Perspective
Norway, biosimilars in different funding systems. What works?
Abstract: Biosimilars can substitute treatment with expensive biological drugs and release money to treat more patients. Experience from Norway shows how this can be done with and without success. Submitted:… Read More »
Biosimilars for prescribers
Author(s): Adjunct Professor Pekka Kurki, MD, PhD
Page: 33-5
Abstract: Biosimilars are copies of original biological medicines. Biosimilarity is a new concept in drug development. Physicians prescribing biologicals need more neutral information on the quality, safety and efficacy of… Read More »
Subsequent entry biologics (biosimilars) in Canada: approaches to interchangeability and the extrapolation of indications and uses
Author(s): Agnes V Klein, MD, DPH, Jian Wang, MD, PhD, Patrick Bedford, BSc, MA
Page: 150-4
Abstract: The principles Health Canada use when extrapolating the indications and uses of a biosimilar product subsequent to a single clinical trial or limited number and scope of clinical trials… Read More »
Role of hospital clinical pharmacist in transplantation, and generic immunosuppressive therapies
Abstract: The pharmacist is an important patient advocate in the transplant multidisciplinary team and can support patients in their medication taking to improve medication adherence. Medicine optimization and patient information… Read More »
Assuring patient-centred care: engaging patients with rheumatoid arthritis in disease monitoring and pharmacovigilance
Abstract: With the advent of complex therapies in the form of biologicals, emerging biosimilars and non-biological complex drugs, monitoring for treatment related benefit and the potential for adverse effects is… Read More »
Licensing and prescribing biosimilars in Australia
Author(s): Professor David A Power, MD, PhD, FRCP, FRACP
Page: 152-4
Abstract: Some years ago, Australian regulatory authorities decided to follow the path laid down by the European Medicines Agency in adopting a process for approval of biosimilars. This has been… Read More »
Biosimilarity in Latin America
Author(s): 1 Chang Chiann, PhD, 2 Leonardo de Souza Teixeira, PhD, 3 Fabiana Fernandes de Santana e Silva Cardoso, MSc, 4 Isabela da Costa César, PhD, 5 Gerson Antônio Pianetti, PhD
Page: 94-6
Abstract: The introduction of new legislation in Latin America for the approval of biosimilar products follows implementation of EU legislation in 2005 for biosimilars approval. The establishment of regulatory processes… Read More »
Biosimilars in oncology: current and future perspectives
Abstract: Cancer represents a significant, and growing, burden on healthcare systems. This is driven, at least in part, by escalating cancer drug budgets. Loss of patent protection on biopharmaceuticals enables… Read More »
Equivalence of generic medicines in general and immunosuppressants in particular – a regulatory opinion on switching of ciclosporin, tacrolimus and mycophenolate mofetil
Author(s): 2 Yang Yu, PharmD, 3 Professor Hubert GM Leufkens, PharmD, PhD, Marc Maliepaard, PhD
Page: 86-90
Abstract: This position paper deals with our regulatory opinion on registered generic immunosuppressants such as ciclosporin, tacrolimus and mycophenolate mofetil, and provides arguments why these medicines are considered equally safe… Read More »
Why bioequivalence and unconditional interchangeability of generic drugs are not the same
Author(s): Professor Teun van Gelder, MD, PhD
Page: 83-5
Abstract: The patents for a number of cornerstone immunosuppressive drugs used in the field of solid organ transplantation have expired. Generic formulations are now available and several professional societies and… Read More »