The FDA issued a final guidance on biosimilars labeling in 2018. The FDA expressed concern that providing data from the studies used to demonstrate biosimilarity could be confusing and irrelevant to the practicing clinician. Instead, the FDA recommends that the biosimilar label includes a description of clinical data that supports the safety and efficacy of the original biologic medicine highlighting any appropriate product-specific modifications that exist between the biosimilar and the original biologic medicine (eg, differences in administration or storage).1
The label information will also be tailored to only include information on the indications for which the biosimilar has been approved, which may be narrower than the original biologic medicine. Many patient and physician groups, as well as Amgen, believe that the information in a biosimilars label should:1
Reference: 1. US Food and Drug Administration. Guidance for industry: labeling for biosimilar products. www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm493439.pdf. Accessed October 29, 2019.