June 17th 2025
With more than 100 next-generation biologics set to lose patent exclusivity in the next 15 years, there is widespread agreement that developing biosimilars for these therapies will benefit society as a whole.
Novartis’ Sandoz Receives Positive CHMP Opinion for Pegfilgrastim Biosimilar
September 27th 2018The company’s biosimiliar to Amgen’s Neulasta (pegfilgrastim) received a positive opinion for marketing authorization from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).
US and EU Talk Inspections, Generics, and Advanced Therapies at Bilateral Meeting
June 22nd 2018FDA, EMA, and senior officials from the European Commission met to discuss the EU-US mutual recognition agreement for inspections, the development of advanced therapies, the requirements for approving generic drugs, and Real-World Evidence used for post-authorization monitoring.