Biosimilars are biological medical products that are highly similar to already licensed biotherapeutic products. They are approved based on the same standards of quality, safety and efficacy as traditional biological drugs. However, there are key differences in designing biosimilars compared to their corresponding innovator products.
In this presentation, Dr. Janka Ryding guides us through some of the bioanalytical considerations that are important for biosimilar drug development.
Learn about bioanalytical program strategy considerations and the role of bioanalytics. Get regulatory guidance and helpful tips for PK and ADA assay development. Find out what to do if bioanalytical drug similarity cannot be demonstrated. Finally, get recommendations for documentation and development reports.