J&J abandons Remicade patent fight against Samsung and its Renflexis biosim

Johnson & Johnson has so far been successful at holding off biosimilar competition to its $5 billion immunology drug Remicade.

Pharma giant Johnson & Johnson is determined to defend Remicade against a growing biosimilar attack, but now the company has dropped its lawsuit accusing Samsung Bioepis of infringing patents on the blockbuster immunology drug. 

Partners Samsung and Merck launched their biosim Renflexis in July, despite the ongoing patent fight. J&J's Janssen unit had sued to block the rollout and asked the court to force Samsung to participate in the "patent dance," a dispute resolution process set out in the Biologics Price Competition and Innovation Act.

But since then, the Supreme Court ruled in the landmark Amgen v. Sandoz case that patent dance violations aren’t enforceable by injunction at the federal level. And with that decision, the first two counts of Janssen's case were moot. Now, J&J has dropped (PDF) the entire lawsuit "with prejudice," meaning it can't bring the allegations in a later filing.

Mingi Hyun, a spokesperson for Samsung Bioepis, said in a statement the company believes "Janssen’s withdrawal of this lawsuit is a win for American patients, as it marks a positive step towards improving patient access to biosimilars in the United States." 

In an emailed statement, a Janssen spokesperson said the company filed the suit "against Samsung to investigate whether their biosimilar infliximab infringes on our manufacturing process patents for Remicade."

"Upon review of Samsung’s [abbreviated Biologics License Application] and manufacturing information, we determined that their manufacturing processes do not infringe," the company's representative wrote. "We have therefore withdrawn our lawsuit."

Samsung Bioepis and Merck rolled out Renflexis at a 35% list price discount to the brand. It remains to be seen how much of a dent the partners can make in Remicade's market share, however; Pfizer so far hasn't made real progress with its first-to-market biosim, Inflectra, launched more than a year ago.

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In fact, Pfizer recently sued J&J for "anticompetitive" contracting on Remicade that it argues has effectively blocked new competition. J&J tied rebates on the existing Remicade patient base—and possibly those using other medical products—to a stipulation against Remicade biosims, Pfizer says. That arrangement shuts down Inflectra's ability to compete, Pfizer says.

J&J countered in a public statement that Pfizer isn't offering enough value to win business in the market.

Remicade generated nearly $5 billion in the U.S. last year. Before biosimilar launches, executives at J&J touted their company's ability to defend the key med; in this year's third quarter, the brand's sales slipped only 1.3% in the U.S. versus the same period last year.

In announcing the results, J&J said its 2018 defense plan for Remicade includes efforts to keep current patients and to "compete vigorously on price." 

Editor's note: This story was updated with a statement from Janssen.