US FDA to review Amgen's Humira biosimilar in July

By Dan Stanton contact

- Last updated on GMT

Image: iStock/Siriwachara
Image: iStock/Siriwachara

Related tags: Rheumatoid arthritis, Psoriatic arthritis

The US FDA has set a date to review Amgen’s ABP501, a biosimilar version of AbbVie’s rheumatoid arthritis biologic Humira (adalimumab).

In a notice filed in the federal register yesterday, the US Food and Drug Administration (FDA) set the date of July 12 for its Arthritis Advisory Committee to review the product.

“The Committee will review analytical, clinical and pharmacokinetic data from studies involving ABP 501, including results from two Phase III comparative efficacy and safety studies conducted in both moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis,”​ Amgen said in a press release.

“The Phase III studies met their primary endpoints showing clinical equivalence to adalimumab. Safety and immunogenicity of ABP 501 were also comparable to adalimumab.”

If the adcomm votes in favour of Amgen’s molecule, it would be the third biosimilar to be approved in the US – after Sandoz’s Zarxio and Pfizer’s Inflectra – and the first version of Humira, AbbVie’s  blockbuster RA biologic.

However, even if the biosimilar is approved, Amgen may end up unable to launch the product for a number of years as AbbVie says Humira’s US exclusivity will not expire until at least 2022​ due to a complex web of manufacturing, formulation and patient-centric patents.

The two firms have been embroiled in litigation over several of these patents, and in January​ Amgen saw an inter partes review (IPR) challenge against two of AbbVie’s formulation patents denied by the Patent Trial and Appeal Board (PTAB).

Meanwhile, fellow biosimilar developer Coherus has been tapping away at AbbVie’s IP maze, and last month saw some success​ with the PTAB agreeing to review AbbVie’s ‘135 patent, relating to Humira’s dosing regimen.

Related topics: Markets & Regulations, Biosimilars

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