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Humira biosimilar proves efficacy in Phase 3 trial

Published on 30/11/16 at 10:27am

US-based biotechnology firm Momenta Pharmaceuticals has announced that its biosimilar version of Abbvie’s autoimmune drug Humira (adalimumab) – currently the world’s best-selling medicine – met its primary endpoint in a Phase 3 psoriasis trial.

The study found that, in moderate-to-severe chronic plaque psoriasis sufferers treated for 48 weeks with M923 alone or alternating with Humira, there was an equal number of patients who achieved a psoriasis severity index reduction of 75% between M923 and its originator drug, meeting the trial’s main objective.

Momenta CEO Craig Wheeler said that the findings "further advance us toward our goal of gaining regulatory approval for this important programme.” 

M923 was developed with Baxalta before its takeover by Shire, who has since terminated its biosimilars programme; the firm is now in the process of transferring the drug to Momenta.

Humira has generated $15 billion in annual sales and has been indicated as a treatment for rheumatoid arthritis, psoriasis, Chrohn’s disease and more. Amgen’s biosimilar version of the drug received FDA approval earlier this year, but faces opposition from Abbvie who claimed that the product would violate at least 10 of its drug’s patents, which it argues should be protected from patent infringement until 2022.

Matt Fellows

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