Merck Millipore has announced the publication of a white paper, "Effective In Vitro Bioanalytical Assays for Comparing Pharmacodynamics of Biosimilar Monoclonal Antibodies", which describes both regulatory and technical aspects of comparability studies for the development of biosimilars.
The white paper describes two bioanalytical approaches involving measurements of ligand binding to compare pharmacodynamics of biosimilars.
Specifically, surface plasmon resonance (SPR) and flow cytometry were used to quantify the binding of two therapeutic mAbs, alemtuzumab and infliximab, to molecules mediating cytotoxicity. Data generated from these comparability studies are highlighted.
The biosimilar therapeutics industry, estimated to be greater than $90 billion, is rapidly expanding and poised to see dramatic growth in the next five years in the United States, Europe and other international markets.
This explosion is being driven by the large size of the biologics industry, upcoming patent expirations on many major branded biologics and the issue of new or updated regulatory guidelines by the FDA, EMA and DBT of India.
While the industry is growing rapidly, developing a biosimilar therapeutic can be expensive, as each new biosimilar must prove that variances from the innovator drug are not clinically significant.
Therefore, there is a critical need for accurate and precise nonclinical, in vitro assays to measure drug potency.
"Although our regulatory bioanalytical services were founded on supporting the development of innovator biologics, we have also helped lead the development of both simple peptide and complex monoclonal antibody biosimilars," says James Hulse, Ph.D., Managing Scientific Director of Discovery and Development Solutions.
Hulse continued, "The regulatory guidelines governing the development of biosimilars are relatively new, and this white paper describes new approaches for development of preclinical data about drug properties and their physiological interactions without the need for animal experiments."