After the first biosimilar of Johnson & Johnson’s big-selling immunology drug Remicade hit the market last year at a modest discount, another has come along with a much deeper pricing slash.
Samsung and marketing partner Merck & Co. Monday launched their Renflexis in the U.S. at a 35% markdown to the blockbuster J&J anti-inflammatory med. Their move follows last year’s launch by Pfizer for its version, Inflectra, at a 15% discount. The prices are before negotiated rebates.
As J&J’s top-selling med, Remicade brought in nearly $5 billion in the U.S. last year. With those critical sales under threat, the company has moved to defend its superstar in court and elsewhere.
Ahead of the Samsung launch, J&J sued for patent infringement and for refusing to participate in a dispute resolution process. A representative for the biosim developer responded that the company is “confident” it’s not infringing J&J’s patents.
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Monday’s launch comes well ahead of the biosim’s expected market debut date in October, but after a Supreme Court ruling made it easier for biosimilar developers to launch their products upon winning U.S. approval. The FDA signed off on Samsung’s Remicade biosim back in April.
Outside of court, J&J has sought to protect Remicade with aggressive contracting, according to a recent note from Bernstein analyst Ronny Gal. The drug giant set up exclusive contracts in nearly half the market, bundled products together for large hospitals and offered deeper discounts to large independent infusion centers. As a result, Remicade sales only fell by 5% in the second quarter compared to the same period last year.
That success had J&J execs thinking positive about future threats to Remicade. On a conference call last week, J&J CFO Dominic Caruso said his company feels “pretty good that Remicade erosion overall, even with the entrant of a new biosimilar, will be less than we previously expected.”
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Renflexis becomes the third biosim to reach the U.S. market after Inflectra and Sandoz’s Zarxio, a biosimilar to Amgen’s Neupogen. That biosim was the first to launch in the U.S. back in September 2015.
Separately, Pfizer has another Remicade biosimilar that hasn’t yet launched in the U.S., according to a recent note by Gal. In what Gal called a “rather unusual situation,” Pfizer could launch a second Remicade biosim to compete with its first. A Pfizer pipeline (PDF) document from May 2017 says the med is in "registration." A Pfizer spokesperson said Monday the FDA has accepted its application for the biosim.