Biological products, also known as biologics, have formed a cornerstone of modern healthcare for decades. Blood transfusions, gene therapy, monoclonal antibody treatment, vaccinations, and many more key clinical processes rely on goods derived from living organisms rather than chemical synthesis. Unfortunately, the development and manufacture of biologics can be extremely expensive. A common topic of debate by key opinion leaders in recent years has been the emergence of biosimilars and how to accelerate clinical trials in biosimilar development programs. What are Biosimilars? Biosimilars aim to reduce the costs associated with biologically-derived treatments without inhibiting the clinical significance of the innovator product. The goal is to identify

The Medicines and Healthcare Products Regulatory Agency (MHRA) has released its 2020-21 business plan, outlining its primary goals for the coming year. Driven by the need to develop new regulatory models and improving patient access to cutting-edge drugs and medical devices, the plan concerns various aspects of the British life sciences industry, including the efficacy and efficiency of clinical trial supplies. In the executive summary, the plan sets out the primary aim of “driving forward a substantial strategic and cultural change through 2020-21”. Though the document discusses a range of granular challenges in healthcare and medicine, two of the biggest issues covered are the