In its June 2025 meeting, the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) adopted positive opinions for six biosimilar medicines. ...more
Legal, Regulatory and Commercial Perspectives on the International Biosimilars Marketplace - The Global Biosimilars market is expected to grow robustly. Market watchers anticipate that Europe in particular will experience...more
Europe has led the way globally with respect to biosimilar medicines since 2005. In that year, the European Medicines Agency (EMA) issued regulatory guidelines for the development and assessment of biosimilars....more