"Insulin Biosimilars: More focus than ever on Glucose Clamp Studies"
Insights from Dr. Tim Heise, Lead Scientist and Chairman of the Board of Directors at Profil:
You will benefit by learning about:
- Recent updates in the regulatory framework for biosimilar insulins
- The design of clinically development programs and glucose clamp studies to achieve approval of biosimilar insulins in important markets like China, Europe, Japan and the USA
Several biosimilar insulins have become available in both Europe and the USA. Further developments are underway as the patent protection of several available insulins are nearing expiration.
The aim of biosimilar insulin development is to demonstrate similarity to existing insulins. In contrast to generics which are believed to be chemically identical to their reference product, biologics such as insulin will always show slight differences to their available counterparts, e.g. due to different starting materials (host cells, tissues, etc.) and differences in the manufacturing processes. Regulatory guidelines were developed, in particular from the European and the US agencies, to lead applicants through the various requirements for the demonstration of biosimilarity.
The webinar will explain the consequences of these guidelines for clinical development programs of biosimilar insulins. It will specifically address recent updates that put less focus on immunogenicity studies and thereby strengthen the importance of providing clear evidence for pharmacodynamic and pharmacokinetic bioequivalence in phase 1 studies. These studies usually use the euglycemic hyperinsulinemic glucose clamp technique, so that it is unsurprising that Profil with its unique experience in (automated) glucose clamp studies have been involved in numerous developments of biosimilar insulins. Based on this vast experience the webinar will explain important aspects for the design and conduct of glucose clamp studies for biosimilar insulins. In particular, we will discuss the importance of achieving high glucose clamp quality to achieve bioequivalence and thereby fulfill the requirements for the approval of biosimilar insulins in Europe and in the US, but also in important Asian markets such as China and Japan.
Meet the presenter
Dr. Tim Heise has more than 25 years of experience in both clinical research and clinical care in diabetes and obesity. He has published well over 150 scientific papers and reviews with a focus on the pharmacology of insulin and anti-diabetic drugs. Dr Heise is a member of the Editorial Board for Diabetes, Obesity and Metabolism and he takes a strong interest in evidence-based medicine.