Senior officials at the US Food and Drug Administration laid out their guiding philosophy on regulating the production of generic versions of biological drugs such as antibodies, insulin or other proteins last Wednesday (August 3) in the New England Journal of Medicine.
Biologics generally have a more complicated production process than small molecule drugs, impeding the ability of generic manufacturers to prove they are producing an identical drug. Drug companies, therefore, have been eagerly awaiting guidance from the FDA as to what constitutes a sufficient level of "biosimilarity" to allow a generic version of a drug to be approved.
In the article, Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research (CDER), and others said that "given the complex nature of biologics, it's unlikely that a 'one size fits all' systematic assessment of biosimilarity can be developed." While the article further stated that unnecessary "and therefore unethical" clinical and preclinical testing of biosimilars should be avoided, it also suggested that more data will be necessary to determine a generic’s similarity to the original than what is required for small molecule generics, according to Reuters.