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Amgen Seeks FDA Approval for First Biosimilar of Humira

Amgen Inc.AMGN announced the submission of a biologics license application (BLA) seeking FDA approval for ABP 501, a biosimilar version of AbbVie Inc.'s ABBV best-selling drug, Humira. The application is Amgen's first BLA submitted under the 351(k) biosimilar pathway. The company believes that it is the first to file a biosimilar application for Humira.

We note that Humira, an anti-TNF-α monoclonal antibody, is approved in many countries for the treatment of a wide range of inflammatory diseases. Humira delivered worldwide sales of $10.3 billion in the first nine months of 2015 and was one of the top-selling products in the U.S. in 2014.

Amgen currently has nine biosimilar candidates in its portfolio representing huge commercial opportunity - 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.

However, 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 September. Zarxio is the biosimilar version of Amgen's blockbuster drug, Neupogen. And it's not just Neupogen. Amgen is also likely to face biosimilar competition for a couple of key drugs in its portfolio - Neulasta and Enbrel. Sandoz announced that regulatory applications for the biosimilar versions of both Neulasta and Enbrel are currently under FDA review.

According to sources, the market for biosimilars can grow to $20 billion in 2020. Not surprisingly, competition in this space is intensifying with pharmaceutical and biotech companies racing to develop biosimilars.

Amgen is a Zacks Rank #3 (Hold) stock. A better-ranked stock in the health care sector is Baxalta Incorporated BXLT , carrying a Zacks Rank #1 (Strong Buy). The company is also exploring the world of biosimilars.

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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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