Where Pfizer Stands in Biosimilars after 2017
PFE’s biosimilar revenue trends
In 4Q17, Pfizer (PFE) generated revenues of $165 million from the sale of biosimilars, which represents an ~80% rise on a YoY (year-over-year) basis. In 4Q17, in the US and in international markets, biosimilars generated revenues of $44 million and $120 million, respectively, compared with $4 million and $88 million in 4Q16.
Pfizer biosimilar Inflectra generated revenues of $135 million in 4Q17, compared with $61 million in 4Q16. In 4Q17, in the US and in international markets, Inflectra reported revenues of $44 million and $91 million, respectively.
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In fiscal 2017, Pfizer’s biosimilars generated revenues of $531 million, which reflected a ~37% rise on a YoY basis. In 2017, in the US and in international markets, Pfizer’s biosimilars reported revenues of $118 million and $413 million, respectively, compared with $4 million and $315 million in 2016.
In December 2017, the FDA (US Food and Drug Administration) approved Pfizer’s Ixifi, a biosimilar to Johnson & Johnson’s (JNJ) Remicade (infliximab). The FDA has approved Ixifi for all indications, according to the reference product, Remicade. Ixifi has been approved for the treatment of Crohn’s disease, pediatric Crohn’s disease, rheumatoid arthritis, ulcerative colitis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis.
The FDA’s approval of Ixifi was based on the results of the Reflections B537-02 trial.
Pfizer’s biosimilars commercialized outside of US markets include Inflectra (infliximab), Retacrit (epoetin alpha), and Nivestim (filgrastim). Nivestim is a biosimilar to Amgen’s (AMGN) Neupogen.
Pfizer is now conducting clinical trials with 13 distinct biosimilar molecules, which are at different stages of trials.
In January 2017, Pfizer announced that its Reflections B3281006 clinical met its primary endpoint. Pfizer conducted the Reflections B3281006 trial to evaluate and compare the safety and efficacy of Pfizer’s PF-05280586, a biosimilar to Roche’s (RHHBY) Rituxan.
In the clinical trial, CD20-positive indolent follicular lymphoma patients receiving Pfizer’s PF-05280586 (the biosimilar to Rituxan) demonstrated equivalence in ORR (overall response rate) when compared with the reference molecule (Rituxan).
Now let’s take a closer look at how Pfizer’s internal medicines performed in 2017.