome, rheumatoid arthritis and seronegative spondylarthropathies. His scientific interests include the characterization of disturbances of humoral autoimmunity and abnormalities of B cell subsets in the blood versus tissue (lupus, neonatal lupus syndromes, Sjögren's syndrome), exploring innovative therapeutic approaches with a main focus on B cell directed therapy, as well as improving diagnostic tools in autoimmune diseases. In addition, his group is interested in the complex activation of the immune and coagulation system.

Professor Dörner has been awarded a number of international and national awards, such as the “Senior Scholar Award” of the American Society of Rheumatology, the “H Schultze Award” of the German League against Rheumatism, and the “Schoen Award” of the German Society of Rheumatology. He has served as a member of editorial boards of leading journals in rheumatology, including Arthritis and Rheumatism, Arthritis Research and Therapy, and Rheumatology Reviews.

Prof. Thomas Dörner (Bio)
37:03 5
Discussion - Considering biosimilar trials
Professor Gilberto Castañeda-Hernández image
Professor Gilberto Castañeda-Hernández

Pharmacology Researcher,
Center for Research and Advanced Studies of the National Polytechnic Institute, Mexico

Professor Gilberto Castañeda-Hernández is a pharmacology researcher at the Center for Research and Advanced Studies of the National Polytechnic Institute, Mexico.

Professor Castañeda-Hernández serves as the Director of Biopharmaceutics and Clinical Sciences for the Pharmaceutical Association Mexicana, and has served in leadership roles in the Western Pharmacology Society and the Mexican Association of Pharmacology. Professor Castañeda-Hernández is also a member of the Board of Clinical Pharmacology of the International Union of Pharmacology.

Professor Castañeda-Hernández has research interests in the study of pharmacokinetic and pharmacodynamic mechanisms involved in the action of drugs in intact organisms; the evaluation of generic drugs in terms of bioavailability and bioequivalence; and the optimization of drug use in special patient populations. Professor Castañeda-Hernández has published widely on these and other topics.

Prof. Gilberto Castañeda-Hernández (Bio)
Professor João Gonçalves image
Professor João Gonçalves

Professor of Immunology and Biotechnology,
University of Lisbon, Portugal

Professor João Gonçalves is Head of the Biopharmaceutical Biotechnology Unit at the Institute of Innovative Medicines and Instituto de Medicina Molecular and Professor of Immunology and Biotechnology, both part of the Faculty of Pharmacy, University of Lisbon, Portugal. He is also Head of Antibody Engineering Laboratory at iMed – Faculdade Farmacia Universidade Lisboa.

Professor Gonçalves has a pharmaceutical degree and PhD in Immunology at the University of Lisbon, and has obtained Pharmaceutical Medicine management post-graduation from the University of California at San Diego. His research focuses on therapeutic antibody discovery and development ranging from autoimmune diseases to oncology. Professor Gonçalves is also member of the Portuguese Pharmacopoeia Commission and Portuguese Commission of Medicines Evaluation. He is a member of the editorial board of several scientific journals and has authored more than 70 scientific papers.

Prof. João Gonçalves (Bio)
Professor John Isaacs image
Professor John Isaacs

Director of the Institute of Cellular Medicine,
Newcastle University, UK

Prof. Isaacs graduated from London University with a first class degree in Physiology and Medicine, followed by junior posts in London (Hammersmith Hospital) and Harvard (Beth Israel Hospital). He read for his PhD in Immunology at Cambridge. Over the past 20 years he has studied the potential of novel immunotherapies to treat rheumatoid arthritis, ranging from target identification to early and late-stage clinical trials. He has performed several pioneering translational studies, challenging existing dogma and informing the design of subsequent generations of therapeutic agents. In 1999 he received the British Society for Rheumatology Michael Mason Medal. In 2010 he presented the Heberden Round to the Society.

Prof. Isaacs is currently Director of the Institute of Cellular Medicine at Newcastle University and consultant rheumatologist at the Freeman Hospital.

Nationally, he chairs Arthritis Research UK’s Clinical Study Group for Inflammatory Arthritis, developing an internationally competitive research strategy for the UK. He also leads the MRC/ABPI £4.5m Immunology and Inflammation initiative, ‘seeking a cure for inflammatory arthritis’. He is a member of the Committee for the Safety of Medicine’s Expert Advisory Group on Clinical Trials.

Prof. John Isaacs (Bio)
Professor Thomas Dörner image
Professor Thomas Dörner

Professor of Rheumatology and Clinical Immunology,
Charité University Hospitals, Germany

Professor Thomas Dörner serves as Professor of Rheumatology and Clinical Immunology at Charité University Hospitals Berlin, Germany and group leader of the “B cell memory group” at the German Research Centre of Rheumatology Berlin.

Since 1998, Professor Dörner has participated in various clinical trials of rheumatic diseases, including SLE, Sjögren's syndrome, rheumatoid arthritis and seronegative spondylarthropathies. His scientific interests include the characterization of disturbances of humoral autoimmunity and abnormalities of B cell subsets in the blood versus tissue (lupus, neonatal lupus syndromes, Sjögren's syndrome), exploring innovative therapeutic approaches with a main focus on B cell directed therapy, as well as improving diagnostic tools in autoimmune diseases. In addition, his group is interested in the complex activation of the immune and coagulation system.

