Roman Sinichkin /
11 July 2016Americas

USFDA says Amgen’s Humira biosimilar meets ‘highly similar’ threshold

The US Food and Drug Administration (FDA) has said that an Amgen biosimilar is indeed “highly similar” to AbbVie’s drug Humira (adalimumab) in a document released for the advisory committee panel meeting due to be held tomorrow.

The panel will discuss ABP 501, a biosimilar of Humira, a drug used to treat multiple types of arthritis, Crohn’s disease, psoriasis, ulcerative colitis and ankylosing spondylitis.

Due to the apparent similarity of the two drugs, it may be likely that Amgen will get approval of its biosimilar by the FDA, causing further tension between the two companies due to their pending US patent litigation over Humira.

In the document, the FDA said: “The data submitted by Amgen support a demonstration that ABP 501 is highly similar to US-licensed Humira, notwithstanding minor differences in clinically inactive components, and support a demonstration that there are no clinically meaningful differences between ABP 501 and US-licensed Humira in terms of the safety, purity and potency of the product.”

The FDA will announce its decision on the case by September 25, 2016.

Mark Schoenebaum, analyst at investment banking advisory firm, Evercore ISI, reportedly wrote in an email to clients: “If AbbVie were to file and subsequently win a preliminary injunction, Amgen would be barred from marketing, either until litigation completes if the biosimilar is ultimately found not to infringe, or until the expiry of the infringed patent if AbbVie were granted a permanent injunction (thus at least 2022 depending on the patent).”

Other companies such as Coherus Biosciences, Novartis and Pfizer are also in the process of developing their own versions of Humira’s biosimilars.

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