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Amgen drug pair become first Humira biosimilars to win EU approval

Published on 30/01/17 at 09:59am

Good news for Amgen as its two biosimilar versions of AbbVie’s blockbuster rheumatoid arthritis (RA) drug Humira (adalimumab) have been awarded recommendation for approval by the European Medicines Agency (EMA) for the treatment of moderate to severe RA in patients who have not responded to methotrexate or have not been previously treated with it.

Amgevita (ABP 501) and Solymbic have become the first Humira biosimilars recommended for use in EU, following decision by the EMA’s Committee for Medicinal Products for Human Use (CHMP). Amgevita is now indicated in the EU as a treatment for range of arthritic and psoriatic conditions, in addition to hidradentis suppurativa, Crohn’s disease and ulcerative colitis. Solymbic is indicated for a slightly narrower range of these same conditions, including enthesitis-related arthritis, which Amgevita does not share.

“This represents another significant milestone for our biosimilars portfolio and is an important step in our effort to develop high-quality biologic medicines for patients suffering from chronic inflammatory diseases,” explained Sean Harper, Amgen's executive VP of R&D.

Amgevita was given the go-ahead by the FDA in September 2016, under the name Amjevita, for all the same eligible indications as its parent Humira, becoming the first biosimilar authorised for use in the US.

As these recommendations were announced, AbbVie revealed that its best-selling drug raked in $16 billion last year, up from $14 billion in 2015. The drug made over $20 billion in both 2014 and 2013.

Matt Fellows

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