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Amgen Wins Favorable CHMP Opinion for Humira Biosimilar

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Amgen Inc.AMGN announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion on the company's marketing authorization application (MAA) for ABP 501, a biosimilar version of AbbVie Inc.'s ABBV best-selling drug, Humira (adalimumab). This marks the first time that an adalimumab biosimilar has received a CHMP recommendation.

Amgen's share price movement shows that the stock has outperformed the Zacks classified Medical-Biomed/Genetics industry year to date. Specifically, the company gained 7.5%, while the industry increased 2.1%.

ABP 501 was approved in the U.S. in Sep 2016 under the brand name Amjevita. It is approved for all indications of Humira, including rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), psoriatic arthritis (PsA), ankylosing spondylitis(AS), Crohn's disease (CD) in adults, ulcerative colitis (UC), plaque psoriasis (PsO) - all in specific patient populations. Amjevita was the first biosimilar version of Humira approved by the FDA and Amgen's first approved biosimilar. However, Amjevita has not been launched yet due to the ongoing litigation with AbbVie.

The MAA submission for ABP 501 was supported by comprehensive analytical, pharmacokinetic and clinical data. The filing also includes results from two phase III studies on moderate-to-severe PsO and moderate-to-severe RA. Both the studies met the primary endpoint, demonstrating no clinically meaningful difference with Humira. Safety and immunogenicity of ABP 501 was also comparable to the reference product.

Currently, Amgen has nine biosimilar candidates in its portfolio, representing annual revenues of more than $3 billion. The company is working on developing biosimilar versions of drugs like Avastin, Herceptin, Remicade, Rituxan and Erbitux. Amgen has collaborated with Allergan plc AGN for the worldwide development and commercialization of four oncology antibody biosimilars.

However, Amgen 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. Sandoz received approval for a biosimilar version of Enbrel, Erelzi, in Aug 2016. However, Erelzi is yet to be launched in the U.S.

Since the biosimilar market is highly lucrative, competition is intensifying with numerous pharmaceutical and biotech companies eyeing to foray into the space.

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Amgen currently 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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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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