Renflexis

Product Profile:

Infliximab-abda (Renflexis)

Drug Category: Anti-TNF/Autoimmune

Target Indications: Crohn’s disease (adult and pediatric), ulcerative colitis, rheumatoid arthritis, plaque psoriasis, ankylosing spondylitis, psoriatic arthritis

Manufactured by Samsung Bioepis; Marketed by Merck

Summary: Renflexis (initially designated SB2) is a biosimilar version of infliximab (reference product, Remicade, Jannsen) manufactured by Samsung Bioepis/Merck. It is marketed in the US by Merck. A biologic license application for approval via the 351(k) biosimilar pathway was submitted to the Food and Drug Administration (FDA) in May 2016. The biologic was approved by the FDA in April 2017 and entered the market in July 2017 at a discount of 35% off the list price of Remicade.

About the Manufacturer

Samsung Bioepis Co., Ltd. develops and produces biopharmaceutical and biosimilar products. Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen that operates as a subsidiary of Samsung Biologics Co., Ltd.  In Early 2013 Samsung Bioepsis and Merck entered into a business agreement to develop and commercialize biosimilars. Samsung Bioepis Co., Ltd. also entered into a strategic collaboration agreement with Takeda Pharmaceutical Company Limited in August 2017. The company was incorporated in 2012 and is based in Incheon, South Korea.

News, Commentary, and Intelligence

Competitor Products and Manufacturer Analysis

BIOSIMILARS APPROVED BY THE FDA: FDA FILING DATES AND ACTIONS

Biosimilar

Manufacturer

Brand Name & Designation

Innovator Product

FDA Filing Date

Status

Infliximab

Celltrion/Pfizer

Inflectra (infliximab-dyyb)

Remicade

August 8, 2014

Approved April 5, 2016; marketed

Infliximab

Samsung Bioepis/Merck

Renflexis (infliximab-abda)

Remicade

May 23, 2016

Approved April 21, 2017; marketed

Infliximab

Pfizer

Ixifi (infliximab-qbtx)

Remicade

April 2017

Approved December 14, 2017, all indications; will not be marketed in US

Infliximab Biosimilar(s) in Development

Company name, Country

Product name

 

Stage of development

Amgen

ABP 710

 

FDA BLA Application filed December 17, 2018

Nichi-Iko Pharmaceutical,  Japan

NI-071

 

Phase III trial in rheumatoid arthritis expected to be completed in March 2015 . Approved in Japan in September 2017. US phase III trial in rheumatoid arthritis expected to be completed February 2019

Updated December 17, 2018

Amgen Submits Application for Biosimilar Inflximab

(December 17, 2018) ABP 710 was the subject of a phase 3 trial in patients with moderate-to-severe rheumatoid arthritis.

Infliximab Biosimilars Savings Could Exceed $400 Million Dollars Annually

(June 21, 2018) Everyone with an opinion believes that biosimilar drug use will save the health system considerable money. Calculations for biosimilar savings have been hampered by several factors. For example, previous high estimates have not been based on real-life scenarios.

How Will Biosimilars Be Affected by Trump’s Drug Price Reform Measures?

(May 14, 2018) When President Trump announced the broad strokes of his drug price reform initiative, some of these measures seemed on target to benefit the biosimilars industry. However long awaited, makers of originator biologics seemed not to be worried about its implications. The President may not be able to effect much change, without causing unintended adverse consequences

Plans Use Step Therapy to Encourage Utilization of Remicade Over Biosimilars

(May 9, 2018) Health plans and insurers are not yet turning to biosimilar infliximab as a preferred therapy, according to Gillian Woollett, DPhil, MA, of Avalere. Her new report surveyed publicly available policy about health plans across the nation. The principal finding was that step therapy was commonly used  to encourage use of the originator product.

Celltrion and Inflectra, Mylan and Botox, and a Biosimilar Blooper

(March 2, 2018) The second quarter is expected to be rife with news regarding Food and Drug Administration approval decisions on a biosimilar for rituximab and two pending applications for trastuzumab. Although biosimilars have not generated much news of importance lately, we wrap up the week with some items of interest.

A Health System Biosimilar Survey’s Implications

(November 30, 2017) When asked about potential cost savings with the infliximab biosimilar, nearly one-quarter of health system respondents did not believe that it represented a cost savings opportunity for their organization, according to a newly published survey in the Journal of Managed Care and Specialty Pharmacy.

News in the Courts on Biosimilars

(November 14 2017) According to a Reuters report, Janssen Biotech withdrew its patent lawsuit against Samsung Bioepis on November 10. The suit alleged infringement in the manufacture of Samsung’s infliximab biosimilar. The action, which was filed in U.S. District Court of New Jersey, means that Merck and Samsung, which launched Renflexis™ in July, is no longer at risk…

Living With Crohn's Disease

Understanding Biosimilars

Clinical Trials of Renflexis

Published Trial Results

A randomised, double-blind, phase III study comparing SB2, an infliximab biosimilar, to the infliximab reference product Remicade in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy.

Extension Trial Results

Safety, immunogenicity and efficacy after switching from reference infliximab to biosimilar SB2 compared with continuing reference infliximab and SB2 in patients with rheumatoid arthritis: results of a randomised, double-blind, phase III transition study.

The study was extended after 54 weeks to week 78 whereby study participants receiving the reference product were switched to SB2 or stayed on the reference product, while those receiving SB2 remained on SB2. The ACR20 responses were similar across all three study arms.

Ref INF/SB2
N=94
INF/INF
N=101
SB2/SB2
N=201
ACR20
63.5%
68.8%
68.3%
ACR50
37.6%
47.3%
40.6%
ACR70
22.4%
31.2%
25.6%

The number of TEAEs was similar across the groups, 35.6%-40.3%). The most common TEAEs in the extended study were latent tuberculosis, nasopharyngitis and worsening RA. The average number of patients ADA negative during the first 52 weeks that became ADA positive in the extension were 14.9% staying on the reference product, 14.6% switching to SB2 and 14.1% staying on SB2.

Phase I Trial: Pharmacokinetic, safety, tolerability and immunogenicity study of SB2 in healthy subjects.

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