Author byline as per print journal: Richard O Dolinar, MD; Michael S Reilly Abstract  Biologicals are advanced prescription drugs to treat cancer, rheumatoid arthritis HIV/AIDS, multiple sclerosis and other debilitating diseases. In November 2010, the US Food and Drug Administration (FDA) began consultation with patient groups, physicians and industry on how to approve the first copies…

Author(s): Michael S Reilly, Esq, Richard O Dolinar, MD

biologicals, biosimilars, FDA guidelines, patient safety, pharmacovigilance

DOI: 10.5639/gabij.2013.0201.014

Abstract: ‘Non-binding recommendations’ from regulatory bodies are in place for evaluation and production of generic liposomal doxorubicin injection. However, how these nano-sized generics (‘nanosimilars’) should be characterized and evaluated, and particularly when the ‘reference listed product’ is no longer in production are among the major issues. We discuss these issues with respect to complexity of…

Author(s): Professor S Moein Moghimi, PhD, Z Shadi Farhangrazi, PhD

adverse reactions, complement system, immunogenicity, liposomes, nanoparticle size, vesicle morphology

DOI: 10.5639/gabij.2014.0302.017

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 individual physicians have given their opinions on the issue of generics substitution. In this issue of GaBI Journal, several hot topics related to implementation of…

Author(s): Professor Teun van Gelder, MD, PhD

bioequivalence, generics substitution, immunosuppression, transplantation

DOI: 10.5639/gabij.2013.0202.020

Objective: One of the questions that the advent of biosimilars raises is whether the different nature of biological medicines would also imply the need for a different policy approach by Member States in the European Union (EU). To assess the policy environment the European Biopharmaceutical Enterprises (EBE) conducted a brief descriptive policy survey of pricing…

Author(s): European Biopharmaceutical Enterprises

biological medicines, biosimilars, off-patent market, pricing and reimbursement policy

DOI: 10.5639/gabij.2015.0401.006

Introduction: The healthcare sector is one of the most rapidly expanding and dynamic industries in the world. Pharmaceutical expenditure is now growing faster than other components of healthcare overheads. Globally, pressures to manage pharmaceutical spending have led to increased prescribing of generic drugs. Use of generic drugs in private medical centres in Malaysia, however, remains…

Author(s): Muhamad Ali SK Abdul Kader, MD, Rohit Kumar, MPharm, Mohamed Azmi Ahmad Hassali, PhD, Navneet Kaur, PhD

generics, Malaysia, perceptions, pharmaceuticals, private hospitals

DOI: 10.5639/gabij.2014.0302.019

Author byline as per print journal: Gary L O’Brien1, BPharm, MPharm; Donal Carroll2, BSc (Hon) Pharmacy; Mark Mulcahy3, BComm, MSc, PhD; Valerie Walshe4, BA, MA, PhD; Professor Garry Courtney2, MB, FRCPI; Professor Stephen Byrne1, BSc (Hon) Pharmacy, PhD Background and aim: Biosimilar medicines are not considered exact replicas of originator biological medicines. As a result, prescribers…

Author(s): Professor Garry Courtney, MB, FRCPI, Professor Stephen Byrne, BSc (Hon) Pharmacy, PhD, Gary L O’Brien, BPharm, MPharm, Donal Carroll, BSc (Hon) Pharmacy, Mark Mulcahy, BComm, MSc, PhD, Valerie Walshe, BA, MA, PhD

biologicals, evidence-based, inflammatory bowel disease (IBD), secondary care, switching

DOI: 10.5639/gabij.2018.0701.004

Abstract: With a number of patents on biological medicines soon to expire in the US, multiple stakeholders – from policymakers to manufacturers to payers – have been debating the structure of regulatory frameworks and in particular, naming conventions for biosimilars. A key area of concern has been the potential impact of naming, and specifically, whether…

Author(s): Jacqueline Vanderpuye-Orgle, MSc, PhD, Joseph P Fuhr, PhD, Amitabh Chandra, PhD, John Romley, PhD, Tiffany Shih, PhD, Suepattra G May, MPH, PhD

biosimilar, market uptake, nomenclature, regulatory, specialty pharmaceuticals

DOI: 10.5639/gabij.2015.0402.015

Author byline as per print journal: Christoph Baumgärtel, MD, MSc; Brian Godman, BSc, PhD Abstract: Stricter bioequivalence criteria are in place for generics where there are narrow therapeutic indexes such as generic immunosuppressives, enhancing their acceptance despite limited published studies. No serious issues have been reported to date with generic ciclosporin despite being on the market…

Author(s): Brian Godman, BSc, PhD, Christoph Baumgärtel, MD, MSc

bioequivalence, ciclosporin, EMA, generics, immunosuoppressives, narrow therapeutic index drugs

DOI: 10.5639/gabij.2015.0404.035

Author byline as per print journal: Frank Mueller, MSc, Manal Moussa, MSc, Maria El Ghazaly, MSc, Jan Rohde, PhD, Nicole Bartsch, MSc, Antje Parthier, PhD, Frank Kensy, Dr Ing Background: Osteoporosis is a bone disease of the elderly that leads to increased risk of fracture. Currently, it affects more than 200 million adults worldwide, placing…

Author(s): et al., Frank Mueller, MSc

fermentation, hansenula polymorpha, parathyroid hormone fragment, recombinant protein, rPTH 1-34

DOI: 10.5639/gabij.2013.0203.035

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 during product development are discussed. The principles underlying the regulatory framework for subsequent entry biologics (SEBs or biosimilars) in Canada explain the position taken by…

Author(s): Agnes V Klein, MD, DPH, Jian Wang, MD, PhD, Patrick Bedford, BSc, MA

biosimilar, Canada, reference biological product, subsequent entry biologics (SEBs)

DOI: 10.5639/gabij.2014.0303.033

Abstract: Biosimilars have been approved in Europe since 2006. With patents on originator biologicals expiring and ever-tightening healthcare budgets biosimilars are likely to take an increasing share of the biologicals market. In light of these facts, this article gives estimated patent expiry dates for just some of the best-selling biologicals. Submitted: 19 November 2015; Revised:…

Author(s): GaBI Journal Editor

biological, biosimilar, patent

DOI: 10.5639/gabij.2015.0404.040

Introduction: A survey of the views of European physicians on familiarity of biosimilar medicines has demonstrated the need for distinguishable non-proprietary names to be given to all biologicals. Methods: The Alliance for Safe Biologic Medicines recruited 470 prescribers with clinical experience of biologicals in France, Germany, Italy, Spain and the UK to answer questions relating…

Author(s): Michael S Reilly, Esq, Richard O Dolinar, MD

biological, biosimilar, Europe, INN, pharmacy substitution, prescribers

DOI: 10.5639/gabij.2014.0302.018