Tag: HUMIRA

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Fall Brings a Flurry of Biosimilar Approvals: FDA Approves Biosimilars of Enbrel® and Humira®
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Extension of Term for Australian Patents Relating to AbbVie’s Blockbuster Drug HUMIRA Denied

Fall Brings a Flurry of Biosimilar Approvals: FDA Approves Biosimilars of Enbrel® and Humira®

The United States biosimilars market is beginning to grow, with two recent approvals for biosimilars: Erelzi® and Amjevita®.

On August 30, 2016, the Food & Drug Administration (“FDA”) approved Sandoz’s application for a biosimilar of Enbrel®.  The product is called Erelzi and is the first biosimilar of etanercept to be approved by the FDA.  Like Enbrel, Erelzi is administered by injection and is approved to treat moderate to severe rheumatoid arthritis and moderate to severe plaque psoriasis, among other conditions.  Erelzi is approved as a biosimilar, not interchangeable, product. It is identified as etanercept-szzs.

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Extension of Term for Australian Patents Relating to AbbVie’s Blockbuster Drug HUMIRA Denied

In a recent decision the Australian Patent Office has rejected applications to extend the term of three patents related to the highly successful anti-inflammatory drug HUMIRA.

The patents are part of a family in which extensions of term had been granted in connection with earlier patents. These earlier extensions were based on the initial listing of HUMIRA on the Australian Register of Therapeutic Goods (ARTG) for the treatment of rheumatoid arthritis.

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