Professor Dörner has been awarded a number of international and national awards, such as the “Senior Scholar Award” of the American Society of Rheumatology, the “H Schultze Award” of the German League against Rheumatism, and the “Schoen Award” of the German Society of Rheumatology. He has served as a member of editorial boards of leading journals in rheumatology, including Arthritis and Rheumatism, Arthritis Research and Therapy, and Rheumatology Reviews.

Prof. Thomas Dörner (Bio)
Associate Professor Robert Strohal image
Associate Professor Robert Strohal

Head of the Department of Dermatology and Venerology ,
Federal University Teaching Hospital, Austria

Associate Professor Robert Strohal studied medicine at the University of Innsbruck Medical School, Innsbruck, Austria and completed his residency in Dermatology at the University of Vienna School of Medicine. Professor Strohal is currently Head of the Department of Dermatology and Venerology at the Federal University Teaching Hospital Feldkirch, Austria.

Professor Strohal serves as senior physician at the Division of Immunology, Allergy and Infectious Diseases, Department of Dermatology, University of Vienna School of Medicine. During his sabbatical in 2001 at IDI Farmaceutici, Rome, he worked on melanoma antigen transduced autografts as a new form of tumor vaccine. In 2002, he became Head of the Department of Dermatology and Venerology at the Federal University Teaching Hospital Feldkirch, Austria, where he also established a new biomedical research institute called VIDIT (Vorarlberg Institute for Dermatologic Investigation and Treatment), which he also heads.

In addition, Professor Strohal serves as an external expert for various research and funding programs associated with the European Commission (EC); as Board Secretary of the European Association of Dermato-Oncology; as delegate of the Austrian Society of Dermatology and Venerology at the UEMS in Brussels; as President of the Austrian Wound Association and chair of the Austrian Task Force Biologics in Dermatology. Professor Strohal and his department are involved in several multinational clinical trials studying biologics and psoriasis, topical immuno-modulators and atopic eczema, and adjuvant melanoma therapy, and leads various investigator-initiated studies. Professor Strohal is well published in the field of clinical dermatology, immuno-dermatology, infection control and dermato-oncology, and he has received eight national and international scientific awards.

Assoc. Prof. Robert Strohal (Bio)
Professor Iain B. McInnes image
Professor Iain B. McInnes

Muirhead Professor of Medicine, Director of the Institute of Infection, Immunity and Inflammation,
University of Glasgow, UK

Professor Iain McInnes studied medicine at the University of Glasgow and graduated with honours in 1989 before training in internal medicine and rheumatology. He completed his membership of the Royal College of Physicians (MRCP) in 1992 and became a fellow (FRCP) in 2003. He completed his PhD and post-doctoral studies via fellowships from the Wellcome Trust, the Arthritis Research Campaign (ARC, UK) and the National Institute of Health (NIH) Fogarty Fellowship Programme in both Glasgow and Bethesda, Maryland, USA.

Professor McInnes’ research interests include understanding the role of cytokines in inflammatory synovitis. He leads a trials unit specialising in the use of biologic agents in early clinical trials in inflammatory arthritis. Professor McInnes has published widely in the areas of immunobiology and rheumatology, and he is Associate Editor of Annals of Rheumatic Diseases and a member of the executive Editorial Board of the European Journal of Immunology. His work, together with that of his colleagues at the University of Glasgow, has been widely recognised and has received many prizes and lectureships including the Michael Mason Prize 2001 from the British Society for Rheumatology, the Albrecht Hasinger Lectureship 2002, the Nana Svartz Lectureship 2008, and the Dunlop Dotteridge Lectureship for the Canadian Rheumatology Association in 2010. He gave the British Society of Rheumatology (BSR) Droitwich Lecture in 2012, and the Gerald Weissmann Lecture in Rheumatology in New York in 2013. A previous Chairman of The European League Against Rheumatism (EULAR) Scientific Committee, he is now Liaison Officer to the American College of Rheumatology for EULAR. He was elected a fellow of the Royal Society of Edinburgh in 2008, and in 2012 was elected as a Fellow of the Academy of Medical Sciences.

Prof. Iain B. McInnes (Bio)
Professor Valderilio Azevedo image
Professor Valderilio Azevedo

Adjunct Professor of Rheumatology,
Federal University of Paraná, Brazil

Professor Valderilio Azevedo currently serves as Adjunct Professor of Rheumatology at the Federal University of Paraná, Brazil. In this role, Professor Azevedo coordinates the spondyloarthritis outpatient clinic of the University Hospital, and leads the Spondyloarthritis Research Team.

As well as being a member of ASAS (Assessment of SpondyloArthritis International Society), Professor Azevedo sits on the Steering Committee of GRAPPA (Group for Research and Assessment of Psoriasis and Psoriatic Arthritis) and is a member of the Executive Committee of the Américas Health Foundation and R & D Director for new biopharmaceuticals products development at Edumed Health Research and Biotechnology, coordinating the Translational Medicine Group. Professor Azevedo is the author on many peer-reviewed publications on the topic of biosimilars in rheumatology.

Prof. Valderilio Azevedo (Bio)
02:07

Date of preparation: 15 November 2017