Abstract: The situation in many countries regarding the procedure used to evaluate ‘biosimilars’ is not always clear. In this issue of GaBI Journal, Azevedo et al. review the regulatory situation for biosimilars in Latin America. It is intended to publish reviews covering the regulatory situation with biosimilars in other countries/geographical areas in future issues of […]
Author byline as per print journal: Gianluca Trifirò, MD, PhD; Meteb Al-Foheidi, MD, FRCPC; Ali M Alhomaidan, PhD; Ahmed H Aljedai, PharmD, MBA, BCPS, FCCP, FAST; Musaed Abdullah Alkholief, PhD; Mohammad A Alsenaidy, MSc, PhD; Aws Alshamsan, BPharm, RPh, PhD; Tore Kristian Kvien, MD, PhD Introduction: A meeting was organized by the Generics and Biosimilars […]
Abstract: Biological and biotechnological medicines are important pharmaceutical innovations due to their influence on the treatment of many conditions and because they have led the way in devising new and innovative pharmacological therapies. In addition, biosimilars, which can be authorized on the date of expiry of a biological originator’s patent, give an opportunity for the […]
Author byline as per print journal: Valderilio Feijó Azevedo, MD, PhD; Eduardo Mysler, MD; Alexis Aceituno Álvarez, PharmD, PhD; Juana Hughes, MSc; Francisco Javier Flores-Murrieta, PhD, FCP; Eva Maria Ruiz de Castilla, MS, MAA, PhD Abstract: With the emergence of biosimilars as a new class of biotherapeutic agents, the use of these products in Latin America has become a focus […]
Abstract: The arrival of biosimilars has led to considerable debate on how they can be used in clinical practice. A particular concern is related to the question of whether a biosimilar can be safely interchanged with the originator product or other biosimilars. Here we will discuss challenges to the regulatory approach for establishing interchangeability, in […]
Introduction: The Association of Southeast Asian Nations (ASEAN) Overview Workshop on GMP for Biologicals and Biosimilars was co-organized with the Generics and Biosimilars Initiative (GaBI). This meeting was intended to improve the understanding of the good manufacture practice (GMP) inspection framework for biological (and biosimilar) drugs among ASEAN countries. Methods: The workshop was held on […]
Author byline as per print journal: Steven Simoens, PhD; Claude Le Pen, PhD; Niels Boone, PharmD; Ferdinand Breedveld, MD, PhD; Antonella Celano; Antonio Llombart-Cussac, MD, PhD; Frank Jorgensen, MPharm, MM; Andras Süle, PhD; Ad A van Bodegraven, MD, PhD; Rene Westhovens, MD, PhD; Jo De Cock Introduction/Objectives: This manuscript aims to provide guidance to policymakers with […]
Abstract: As the number of innovator biologics and biosimilars increases worldwide, a growing debate has focused on how these products should be named. The simple concept of a name can have significant impact on prescribing, dispensing, and adverse event reporting processes and, consequently, patient safety. Submitted: 2 January 2014; Revised: 10 January 2014; Accepted: 11 […]
Abstract: This paper provides a detailed comparison of biosimilars guidelines issued in Canada, the European Union, Japan and Korea; and by the World Health Organization (WHO). This comparison highlights the need for harmonization of global regulatory standards for the approval of biosimilars. Biosimilars are recognized around the world as safe and effective medicines. Despite this […]
Author byline as per print journal: Barbara Milan, Sara Gaspani Introduction: The current pipeline of promising oral hepatitis C drugs could lead to a revolution in treatment for this disease in both developed and developing countries. At present, the recommended treatment is pegylated interferon alpha (in combination with ribavirin). However, the limited availability and high […]
Abstract: The AIFA’s position paper recognizes the relevance of biosimilars to ensure the sustainability of drug expenditure but the new price and reimbursement procedure may not favour their prompt market access. Submitted: 26 June 2013; Revised: 10 July 2013; Accepted: 11 July 2013; Published online first: 24 July 2013 In the final position paper on […]
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 […]
