On September 23, 2016, the FDA approved Amgen's application to market Amjevita (adalimumab-atto), a biosimilar to AbbVie's HUMIRA (adalimumab) fully human anti-TNF-α antibody. This marks the fourth biosimilar approved by the FDA pursuant to the BPCIA. Amgen submitted Biologics License Application ("BLA") 761024 on November 25, 2015 pursuant to subsection (k) of the BPCIA, which the FDA accepted on or around January 22, 2016. According to the FDA's press release, Amjevita is approved for the following indications in adult patients:
• moderately to severely active rheumatoid arthritis;
• active psoriatic arthritis;
• active ankylosing spondylitis (an arthritis that affects the spine);
• moderately to severely active Crohn's disease;
• moderately to severely active ulcerative colitis; and
• moderate to severe plaque psoriasis.
The biosimilar was also indicated for moderately to severely active polyarticular juvenile idiopathic arthritis in patients four years or older.
Notwithstanding the approval, it is unlikely that Amgen will begin marketing Amjevita anytime soon. As we previously reported, AbbVie filed suit against Amgen in the U.S. District Court for the District of Delaware on August 4, 2016, pursuant to the BPCIA and 35 U.S.C. § 271(e)(2)(C). In its Counterclaims and Answer, Amgen reported that it had certified to AbbVie that it would not begin commercial marketing of its biosimilar before at least one of the patents identified by AbbVie had expired on December 31, 2016. Moreover, Amgen stated several times in its court filing that it intends to fully comply with the 180-day Notice of Commercial Marketing provision of the BPCIA. This would necessarily delay the launch of Amjevita until at least March of 2017. Finally, even though the present litigation only encompasses 10 of the 61 patents identified by AbbVie and Amgen during the so-called patent dance, AbbVie suggested multiple times in its complaint that it would seek to enforce the remaining patents once it received commercial-marketing notice from Amgen. It would not be surprising if AbbVie also sought an injunction from the Court to prevent Amgen from launching before the patent issues have been resolved. We will continue to monitor the case a report any updates as warranted.
