News|Articles|January 5, 2017

Pfizer’s Humira Biosimilar Displays Positive Top Line Results

PF-06410293 met primary endpoints during clinical trials and demonstrated similar efficacy to its reference product.

Results from a REFLECTIONS B538-02 trial with Pfizer’s investigational Humira (adalimumab) biosimilar, PF-06410293, showed that the drug met its primary endpoint, and demonstrated similar efficacy to its reference product. PF-06410293 is being evaluated in combination with methotrexate as a treatment for moderate to severe rheumatoid arthritis, the company said in a Jan. 5, 2017 announcement.

PF-06410293 is Pfizer’s second proposed inflammation biosimilar. The company’s pipeline consists of eight biosimilar molecules in mid- to late-stage development. Pfizer also said it has several other biosimilar molecules currently in early-stage development. Pfizer will likely face competition in the Humira biosimilar market. FDA approved the first biosimilar to Humira, Amjevita (adalimumab-atto), marketed by Amgen in the United States, in late September 2016.

Source: Pfizer

 


Related to this article

Ask the Expert: Post-Approval Changes
In this episode of Ask the Expert, Siegfried Schmitt, PhD, vice president, Technical at Parexel, and Susan J. Schniepp, distinguished fellow at Nelson Labs, discuss how companies should approach post-approval changes to their CMC regulatory filings.