About Raymond Kaiser, Ph.D.

Dr. Raymond Kaiser is the Global Vice President, Early Phase Biopharmaceutical Solutions (BioA, CMC) at Covance. Dr. Kaiser is an expert in the research, development, QA/QA and technical support of biologic, biosimilar and vaccine products. He has spent over 20 years in the biopharmaceutical industry and published over 50 papers and patents on various aspects of the development, characterization and manufacture of biologics and vaccines. Prior to joining Covance, Dr. Kaiser was Executive Director in the Bioprocess R&D Department at Merck Research Laboratories.

Why Comparability Studies are the Key to a Biosimilar’s Success

Comparability Studies are the Key to a Biosimilar’s SuccessBiosimilars, which are new versions of innovator biopharmaceutical products that are marketed after expiration of patents, have emerged as one of the fastest growing development opportunities in the biopharmaceutical sector. In the U.S. alone, industry analysts estimate that biologics worth $80 billion are slated to go off patent by 2015.

Regulatory agencies evaluate biosimilars based on their level of similarity to, rather than the exact replication of, the innovator drug. In the U.S., recent guidance by the FDA says it will “consider the totality of the evidence” when assessing follow-on products. This approach requires sponsors to demonstrate robust chemical comparability to the innovator compound. Continue reading