The Extrapolation of Biosimilar Indications: Understand the Practical Implications

Dr. Gregory F. Schimizzi, a rheumatologist and co-founder of Carolina Arthritis Associates, P.A., in Wilmington, NC, talks about indication extrapolation, or the approval of a biosimilar for an indication that it was not approved for in a trial. He also shares some of the FDA recommendations to biosimilar manufacturers for what to consider before setting out to study and manufacture a biosimilar. These included MOA, PK/distribution, immunogenicity, differences in expected toxicities, and any other factor possibly affecting safety or efficacy. He also explains the importance of scientific justification for expanding biosimilar indications and notes that manufacturers should consider extrapolating data from patient populations that are most likely to develop toxicity reactions to the product.