Pfizer Receives FDA Approval for Remicade® Biosimilar

IXIFI is Pfizer’s second biosimilar to Remicade® (Inflectra was launched in late 2016).

In mid-December 2017, the US Food and Drug Administration approved another biosimilar – this one from Pfizer for Johnson & Johnson’s Remicade® (infliximab). It is, in fact, the second biosimilar of Remicade for which Pfizer has received approval. The company launched Inflectra in late 2016.

The new biosimilar  IXIFI™ (PF-06438179, infliximab-qbtx)  is a chimeric human-murine monoclonal antibody (mAb) against tumor necrosis factor and was approved for all eligible indications of the reference product, including rheumatoid arthritis, Crohn's disease, pediatric Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.

Pfizer has three biosimilars approved for marketing outside of the United States  INFLECTRA® (infliximab), Retacrit (epoetin zeta), and Nivestim (filgrastim). It also supplies Celltrion’s INFLECTRA® (infliximab-dyyb) in the U.S. and certain parts of the world. The company sold the rights for the development, commercialization and manufacture of PF-06438179 in the 28 EU member states, as well as three of the four member states of the European Free Trade Association (EFTA) (Iceland, Liechtenstein and Norway) that form the European Economic Area (EEA) in February 2017. Looking to the future, Pfizer has a pipeline of 13 different biosimilars at different stages of development.

The approval of IXIFI was based on the results of clinical studies, including the Phase 3 B537-02 study in patients with moderate to severe active RA. The evidence supported the claim that there is a high degree of similarity to the reference product.


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