FDA Accepts BLA for Amgen’s Humira® Biosimilar

January 28, 2016

On November 25, 2015, Amgen Inc. submitted a Biologics License Application (BLA) for ABP 501, the company’s biosimilar candidate to Humira® (adalimumab). Earlier this week, Amgen announced that its BLA has been accepted for review by the FDA.

In its press release, which was published on Tuesday, January 26, Amgen stated that the BLA “is based on analytical, clinical, and pharmacokinetic data.” In addition, the company stated that “Phase 3 comparative efficacy and safety studies were conducted in both moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis. The Phase 3 studies met their primary endpoints showing clinical equivalence to adalimumab. Safety and immunogenicity of ABP 501 were also comparable to adalimumab. Data to support the transition of adalimumab patients to ABP 501 are included in the submission.”

Amgen’s ABP 501 has a BsUFA target action date of September 25, 2016. It will be very interesting to see the outcome of FDA’s review later this year.

Do you have a biosimilar product in development? Are you in the process of obtaining FDA approval for a biosimilar product? We can help. Using our unique approach to FDA, which combines extensive scientific knowledge with regulatory expertise, we have a proven track record of helping our clients achieve successful interactions with the Agency. We can develop your 315(k) BLA, or any other FDA submission. To learn more about how we can help you, contact us today.



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