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6 April 2016Americas

US approves second biosimilar drug

The US Food and Drug Administration (FDA) has approved a biosimilar version of Janssen Biotech’s drug Remicade (infliximab).

The drug, called Inflectra (biosimilar infliximab) and marketed by Celltrion, is only the second biosimilar to be approved in the US.

According to the FDA, it will be used to treat patients with different types of arthritis, colitis, psoriasis, spondylitis, and Crohn’s disease.

The commercial rights for Inflectra belong to Pfizer but Hospira, now a Pfizer-owned company, entered into an agreement with Celltrion in 2009 that gave it the rights to several potential biosimilar products, including Inflectra.

In March last year, LSIPR reported that the FDA had approved what was then the first biosimilar product, Sandoz’s cancer product Zarxio (filgrastim-sndz).

Zarxio is a biosimilar version of Amgen’s Neupogen (filgrastim), an injection that helps to reduce the risk of infection in cancer patients receiving chemotherapy.

Both parties are embroiled in a high-profile lawsuit that centres on whether the so-called patent dance is optional under provisions set out in the Biologics Price Competition and Innovation Act.

Sandoz unsuccessfully appealed against the US Court of Appeals for the Federal Circuit’s refusal to hear a previous ruling en banc. That decision said that a biosimilar applicant must give 180-days’ pre-marketing notice after the biosimilar application has been approved by the FDA.

Sandoz has now petitioned the US Supreme Court.

John Labbe, partner at law firm Marshall, Gerstein & Borun, said: “Celltrion has already agreed not to market Inflectra until after June 29, the date one of Janssen’s patents expires. What remains to be seen, however, is whether Celltrion will agree to give Janssen 180-days’ notice before launching Inflectra.”

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More on this story

Americas
3 December 2015   Following the Federal Circuit’s ruling in Amgen v Sandoz, biosimilar applicants should weigh up several factors when deciding whether to opt into the so-called patent dance. Gerard Norton and Michael Montgomery of Fox Rothschild discuss the potential strategies.

More on this story

Americas
3 December 2015   Following the Federal Circuit’s ruling in Amgen v Sandoz, biosimilar applicants should weigh up several factors when deciding whether to opt into the so-called patent dance. Gerard Norton and Michael Montgomery of Fox Rothschild discuss the potential strategies.

More on this story

Americas
3 December 2015   Following the Federal Circuit’s ruling in Amgen v Sandoz, biosimilar applicants should weigh up several factors when deciding whether to opt into the so-called patent dance. Gerard Norton and Michael Montgomery of Fox Rothschild discuss the potential strategies.