FDA Accepts Samsung Bioepis' BLA for Remicade Biosimilar

May 24, 2016
BioPharm International Editors

FDA accepted for review Samsung Bioepis’ BLA for SB2, a biosimilar to Remicade (infliximab).

FDA has accepted for review Samsung Bioepis’ Biologics License Application (BLA) for SB2, a biosimilar candidate referencing Remicade (infliximab), for the treatment of rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis. According to a May 24, 2016 press announcement, this is the first Samsung Bioepis biosimilar candidate submitted for review in the United States. If approved, Merck will handle the marketing and distribution of SB2 in the US.

If FDA gives the green light to SB2, it will be the second mAb biosimilar (and second Remicade biosimilar) to hit the US market. Celltrion and Pfizer’s Remicade biosimilar Inflectra (infliximab) was approved by FDA on April 5, 2016. Inflectra is the first monoclonal antibody (mAb)-based biosimilar to be approved in the US. The drug was approved for all of Remicade’s indications except pediatric ulcerative colitis, which is still covered by orphan drug exclusivity until September 23, 2018.

In early April 2016, Samsung Bioepis received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) for its Remicade biosimilar Flixabi (infliximab) in Europe. If granted marketing authorization, Biogen will commercialize the drug in the European Union. Samsung Bioepis currently has 13 biosimilar candidates in its pipeline, including drugs referencing etanercept, adalimumab, insulin glargine, trastuzumab, and bevacizumab.  

Source: Samsung Bioepis