Earlier today, Fresenius Kabi announced that the U.S. Food and Drug Administration (FDA) approved IDACIO (adalimumab-aacf), a biosimilar referencing HUMIRA. IDACIO is approved for use in the treatment of chronic autoimmune diseases for all eligible indications of the reference product and, according to Fresenius, is expected to launch in the…
Alvotech announced yesterday the launch of HUKYNDRA, a high-concentration, low-volume, citrate-free biosimilar to HUMIRA (adalimumab), in Belgium, Bulgaria, Croatia, Czech Republic, Latvia, Romania, and Slovenia. Through a strategic partnership with STADA, Alvotech supplies HUKYNDRA (adalimumab) autoinjectors and pre-filled syringes with drug product and drug substance manufactured in its vertically integrated…
Last week, AbbVie held its third quarter 2022 earnings conference call, which included considerable discussion of forthcoming competition with biosimilars to HUMIRA (adalimumab) in 2023. Some highlights below: According to Rick Gonzalez, AbbVie Chairman and CEO, “[t]he current market dynamics do not change our long-term guidance for aesthetics and we…
On August 31, 2022, Biocon Biologics released a statement regarding three recent on-site FDA inspections of seven manufacturing facilities spanning two sites in Bengaluru, India and one site in Johor, Malaysia. The inspections took place between August 11 and August 30, 2022. The inspections were triggered by three preapproval inspections…
Last week Samsung Bioepis and Organon announced FDA approval of their citrate-free, high-concentration (100 mg/ml) HUMIRA biosimilar, HADLIMA (adalimumab-bwwd). HADLIMA was previously approved by FDA as a low concentration (50 mg/ml) formulation in July 2019. The low-concentration product has been available in various markets outside the United States, with over…
On August 2, 2022, Coherus BioSciences, Inc. announced that the FDA approved CIMERLI™ (ranibizumab-eqrn) as a biosimilar interchangeable with LUCENTIS® (ranibizumab injection) for all five indications, with 12 months of exclusivity. Retina indications for which CIMERL is interchangeable include Neovascular (wet) Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion…
Alvotech and Stada recently announced the launch of HUKYNDRA® to patients in certain European countries, including France, Germany, Finland, and Sweden. HUKYNDRA® is a biosimilar of HUMIRA® (adalimumab) developed by Alvotech and is authorized for the treatment of a range of inflammatory conditions including psoriasis, Crohn’s disease, and ulcerative colitis….
Celltrion recently announced that it will start selling Yuflyma, an adalimumab biosimilar, in the U.S. in July 2023. The announcement stems from Celltrion’s recently inked patent agreement with AbbVie which allows Celltrion to market a high-concentration formulation of the drug. As a company official stated, “By entering the U.S. market…
Alvotech Holdings S.A. (“Alvotech”) announced on February 28th that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics Licensing Application (BLA) for ATV02 (100 mg/mL) that includes new data supporting interchangeability between ATV02 and Humira. According to Alvotech’s press release, the data are from a…
Results of the PROPER study, an interim analysis assessing the safety and efficacy of switching from Abbvie’s Humira to Samsung Bioepsis’s biosimilar adalimumab product, SB5, were presented last week at the European Crohn’s and Colitis Organization’s annual meeting. SB5 received EU marketing authorization in August 2017. According to the presentation, the…