R&D Industry Finds Biosimilar Interchangeability Statement By EU Regulators ‘Concerning’
A joint statement from the European Medicines Agency and Heads of Medicines Agencies on biosimilar interchangeability is “concerning,” says Europe’s R&D-based industry federation, EFPIA.
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Finnish Biosimilar Substitution Proposals Get Pushback From Industry
Finnish government proposals to introduce pharmacy-level substitution for biosimilars have been criticized by the country’s generics and biosimilars industry association.
US Bill Seeks To Eliminate Biosimilar Interchangeability Trial Burden
Sen. Mike Lee, R-UT, has introduced draft legislation in the US that would stop the FDA from requiring biosimilars to conduct ‘unnecessary’ switching studies in order to obtain an interchangeability designation.