FDA Unveils Draft Guidance on Biosimilar Labeling

FDA released on Thursday draft guidance on biosimilar labels. According to the guidance, biosimilar labeling—as with generics—should include a description of the clinical data that supported safety and efficacy of the reference product. FDA notes, however, that in situations where a biosimilar is not approved for the same indications as its reference product—unlike with generics—"it may be necessary to include information in the biosimilar product labeling relating to an indication(s) for which the biosimilar product applicant is not seeking licensure, in order to help ensure safe use (e.g., when safety information in the reference product labeling is related to use of the product and is not specific to a particular approved indication(s) or when information specific to only the biosimilar product’s indication(s) cannot be easily extracted).” The draft guidance also states that the label should be written in a way that does not imply that the biosimilar product is approved for a reference product indication or use that has not been approved for the biosimilar product. “The overall risk-benefit profile of the reference product is relevant to the biosimilar product, even if a particular serious adverse reaction or other risk included in the reference product labeling may not have been reported with the biosimilar product at the time of licensure,” FDA said. Read More (NCPIE source: APhA Pharmacy Today 4/1/16)
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guida...