Dr. Slamon Discusses the Approval Process for Biosimilars

Dennis J. Slamon, MD, PhD, director, Clinical/Translational Research, Revlon/University of California, Los Angeles (UCLA) Women's Cancer Research Program, Jonsson Comprehensive Cancer Center, UCLA, discusses the approval process for biosimilars.

There are strict rules that both the FDA and the European Medicines Agency have laid down regarding the approval of biosimilars, Slamon says. This includes parameters for safety, efficacy, and pharmacology. The biosimilar must show that it is similar within a confidence interval—it cannot be inferior or superior. If a biosimilar has the same safety profile as the original biologic, but exceeds it in efficacy, it will not be approved. It must go back and go through formal testing, as it is considered a new compound, says Slamon.

Legally, it is difficult to get a biosimilar approved, Slamon explains, but creating a biosimilar to meet the regulatory criteria is also a challenge.