This article is more than 5 years old. Information may no longer be current.

Humira Biosimilar Accepted for EMA, FDA Review

Issue: March 2017

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

Boehringer Ingelheim’s biosimilar candidate to Humira, called BI 695501, has been accepted for review by the FDA and the European Medicines Agency, according to a press release.

“The acceptance of our regulatory filings by the FDA and [the European Medicines Agency] EMA is a critical milestone as we explore innovative ways for biosimilars to expand overall treatment options and seek to improve the lives of patients with chronic and life-threatening diseases,” Martina Flammer, vice president of Clinical Development and Medical Affairs, Specialty Care at Boehringer Ingelheim, said in the release.

Martina Flammer

In October, the company announced results for BI 695501’s phase 3 study in patients with active rheumatoid arthritis.

“If approved, we believe BI 695501 can offer a high quality, economically sustainable treatment option to patients with inflammatory diseases in the [United States] U.S.,” Flammer said.

Reference:

www.boehringer-ingelheim.us/press-release/boehringer-ingelheim-biosimilar-candidate-humira-accepted-ema-and-fda-regulatory