On Friday, April 21st, the FDA approved its fifth biosimilar, Renflixis (infliximab-abda). While the second biosimilar approved for Remicade (infliximab)- the first being Inflectra (infliximab-dyyb), approved in April 2016. Renflexis is noteable as the first biosimilar to be approved without a meeting of an FDA Advisory Committee.
Advisory committees provide FDA with independent opinions and recommendations from outside experts on applications to market new drugs, and on FDA policies. The marketing applications include data to show the safety and effectiveness of human drugs. The outside experts receive summary information about the applications and copies of FDA’s review of the application documents. Based on this information, advisory committees may recommend approval or disapproval of a drug’s marketing application. FDA generally follows an advisory committee’s recommendation, but is not bound to do so.
Renflixis (infliximab-abda) is also the first biosimilar approved after the finalization of the FDA’s Naming Guidance in January 2017.
Read more about Renflixis (infliximab-abda) here.