Case Study

Three Ways To Maximize Post Marketing Research For Biosimilars

Source: UBC
Three Ways To Maximize Post Marketing Research For Biosimilars

Proving therapeutic equivalence is an important step in the approval process for a biosimilar. The research needed is time, labor and resource intensive, making it critical to maximize the investment. UBC’s Clinical Development team is supporting a sponsor with a Phase IV study of a gastroenterology biosimilar. This late phase study has yielded three important lessons for biosimilar manufacturers.