• European Commission: Non-EU Reference Product OK for EU Biosimilars

    The European Commission plans to allow the use of a reference product not authorized in the EU in support of a biosimilar application, according to a  speech  delivered by Health and Consumer Policy Commissioner Dalli at the 18thEuropean Generic Medicines Association Annual Conference. Dalli announced "that after careful analysis of the scientific and regulatory elements, the European Commission will revise its interpretation" of existing EU law. The details o...
  • Brazil: Risk Management Plans Shouldn't Prevent Drug Access for Generic Companies

    A proposed new standard that defines the criteria for inclusion and exclusion of drugs in list of drugs used as the reference drugs by generics (Reference Listed Drug) was adopted by the Board of Brazil's national regulatory agency, Anvisa, on 14 June. A key provision of the proposal would require the reference drug manufacturer to provide the drug for purchase by a generic company. The purpose of the provision is to ensure that generic companies can obtain the d...