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Mylan Fujifilm Kyowa Team Up to Market Humira Biosimilar

Zacks

Mylan N.V. MYL is partnering with Fujifilm Kyowa Kirin Biologics Co., Ltd. to commercialize a biosimilar to AbbVie’s ABBV blockbuster arthritis drug Humira (adalimumab). Adalimumab is developed by Fujifilm Kyowa Kirin Biologics.

Mylan intends to seek approval and commercialize the product in Europe. The European Medicines Agency (“EMA”) accepted a marketing authorization application for review for the proposed biosimilar to Humira in May 2017, and the companies expect to receive the EMA’s decision during the second half of 2018.

Under the agreement, Mylan will have an exclusive license to commercialize the biosimilar in Europe and will receive an upfront fee from Fujifilm Kyowa Kirin. The company will also be responsible for the sales activity of the product in European countries. On the other hand, Fujifilm Kyowa Kirin Biologics will be eligible to receive a subsequent commercialization milestone payment and sales royalties.

Over a year, shares of Mylan increased 6.2% compared with the industry’s fall of 27.9%.


Humira is a TNF-inhibitor aimed at treating multiple chronic inflammatory conditions. It is approved in Europe for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis.

We note that few days ago, Biogen Inc. BIIB and partner Samsung Bioepis announced resolution of an ongoing patent dispute with AbbVie regarding Biogen’s biosimilar version (Imraldi) of AbbVie’s 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.

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.

Zacks Rank

Mylan 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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