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Amgen's Biosimilar of Abbvie's Humira Gets FDA Approval

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Amgen, Inc. (AMGN - Free Report) today announced the approval of Amjevita (adalimumab-atto), a biosimilar version to AbbVie Inc.’s (ABBV - Free Report) rheumatoid arthritis (RA) drug Humira.

Amjevita has been approved for the same indications that Humira is being used for – including rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), adult Crohn’s disease (CD), ulcerative colitis (UC), plaque psoriasis (PsO) – all in specific patient populations. The U.S. sales of Humira were about $8.4 billion in 2015.

We remind investors that in July, the FDA’s Arthritis Advisory Committee voted in favor of an approval of Amjevita.

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

Amjevita is the first biosimilar version of Humira to be approved by the FDA as well as Amgen’s first biosimilar medicine to be approved.

Amgen is exploring the world of biosimilars and expects to launch five such new products between 2017 and 2019. The biosimilars opportunity represents annual revenues of more than $3 billion for Amgen. The company also has a partnership with Allergan, Inc. (AGN - Free Report) for the worldwide development and commercialization of oncology antibody biosimilar medicines.

Other than Amjevita, other candidates being developed include biosimilar versions of Roche’s Avastin (ABP 215), Herceptin (ABP 980; breast cancer) and Rituxan (ABP 798), Eli Lilly and Company’s (LLY - Free Report) Erbitux (ABP 494), and Johnson & Johnson/Merck’s Remicade (ABP 710).

Amgen has also tied up with Daiichi Sankyo for the commercialization of nine biosimilars in Japan, including biosimilars of Humira, Avastin and Herceptin.

The approval of Amjevita would be a huge boost for Amgen which itself is facing biosimilar threats for quite a few of its key drugs. Anemia drug Aranesp faces competition in Europe from biosimilars marketed by companies like Pfizer and Novartis. Biosimilars are also starting to have a negative impact on sales of its key products like Neupogen and Neulasta in the EU. In August this year, Novartis’ generic arm, Sandoz received FDA approval for a biosimilar version of Amgen’s blockbuster RA drug Enbrel.

Both Amgen and AbbVie are Zacks Rank #3 (Hold) stocks. You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.

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