GaBI Journal publishes a comprehensive Biosimilars 2012–2013 book series of peer-reviewed scientific articles addressing almost all aspects of biosimilars medicines. The objective of the Biosimilars educational series is to provide a structural compilation of expert peer reviewed papers covering the current issues and practical experiences on the use of biosimilars, as well as the future development of biosimilars. The goal is to share … Read more »
As more biological products are going off patent protection, the development of follow-on biologics (biosimilars) has received much attention from both the biotechnology industry and the regulatory agencies since the United States (US) Congress passed the Biologics Price Competition and Innovation (BPCI) Act (as part of the Affordable Care Act) on 23 March 2010. In order to obtain input on specific issues and challenges associated … Read more »
The objective of this educational series is to offer an update on the current issues and practical experiences in the use of generic immunosuppressants in transplantation, as well as the possible recommendations to increase higher uptake. The educational series will be produced in a structured format intended for healthcare practitioners, including transplantation specialists, transplantation pharmacists, and regulators. Topics … Read more »
Currently, non-biological complex drugs (NBCDs) such as iron-carbohydrates, liposomal drugs and the glatiramoids, are approved under the generics pathway. However, unlike small molecule drugs, which are considered therapeutically equivalent, there are various discussions that follow-on NBCDs are not therapeutically equivalent and may have a different tolerability profile. Like proteins, NBCDs can be difficult or impossible to completely … Read more »
The traditional INN naming system for small molecule drugs has been working well without any particular concerns since 1950s. However, with the introduction of biological medicines in 1990s and subsequently biosimilars after the originator drugs become off patent, due to the ‘ similar ‘ nature of biological and biosimilar medicines, many biosimilar medicines from different companies will enter the market for patient access. This … Read more »
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