Repeat dose toxicity and comparative bioavailability of biosimilars
Product characterization, toxicity studies, toxicokinetics and immunogenicity for biosimilars, or follow-on biologicals, require regulatory knowledge and experience. Our experts can help you plan the best biosimilar development package and provide you with high quality data for regulatory submission.
Biosimilars are emerging as a fast-growing development opportunity in the biopharmaceutical sector. The European Medicines Agency (EMA), the US Food and Drug Administration (FDA) and many others have published guidelines aimed specifically at biosimilar development.
Our preclinical biosimilar development strategy integrates the concept of comparability with existing knowledge of the biopharmaceutical reference drug. We offer a comprehensive program covering all aspects of regulatory toxicology to ensure data continuity throughout testing.
Citoxlab has extensive experience with a wide range of biologicals and biosimilars, including non-glycosylated proteins, monoclonal antibodies, metabolic hormones and immune-modulatory drugs.
We can help you in the following areas :
- Protein chemistry and structural characterization
- Stability and release
- Immunochemistry / PK-PD studies
- Toxicology studies
- Discovery models