Seven biosimilars to AbbVie’s Humira® (adalimumab): Coherus Biosciences’ Yusimry®, Organon and Samsung Bioepis’ Hadlima®, Sandoz’s Hyrimoz®, Celltrion’s Yuflyma®, Fresenius Kabi’s Idacio®, Biocon Biologics’ Hulio® and Boehringer Ingelheim’s Cyltezo® are now commercially available in the US.
Each became authorised for supply in the US in July 2023 following their respective settlements with AbbVie. Samsung Bioepis settled with AbbVie on 5 April 2018, Viatris settled on 17 July 2018 (Biocon Biologics acquired Viatris’ global biosimilars business in November 2022), Sandoz settled on 11 October 2018, Fresenius settled on 18 October 2018, Boehringer settled on 14 May 2019, and Coherus settled on 27 November 2019, and Celltrion obtained a licence from AbbVie on 27 April 2022.
AbbVie entered into other deals with biosimilar entrants enabling US market entry, including: Alvotech (market entry on 1 July 2023, which has been delayed by a recent CRL from the FDA), Momenta (market entry on 20 November 2023), and Pfizer (market entry on 20 November 2023).