Merck Announces US Launch of Biosimilar Infliximab Renflexis

Merck today announced the US launch of its biosimilar infliximab, Renflexis, which it developed under a joint venture with Samsung Bioepis.

Merck’s product, a tumor necrosis factor (TNF) blocker referenced on Janssen Biotech’s Remicade, was approved by the FDA on April 21, 2017 for the treatment of Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.

Merck will introduce the drug at a US list price of $753.39, which it says represents a 35% discount to the price of the reference Remicade. That price point puts renewed pressure on Janssen; while Remicade earned the Johnson and Johnson division $4.8 billion in 2016, or 9.7% of its 2016 revenue, Remicade’s sales slipped after competition from Celltrion's biosimilar infliximab, Inflectra. When Pfizer, which has commercialization rights to the drug, introduced Inflectra in 2016, it set its product’s list price at only a 15% discount to that of Remicade; Merck’s deeper discount has the potential to encroach on Remicade’s sales figures even further.

“Merck looks forward to launching Renflexis in the United States to help meet the needs of patients, physicians and payers,” said Dora Bibila, general manager of Merck Biosimilars. “As a global healthcare leader, Merck believes that biosimilars have the potential to help increase access to these important medicines while also providing savings for the health care system.” Merck plans to make available comprehensive education and support services for healthcare professionals, patients, and caregivers, including reimbursement and access support.

Despite Merck’s move to introduce Renflexis to the United States, Janssen seeks to retain its hold on the infliximab market through litigation. Earlier this year, Janssen filed a district court lawsuit to prevent the sale of Merck and Samsung Bioepis’ infliximab product in the US, saying that the biosimilar product’s manufacturers had violated several of its patents.

Samsung Bioepis, for its part, believes that the case will be resolved in its and Merck’s favor. “We are confident we do not infringe on Janssen’s patents,” a company spokesperson, told Reuters. “We will take all necessary measures against Janssen's attempts to violate patient rights and deny patient access to effective, lower-cost treatment options."