What are biologics? In this article, we explore the definitions, potential applications, benefits and ever-changing regulations of this growing family of therapeutics.
With the reality of Brexit already impacting the UK’s clinical trials environment, Zamas Lam (QPS; DE, USA) discusses the effect this will have on bioanalytical research, and suggests 10 questions to ask when relocating UK-based preclinical and bioanalysis research projects.
2. Given the complexity and cost of development and manufacturing, are biosimilars more affordable therapeutic options?
In this ‘Ask the Experts’ feature, the experts discuss the complexity and cost of development and whether biosimilars are more affordable therapeutic options.
In this ‘Ask the Experts’ feature we will be discussing what is required to gain approval for a biosimilar.
In this ‘Ask the Experts’ feature we will be discussing the use of biosimilars with a number of leading experts across the field. The series will explore the role of biosimilars, address the benefits and challenges of creating them and how they have gained momentum within the pharmaceutical industry.
12. How do you see the field evolving over the next 5-10 years? What are the main obstacles to be overcome?
In our final instalement, our experts look towards the future and comment on how they see the field evolving over the next 5-10 years.
11. What are the different challenges that you have experienced with different regulatory regions? Are the challenges consistent across the regulatory authorities?
Our experts explore, the different challenges they have experienced with different regulatory regions.
In this feature we ask the question: how can the biosimilars field be regulated and standardized?
8. What are the challenges for demonstrating that immunogenicity risks for the biosimilar are less or equivalent to the innovator material?
In this feature, our experts discuss what the challenges are for demonstrating that immunogenicity risks for the biosimilar are less or equivalent to the innovator material.
We asked our experts: what have been the most exciting advances in developing biosimilars?