US Bill Seeks To Eliminate Biosimilar Interchangeability Trial Burden
‘Biosimilar Red Tape Elimination Act’ Would Remove Need For Switching Studies
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.
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The recent statement by the EMA and HMA affirming the interchangeability of biologics and biosimilars has given a boost to Europe’s biosimilars industry ahead of key legislative reforms, heard delegates to Medicines for Europe’s 18th Biosimilar Medicines Conference in Brussels.
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.
Coherus Biosimilar Used ‘Scientific Justification’ To Skip Switch Study, Still Get Interchangeability With Lucentis
Information on mechanism of action, pharmacokinetics, immunogenicity and toxicity convinced the US FDA there was no risk in terms of safety or diminished efficacy of switching between Cimerli and the reference product, Genentech’s eye drug Lucentis.