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Amgen's Biosimilar of AbbVie's Humira to Face FDA Panel

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Amgen Inc.AMGN announced that the FDA's Arthritis Advisory Committee will review data supporting the company's biologics license application for ABP 501, a biosimilar version of AbbVie Inc.'s ABBV best-selling drug, Humira.

A final decision regarding the approval status of ABP 501 is expected by Sep 25, 2016. It is also under review in the EU.

Humira, an anti-TNF-α monoclonal antibody, is approved in many countries for the treatment of a wide range of inflammatory diseases. The drug recorded worldwide sales of $14 billion in 2015 and was one of the top-selling products in the U.S. in 2014.

Currently, Amgen has nine biosimilar candidates in its portfolio representing annual revenues of more than $3 billion. The company plans to launch its first biosimilar in 2017 followed by four others through 2019, subject to approval.

We note that Amgen itself is facing biosimilar competition in the U.S. Zarxio, the first FDA-approved biosimilar, was launched by Novartis AG's NVS generic arm, Sandoz, in Sep 2015. Zarxio is the biosimilar version of Amgen's blockbuster drug, Neupogen. A couple of key drugs from Amgen's portfolio - Neulasta and Enbrel - could also start facing biosimilar competition soon.

Notably, Sandoz's biosimilar version of Enbrel is expected to come up before the FDA's Arthritis Advisory Committee next month.

Considering that the market for biosimilars is highly lucrative, competition in this space is intensifying with pharmaceutical and biotech companies racing to develop the same.

Amgen is a Zacks Rank #3 (Hold) stock. Bristol-Myers Squibb Company BMY is a better-ranked stock in the health care sector, carrying a Zacks Rank #1 (Strong Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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