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 a largely successful process, resulting in the licensing of biosimilars for many peptides, especially epoetin and granulocyte colony-stimulating factor (G-CSF). Aside from the availability of […]
Abstract: New regulations for the development of biosimilars have been introduced in Europe and a new class of biosimilars – monoclonal antibodies – is expected on the market soon, which will both challenge and benefit our healthcare systems. Submitted: 3 June 2013; Revised: 16 July 2013; Accepted: 23 July 2013; Published online first: 5 August […]
Author byline as per print journal: Michael Sarshad, BSc, MBA; Rosanne Campbell, BComm, PGdip, MSc; Peter J Pitts, BA; Jacqueline anderpuye- Orgle, MSc, PhD Abstract: As the number of biosimilar product approvals continues to grow, it will become even more important to collect pharmacovigilance data that are accurate and attributable to the specific product. Different […]
Introduction: The number of biosimilars, or similar biotherapeutic products, is expanding rapidly worldwide. A further 12 blockbuster biologicals are set to add to this number by 2020. Agreement about the best practices for the regulation, use, interchangeability and pharmacovigilance of biosimilars is lacking in many countries including in the Middle East and North Africa (MENA).Methods: […]
Author byline as per print journal: Alessandro Curto, MSSc, Katelijne Van de Vooren, MSc, Roberta Lo Muto, MSc, Silvy Duranti, MBA, Professor Livio Garattini Introduction: Health care in Italy is mainly delivered through the country’s National Health Service (NHS), a public service funded by general taxation. The system is highly decentralized and each one of […]
Abstract: Dr Brian Godman reviews Mr Gustaf Befrits’ paper on the case for biosimilars from a payer’s perspective. Biosimilars are increasingly important to payers with growing resource pressures. However, key issues need addressing to fully capture their benefits. Submitted: 17 January 2013; Revised: 4 February 2013; Accepted: 8 February 2013; Published online first: 11 March 2013 Gustaf Befrits has provided us with […]
Abstract: The clinical importance of biopharmaceuticals for the management of life threatening diseases is increasing but costs have become a major obstacle to the administration of these medicines, especially in resource limited healthcare systems. Introduction of biosimilars as a cost-effective alternative to innovator biopharmaceuticals has attracted the attention of both industry and policymakers. However, due […]
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 […]
Abstract: Biosimilars have the potential for making savings in healthcare costs, and with resource allocation, if competition is permitted at the level of treatment induction. Submitted: 24 August 2012; Revised: 17 January 2013; Accepted: 4 February 2013; Published online first: 13 February 2013 The last decade or so has seen the introduction of many truly innovative biological pharmaceuticals that have had a […]
Author byline as per print journal: Professor Joan Rovira, PhD; Leandro Lindner, BSc; Emmanuel Giménez, BSc; Professor Jaime Espín, PhD; Antonio Olry de Labry, PhD; Leticia García, BSc Introduction and study objectives: To describe the development of biosimilars in 24 European Union (EU) Member States, plus Norway and Switzerland, and to identify the key parameters […]
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 the development and production of similar biological medicines, or biosimilars. Biosimilars are currently available for use in oncology in the supportive care setting; the focus […]
Author byline as per print journal: Thijs J Giezen, PharmD, PhD; Sabine MJM Straus, MD, PhD Abstract: Post-marketing surveillance is essential to detect, assess and prevent adverse reactions of chemically synthesized small molecule drugs as well as biologicals, as the full safety profile can only be known after they have been placed on the market. Biologicals have […]
