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Amgen's (AMGN) Humira Biosimilar Receives Approval in EU

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Amgen, Inc. (AMGN - Free Report) announced that its biosimilar version of AbbVie Inc.’s (ABBV - Free Report) rheumatoid arthritis (RA) drug Humira has been approved by the European Commission (EC). The approval grants marketing rights in 28 member countries of the European Union (EU) under a unified label of Amgevita.

The biosimlar version of Humira was approved in the U.S. in September last year by the trade name of Amjevita. However, Amjevita is yet to be launched in the U.S.

Amgevita is approved for indications currently treated by Humira including RA, juvenile idiopathic arthritis (JIA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), adult Crohn’s disease (CD), ulcerative colitis (UC), and plaque psoriasis (PsO) in patients as monotherapy or in combination with methotrexate.

Humira is AbbVie’s bestselling drug. It generated $16 billion in sales in 2016 and contributed 63% of total revenue. Humira’s sales increased 16% year over year in 2016.

The shares of the company have risen 13.6% since the beginning of this year, outperforming the Zacks classified Medical - Biomedical and Genetics industry, which increased 6% in the same period.

The approval of Amgevita is based on positive analytical, pharmacokinetic and clinical data from two phase III studies comparing the safety and immunogenicity of Amgevita with Humira in patients with moderate-to-severe RA and moderate-to-severe plaque psoriasis. The studies met their primary endpoints.

The launch of Amgevita will face a barrier as the exclusivity of Humira expires in Oct 2018. The drug is already facing an infringement lawsuit in the U.S., where its exclusivity has expired in Dec 2016. However, AbbVie is looking for the patent’s extension till 2022.

Quite a few companies are working to bring Humira biosimilars to the market. In Jan 2017, Pfizer, Inc. (PFE - Free Report) announced that its Humira biosmilar has met primary endpoints in a comparative safety and efficacy study.

We note that Amgen’s portfolio consists of a total of nine biosimilar candidates, which includes ABP 215, a biosimilar version of Roche Holding AG’s (RHHBY - Free Report) Avastin, produced in collaboration with partner Allergan plc. (AGN - Free Report) . A Marketing Authorization Application (MAA) was submitted to the European Medicines Agency (EMA) in Dec 2016. Other biosimilar candidates under development include the biosimilar versions of Roche’s Rituxan, Eli Lilly’s Erbitux, and Johnson and Johnson/Merck’s Remicade. Amgen has also tied up with Daiichi Sankyo for the commercialization of nine biosimilars in Japan. The biosimilars opportunity represents annual revenues of more than $3 billion for Amgen.

Amgen itself is facing a threat from biosimilars for its key drugs like Aranesp, Neupogen and Neulastain in the EU. Novartis’ generic arm, Sandoz received FDA approval for the company’s blockbuster RA drug Enbrel in August last year.

Competition is already intensifying in the biosimilar market, which according to sources can grow to $20 billion by 2020. The number of pharmaceutical and biotech companies working on biosimilars is growing by the day.

Zacks Rank

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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