Amgen, AbbVie autoimmune news
Amgen filed two inter partes review (IPR) petitions with the U.S. Patent and Trademark Office challenging patents from AbbVie covering a formulation of Humira adalimumab. Amgen alleged that claims in U.S. Patents Nos. 8,916,157 and 8,916,158 are unpatentable on the grounds of obviousness, since the prior art taught a person of skill how to create the Humira formulation. The patents were issued last year.
Amgen has said it hopes to launch ABP 501, a biosimilar of Humira, in 2017. In February, ABP 501 met the primary endpoint of equivalence to Humira in a Phase III trial to treat moderate to severe rheumatoid arthritis. Amgen said it plans to use trials of ABP 501 in RA and plaque psoriasis to support approval in Humira’s other indications, including Crohn’s disease, ankylosing spondylitis, psoriatic arthritis, ulcerative colitis and polyarticular juvenile idiopathic arthritis (see BioCentury, Feb. 9). ...