AbbVie has filed a patent infringement lawsuit in the US seeking a court order blocking Amgen from marketing a biosimilar of Humira (adalimumab). In its litigation, AbbVie argues that Amgen's proposed biosimilar infringes at least 10 patents, adding that it reserves the right to assert up to 51 additional patents.
"In seeking to defend its copycat actions here, Amgen is speaking out of both sides of its mouth," AbbVie explained. The drugmaker added "when biosimilars attempt to knock off its biologic products, Amgen tells a different story," continuing "Amgen has repeatedly recognised how difficult it is to innovate methods of using, formulating, and manufacturing biologics."
Last month, an FDA advisory panel unanimously backed approval of Amgen's biosimilar of Humira, named ABP 501. "The FDA advisory committee's favourable vote last month was an exciting step toward recognising ABP 501 as an important treatment option for patients with inflammatory diseases," remarked Amgen spokeswoman Kelley Davenport, adding "we look forward to continuing to work with the FDA as they complete their review" of the submission.
Bloomberg Intelligence analyst Aude Gerspacher said that the case could prevent the launch of biosimilars of Humira if Amgen is awarded a court order. The analyst estimated that the case could last for two or three years, in addition to appeals.
In May, the US Patent and Trademark Office agreed to hear a challenge filed by Coherus BioSciences against a patent held by AbbVie for Humira. AbbVie CEO Richard Gonzales previously said that the drugmaker is prepared to take steps to prevent the launch of biosimilars of Humira until at least 2022.
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