Welcome to the sixth edition of Biosimilars Newsletter, a quarterly publication dedicated to keeping you updated on current biosimilars news, including the global regulatory landscape, biosimilars articles and reports, and company news as reported by the respective company's press releases. The "Hot Topic" for this issue explores iterative signal detection and overall benefit-risk management’s essential role in demonstrating the safety of drugs and biosimilars in development to ensure that their benefits continue to outweigh their risks.