Question

Discuss the clinical development of a biosimilar medicinal product as compared to the development of an innovator medicinal product (e.g. what types of nonclinical and clinical studies are required for the development of an innovator product versus biosimilar product)

Answer 1

Biosimilar product is a biological drug (generally a monoclonal antibody) that is better to existing original drug or innovator drug or most of the times similar to the drug.

The nonclinical studies involve strictly adhering to the guidelines issued by FDA and EMA in development of biosimilars and include the following steps hybridoma cultures, recombinant expression of protein, careful purification, characterization by various biophysical techniques and a very thorough comparison of the biological biosimilar product mass, post-translational modifications and amino acids modifications like phosphorylations and point mutations to be established by mass spectroscopy. The PK, PD and immunogenicity are also very important in this validation. At every step, the product has to be compared to innovator and compatibility conditions have to be a shown with all stringent conditions with proper validations.

Once the molecule is characterised in a nonclinical lab and convinced it will be taken for clinical studies where the animal studies and include the parameters like population, design, endpoint, sample size duration and analytical methods.