IL-23 receptor antagonist icotrokinra hit co-primary phase III endpoints in moderate to severe plaque psoriasis, positioning the oral peptide at the forefront of a multibillion-dollar franchise for partners Protagonist Therapeutics Inc. and Johnson & Johnson.
Although last year’s massive U.S. launch of Humira biosimilars captured headlines, the market adoption of those competitors has been nothing to write home about, even with discounts as low as 85% off the innovator price.
Although last year’s massive U.S. launch of Humira biosimilars captured headlines, the market adoption of those competitors has been nothing to write home about, even with discounts as low as 85% off the innovator price.
With the biggest biosimilar launch in the U.S. just days away, Humira’s (adalimumab) record-breaking ride is quickly slowing down, but the Abbvie Inc. mega-blockbuster immunology drug is nowhere near the end of its road. Meanwhile, the U.S. journey is just beginning for the eight adalimumab biosimilars that could come to market as early as July 1 through licensing agreements with Abbvie. Besides revving their engines against Humira, the new launches will be looking to overtake Amgen Inc.’s biosimilar, Amjevita, which got a five-month headstart in the U.S., thanks to the first-mover status Amgen earned for being the first to sign a licensing agreement with Abbvie.
For the first time since Congress opened the door to biosimilars in 2010, the FDA approved nearly as many biosimilars in 2019 as it did new biologics. As the first decade of biosimilars came to a close, the agency’s Center for Drug Evaluation and Research (CDER) approved 10 biosimilars referencing seven blockbuster biologics, bringing the total number of approved biosimilars to 26.