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 →
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 →
Amgen wins one, loses one in biosimilar battle
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FDA panel recommends Amgen biosimilar drug for approval
A Food and Drug Administration panel recommended an Amgen biosimilar drug for approval July 12, just days after it said the biosimilar performed like a drug it mimicked. ABP 501, 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 Read More →
FDA finds Amgen biosimilar replicates effects of Humira
The Food and Drug Administration said a new Amgen biosimilar replicates the effects of a competitor’s blockbuster drug July 8. ABP 501 replicates the effects of Humira, which is approved to treat nine conditions including rheumatoid arthritis, skin disorders and colon inflammation. The drug, made by Chicago-based competitor AbbVie, typically costs $20,000 per year for Read More →
Amgen suffers setback as patent office refuses to review competitor’s drug
The U.S. Patent and Trademark Office handed Amgen a potential setback Jan. 14 when it declined to review two patent expiration dates on a competitor’s drug. In June, Thousand Oaks-based biotech giant Amgen asked the agency to review two formulation patents for Humira, made by Chicago-based competitor AbbVie, arguing that the patents should not have Read More →
