FDA documents find Amgen's ABP 501 'highly similar' to Humira

11 July 2016

A biosimilar version of the world’s best-selling drug is ‘highly similar’ to the reference product, according to a US Food and Drug Administration staff briefing documents published ahead of tomorrow’s committee meeting.

The documents consider the similarity of ABP 501, a product being developed by US biotech major Amgen (Nasdaq: AMGN), to Humira (adalimumab), a mega-blockbuster arthritis drug marketed by US pharma major AbbVie (NYSE: ABBV).

The FDA’s Arthritis Advisory Committee will take the briefing documents into account as they consider whether Amgen should receive licensure for the indications for which Humira is currently authorized. These include rheumatoid and psoriatic arthritis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis.

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