Center for Biosimilars®
WEBMarket remonopolization by a biosimilar drug in Poland led to significant price increases for etanercept, resulting in over €3.42 million in excess health care costs, according to a recent study. Sandoz Reports 29% Growth in Biosimilar Revenues for First Half of 2024. By Skylar Jeremias. August 27th 2024.
FDA Approves Semglee Insulin Glargine as First Interchangeable …
WEBJul 29, 2021 · The FDA has approved Biocon Biologic's Semglee insulin glargine as an interchangeable biosimilar, referencing Lantus. The approval carries with it many hopes for stronger competition in the insulin market, which is dominated by a handful of brands and characterized by stubbornly high prices. The approval of Semglee was much anticipated; it …
FDA Approves Amgen's Trastuzumab Biosimilar, Kanjinti
WEBJun 13, 2019 · The FDA has approved Amgen’s ABP 980, a trastuzumab biosimilar referencing Herceptin. The drug, trastuzumab-anns, will be sold as Kanjinti. Kanjinti was approved for the treatment of HER2-positive breast cancer and gastric cancer.. The news of the approval comes just a week after the 2019 American Society of Clinical Oncology Annual Meeting, where researchers reported new safety data from ...
FDA Approves High-Concentration Formulation of Samsung …
WEBAug 17, 2022 · Hadlima, 1 of 7 FDA-approved biosimilars referencing Humira (adalimumab), now will be offered in a high-concentration, citrate-free (100 mg/mL) version, as the FDA had granted the new formulation regulatory approval. The low-concentration (50 mg/mL) formulation of Hadlima (adalimumab-bwwd) was originally approved in …
Ophthalmology - Center for Biosimilars
WEBOct 19, 2019 · Skylar Jeremias. May 20th 2024. The FDA approved the first 2 biosimilars referencing Eylea (aflibercept)—Yesafili (aflibercept-jbvf) and Opuviz (aflibercept-yszy)—for the treatment of ophthalmic conditions. Coherus Biosciences Cites Biosimilars as Main Drivers of 2023 Revenue Growth.
Kashiv, Amneal Receive First FDA Approval for Their Filgrastim …
WEBMar 3, 2022 · Releuko, a filgrastim biosimilar developed by Kashiv Biosciences and Amneal Pharmaceuticals, has received FDA approval, the first of 2022. The FDA has approved Releuko (filgrastim-ayow), a filgrastim biosimilar referencing Neupogen developed by Amneal Pharmaceuticals and Kashiv Biosciences. The biosimilar marks the …
FDA Approves Pfizer's Rituximab Biosimilar, Ruxience
WEBJul 23, 2019 · This article has been updated. The FDA has approved Pfizer’s rituximab biosimilar, Ruxience (rituximab-pvvr), referencing Rituxan. The biosimilar was approved to treat non-Hodgkin lymphoma, chronic lymphocytic leukemia, and granulomatosis with polyangiitis and microscopic polyangiitis. The fact that …
FDA Approves Autoinjector Version of Neulasta Biosimilar
WEBMar 6, 2023 · The original version of Udenyca was approved in November 2018 and launched on the US market in January 2019. It is 1 of 6 FDA-approved biosimilars referencing Amgen’s Neulasta. In addition to the 2 FDA-approved presentations for the biosimilar, another application for an on-body injector version is under review.
Part 1: Biosimilars to Bring a Bumper Crop of Adalimumab Options
WEBSep 6, 2022 · Readers can also check out part 2, part 3, part 4, podcast 1, and podcast 2 now.. For most of the decade, AbbVie’s Humira (adalimumab) has been the most profitable drug in the world. It took a global pandemic to knock the injectable biologic for inflammatory diseases into second place in 2021, but it still reached $20.7 billion in sales, topped only by Pfizer’s vaccine for COVID-19.
Biocon, Mylan Launch Semglee and Seek Biosimilar, …
WEBAug 31, 2020 · Biocon Biologics and Mylan said they have launched the long-acting insulin glargine product Semglee on the US market and hope to obtain formal biosimilar status for it. Semglee was approved in June as an equivalent to Sanofi’s Lantus insulin glargine, but not as a biosimilar, owing to the regulatory pathway taken.