Third Biosimilar Launches in the United States


Renflexis is a biosimilar of Remicade, which treats inflammatory conditions, including Crohn’s disease, rheumatoid arthritis, and psoriatic arthritis.

The biosimilar infliximab-abda (Renflexis) is now being commercialized in the United States following its April 2017 FDA approval.

Infliximab-abda is a tumor necrosis factor (TNF) blocker and is a biosimilar referencing infliximab (Remicade), according to a press release. It is indicated to treat Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.

The biosimilar will be priced at a wholesale acquisition cost of USD $753.39, a 35% reduction to the current wholesale acquisition cost of infliximab.

“Since we were established 5 years ago, we have strived to bring high-quality treatment options at a lower cost to US patients,” Christopher Hansung Ko, president and CEO of Samsung Bioepis, said in a release. “Renflexis is our first step in meeting this important commitment. We firmly believe biosimilars will play an instrumental role in making health care more accessible to patients across the US, and we will continue our relentless drive to advance one of the industry’s strongest pipelines.”

Infliximab-abda is Samsung Bioepis’ first drug to launch in the United States, according to the release.

Biosimilars are heralded as an affordable alternative to expensive biologic medications. Although they show significant potential to reduce the overall cost of treatment, prescriber uptake has been slow largely due to the current reimbursement model.

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