Dr. Rugo Discusses Regulatory Process Behind Biosimilars

Hope S. Rugo, MD
Published: Wednesday, Apr 03, 2019



Hope S. Rugo, MD, director, Breast Oncology and Clinical Trials Education, University of California San Francisco Helen Diller Family Comprehensive Cancer Center, discusses the regulatory process behind biosimilars in oncology.

Biosimilars are carefully regulated by international agencies, Rugo says. Additionally, the World Health Organization has shared insight on the criteria a biosimilar has to meet to receive regulatory approval. The FDA and European Medicines Agency also have rigid guidelines for biosimilar approval. To receive approval, a biosimilar has to demonstrate similarity to the originator product based on analytic tests, as well as pharmacodynamic and pharmacokinetic markers.

For example, a biosimilar cannot show immunogenicity that is different from the reference product. The drug has to demonstrate clinical similarity in a setting in which the reference product is highly effective and has a sensitive indication––similar to the case of trastuzumab (Herceptin) combined with chemotherapy in the treatment of patients with HER2-positive breast cancer. Efficacy has been agreed upon as the most important benchmark for similarity, and some biosimilar studies have also looked at event-free survival and progression-free survival as endpoints. This builds confidence in the biosimilar, Rugo notes.
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Hope S. Rugo, MD, director, Breast Oncology and Clinical Trials Education, University of California San Francisco Helen Diller Family Comprehensive Cancer Center, discusses the regulatory process behind biosimilars in oncology.

Biosimilars are carefully regulated by international agencies, Rugo says. Additionally, the World Health Organization has shared insight on the criteria a biosimilar has to meet to receive regulatory approval. The FDA and European Medicines Agency also have rigid guidelines for biosimilar approval. To receive approval, a biosimilar has to demonstrate similarity to the originator product based on analytic tests, as well as pharmacodynamic and pharmacokinetic markers.

For example, a biosimilar cannot show immunogenicity that is different from the reference product. The drug has to demonstrate clinical similarity in a setting in which the reference product is highly effective and has a sensitive indication––similar to the case of trastuzumab (Herceptin) combined with chemotherapy in the treatment of patients with HER2-positive breast cancer. Efficacy has been agreed upon as the most important benchmark for similarity, and some biosimilar studies have also looked at event-free survival and progression-free survival as endpoints. This builds confidence in the biosimilar, Rugo notes.

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