AURIGON, A VETERAN IN THE DEVELOPMENT OF BIOSIMILARS
Biosimilars are biologic medicines that are developed to provide safe, effective alternative versions of existing similar biologic medicines (known as “reference products” or “originators”) with scientifically comparable quality, safety and efficacy.
To assess this, potential biosimilars go through a comprehensive comparability exercise with regard to:
Besides a large number of new biologic medicines (NBE), Aurigon has successfully supported customers in the non-clinical development of biosimilars. Typical studies include:
- comprehensive biological characterisation (i.e. potency, immunochemistry)
- performance and evaluation of product-specific in vitro assays
- non-clinical comparability in vitro
- non-clinical comparability in vivo
- comparative pharmacokinetics
- comparative pharmacodynamics in relevant models
- immunogenicity testing
- local tolerance
- repeated-dose toxicity studies.
All studies are consequently designed as comparative originator / biosimilar studies.