The FDA announced Friday that it approved Amgen's Amjevita (adalimumab-atto), also known as ABP 501, as a biosimilar to AbbVie's Humira (adalimumab) for multiple inflammatory diseases. The decision follows unanimous backing from an FDA advisory panel in July. Specifically, Amjevita was cleared for use in adults to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis and plaque psoriasis, as well as for polyarticular juvenile idiopathic arthritis in patients four years of age and older.
According to the FDA, its decision was based on a review of evidence that included structural and functional characterisation, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data "that demonstrates Amjevita is biosimilar to Humira." The agency pointed out that Amgen's product was "approved as a biosimilar, not as an interchangeable product." Amgen unveiled Phase III results last November showing that its therapy was clinically equivalent to Humira in the treatment of patients with moderate-to-severe rheumatoid arthritis. Clinical equivalence was also demonstrated in a separate late-stage study reported in 2014 involving patients with moderate-to-severe plaque psoriasis.
Commenting on the news, a spokesperson for AbbVie said "we anticipated Amgen's product would be approved," adding that "AbbVie and Amgen are currently in litigation over AbbVie's Humira-related intellectual property." The US lawsuit is seeking a court order blocking Amgen from marketing a biosimilar of Humira, which garnered $14 billion in sales last year. In its complaint, AbbVie argued that Amgen's proposed biosimilar infringes at least 10 patents, adding that it reserves the right to assert up to 51 additional patents. AbbVie CEO Richard Gonzalez has said that his company was prepared to take action to prevent the launch of a biosimilar of Humira until 2022. Meanwhile, the US Patent and Trademark Office agreed earlier this year to hear a challenge filed by Coherus BioSciences against a patent protecting Humira.
Regarding the FDA's Amjevita decision, Janet Woodcock, director of the agency's Center for Drug Evaluation and Research, remarked "this is the fourth FDA-approved biosimilar," adding "the biosimilar pathway is still a new frontier and one that we expect will enhance access to treatment for patients with serious medical conditions." Novartis' Zarxio (filgrastim-sndz), a biosimilar of Amgen's Neupogen (filgrastim) approved in March 2015, was the first biosimilar cleared in the US. Earlier this year, the agency approved Celltrion's Inflectra (infliximab-dyyb), a biosimilar version of Johnson & Johnson's and Merck & Co.'s Remicade (infliximab), followed by Novartis' Erelzi (etanercept-szzs) as a biosimilar version of Amgen's Enbrel (etanercept) last month.
Meanwhile, Amgen also submitted a marketing application for its proposed biosimilar of Humira to European regulators in December 2015.
For related analysis, see ViewPoints: How the FDA learned to stop worrying and love biosimilars and KOL Views: Is it a question of 'when' rather than 'if' there is a biosimilars explosion in the US market? For additional information on the biosimilar market, learn more at Biosimilar Index: Tracking the Biosimilar Development Landscape.
To read more Top Story articles, click here.