November 24, 2023
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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 U.S. Food and Drug Administration and agreed on Oct. 28 to abide by the BPCIA notice requirement.

The two companies filed a proposed schedule for the patent infringement litigation that could go as long as 2019 with the Delaware District Court on Nov. 1.

The Thousand-Oaks based biotech company also announced approval by the FDA for its drug Enbrel, expanding its use to treat pediatric patients with chronic plaque psoriasis.

The approval came after the results of a Phase 3 study and makes the drug the first systemic therapy available to patients aged 4-17.

• Contact Marissa Nall at Bloomberg News contributed to this report.