It was with great pleasure that I assumed the role of Editor-in-Chief (EiC) of GaBI Journal in January of this year. Taking over the helm from Professor Philip D Walson is a considerable challenge; Phil’s excellent, thorough example will be very difficult to follow. My experience is restricted largely to biosimilars with which I have been involved since their concept and I will be relying on able colleagues for their expertise with generics! I hope to be able to carry out the important job of EiC effectively and efficiently.
In this issue of GaBI Journal, we have a number of papers on diverse topics.
In the first Original Research article Tomás Abbot, et al. describe budget impact analysis of Rixathon, a rituximab intravenous biosimilar in patients with follicular lymphoma and large B-cell non-Hodgkin lymphoma in a study conducted in Chile. They conclude that adoption of Rixathon biosimilar rather than the originator product resulted in clear overall cost savings. This clearly increases patient accessibility to rituximab treatment.
In the second Original Research article Dhananjay Panigrahi, et al. have conducted pharmacokinetic (PK) bioequivalence studies of a new Etoricoxib tablet formulation developed using proprietary MiST technology involving risk assessment and mitigation using commercially available software.
The simulated data generated were in line with the observed PK data obtained from the bioequivalence study. This work demonstrates application of predictive modelling and simulation tools to accelerate new product development.
Adjunct Professor Pekka Kurki has contributed a Perspective on Comparative efficacy studies of biosimilars: data versus theoretical risks, beliefs, and comfort. Professor Kurki is well known as a strong supporter of biosimilars and has been very active in development of regulatory processes for their assessment from their concept. His views on reducing the need for clinical efficacy studies have been the subject of numerous publications. His Perspective reviews the current status of regulatory guidance on clinical trials and encourages regulatory agencies, especially the US Food and Drug Administration, to take notice of the accumulating evidence for significant changes in the need for clinical efficacy studies.
Andriy Krendyukov, et al. present a Perspective on current understanding, knowledge, and perception of biosimilars in a changing landscape of regulatory requirements. They note that even in established biosimilar markets, understanding of biosimilar specific terms such as switching and extrapolation is variable and knowledge of evidence required for biosimilar development and approval is lacking and/or outdated. Lack of familiarity with these concepts and the evidence required to support biosimilar development may deter healthcare providers from using biosimilars to their full advantage.
More education for healthcare professionals is required in therapeutic areas where biosimilars are prescribed, and this should be updated regularly in step with evolving regulations.
To close, I wish everyone all the best for a happy and prosperous new year and encourage authors to submit relevant papers for consideration for publication in GaBI Journal.
Robin Thorpe, PhD., FRCPath
Editor-in-Chief, GaBIJournal
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Disclosure of Conflict of Interest Statement is available upon request.
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