Momenta ramps up biosim pressure on AbbVie's Humira with phase 3 psoriasis win

A Momenta Pharmaceuticals biosimilar to AbbVie's Humira passed a phase 3 test in psoriasis, the biotech reports.

Biosim pressure on AbbVie stalwart anti-inflammatory med Humira continues to mount. As the North Chicago pharma works in court to fend off a now-approved Amgen copy, Boston biotech Momenta reported on Tuesday that its candidate passed an important phase 3 trial in psoriasis.

Following 16 weeks of treatment, the proportion of patients with moderate-to-severe plaque psoriasis who saw a 75% reduction in their Psoriasis Area and Severity Index score was “equivalent” in the original and biosim, Momenta said.

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In the trial, patients received up to 48 weeks of either the Momenta candidate, M923, Humira or an alternating regimen between Humira and M923.

The results "further advance us toward our goal of gaining regulatory approval for this important program" and support the candidate's "biosimilarity," Momenta CEO Craig Wheeler said in a statement.

Responsible for $14 billion in annual sales, Humira is a leading target in the biosim arms race, with Momenta, Amgen, Novartis and Merck each working respective candidates through development with collaborators.

For its part, Momenta developed M923 with Baxalta, which has since been acquired by Shire. As part of that acquisition, Shire said it plans to exit biosims. It's “in the process” of transferring the candidate to Momenta, the Cambridge biotech said in a statement.

Back in September, Amgen became the first to win a coveted FDA approval for a Humira biosim, picking up a green light in 7 Humira indications for Amjevita. That came after an FDA panel unanimously backed the drug in a decision that one expert described as “easy.”

That drug still faces a tough road to market, though, as AbbVie has sued for patent infringement and says its IP shield should protect Humira until 2022.


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