In The News,

Valerie Reynolds Quoted in Managed Healthcare

Remicade will now have a biosimilar

Written by Tracy Walker
Wednesday, 24 August 2016


Johnson & Johnson’s autoimmune disease drug Remicade (infliximab) will now have a biosimilar, a federal court ruled.

The court ruled that J&J’s patent was invalid for Remicade, which was originally licensed in 1998. Lower-priced Inflectra (infliximab-dyyb, Pfizer), a biosimilar to Remicade, was approved in April and likely will launch in October. Janssen Biotech, a J&J subsidiary said in a press release that it is “disappointed with the court’s ruling and plans to appeal the decision to the Court of Appeals for the Federal Circuit.”



“Inflectra . . . would be the second biologic to launch under the biosimilars pathway created by the Affordable Care Act, Zarxio [filgrastim-sndz] being the first,” according to Valerie Reynolds, senior director at ADVI. Sandoz, Inc.’s Zarxio is biosimilar to Amgen Inc.’s cancer drug Neupogen (filgrastim).

“Inflectra would be the first therapeutic and the first immunology product. [The drug’s] launch would provide additional data on how biosimilars will affect the market,” Reynolds says. “In 2017, we are expecting biosimilar launches that will compete with infliximab—adalimumab and etanercept—biosimilars that will be reimbursed under the pharmacy benefit instead of the medical benefit.”

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