Abstract: The importance of obtaining IRB/EC consent for waiver of consent before embarking on retrospective chart review studies was highlighted using the recent case of a manuscript submitted to GaBI Journal. Submitted: 12 March 2016; Revised: 14 March 2016; Accepted: 14 March 2016; Published online first: 28 March 2016 This commentary was prompted by a […]
Abstract: Low-cost generic drug programs (LCGPs) provide affordable generics in the US. However, LCGPs have implications for managed care organizations and researchers relying on claims data. Submitted: 7 March 2016; Revised: 5 April 2016; Accepted: 5 April 2016; Published online first: 18 April 2016 Low-cost generic drug programs (LCGPs) in the US increase the affordability […]
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 […]
Abstract: A novel global and company specific biological qualifier, distinct from the International Nonproprietary Name (INN), is proposed by World Health Organization (WHO) for all biological active substances. Submitted: 14 May 2015; Revised: 2 July 2015; Accepted: 6 July 2015; Published online first: 20 July 2015 Introduction to INN The concept of one single non-proprietary […]
Abstract: The backlog in medicines registration in South Africa is a result of the implementation of pro-generics policies without strengthening the regulator to handle the substantial increase in registration applications that followed. Despite the backlog, more than enough generics are registered to promote price competition and ensure access to affordable medicines. Submitted: 25 February 2015; […]
Abstract: Notwithstanding the scientific and regulatory differences between generic and biosimilar medicines, the European Medicines Agency/Committee for Medicinal Products for Human Use has consistently applied a ‘same active substance’ approach to both. Submitted: 28 November 2014; Revised: 20 January 2015; Accepted: 27 January 2015; Published online first: 30 January 2015 It is often stated that […]
Abstract: The attractiveness of the biosimilar regulatory pathway is threatened by so-called biobetters. This paper provides definitions and an overview of recent developments. Submitted: 27 October 2014; Revised: 7 November 2014; Accepted: 12 November 2014; Published online first: 25 November 2014 Concerning the biosimilar landscape, the European Medicines Agency (EMA) was among the first institutions […]
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 […]
Abstract: Two biosimilar TNF-alfa monoclonal antibody (mAb) products were approved for clinical use in the European Union on 10 September 2013, following a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) in July 2013. The products, with trade names Remsima and Inflectra (INNs infliximab) contain an identical mAb. This approval shows […]
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: Biological product quality is susceptible to unexpected manufacturing issues, and the resulting variation may impact the safety or efficacy of these medicines and increase risks to patients. These risks can be managed more effectively by manufacturers’ adoption of the culture and practices of high reliability organizations and by their sharing of quality risk management […]
Abstract: Dr Brian Godman reviews the paper by Markovic-Pekovic et al. regarding recent reforms in the Republic of Srpska. These include prescribing restrictions where concerns with the value of products and measures to obtain low prices for generics, which is important given the rhetoric. Submitted: 11 June 2013; Revised: 13 June 2013; Accepted: 17 June […]
