Janssen Moves to Block Marketing of Renflexis in Suit Against Samsung Bioepis

With multiple biosimilars to infliximab (Remicade) in the US market, Janssen Biotech, which developed the reference product, has taken steps to block the marketing of at least one of these in the United States. Last week, the company filed a lawsuit in a US District Court to prevent Korea-based Samsung Bioepis from selling its infliximab biosimilar in the United States.

According to Janssen, the Korean company violated 3 of its manufacturing process patents, a claim that Samsung Bioepis disputes: “We are confident we do not infringe Janssen’s patents,” the company said in a statement, adding, “We will take all necessary measures against Janssen’s attempts to violate patient rights and deny patient access to effective, lower cost treatment options.”

Infliximab-abda (Renflexis), developed by Samsung Bioepsis/Merck, was approved by the FDA just about a month ago. This tumor necrosis factor (TNF) inhibitor has been indicated for various inflammatory conditions, including Crohn’s disease (adult and pediatric), ulcerative colitis, rheumatoid arthritis (combined with methotrexate), ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.

Janssen's objections are with the same patents as it did with Celltrion’s infliximab biosimilar, Inflectra. The current lawsuit claims that Samsung Bioepis “short-circuited the patent dispute resolution process” as noted in the Biologics Price Competition and Innovation Act (BPCIA), specifically the information exchange and good-faith negotiations between the plaintiff and the defendant.

Janssen claims that “Bioepis short-circuited the BPCIA’s patent dispute resolution process by withholding the information necessary for Janssen to assess infringement.”

The lawsuit further accuses Samsung Bioepis of serving the notice of commercial marketing much earlier than when it is allowed to legally do so, which is after approval of the abbreviated Biologics License Application.

Infliximab brings in close to $5 billion in sales for Janssen, and the company is definitely worried about the drop in revenue as a result of the biosimilar competition.

With multiple biosimilar products in the pipeline, Samsung Bioepis’ 6 initial offerings are focused on immunology, oncology, and metabolic diseases.

The company plans to proceed marketing Renflexis in the United States as planned.