Insulin biosimilar trials at Profil
Several biosimilar insulins are currently being developed worldwide. Profil has extensive experience in developing and conducting biosimilar insulin trials in healthy participants and people with diabetes. With this vast experience, we can fully support the development of trial design and optimization of data analysis. Furthermore, our scientists can help obtain scientific advice from regulatory authorities in Europe (European Medicines Agency) and the U.S. (Food and Drug Administration).
What are insulin biosimilars?
Biosimilar medicinal products (called: ‘test product’) are very close in structure, biological activity and efficacy, and safety, including immunogenicity, to another already authorized biomedical medicinal product (called: ‘reference product’). However, unlike small molecule drugs and their generic copies, which are usually identical and reproducible, biological medicinal products do not have fully reproducible structures. The complex manufacturing process for proteins may lead to structural differences (e.g., changes in glycosylation patterns) between a biosimilar and a reference product.
Natural variability is inherent in all biological medicines. For this reason, strict controls are always in place during the manufacturing process. However, as such differences can play an important role in immunogenicity and efficacy (pharmacokinetics and possibly pharmacodynamics), it is considered an important quality characteristic.
Regulations on clinical trials for insulin biosimilars
As there may be minor differences between the biosimilar and its reference product, non-clinical and clinical data based on the experience with safety and efficacy gained with the reference product are required for the approval of a biosimilar. Regulatory guidelines for clinical development programs of biosimilar insulins, particularly those of the European and the US agencies, have been developed.
As these early phase clinical trials typically require the use of the automated euglycemic glucose clamp technique, Profil can provide you with its unique experience to meet these requirements including other aspects of e.g. clinical trial design, trial population selection, trial conduct and statistical analysis. As the guidelines clearly request the demonstration of both pharmacokinetic and pharmacodynamic bioequivalence beside immunogenicity data, trials with large sample sizes may be required. It is therefore essential to know the exact regulatory requirements to optimize the design for each individual insulin formulation after consulting regulatory guidelines and possibly gain scientific advice of the regulatory authorities.
