Ph III study of Amgen's Humira biosimilar ABP 501 meets endpoint in psoriasis
US biotech major Amgen (Nasdaq: AMGN) says its Phase III study evaluating the efficacy and safety of its biosimilar candidate ABP 501 compared with AbbVie’s (NYSE: ABBV) blockbuster drug Humira (adalimumab) in patients with moderate-to-severe plaque psoriasis met its primary endpoint.
Amgen’s shares rose 2.9% to $140.05 in afternoon trading on Wednesday, and shares of AbbVie gained 2.7% to $58.16.
The primary endpoint was the Psoriasis Area and Severity Index (PASI) percent improvement from baseline to week 16 of treatment. At week 16, the PASI percent improvement from baseline was within the pre-specified equivalence margin for ABP 501 compared to adalimumab. Safety and immunogenicity of ABP 501 were comparable to adalimumab.
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
Free
7 day trial access
- All the news that moves the needle in pharma and biotech
- Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
- Receive The Pharma Letter daily news bulletin, free forever.
Become a subscriber
£820
Or £77 per month
- Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
- Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
- Daily roundup of key events in pharma and biotech.
- Monthly in-depth briefings on Boardroom appointments and M&A news.
- Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
More on this story...
Today's issue
Company Spotlight
More Features in Biosimilars
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze