Contract Research & Services
Clinical Trials

Pfizer’s Humira biosimilar shows positive top line results

PBR Staff Writer Published 06 January 2017

Results from a Reflections B538-02 study with Pfizer’s investigational Humira (adalimumab) biosimilar, PF-06410293, demonstrated that the drug met its primary endpoint, and showed same efficacy to its reference product.

Humira is currently approved in the US, the European Union and other markets for arthritis related problems and other indications.

The investigational compound PF-06410293, a monoclonal antibody (mAb), met its main objective by showing equivalent efficacy as measured by the American College of Rheumatology 20 (ACR20) response rate during the 12th week of the trial.

REFLECTIONS B538-02 is studying the efficacy, safety and also the immunogenicity of PF-06410293 in comparison to Humira with each drug administered in combination with methotrexate to patients suffering from moderate to severe rheumatoid arthritis.

Pfizer Essential Health research and development head Sumant Ramachandra said: “As the leading global biosimilars company, we continue to advance our commitment to expand access to high-quality treatment options for patients living with chronic, debilitating conditions, such as those in inflammation.

“Inflammation remains one of the core research areas for Pfizer, spanning over 60 years and including a number of assets in various stages of development.”

According to Pfizer, the latest data update on PF-06410293 represents its second proposed inflammation biosimilar and also happens to be third in its proposed biosimilar pipeline molecule to register desired top-line results inside the last four months.

Its biosimilar pipeline comprises eight biosimilar molecules which are between the mid and late stage development stages, while many others are claimed to be in the nascent stage of development.

Pfizer said PF-06410293 is an investigational compound and has not secyred regulatory approval in any country.