Plus   Neg

Amgen Submits BLA For ABP 710 To FDA - Quick Facts

Amgen Inc. (AMGN) said Monday that it has submitted a Biologics License Application or BLA to the U.S. Food and Drug Administration for ABP 710, a biosimilar candidate to Remicade, or infliximab.

ABP 710 is being investigated as a biosimilar candidate to infliximab, an anti-tumor necrosis factor alpha or anti-TNF monoclonal antibody, which is approved in many regions for the treatment of moderate to severe rheumatoid arthritis, chronic severe plaque psoriasis, moderate to severe Crohn's disease, moderate to severe ulcerative colitis, psoriatic arthritis and ankylosing spondylitis.

Amgen noted that the BLA submission includes analytical, pharmacokinetic and clinical data, as well as pharmacology and toxicology data. The Phase 3 comparative efficacy, safety and immunogenicity study was conducted in patients with moderate-to-severe rheumatoid arthritis and confirmed no clinically meaningful differences between ABP 710 and infliximab.

"We're leveraging our deep expertise and heritage in biologics to produce a portfolio of biosimilars to serve patients with the most complex diseases. We're committed to providing patients with serious illnesses access to high-quality biological therapies and look forward to working with the FDA to potentially bring ABP 710 to market," aid David Reese, executive vice president of Research and Development at Amgen.

Amgen has a total of 10 biosimilars in its portfolio, including two that are approved in the U.S. and three that are approved in the European Union or EU.

For comments and feedback contact: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Viacom Inc. and AT&T Inc. said Monday they have reached a new carriage deal, averting a programming blackout that would have left AT&T's more than 24 million pay-TV customers without Viacom channels such as MTV, Comedy Central, Paramount and Nickelodeon. The renewed agreement will keep these Viacom channels on AT&T's DirectTV and U-verse pay TV services. Tribe, a blockchain accelerator backed by Singapore government, announced its partnership with BMW Group Asia, Intel and Nielsen. Tribe Accelerator said the three companies will share their knowledge and subject expertise in their respective fields with Tribe's startups. The companies will help build an inclusive ecosystem "ready for industry 4.0." MillerCoors LLC has filed a lawsuit against Anheuser-Busch Companies LLC, part of Anheuser-Busch InBev, alleging that Anheuser-Busch's ad campaigns associating MillerCoors' products, Miller Lite and Coor Light, with corn syrup is "false and misleading." During the Super Bowl, ABInBev ran an advertising campaign that mocked Miller Lite and Coors Light use corn syrup in brewing.
Follow RTT