Fourth Ustekinumab Biosimilar, Otulfi, Approved in US
Sep 30, 2024 · The FDA has approved the fourth ustekinumab biosimilar, ustekinumab-aauz (Otulfi) from Formycon and Fresenius Kabi, referencing Stelara (Johnson & Johnson [J&J]). 1 The approval covers Crohn disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis. Ustekinumab is a human monoclonal antibody targeting IL-12 and IL-23.
FDA Approves Imuldosa, a Biosimilar to Stelara
Oct 11, 2024 · Stelara is one of the highest-grossing biologics in the US, generating $10.86 billion globally in 2023. Additionally, US sales for Stelara reached $6.4 billion in 2022, according to Johnson & Johnson's annual financial report.It’s also 1 of the first 10 medications selected by CMS for drug price negotiation, which will go into effect at the start of 2026.
FDA Approves Biosimilar Enzeevu for Eye Conditions
Aug 12, 2024 · Sandoz secured another approval, this time for an aflibercept biosimilar. 1 Enzeevu (aflibercept-abzv) is the fourth biosimilar referencing Eylea and is approved to treat neovascular age-related macular degeneration (nAMD) and was granted interchangeability, allowing it to be substituted in place of the reference product at the pharmacy level without provider permission.
FDA Approves First Eylea Biosimilars - Center for Biosimilars
May 20, 2024 · The FDA announced that it approved the first 2 biosimilars referencing Eylea (aflibercept) for the treatment of ophthalmic conditions, including neovascular age-related macular degeneration (AMD), macular edema, and diabetic retinopathy.. Biocon Biologics's Yesafili (aflibercept-jbvf) and Samsung Bioepis' Opuviz (aflibercept-yszy) are vascular endothelial growth factor (VEGF) inhibitors that ...
The Underlying Economics of Unbranded Biologics - Center for …
Feb 26, 2024 · Unbranded biologics primarily serve to uphold inflated list prices, typically prompted by loss of exclusivity, aiming to safeguard market share and counter biosimilar competition, although forthcoming legislative changes targeting high drug costs could lessen their significance moving forward.
FDA Approves First Stelara Biosimilar, Wezlana - Center for …
Nov 1, 2023 · The FDA approved Wezlana (ustekinumab-auub), making it the first approval for a biosimilar referencing blockbuster drug Stelara (ustekinumab). The agency also granted Wezlana an interchangeability designation.
FDA Approves Avzivi, the Fifth Biosimilar to Avastin
Dec 19, 2023 · The FDA has approved the fifth bevacizumab biosimilar, Bio-Thera Solutions’ Avzivi (bevacizumab-tnjn) for the treatment of several types of cancer.. Avzivi is a humanized monoclonal antibody that inhibits vascular endothelial growth factor and references Genentech’s Avastin (bevacizumab).
Samsung Bioepis' Eculizumab Biosimilar Approved in Europe
May 31, 2023 · Health Canada has approved Omlyclo, the first omalizumab biosimilar in Canada, for the treatment of chronic idiopathic urticaria, allergic asthma, and chronic rhinosinusitis with nasal polyps, based on a phase 3 study confirming its bioequivalence to the reference product.
United States - Center for Biosimilars
Dec 16, 2024 · This page was last updated December 16, 2024. About. Editorial
Despite Steep Discounts, Humira Biosimilars Are Priced More Than ...
Jul 17, 2023 · Throughout 2023, 9 FDA-approved adalimumab biosimilars are projected to enter the US market. As of the second week of July 2023, 8 had entered the market, beginning with Amgen’s Amjevita (adalimumab-atto) in January. Amjevita launched with a dual price strategy, where 2 versions of the drug would launch at 2 different prices (5% and 55% lower than the current price of Humira) to both entice ...