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

Amgen, Inc. AMGN currently announced a capitulation of Amjevita (adalimumab-atto), a biosimilar chronicle to AbbVie Inc.’s ABBV rheumatoid arthritis (RA) drug Humira.

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

We remind investors that in July, a FDA’s Arthritis Advisory Committee voted in preference of an capitulation of Amjevita.

The capitulation of Amjevita is formed on certain information from dual proviso III studies comparing a safety, efficiency and immunogenicity of Amjevita with Humira in patients with moderate-to-severe RA and moderate-to-severe board psoriasis. The studies met their primary endpoints.

Amjevita is a initial biosimilar chronicle of Humira to be authorized by a FDA as good as Amgen’s initial biosimilar medicine to be approved.

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Amgen is exploring a universe of biosimilars and expects to launch 5 such new products between 2017 and 2019. The biosimilars event represents annual revenues of some-more than $3 billion for Amgen. The association also has a partnership with Allergan, Inc. AGN for a worldwide growth and commercialization of oncology antibody biosimilar medicines.

Other than Amjevita, other possibilities being grown embody biosimilar versions of Roche’s Avastin (ABP 215), Herceptin (ABP 980; breast cancer) and Rituxan (ABP 798), Eli Lilly and Company’s LLY Erbitux (ABP 494), and Johnson Johnson/Merck’s Remicade (ABP 710).

Amgen has also tied adult with Daiichi Sankyo for a commercialization of 9 biosimilars in Japan, including biosimilars of Humira, Avastin and Herceptin.

The capitulation of Amjevita would be a outrageous boost for Amgen that itself is confronting biosimilar threats for utterly a few of a pivotal drugs. Anemia drug Aranesp faces foe in Europe from biosimilars marketed by companies like Pfizer and Novartis. Biosimilars are also starting to have a disastrous impact on sales of a pivotal products like Neupogen and Neulasta in a EU. In Aug this year, Novartis’ general arm, Sandoz perceived FDA capitulation for a biosimilar chronicle of Amgen’s blockbuster RA drug Enbrel.

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

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