Biomarker Challenges in Biosimilar Drug Development

Biologics have transformed the way several diseases have been traditionally treated and managed over the past several years. Therapeutic antibodies are a class of biologics that has been exceptionally effective in the treatment of life threatening diseases such as cancer and inflammatory diseases.

As patents and exclusivity on several originator biologics are expiring, the industry has been moving in to generate biosimilars. Biosimilars are products that are highly similar to the originator molecules with no clinically meaningful differences in safety, purity and potency.

Owing to the complexity of biological molecules and the variability of sophisticated modern processes by which they are generated, it is extremely difficult to generate fully identical biosimilars. Subtle structural and functional differences can lead to potentially serious consequences when administered into the diseased host. Regulatory agencies require the generation of physicochemical, structural and functional data on candidate biosimilars prior to approval for use in human subjects. Thus, successful development of biosimilars requires the demonstration of pharmacological similarity with the originator biologics.

This webinar focuses on Covance’s experience with in vitro assays to demonstrate pharmacological similarity between biologics and biosimilars.

Speaker

Sinnathamby Gomathinayagam, PhD, Senior Scientist, Biomarker Center of Excellence, Covance

Dr. Gomathinayagam received his PhD in Immunology from the Indian Institute of Science, Bangalore, India. He has over 13 years of experience in studying various aspects of immunity to infectious agents and cancer and has led discovery efforts to identify biomarkers associated with various cancer indications and infectious diseases. Dr. Gomathinayagam joined Covance in 2010 and is a Sr Scientist and therapeutic leader for immunology and inflammation. He also manages the cell culture lab at the Biomarker Center of Excellence where he has developed a number of cell based assays to support the development of Pharmaceutical drugs and biologics/biosimilars.

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