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Biogen Cracks the Case With AbbVie for Humira Biosimilar

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Biogen Inc. (BIIB - Free Report) and partner Samsung Bioepis have announced resolution of an ongoing patent dispute with AbbVie (ABBV - Free Report) regarding Biogen’s biosimilar version (Imraldi) of AbbVie’s blockbuster arthritis drug, Humira, in the EU. Per the settlement agreement, Biogen/Samsung Bioepis plans to launch Imraldi in Europe on Oct 16, 2018.

Also in the United States, Samsung Bioepis entered into a settlement agreement with AbbVie, which would allow the former to bring Humira biosimilar into the U.S. market by Jan 31, 2023.

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.

Notably, Imraldi is the second biosimilar version of Humira to be launched in the EU. Another biotechnology company, Amgen (AMGN), is also expected to launch its biosimilar version of Humira, in the EU come October this year as Amjevita, per a settlement with AbbVie.

Notably, Amjevita was approved in the EU last March and approved in the United States in September 2016.

In the United States, per settlement with AbbVie, Amjevita is likely to be launched on Jan 31, 2023.

Shares of Biogen have underperformed its industry this year so far. The stock has lost 16.6% compared with the industry’s decrease of 6.3%.  


We remind investors that Biogen has a joint venture with Samsung BioLogics for biosimilars called Samsung Bioepis, which already markets a couple of biosimilars in the EU, namely Flixabi, a biosimilar referencing J&J/Merck’s (MRK - Free Report) Remicade and Benepali, a biosimilar referencing Amgen/Pfizer’s (PFE - Free Report) Enbrel. This development in turn makes Imraldi the third anti-TNF biosimilar from Biogen to receive a marketing authorization in the EU.

Biogen is also working with Samsung BioLogics to introduce new biosimilars to the market.

Importantly, Biogen grossed biosimilar revenues of $380 million for a 12-month period ending December 2017 compared with $101 million, logged in 2016. This upside was primarily driven by Benepali, which recorded revenues of $370.8 million compared with the year-ago figure of $100.6 million on increased market share.


Zacks Rank

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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