Pfizer: 'No plans to launch second approved Remicade biosimilar in US'

By Dan Stanton

- Last updated on GMT


Related tags European commission European union

Pfizer says it remains committed to Inflectra and partner Celltrion after gaining US FDA approval for another infliximab biosimilar, Ixifi, developed in-house.

This week, the US Food and Drug Administration (FDA) approved Ixifi (infliximab-qbtx) as a biosimilar to J&J’s TNF-inhibiting monoclonal antibody Remicade.

Ixifi becomes the third infliximab biosimilar to be approved in the US, and the second for Pfizer. The first, Inflectra, was launched in 2016​.

With two approvals, questions are mounting as to Pfizer’s strategy and its commitment to Korean drugmaker Celltrion, which developed Inflectra and manufactures it from its site in Songdo, Incheon.

But according to Pfizer spokesperson Thomas Biegi, the Big Biopharma “is currently evaluating [its] strategic options for this medicine,”​ though has no plan to launch it in the US.

Details surrounding the production of Ixifi were not divulged.

However, he told Biopharma-Reporter Pfizer remains committed to Inflectra and its partner Celltrion, and said there are other markets where the firm does not market Inflectra which may provide opportunities to commercialise Ixifi in the future.

Pfizer divestment to Sandoz

But Europe will not be one of them.

Pfizer acquired Hospira for $17bn in 2015​, adding a number of biosimilar products through its partnership with Celltrion, including Inflectra, which at that time was approved in Europe but not in the US.

Under conditions laid down by the European Commission (EC) concerning the acquisition, Pfizer divested the rights​ to its own infliximab candidate Ixifi (then known as PF-06438179) in the European Economic Area (EEA) to Novartis subsidiary Sandoz.

Number 9, Number 9

Ixifi becomes the ninth biosimilar to be approved in the US, though only three – Neupogen, Inflectra and Renflexis – have so far been launched. The full list is below:

  1. March 2015​​: Sandoz’s Zarxio (filgrastim-sndz), a version of Amgen’s Neupogen
  2. April 2016​​: Pfizer’s Inflectra (infliximab-dyyb ), a version of J&J’s Remicade
  3. August 2016​​: Sandoz’s Erelzi (etanercept-szzs), a version of Amgen’s Enbrel
  4. September 2016​​: Amgen’s Amjevita (adalimumab-atto), a version of AbbVie’s Humira
  5. April 2017​​: Samsung Bioepis/Merck’s Renflexis (infliximab-abda), a version of J&J’s Remicade
  6. August 2017​: Boehringer-Ingelheim’s Cyltezo (adalimumab-adbm), a version of AbbVie’s Humira
  7. September 2017​: Amgen and Allergan’s Mvasi (bevacizumab-awwb), a version of Roche’s Avastin
  8. December 2017​: Mylan and Biocon’s Ogivri (trastuzumab-dkst), a version of Roche’s Herceptin
  9. December 2017: Pfizer’s Ixifi (infliximab-qbtx), a version of J&J’s Remicade

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