Europeans recommend approval of Amgen’s biosimilar of AbbVie’s Humira
The European Medicines Agency recommended the approval of the ABP 501, a biosimilar of AbbVie’s Humira (adalimumab), for treatment of inflammatory diseases, Thousand Oaks-based biotech company Amgen announced on Jan. 27. The EMA recommended ABP 501’s use for moderate-to-severe rheumatoid arthritis, psoriatic arthritis, severe ankylosing spondylitis, severe axial spondyloarthritis without radiographic evidence of AS, moderate-to-severe Read More →
Amgen’s Humira biosimilar delayed, Enbrel approved
Amgen’s Humira biosimilar Amjevita will be delayed at least through 2017 due to litigation by competitor AbbVie. The maker of Humira filed a patent infringement claim against Amgen on Aug. 4, alleging that the drug also violates the Biosimilar Price Competition and Innovation Act. Amgen was approved to market its biosimilar Sept. 23 by the Read More →
Amgen beats analysts’ revenue, earnings per share estimates
Amgen revenues increased 2 percent during the third quarter as it beat analysts’ revenue and earnings per share estimates thanks to cost-cutting measures and lower research measures. Revenues for the Thousand Oaks-based biotech giant increased from $5.72 billion during the third quarter of 2015 to $5.81 billion in 2016, which beat analyst estimates of $5.73 Read More →
FDA gives big win to Amgen in biosimilars race
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FDA approves Amgen biosimilar of AbbVie’s Humira
The Food and Drug Administration approved Amgen’s Humira biosimilar Sept. 23. Amjevita, formerly known as ABP 501 and made by Thousand Oaks-biotech giant Amgen, replicates the effects of Humira, which is approved to treat nine conditions including rheumatoid arthritis, skin disorders and colon inflammation. Humira, made by Chicago-based competitor AbbVie, typically costs $20,000 per year Read More →
FDA approves biosimilar of Amgen’s Enbrel
The U.S. Food and Drug Administration formally approved a competing biosimilar of Amgen’s top-selling drug Enbrel on Aug. 30. Made by Switzerland-based Novartis, Erelzi mimics the effects of Enbrel. Enbrel, which was first approved in 1998, is approved to treat rheumatoid arthritis and other conditions by decreasing the amount of a protein produced by the Read More →
Abbvie sues Amgen to block sales of Humira biosimilar
Thousand Oaks-based biotech giant Amgen faces a lawsuit seeking to block it from selling a biosimilar of AbbVie’s popular Humira. The rheumatoid arthritis medicine is Abbvie’s best seller. Sales were up 17 percent in the second quarter to $4.15 billion and accounted for 61 percent of AbbVie’s 2015 revenue. Abbvie claims Amgen’s proposed copy would Read More →
