FDA Approves Renflexis as Second Infliximab Biosimilar Save

On the 21st of April, the FDA approved another infliximab biosimilar, called Renflexis (Infliximab-abda) following on the biologics license application of the South Korean manufacturer Samsung Bioepis Co. LTD.  In early developmental trials this agent was also called SB2.

This will be the fifth biosimilar to be FDA approved and the fourth TNF inhibitor.  In 2016, the FDA approved biosimilar versions of etanercept (Erelzi), adalimumab (Amjevita) and infliximab (Infectra or infliximab-dyyb).   This will be the second version of infliximab to hit the market and under the new naming system will have the generic name infliximab-abda.

Renflexis will carry the same indications of the originator (Remicade) including active, moderate-severe, rheumatoid arthritis, ankylosing spondylitis, adult and pediatric Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis.

The drug is approved with the same dosing, boxed warnings (serious infections, TB, lymphoma, hepatosplenic T cell lymphoma) and warnings currently found with Remicade and Inflectra. Thus before starting Renflexis, patient must be screened for tuberculosis.

The company had filed for the U.S. FDA approval in March last year. Submitted supplemental data in December 2016 and was granted licensing privileges on 4/21/17. 

The drug is currently approved and in use in Korea under the brand name of Renflexis. It also approved throughout Europe, Norway, Iceland and Australia since 2016, where it is called Flixabi. 

Renflexis will be marketed and distributed in the United States by Merck & Co Inc.

Remicade accounted for about 9.7 percent of Johnson & Johnson's total revenues for fiscal 2016, and biosimilar competition is expected to reduce U.S. sales.

The package insert for Renflexis can be found here.