Time New York: Tue 11 Dec 08:36 am  |  Save 15% on H&R Block Online


Mylan Fujifilm Kyowa Team Up to Market Humira Biosimilar


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.

Today's Stocks from Zacks' Hottest Strategies

It's hard to believe, even for us at Zacks. But while the market gained +21.9% in 2017, our top stock-picking screens have returned +115.0%, +109.3%, +104.9%, +98.6%, and +67.1%.

And this outperformance has not just been a recent phenomenon. Over the years it has been remarkably consistent. From 2000 – 2017, the composite yearly average gain for these strategies has beaten the market more than 19X over. Maybe even more remarkable is the fact that we're willing to share their latest stocks with you without cost or obligation.

See Them Free>>

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

To read this article on Zacks.com click here.

Zacks Investment Research
<-- You can share this post with your network,
or give us your opinion and leave a comment.
Be sure to check our RSS feeds for updates.