Biogen's Humira Biosimilar Imraldi Gets Approval In EU

Biogen Inc. (NASDAQ:BIIB) announced that its biosimilar version of AbbVie, Inc.’s (NYSE:ABBV) top-selling blockbuster drug, Humira has been approved by the European Commission. The biosimilar will be marketed by the trade name of Imraldi.

Imraldi (or SB5) will be used for a whole range of indications including rheumatoid arthritis, axial spondyloarthritis, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, Crohn's disease, ulcerative colitis, polyarticular juvenile idiopathic arthritis, active enthesitis-related arthritis, hidradenitis suppurativa and non-infectious uveitis.

We remind investors that the biosimilar was granted a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) in June this year.

Biogen has a joint venture with Samsung (KS:005930) BioLogics for biosimilars. Samsung Bioepis, the joint venture between the two companies, already marketsa couple of biosimilars in the EU – Flixabi (a biosimilar referencing J&J/Merck & Co., Inc.’s [ (NYSE:MRK) ] Remicade) and Benepali (a biosimilar referencing Amgen/Pfizer’s Enbrel). This makes Imraldi the third anti-TNF biosimilar from Biogen to receive a marketing authorization in the EU.

Benepali is doing quite well, generating sales of $154 million in the first half of 2017 while Flixabi recorded sales of $2.5 million in the same period.

We note that earlier this year, Amgen, Inc. (NASDAQ:AMGN) gained EU approval for Amgevita, its biosimilar version of Humira.

Biogen’s shares have risen 0.6% this year so far while the industry recorded an increase of 7.9%.

Biogen carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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