Tagged as: Humira

Amgen Launches AMJEVITA—First Biosimilar to HUMIRA in the United States

Amgen announced today the launch of AMJEVITA (adalimumab-atto), a biosimilar to AbbVie’s HUMIRA (adalimumab), in the United States.  AMJEVITA was the first HUMIRA biosimilar approved by the FDA and is now the first to be launched in the United States. AMJEVITA is approved to treat seven inflammatory diseases, including moderate-to-severe rheumatoid arthritis in adults,…

Read More

Alvotech and Bioventure Announce Approval of ADALIMUMAB Biosimilar in Saudi Arabia

On January 24, Alvotech and Bioventure, a subsidiary of GlobalOne Healthcare Holding LLC, announced that the Saudi Food & Drug Authority has approved SIMLANDI, a biosimilar referencing HUMIRA (adalimumab), in Saudi Arabia. According to the press release, Bioventure is Alvotech’s exclusive strategic partner for the commercialization of SIMLANDI in the…

Read More

Samsung Bioepis Announces Approval of Citrate-Free, High-Concentration Adalimumab Biosimilar in Canada

On January 3, 2023, Samsung Bioepis announced that Health Canada has approved their citrate-free, high concentration (40 mg/0.4 mL) HUMIRA biosimilar, HADLIMA (also known as SB5). HADLIMA is indicated for the treatment of rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis, ankylosing spondylitis (AS), psoriatic arthritis, adult Crohn’s disease, ulcerative colitis,…

Read More

Fresenius Kabi Announces FDA Approval of Adalimumab Biosimilar

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…

Read More

Alvotech Broadens Access to HUMIRA (adalimumab) Biosimilars

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…

Read More

AbbVie’s Q322 Earnings Call Highlights Oncoming Adalimumab Biosimilar Competition

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…

Read More

Biocon and Alvotech Release Statements on FDA Inspections

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…

Read More

Samsung Bioepis and Organon Announce FDA Approval of Citrate-Free, High-Concentration Adalimumab Biosimilar

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…

Read More

Coherus Announces FDA Approval of CIMERLI (ranibizumab-eqrn)

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…

Read More