Thursday, 22 Jun 2017

You are here

FDA Approves Renflexis as Second Infliximab Biosimilar

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.

Disclosures: 
The author has no conflicts of interest to disclose related to this subject

Add new comment

More Like This

Golimumab Fails in Polyarticular Juvenile Arthritis

Treatment options for children with active polyarticular juvenile idiopathic arthritis (polyJIA) have lagged behind that seen with adult rheumatoid arthritis. Excluding new biosimilar indications, there are 9 currently approved biologics for adult RA, but only 5 of these have been approved for use in polyarticular JIA (pJIA) - abatacept, tocilizumab, etanercept, infliximab, and adalimumab.

Inflammatory Arthritis Stable after Switch to Biosimilar Infliximab

The DANBIO registrys has demonstrated that switching from infliximab (Remicade) to biosimilar CT-P13 (Inflectra in the U.S., Remsima in Europe) does not appear to have any negative effect on inflammatory arthritis disease activity, Danish researchers reported.

NOR-SWITCH Study Validates Biosimilar Use in Multiple Indications

Lancet reports the results of the NOR-SWITCH study - a trial performed in Norway as biosimilars were being introduced. This study was designed to assess the efficacy and safety of transitioning from the originator (Remicade) to the less expensive biosimilar CT-P13 (Remsima/Inflectra) in the treatment of Crohn's disease, ulcerative colitis, spondyloarthritis, rheumatoid arthritis, psoriatic arthritis, and chronic plaque psoriasis.

Is the Jury Still Out on Triple Therapy vs. MTX + TNF inhibitor?

There are several trials that test the efficacy and safety of combination tumor necrosis factor inhibitor (TNFi) plus methotrexate against triple therapy (methotrexate plus hydroxychloroquine plus sulfasalazine) in patients with rheumatoid arthritis.

Cautious Optimism for Biosimilars in Rheumatology


In April 2016, the FDA approved Inflectra, a biosimilar to infliximab (Remicade), which was the first monoclonal antibody biosimilar, and MedPage Today reported on the clinical and legal issues being faced. Here we review subsequent developments regarding biosimilars for rheumatic diseases.