Dr. Pegram on the Manufacturing Process of Biosimilars

Mark D. Pegram, MD, Susy Yuan-Huey Hung Professor, co-director, Stanford’s Molecular Therapeutics Program, director, Breast Cancer Oncology Program, Stanford Women’s Cancer Center, discusses the manufacturing process of biosimilars.

In terms of similarity of these complex, large molecules that are manufactured by living cells, it is likely that every molecule in a single batch will be subtly different from each other, Pegram says. These differences are due to post-translational modifications, such as deamination, oxidation, and glycosylation. Some of these modifications can be clinically important, but we are now able to measure these attributes so precisely that they can be compared head-to-head with the reference product and show that it is highly similar on all fronts.

The FDA requires that biosimilars meet strict criteria in terms of structure, binding to targets, and activation of the immune system, in order to meet rigorous approval standards. All these factors are measurable in the laboratory and are “critical quality attributes” that are considered when comparing biologics to biosimilars. These data sets are then sent to regulators to determine biosimilarity.