Pfizer: US Remicade biosimilar will launch at 15% discount in November

By Dan Stanton contact

- Last updated on GMT

Image: iStock/Bychykhin_Olexandr
Image: iStock/Bychykhin_Olexandr

Related tags: Monoclonal antibodies

Pfizer’s Inflectra will become the first monoclonal antibody biosimilar available in the US when it is launched next month.

The Big Pharma firm announced yesterday evening it will begin shipping Inflectra, its version of J&J’s Remicade (infliximab) to the US late November.

The product – made by Pfizer’s partner Celltrion - will be the second biosimilar product to be available in the US following the launch of Sandoz’s alternative to Amgen’s Neupogen (filgrastim), Zarxio, in September 2015​.

Like Zarxio, Inflectra will be introduced at a 15% discount to the current wholesaler acquisition cost (WAC) of its reference product.

And Inflectra too has not been deemed interchangeable as the US FDA is yet to issue guidance on how interchangeability will be determined.

While Pfizer previously said it wanted to launch the mAb in the US as soon as possible​, the late November date is around eight weeks after the 180-days’ period required for the reference product sponsor from the date of US FDA approval (April 5​).

J&J up for a fight

J&J has said​ that while it could not stop the launch of the biosimilar, Pfizer would be doing so at risk as certain patent legislation is ongoing.

And in a statement sent to Biopharma-Reporter yesterday, J&J subsidiary Janssen reiterated this sentiment.

“We will continue to defend our intellectual property rights relating to our innovative medicines, and consider this commercial launch of the infliximab biosimilar to be an at-risk launch.”

The firm also said Remicade will compete with the biosimilar “through a variety of innovative contracting options, discounts and rebates to payers, providers and pharmacy benefit managers (PBMs).”

US sales of Remicade in 2015 pulled in close to $4.5bn. But in some markets where the product has already seen biosimilar competition, Remicade has been all but wiped-out​ through discounts and switching.

Related topics: Markets & Regulations, Biosimilars

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