Industry Insights

Article sourced from https://www.fda.gov/drugs/news-events-human-drugs/pharmacodynamic-biomarkers-their-role-biosimilar-product-development?utm_medium=email&utm_source=govdelivery A biosimilar product (biosimilar) is highly similar to, and has no clinically meaningful differences from, an FDA-approved reference product. Biosimilars may spur competition... A biosimilar product (biosimilar) is highly similar to, and has no clinically meaningful differences from, an FDA-approved reference product. Biosimilars may spur competition and result in additional safe, [...]

Article sourced from https://www.centerforbiosimilars.com/view/eye-on-pharma-fda-ema-accept-biosimilar-applications-biosimilar-trials-begin The FDA and the European Medicines Agency (EMA) accepted applications for a trastuzumab biosimilar and an ustekinumab biosimilar... The FDA and the European Medicines Agency (EMA) accepted applications for a trastuzumab biosimilar and an ustekinumab biosimilar, respectively, and Altos Biologics completed patient enrollment for a phase 3 trial assessing an aflibercept [...]

Article sourced from https://www.centerforbiosimilars.com/view/white-paper-argues-increased-competition-will-improve-biosimilar-uptake-savings A white paper touting biosimilar successes in the United States reasoned that increased market competition will help improve utilization rates, generate substantial savings, and encourage payers to cover biosimilars. A white paper touting biosimilar successes in the United States reasoned that increased market competition will help improve utilization rates, generate substantial savings, [...]

Trastuzumab was the first approved monoclonal antibody to target the oncogene HER2 protein... Trastuzumab was the first approved monoclonal antibody to target the oncogene HER2 protein, and its development was a life-changing therapy for women with HER2+ breast cancer. The significance of the role trastuzumab has played in treatment of breast cancer was recognized in [...]